REMS: FDA approved a REMS for mycophenolate due to the risk of embryo-fetal toxicity. The REMS consists of the following: elements to assure safe use. See the FDA REMS website for specific information ([Web]). |
Mycophenolate mofetil and mycophenolate sodium are immunosuppressive agents.1, 27, 600 Mycophenolate mofetil is hydrolyzed in vivo to mycophenolic acid, the pharmacologically active metabolite.1, 600 Mycophenolate sodium delayed-release tablets release the active moiety, mycophenolic acid, in the intestine.27
Mycophenolate mofetil (CellCept®, Myhibbin®) is used in conjunction with other immunosuppressants for the prevention of rejection of kidney, heart, or liver allografts in adult and pediatric patients ≥3 months of age.1, 600
Mycophenolate sodium (Myfortic®) is used in conjunction with cyclosporine and corticosteroid therapy for the prevention of rejection of kidney allografts in adults and in pediatric patients ≥5 years of age who are at least 6 months post kidney transplant.27
Mycophenolate mofetil is used for the prevention of rejection of renal allografts in adults and pediatric patients ≥3 months of age.1, 600 Efficacy of mycophenolate mofetil for this use was principally established based on findings from 3 randomized, double-blind trials in adults and an open-label multicenter study in pediatric patients.1, 3, 4, 5, 600 In clinical trials in renal transplant patients, a regimen consisting of mycophenolate mofetil, cyclosporine, and corticosteroids was more effective than regimens consisting of either azathioprine or placebo in combination with cyclosporine and corticosteroids in preventing acute rejection, graft loss, or patient death at 6 months following transplantation.1, 600
Mycophenolate sodium is used for the prevention of rejection of renal allographs in adults and in pediatric patients ≥5 years of age who are at least 6 months post kidney transplant.27 Efficacy of mycophenolate sodium for this use was principally established based on findings from 2 randomized, double-blind, comparative trials.27, 30, 31 In clinical trials in de novo or stable renal transplant patients, a regimen consisting of mycophenolate sodium, cyclosporine, and/or corticosteroids was as effective as a regimen consisting of mycophenolate mofetil, cyclosporine, and corticosteroids in preventing acute rejection, graft loss, or death.27, 28, 31
Efficacy and safety of mycophenolate mofetil were evaluated in 3 randomized, double-blind, multicenter trials in adults undergoing cadaveric renal transplantation.1, 3, 4, 5, 600 In each trial, mycophenolate mofetil was given in 2 different dosages (1 or 1.5 g twice daily) in immunosuppressive regimens that included cyclosporine, corticosteroids, and (in one study) antithymocyte globulin.1, 3, 4, 5, 600 Mycophenolate mofetil was compared with azathioprine (1-2 mg/kg daily or 100-150 mg daily) in 2 studies and with placebo in a third study; patients receiving azathioprine or placebo in these studies also received cyclosporine and corticosteroids. 1, 3, 4, 5, 600 In these trials, the primary efficacy end point was the rate of treatment failure, defined as the first occurrence of an acute episode of biopsy-proven acute rejection, patient death, graft loss, or early termination of the study for any reason without a prior biopsy-proven acute rejection episode, in the first 6 months after transplantation.1, 3, 4, 600 Results of these studies indicate that mycophenolate mofetil was more effective than azathioprine or placebo in reducing the incidence of treatment failure at 6 months following transplantation.1 When mycophenolate mofetil was compared with azathioprine, the treatment failure rates at 6 months for mycophenolate mofetil 2 g/day, mycophenolate mofetil 3 g/day, azathioprine (1-2 mg/kg daily), and azathioprine (100-150 mg daily) were 31.1-38.2, 31.3-34.8, 47.6, and 50%, respectively.1, 3, 4, 5, 600 When mycophenolate mofetil was compared with placebo, treatment failure rates at 6 months for mycophenolate mofetil 2 g/day, mycophenolate mofetil 3 g/day, and placebo were 30.3, 38.8, and 56%, respectively.1, 600 The cumulative incidence of combined 1-year graft loss or patient death for mycophenolate mofetil 2 g/day, mycophenolate mofetil 3 g/day, and control (placebo or azathioprine) were 8.5-11.7%, 10-11.5, and 11.5-13.6%, respectively.1, 600
Safety and efficacy of mycophenolate sodium delayed-release tablets were evaluated in 2 multicenter, randomized, double-blind, comparative trials.27, 28, 30, 31 In one 12-month study, 423 de novo renal transplant patients (18-75 years of age) who were receiving their first cadaveric (84%), living-unrelated, or human leukocyte antigen (HLA)-mismatched living-related donor kidney transplant, were randomized to receive (within 24-48 hours of transplantation) mycophenolate sodium (mycophenolic acid 720 mg twice daily) or mycophenolate mofetil (1 g twice daily) in conjunction with cyclosporine and corticosteroids.27, 31 Patients undergoing transplantation at centers that routinely used induction therapy with antithymocyte or antilymphocyte antibody preparations (about 41%) were allowed to receive such therapy.27, 31 The primary efficacy end point was the rate of treatment failure, defined as the first occurrence of acute rejection episode (biopsy-proven), graft loss, patient death, or loss to follow-up, in the first 6 months after transplantation.27, 31 Mycophenolate sodium was as effective as mycophenolate mofetil in reducing the incidence of treatment failure rates at 6 and 12 months following transplantation.27, 31 The treatment failure rates at 6 months for mycophenolate sodium and mycophenolate mofetil in this study were 25.8 and 26.2%, respectively, while at 12 months, treatment failure rates were 28.6 and 28.1%, respectively.27, 31
In the other 12-month study, maintenance therapy with mycophenolate sodium delayed-release tablets was evaluated in 322 renal transplant patients (18-75 years of age) who had undergone primary or secondary cadaveric or living donor kidney transplantation, were at least 6 months posttransplant, and were receiving immunosuppressive regimens that included mycophenolate mofetil and cyclosporine, with or without corticosteroids, for at least 2 weeks before study entry.27, 30 Patients were randomized to continue mycophenolate mofetil (1 g twice daily) or to switch to mycophenolate sodium (mycophenolic acid 720 mg twice daily).27, 30 The incidence of treatment failure (defined as the first occurrence of acute rejection episode [biopsy-proven], graft loss, patient death, or loss to follow-up) at 6 and 12 months in patients receiving mycophenolate sodium was similar to that in patients receiving mycophenolate mofetil.27, 30 The treatment failure rates at 6 months for mycophenolate sodium and mycophenolate mofetil in this study were 4.4 and 6.7%, respectively, while at 12 months, treatment failure rates were 7.5 and 12.3%, respectively.27, 30 Results of this and other studies indicate that mycophenolate sodium can be substituted for mycophenolate mofetil without loss of efficacy.27, 29, 30
Mycophenolate mofetil therapy has been associated with a high incidence of adverse GI effects and a high proportion of patients receiving the drug required dosage reductions, interruptions in therapy, or discontinuance of the immunosuppressant due to adverse effects.28, 29, 30, 31 Such changes in drug therapy have a negative impact on transplant outcomes (higher incidence of acute rejection, decreased graft survival).28, 29, 30, 31 Mycophenolate sodium delayed-release tablets were designed to improve GI tolerance by delaying release of mycophenolic acid until the drug reaches the small intestine. 28, 29 However, results of comparative clinical studies have shown that incidence of adverse GI effects reported in patients receiving mycophenolate sodium have been similar to those in patients receiving mycophenolate mofetil.28, 30, 31
In an open-label multicenter study in pediatric patients 3 months to 18 years of age who underwent cadaveric renal transplantation, mycophenolate mofetil was administered by oral suspension in a dosage of 600 mg/m2 twice daily (maximum daily dosage 1 g twice daily) in conjunction with cyclosporine and corticosteroids. 1, 600 In this study, the overall biopsy-proven rejection rate at 6 months was comparable to that reported in adults. 1, 600 In addition, the rate of biopsy-proven rejection was similar across the various age groups (i.e., 3 months to younger than 6 years of age, 6 years to younger than 12 years of a 12-18 years of age).1, 600 At 12 months, the combined incidence of graft loss (5%) and patient death (2%) in children was similar to that observed in adults.1, 600
Safety and efficacy of mycophenolate sodium have been established in stable renal transplant pediatric patients 5-16 years of age who were initiated on the drug at least 6 months posttranplant.27 Use of mycophenolate sodium in this age group is supported by evidence from adequate and well controlled studies in a similar adult renal transplant population and additional pharmacokinetic data in renal transplant pediatric patients.27 Safety and efficacy of mycophenolate sodium in pediatric de novo renal transplant patients have not been established .27
The Kidney Disease: Improving Global Outcomes (KDIGO) Transplant Work Group published guidelines for the care of kidney transplant recipients in 2009.900 The working group generally recommends first-line use of tacrolimus with mycophenolate for maintenance immunosuppression following induction.900 Although mycophenolate mofetil is the preferred antimetabolite, enteric-coated mycophenolate sodium can also be used.900 Evidence suggests that mycophenolate improves long-term graft survival compared to azathioprine.900
A consensus guideline on maintenance immunosuppression in solid organ transplant recipients was published in 2022 by the American College of Clinical Pharmacy (ACCP), American Society of Transplantation (AST), and International Society for Heart and Lung Transplantation (ISHLT).1000 The guideline generally recommends mycophenolic acid over azathioprine for the prevention of acute rejection in kidney transplant.1000 Kidney transplant recipients with GI side effects may benefit from conversion of mycophenolate mofetil to enteric-coated mycophenolate sodium, which is a safe and effective alternative to mycophenolate mofetil.1000 In patients who are intolerant to mycophenolic acid products (e.g., those with GI toxicity), azathioprine may be used in place of mycophenolic acid.1000
Mycophenolate mofetil is used for the prevention of rejection of cardiac allografts in adults and pediatric patients ≥3 months of age.1, 600 This indication for mycophenolate mofetil is based on the results of a double-blind, randomized, multicenter active-controlled trial in adults undergoing their first cardiac transplantation.1, 7, 600
Mycophenolate sodium has also been used for the prevention of heart transplant rejection† .650, 651
Efficacy and safety of mycophenolate mofetil have been evaluated in a double-blind, randomized, multicenter active-controlled trial that enrolled 650 adults (578 of whom received at least one dose of either study drug) undergoing their first cardiac transplantation.1, 7, 600 Patients were randomized to receive oral mycophenolate mofetil (1.5 g twice daily) or oral azathioprine (1.5-3 mg/kg daily) in immunosuppressive regimens that included cyclosporine and corticosteroids.1, 7, 600 In this study, there were 2 primary efficacy end points; the first one was defined as the proportion of patients who had at least one endomyocardial biopsy-proven rejection with hemodynamic compromise after transplantation, underwent retransplantation, or died within the first 6 months, while the second primary efficacy end point was defined as the proportion of patients who died or underwent retransplantation during the first 12 months after the original transplantation.1, 600 At 6 months, the incidence of biopsy-proven rejection accompanied by hemodynamic compromise in patients receiving mycophenolate mofetil (35%) was similar to that seen in patients receiving azathioprine (32%).1, 600 At 12 months, mycophenolate mofetil was at least as effective as azathioprine in preventing death or retransplantation (6.2 vs 11.4%, respectively).1, 600
Safety and efficacy of mycophenolate mofetil in pediatric cardiac transplant patients are supported by evidence from adequate and well-controlled studies and pharmacokinetic data in the adult cardiac transplant population.1, 600
According to the 2022 ACCP/AST/ISHLT consensus guideline for maintenance immunosuppression in solid organ transplant recipients, mycophenolic acid has shown better patient and allograft survival compared to azathioprine with a lower incidence and severity of acute rejection in cardiac transplant.1000 Mycophenolate sodium is a safe and effective alternative to mycophenolate mofetil in this population, particularly in those with GI side effects.1000 In patients who are intolerant to mycophenolic acid products (e.g., those with GI toxicity), azathioprine may be used in place of mycophenolic acid.1000
Mycophenolate mofetil is used for the prevention of rejection of hepatic allografts in adults and pediatric patients ≥3 months of age.1, 600 This indication for mycophenolate mofetil is based on the results of one double-blind, randomized, active-controlled, multicenter trial that enrolled 565 adults undergoing primary hepatic allotransplantation.1, 9, 600
Mycophenolate sodium has also been used for the prevention of liver transplant rejection†.652, 653, 654, 655, 656
Efficacy and safety of mycophenolate mofetil in patients undergoing hepatic allotransplantation are based on the results of a double-blind, randomized, active-controlled, multicenter trial.1, 9, 600 A total of 565 adults were randomized to receive mycophenolate mofetil (1 g IV twice daily for up to 14 days, followed by 1.5 g given orally twice daily) or azathioprine (1-2 mg/kg IV daily followed by the same dosage orally) in immunosuppressive regimens that included cyclosporine and corticosteroids.1, 9, 600 In this study, there were 2 primary efficacy end points; the first was defined as the proportion of patients who had one or more biopsy-proven and treated rejection, who underwent retransplantation, or who died, while the second primary efficacy point was defined as the proportion of patients who experienced graft loss (by death or undergoing retransplantation) during the first 12 months after the primary transplantation.1, 600 At 6 months, the incidence of one or more episodes of biopsy-proven and treated rejection, retransplantation, or death was 38.5 or 47.7% in those receiving mycophenolate mofetil or azathioprine, respectively.1, 9, 600 At 12 months, mycophenolate mofetil and azathioprine were similarly effective in preventing retransplantation or death.1, 9, 600
Safety and efficacy of mycophenolate mofetil in pediatric hepatic transplant patients are supported by evidence from adequate and well-controlled studies and pharmacokinetic data in the adult hepatic transplant population.1, 600
According to the 2022 ACCP/AST/ISHLT consensus guideline for maintenance immunosuppression in solid organ transplant recipients, mycophenolate is more effective than azathioprine in reducing acute rejection post liver transplant at 12 months.1000 Liver transplant recipients with GI side effects may benefit from conversion of mycophenolate mofetil to enteric-coated mycophenolate sodium, which is a safe and effective alternative to mycophenolate mofetil.1000
Mycophenolate mofetil has been used in combination with corticosteroids in the treatment of autoimmune hepatitis† .657, 658
The American Association for the Study of Liver Diseases practice guidelines for the diagnosis and management of autoimmune hepatitis recommends mycophenolate mofetil as a second-line treatment option in adults and children with autoimmune hepatitis who do not respond to first-line therapy.996
Antineutrophil Cytoplasmic Antibody-Associated Vasculitis
Mycophenolate mofetil is used in the management of antineutrophil cytoplasmic antibody-associated vasculitis, including granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), and eosinophilic granulomatosis with polyangiitis (EGPA) † .659, 660, 997
Based on the American College of Rheumatology (ACR)/Vasculitis Foundation guideline for the management of antineutrophil cytoplasmic antibody-associated vasculitis, mycophenolate mofetil may be used as an alternative therapy for remission induction in active, nonsevere GPA.997 Mycophenolate mofetil may be used as alternative therapy for maintenance of remission in patients with GPA/MPA who are unable to take other preferred therapies.997 In the management of EGPA, mycophenolate mofetil may be used in remission induction therapy in patients with active nonsevere disease, and also as an alternative agent for remission maintenance in patients with severe EGPA.997
Mycophenolate mofetil is used in the prevention of graft-vs-host disease (GVHD)† and the treatment of chronic GVHD†.661, 662, 663, 998, 999
Consensus recommendations from the European Society for Blood and Marrow Transplantation recommend mycophenolate mofetil for GVHD prophylaxis for allogeneic hematopoietic cell transplant recipients receiving nonmyeloablative conditioning and dose-reduced conditioning; mycophenolate mofetil is also recommended as an alternative antimetabolite to methotrexate for patients receiving myeloablative conditioning.998 According to the American Society for Blood and Marrow Transplant consensus conference on clinical practice in chronic GVHD, mycophenolate mofetil is a second-line treatment option for chronic GVHD.999
Immune Checkpoint Inhibitor Therapy-Associated Toxicities
Mycophenolate mofetil is used in the management of toxicities associated with immune checkpoint inhibitor therapy†.1001, 1002 According to the American Society of Clinical Oncology guideline for the management of immune-related adverse events in patients treated with immune checkpoint inhibitor therapy, mycophenolate mofetil may be used for the management of steroid-refractory hepatitis, nephritis, pneumonitis, myocarditis, myositis, and hematologic immune-related toxicities.1001 The Society for Immunotherapy of Cancer practice guideline on immune checkpoint inhibitor-related adverse events also similarly recommends mycophenolate mofetil for management of toxicities including steroid-refractory hepatitis, pneumonitis, myocarditis, myositis, and nephritis.1002
Intestinal Allotransplantation
Mycophenolate has been used for the prevention of rejection of intestinal allografts† .669, 1000
The 2022 ACCP/AST/ISHLT consensus guideline for maintenance immunosuppression in solid organ transplant recipients provides recommendations on the use of mycophenolic acid in intestinal transplant.1000 The guideline states that, although no studies have directly compared mycophenolic acid to azathioprine, mycophenolic acid has been adopted as a standard component of early maintenance immunosuppression in this population in lieu of azathioprine.1000 In patients who are intolerant to mycophenolic acid products (e.g., those with GI toxicity), azathioprine may be used in place of mycophenolic acid.1000
Mycophenolate mofetil and mycophenolate sodium have been used for the prevention of rejection of lung allografts† in patients who have undergone lung transplantation.500, 501, 502, 503, 504, 505, 506, 507, 508, 509 Following lung transplantation, acute allograft rejection and chronic lung allograft dysfunction, including bronchiolitis obliterans syndrome (BOS), are major complications affecting long-term graft and patient survival.500 501, 504, 507, 508, 509
The 2022 ACCP/AST/ISHLT consensus guideline for maintenance immunosuppression in solid organ transplant recipients provides recommendations on the use of mycophenolate mofetil and mycophenolate sodium in lung transplant.1000 The guideline states that while comparative data have variable results, some observational and cohort data have demonstrated less acute rejection with mycophenolic acid as compared to azathioprine and potential benefit in switching to mycophenolic acid in the setting of BOS.1000 Available data for mycophenolate sodium indicate that it can be utilized in combination with corticosteroids and a calcineurin inhibitor in lung transplant; however, there are no data directly comparing mycophenolate sodium and mycophenolate mofetil.1000 In patients who are intolerant to mycophenolic acid products (e.g., those with GI toxicity), azathioprine may be used in place of mycophenolic acid.1000
Mycophenolate mofetil and mycophenolate sodium are used for the treatment of lupus nephritis†.677, 678, 1003, 1004
The 2024 KDIGO guideline for the management of lupus nephritis recommends glucocorticoids plus mycophenolic acid analogs (mycophenolate mofetil or mycophenolate sodium) as one of the initial treatment options for patients with class III or IV disease with or without a membranous component.1003 After completion of initial therapy, patients with class III or IV disease should be placed on mycophenolic acid analogs for maintenance.1003
The ACR published an updated guideline for the screening, treatment, and management of lupus nephritis in 2024.1004 Based on the guideline, the preferred first-line treatment for patients with class III (focal) or class IV (diffuse) disease with or without class V (membranous) disease, or for pure class V disease, is a triple immunosuppressive regimen consisting of a glucocorticoid pulse/taper, a mycophenolic acid analog (mycophenolate mofetil or mycophenolate sodium), and a calcineurin inhibitor (or belimumab in patients with class III/IV disease).1004
Pancreatic Allotransplantation
Mycophenolate mofetil and mycophenolate sodium have been used for the prevention of rejection in pancreas transplant recipients† .664, 665, 666, 667, 668, 1000
According to the 2022 ACCP/AST/ISHLT consensus guideline for maintenance immunosuppression in solid organ transplant recipients, mycophenolate is more effective than azathioprine in reducing acute rejection post pancreas transplant at 12 months.1000 Pancreatic transplant recipients with GI side effects may benefit from conversion of mycophenolate mofetil to enteric-coated mycophenolate sodium, which is a safe and effective alternative to mycophenolate mofetil.1000 In patients who are intolerant to mycophenolic acid products (e.g., those with GI toxicity), azathioprine may be used in place of mycophenolic acid.1000 In patients who are intolerant to mycophenolic acid products (e.g., those with GI toxicity), azathioprine may be used in place of mycophenolic acid.1000
Mycophenolate mofetil and mycophenolate sodium have been used in the management of systemic sclerosis (often called scleroderma)† and systemic sclerosis-associated interstitial lung disease†.300, 301, 302, 303, 304, 305, 306, 307, 308, 310, 311, 312, 313, 314, 315, 316, 317, 318, 319, 320
According to the European Alliance of Associations for Rheumatology (EULAR) guideline for the treatment of systemic sclerosis, mycophenolate mofetil should be considered for the treatment of systemic sclerosis skin fibrosis as well as for the treatment of systemic sclerosis-associated interstitial lung disease.318 The American Thoracic Society guideline for the treatment of systemic sclerosis-associated interstitial lung disease also recommends mycophenolate for treatment of this condition.319
Mycophenolate mofetil has been used for the treatment of Takayasu arteritis† .679, 680, 1005
Based on the EULAR guideline for the management of large vessel vasculitis, mycophenolate mofetil is suggested as an alternative treatment option for Takayasu arteritis.1005 According to the ACR/Vasculitis Foundation guideline for the management of giant cell arteritis and Takayasu arteritis, a nonglucocorticoid immunosuppressive agent (e.g., mycophenolate mofetil) in combination with glucocorticoids is recommended over glucocorticoid monotherapy or tocilizumab for the treatment of active Takayasu arteritis.1006
Vascularized Composite Allotransplantation
Mycophenolate mofetil and mycophenolate sodium have been used for the prevention of vascular composite allograft rejection†.670, 671, 672, 673, 674, 675, 676 A vascularized composite allograft is the transplantation of multiple structures (e.g., skin, bone, muscles, blood vessels, nerves) as a functional, composite unit from donor to recipient.673 Regimens for prevention of rejection in vascularized composite allotransplantation are largely derived from solid organ transplantation.670 Mycophenolate has been used as part of maintenance immunosuppression regimens in patients after various transplants (e.g., face, hand).674, 675, 676
Dispensing and Administration Precautions
Mycophenolate mofetil is available as oral capsules, film-coated tablets, or powder for oral suspension, and as mycophenolate mofetil hydrochloride lyophilized powder for injection for IV infusion (CellCept®).1 Mycophenolate mofetil is also available as a ready-to-use oral suspension (Myhibbin®).600 Mycophenolate sodium is available as oral delayed-release (enteric-coated) tablets (Myfortic®).27
Do not use mycophenolate mofetil or mycophenolate sodium without the supervision of a clinician with experience in immunosuppressive therapy.1, 27, 600
Do not use mycophenolate mofetil oral dosage forms (capsules, tablets, or oral suspension) interchangeably with mycophenolic sodium delayed-release tablets without supervision of a clinician with experience in immunosuppressive therapy.1, 27, 600
Because of the teratogenic potential of the drug, mycophenolate oral and parenteral preparations should be handled and prepared with care.1
If a dose of mycophenolate mofetil is missed, the dose should be taken as soon as it is remembered unless it is closer than 2 hours to the next scheduled dose; in this case, continue to take mycophenolate mofetil at the usual times.1, 600
Oral mycophenolate mofetil should be administered as soon as possible following renal, cardiac, or hepatic transplantation.1, 600 The manufacturers recommend that mycophenolate mofetil tablets, capsules, and oral suspension be administered on an empty stomach; however, in stable renal transplant recipients, the drug may be given with food, if necessary.1, 600
Mycophenolate mofetil tablets: Do not crush mycophenolate mofetil film-coated tablets.1 Store the tablets at 25°C (excursions permitted to 15—30°C).1 Dispense in light-resistant containers (e.g., original container).1
Mycophenolate mofetil capsules: Do not open or crush mycophenolate mofetil capsules.1 Store the capsules at 25°C (excursions permitted to 15—30°C).1 Avoid inhalation of mycophenolate mofetil powder contained in the oral capsules and avoid contact with the skin or mucous membranes.1 In case of accidental skin or mucous membrane contact, wash the affected area thoroughly with soap and water.1 If contact with the eyes occurs, wash eyes with water.1
Mycophenolate sodium delayed-release tablets: Mycophenolate sodium may be administered as soon as possible following renal transplantation in adults.27 Mycophenolate sodium delayed-release tablets should not be crushed, chewed, or cut; the tablets should be swallowed whole in order to maintain the integrity of the enteric coating.27 Mycophenolate sodium delayed-release tablets are administered on an empty stomach, 1 hour before or 2 hours after food.27 Store the tablets at 20—25°C (excursions permitted to 15—30°C).27 Dispense the tablets in a tight container, and keep out of reach and sight of children.27 If for any reason the tablets must be crushed, avoid inhalation of the powder, or direct contact of the powder, with skin or mucous membranes.27
Mycophenolate mofetil oral suspension (CellCept®): The suspension should be reconstituted by a pharmacist prior to dispensing to the patient.1 Refer to the full prescribing information for a complete description of the steps for reconstitution.1 Do not mix the suspension with any other drugs.1 After reconstitution, the oral suspension contains 200 mg/mL of mycophenolate mofetil.1 Following reconstitution, write the date of expiration of the constituted suspension on the bottle label (the shelf-life of the constituted suspension is 60 days).1 Dispense the drug with the instructions for use and oral dispensers.1 Alert patients to read the important handling information described in the instructions for use.1 Store the dry powder and reconstituted suspension at 25°C (excursions permitted to 15—30°C).1 Storage of the reconstituted suspension in a refrigerator at 2—8°C is acceptable; do not freeze.1 Discard any unused portion 60 days after reconstitution.1
Use care to avoid inhalation or direct contact with skin or mucous membranes of the dry powder or the constituted suspension.1 Use of disposable gloves is recommended during reconstitution and when wiping the outer surface of the bottle/cap and the table surface after reconstitution.1 In case of accidental skin or mucous membrane contact, wash the affected area thoroughly with soap and water.1 If contact with the eyes occurs, wash eyes with water.1 Advise patients that they and others should also avoid inhalation or contact of the skin or mucous membranes with the oral suspension, and instruct the patients on steps to take if such contact (including ocular contact) occurs.1
Mycophenolate mofetil oral suspension (Myhibbin®): Store the oral suspension at 20—25°C (excursions permitted to 15—30°C); do not freeze.600 Follow applicable special handling and disposal procedures.600 Use of disposable gloves is recommended when wiping the outer surface of the bottle/cap.600 Avoid direct contact with skin or mucous membranes.600 In case of accidental skin or mucous membrane contact, wash the affected area thoroughly with soap and water.600 If contact with the eyes occurs, wash eyes with water.600 Do not use the suspension after 60 days of first opening the bottle.600 Do not mix the oral suspension with any liquids prior to administration.600
Mycophenolate mofetil oral suspension (CellCept®, not Myhibbin®): It is recommended that mycophenolate mofetil powder for oral suspension be reconstituted at the time of dispensing by adding 94 mL of water (about 47 mL initially followed by another 47 mL after vigorous shaking for 1 minute) to provide a suspension containing 200 mg/mL.1 The bottle should be shaken well again for 1 minute to suspend the powder.1
Once reconstituted, do not mix mycophenolate mofetil oral suspension with any liquids prior to administration.1
If needed, mycophenolate mofetil oral suspension can be administered by a nasogastric tube (minimum 1.7 mm in interior diameter; minimum French size number 8).1, 600
IV mycophenolate mofetil hydrochloride, which should be initiated within 24 hours following transplantation, generally is reserved for patients who cannot tolerate or are unable to take an oral dosage form.1 The drug can be administered IV for up to 14 days.1 Oral therapy should replace parenteral therapy as soon as possible.1
Prior to use, IV mycophenolate mofetil hydrochloride must be reconstituted and further diluted.1 Refer to the full prescribing information for the full steps for preparation.1 Strict aseptic technique must be observed since the drug contains no preservative.1 Discard unused portion of the reconstituted solutions.1
Store the powder and reconstituted infusion solution at 25°C (excursions permitted to 15°C to 30°C).1
The drug is incompatible with IV infusion solutions other than 5% dextrose and should not be mixed or administered concurrently via the same infusion catheter with other IV drugs or infusion admixtures.1
Mycophenolate mofetil hydrochloride powder for injection is reconstituted by adding 14 mL of 5% dextrose injection to a vial labeled as containing 500 mg of mycophenolate mofetil; the vial should be gently shaken.1
The reconstituted solution is slightly yellow.1
For a 1-g IV infusion dose, the contents of 2 reconstituted vials are diluted into 140 mL of 5% dextrose injection, while for a 1.5-g IV infusion dose, the contents of 3 reconstituted vials are diluted into 210 mL of 5% dextrose injection.1 The concentration of mycophenolate mofetil in the resulting solutions is 6 mg/mL.1
IV administration of mycophenolate mofetil hydrochloride should be started within 4 hours of reconstitution and dilution of the drug.1
Mycophenolate mofetil hydrochloride should be infused IV over a period of no less than 2 hours by either a peripheral or central vein; the drug should not be administered by rapid IV (“bolus”) injection or rapid IV infusion.1
Dosage of mycophenolate mofetil and mycophenolate mofetil hydrochloride are both expressed in terms of mycophenolate mofetil.1, 600 Dosage of mycophenolate sodium is expressed in terms of mycophenolic acid.27
Mycophenolate mofetil tablets, capsules, and oral suspension (CellCept®) reportedly are bioequivalent.1 Mycophenolate sodium delayed-release tablets should not be used interchangeably with mycophenolate mofetil tablets, capsules, or oral suspension without supervision of a clinician, because absorption of the drug from these preparations is not equivalent.27
For the prevention of renal allograft rejection in adults, the usual dosage of mycophenolate mofetil is 1 g administered IV (infused over no less than 2 hours) or orally, twice daily (2 g total daily dosage).1, 600
When mycophenolate sodium delayed-release tablets are used for the prevention of renal allograft rejection in adults, the usual dosage is 720 mg of mycophenolic acid twice daily (1440 mg total daily dosage).27
For the prevention of cardiac allograft rejection in adults, the usual dosage of mycophenolate mofetil is 1.5 g administered IV (infused over no less than 2 hours) or orally, twice daily (3 g total daily dosage).1, 600
For the prevention of hepatic allograft rejection in adults, the usual dosage of mycophenolate mofetil hydrochloride is 1 g administered IV (infused over no less than 2 hours) twice daily (2 g total daily dosage), or 1.5 g administered orally twice daily (3 g total daily dosage).1, 600
For the initial therapy of active class III (focal) or class IV (diffuse) lupus nephritis†, the recommended mycophenolate mofetil dosage is 1-1.5 g orally twice daily for at least 6 months, and the recommended dosage of mycophenolate sodium delayed-release tablets is 0.72-1.08 g twice daily for at least 6 months.1004 The mycophenolic acid analog is used in conjunction with glucocorticoids.1004
For the maintenance therapy of active class III (focal) or class IV (diffuse) lupus nephritis†, the recommended mycophenolate mofetil dosage is 1-2 g daily, and the recommended dosage of mycophenolate sodium delayed-release tablets is 720-1440 mg daily.1004 The dosage of mycophenolate mofetil in the early maintenance phase is approximately 750-1000 mg twice daily, and approximately 540-720 mg twice daily for mycophenolic acid (mycophenolate sodium).1004
Pediatric dosing of mycophenolate mofetil is based on body surface area.1, 600
Mycophenolate sodium should be administered as maintenance therapy only in stable pediatric renal transplant recipients; safety and efficacy of the drug in de novo pediatric renal transplant recipients have not been established.27
For the prevention of renal allograft rejection in pediatric patients ≥3 months of age, the usual dosage of mycophenolate mofetil (as the oral suspension) is 600 mg/m2 administered orally twice daily, up to a maximum total dosage of 2 g daily or 10 mL of the oral suspension.1, 600
Pediatric patients with body surface area ≥1.25 m2 may be dosed with mycophenolate mofetil capsules or tablets.1 Children with a body surface area of 1.25 to <1.5 m2 can receive 750 mg (as capsules) twice daily for a total daily mycophenolate mofetil dosage of 1.5 g, while children with a body surface area ≥1.5 m2 can receive a dosage of 1 g (as capsules or tablets) twice daily for a total daily mycophenolate mofetil dosage of 2 g.1
For the prevention of renal allograft rejection in pediatric patients ≥5 years of age who are at least 6 months post kidney transplant, the usual dosage of mycophenolic acid (administered as mycophenolate sodium delayed-release tablets) is 400 mg/m2 twice daily (up to a maximum of 720 mg twice daily).27 Pediatric patients with a body surface area of 1.19-1.58 m2 may receive a daily dosage of 1080 mg (administered as three 180-mg tablets or one 180-mg tablet and one 360-mg tablet twice daily).27 Pediatric patients with a body surface area greater than 1.58 m2 may receive a daily dosage of 1440 mg (administered as four 180-mg tablets or two 360-mg tablets twice daily).27 A mycophenolate sodium dosage form suitable for providing an appropriate dosage for pediatric patients with a body surface area less than 1.19 m2 is not commercially available in the US.27
For the prevention of cardiac allograft rejection in pediatric patients ≥3 months of age, the usual dosage of mycophenolate mofetil (as the oral suspension) is 600 mg/m2 administered orally twice daily.1, 600 If well tolerated, the dosage can be increased to a maintenance dosage of 900 mg/m2 twice daily, up to a maximum total daily dosage of 3 g or 15 mL of the oral suspension.1, 600 The dosage may be individualized based on clinical assessment.1, 600
Pediatric patients with body surface area ≥1.25 m2 may be dosed with mycophenolate mofetil capsules or tablets.1 Children with a body surface area of 1.25 m2 to <1.5 m2 can receive 750 mg (as capsules) twice daily as the starting dosage, for a total daily mycophenolate mofetil dosage of 1.5 g, while children with a body surface area ≥1.5 m2 can receive a starting dosage of 1 g (as capsules or tablets) twice daily for a total daily mycophenolate mofetil dosage of 2 g.1 The maximum maintenance dosage is 3 g total daily.1
For the prevention of hepatic allograft rejection in pediatric patients ≥3 months of age, the usual dosage of mycophenolate mofetil (as the oral suspension) is 600 mg/m2 administered orally twice daily.1, 600 If well tolerated, the dosage can be increased to a maintenance dosage of 900 mg/m2 twice daily, up to a maximum total daily dosage of 3 g or 15 mL of the oral suspension.1, 600 The dosage may be individualized based on clinical assessment.1, 600
Pediatric patients with body surface area ≥1.25 m2 may be dosed with mycophenolate mofetil capsules or tablets.1 Children with a body surface area of 1.25 to <1.5 m2 can receive 750 mg (as capsules) twice daily as the starting dosage for a total daily mycophenolate mofetil dosage of 1.5 g, while children with a body surface area ≥1.5 m2 can receive a starting dosage of 1 g (as capsules or tablets) twice daily for a total daily mycophenolate mofetil dosage of 2 g.1 The maximum maintenance dosage is 3 g total daily.1
Dosage Modification for Neutropenia
If neutropenia (absolute neutrophil count [ANC] of less than 1300/mm3) develops, mycophenolate therapy should be temporarily discontinued or the dosage reduced; suitable diagnostic tests should be performed, and appropriate patient management should be instituted.1, 27, 600
Dosage adjustment of mycophenolate mofetil preparations is not necessary in renal transplant recipients with severe hepatic parenchymal disease; however, it is not known whether dosage adjustment is needed in hepatic impairment of other etiologies.1, 600 No data are available for heart transplant patients with severe hepatic parenchymal disease.1, 600
The manufacturer makes no specific dosage recommendations for mycophenolic acid (administered as mycophenolate sodium delayed-release tablets) in patients with hepatic impairment.27
Dosage adjustment of mycophenolate mofetil preparations is not necessary in renal transplant recipients experiencing postoperative delayed graft function.1, 600
Mycophenolate mofetil dosages exceeding 1 g twice daily should be avoided in renal transplant recipients with severe chronic impairment of the graft (glomerular filtration rate less than 25 mL/minute per 1.73 m2); closely monitor these patients.1, 600
The manufacturer makes no specific dosage recommendations for mycophenolic acid (administered as mycophenolate sodium delayed-release tablets) in patients with renal impairment.27
The manufacturers make no specific dosage recommendations for mycophenolate mofetil or mycophenolic acid (administered as mycophenolate sodium delayed-release tablets) in geriatric patients.1, 27, 600
In general, dosage selection for geriatric patients should be cautious, taking into consideration the presence of decreased hepatic, renal, or cardiac function and of concomitant drug therapies.1, 27, 600
Fetal/Neonatal Morbidity and Mortality
The prescribing information for mycophenolate contains a boxed warning regarding embryofetal toxicity.1, 27, 600 Mycophenolate may cause fetal toxicity when administered to pregnant women.1, 27, 600 Use of mycophenolate has been associated with increased risk of first-trimester pregnancy loss and serious congenital malformations, especially external ear and other facial abnormalities (e.g., cleft lip and palate), and anomalies of the distal limbs, heart, esophagus, kidney and nervous system.1, 27, 600 Congenital malformations and pregnancy loss have been observed in animals receiving mycophenolate at doses less than the recommended human dose.1, 27, 600
Avoid use of mycophenolate during pregnancy if safer treatment options are available.1, 27, 600 Advise females of reproductive potential of the potential risks of fetal toxicity and counsel them regarding pregnancy prevention and planning.1, 27, 600 Perform a blood or urine pregnancy test (i.e., having a sensitivity of at least 25 mIU/mL for human chorionic gonadotropin [HCG]) immediately prior to beginning mycophenolate therapy, and repeat the pregnancy test with the same sensitivity 8—10 days later.1, 27, 600 Perform repeat pregnancy tests during routine follow-up visits, and discuss the results of all pregnancy tests with the patient.1, 27, 600 If a pregnancy test is positive, consider alternative immunosuppressants with less potential for embryofetal toxicity whenever possible.1, 27, 600
Counsel patients of reproductive potential regarding use of acceptable contraception; refer to the prescribing information for acceptable contraceptive methods.1, 27, 600 Advise patients to use acceptable forms of contraception throughout the entire therapy and for 6 weeks after discontinuance of mycophenolate, unless the patient commits to continuous abstinence.1, 27, 600 Advise patients that concomitant use of mycophenolate and certain oral hormonal contraceptives may result in decreased concentrations of the oral hormonal contraceptive.1, 27, 600 Sexually active male patients and/or their female partners are recommended to use effective contraception during treatment of the male patient and for ≥90 days after discontinuation of treatment.1, 27, 600 Male patients should not donate sperm during treatment with mycophenolate and for ≥90 days after cessation of treatment.1, 27, 600
Because of the risk of fetal/neonatal morbidity and mortality, mycophenolate products are available only through a Risk Evaluation and Mitigation Strategy (REMS) program.601
Management of Immunosuppression
The prescribing information for mycophenolate sodium contains a boxed warning regarding immunosuppression management.27 Mycophenolate sodium should be prescribed only by clinicians experienced in immunosuppressive therapy and the management of patients receiving these drugs.27 Patients receiving the drug should be managed in facilities equipped with adequate laboratory and supportive medical resources, and the clinician responsible for maintenance therapy should have complete information requisite for follow-up of the patients.27
Lymphoma and Other Malignancies
The prescribing information for mycophenolate contains a boxed warning regarding malignancy risk.1, 27, 600 There is potential for the development of lymphoma and other malignancies, particularly of the skin, as a result of use of immunosuppressants including mycophenolate.1, 27, 600 The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent.1, 600 Advise patients with increased risk of skin cancer to limit their exposure to sunlight or other ultraviolet light by wearing protective clothing and using broad-spectrum sunscreen with a high protection factor.1, 27, 600
Posttransplant lymphoproliferative disorder (PTLD) occurred in 0.4-1% of kidney, heart, and liver allograft recipients receiving mycophenolate mofetil in conjunction with other immunosuppressive agents in clinical studies.1, 600 Most cases of PTLD appear to be related to Epstein Barr Virus (EBV) infection.1, 27, 600 The risk of PTLD appears greatest in individuals who are EBV seronegative, a population which includes many small children.1, 27, 600 In pediatric patients, no other malignancies besides PTLD were observed in clinical trials.1, 600
Serious Infections, Including New or Reactivated Viral Infections
The prescribing information for mycophenolate contains a boxed warning regarding serious infections.1, 27, 600 Patients receiving immunosuppressants, including mycophenolate, are at increased risk of developing bacterial, fungal, protozoal , and new or reactivated viral infections, including opportunistic infections.1, 27, 600 These infections may lead to serious outcomes, including hospitalizations and mortality.1, 27, 600 The risk increases with the total immunosuppressive load.1, 27, 600 Due to the risk of oversuppression of the immune system (which can increase susceptibility to infection), use combination immunosuppressant therapy with caution.27 Serious viral infections reported include polyomavirus-associated nephropathy (PVAN), especially due to BK virus infection; JC virus-associated progressive multifocal leukoencephalopathy (PML); cytomegalovirus (CMV) infections; reactivation of hepatitis B virus (HBV) or hepatitis C virus (HCV); and COVID-19.1, 27, 600 Consider dosage reduction or discontinuation of mycophenolate therapy in patients with new infections or reactivated viral infections, weighing the risk that reduced immunosuppression represents to the functioning allograft.1, 27, 600 PVAN, especially due to BK virus infection, is associated with serious outcomes (e.g., deteriorating kidney function, renal graft loss); monitoring may help identify patients at risk for PVAN.1, 27, 600 PML, which is sometimes fatal, commonly presents with hemiparesis, apathy, confusion, cognitive deficiencies, and ataxia.1, 27, 600 Consider PML in the differential diagnosis in immunosuppressed patients reporting neurologic symptoms;1, 27, 600 consider consultation with a neurologist as clinically indicated.27 The risk of CMV viremia and CMV disease is highest among transplant recipients seronegative for CMV at time of transplant who receive a graft from a CMV seropositive donor.1, 27, 600 Routinely provide therapeutic approaches to limiting CMV disease.1, 27, 600 Monitoring may help identify patients at risk for CMV disease.1, 27, 600 Viral reactivation has been reported in patients infected with HBV or HCV.1, 27, 600 Monitoring infected patients for clinical and laboratory signs of active HBV or HCV infection is recommended.1, 27, 600
Other Warnings and Precautions
Severe neutropenia (i.e., absolute neutrophil counts [ANC] of less than 500/mm3) has been reported in patients receiving 3-g daily dosages of mycophenolate mofetil.1, 600 Neutropenia has been observed most frequently between 31-180 days posttransplant in patients receiving immunosuppressive therapy for the prevention of rejection of kidney, heart, or liver allograft.1, 600 Neutropenia may be related to mycophenolate, concomitant therapies, viral infection, or a combination of these causes.1, 27, 600
Monitor patients for blood dyscrasias including neutropenia during therapy.1, 27, 600 Complete blood cell counts (CBCs) should be performed weekly during the first month of therapy, twice monthly during the second and third month, and then monthly thereafter, during the first year.1, 27, 600 If neutropenia (ANC of less than 1300/mm3) develops (or anemia with mycophenolate sodium therapy), mycophenolate therapy should be temporarily discontinued or the dosage reduced, suitable diagnostic tests should be performed, and appropriate patient management should be instituted.1, 27, 600
Instruct patients receiving mycophenolate mofetil to immediately report any evidence of infection, unexpected bruising, bleeding, or any other manifestation of bone marrow depression.1, 600
Pure red cell aplasia (PRCA) has been reported in patients receiving immunosuppressive regimens containing mycophenolate.1, 27, 600 The mechanism for mycophenolate-induced PRCA has not been determined; the relative contribution of other immunosuppressants and their combinations in an immunosuppressive regimen is also unknown.27 In some cases, PRCA was found to be reversible with dosage reduction or discontinuance of mycophenolate.1, 27, 600 However, clinicians should consider the possibility of graft rejection if immunosuppression is reduced in transplant patients.1, 27, 600 Changes to mycophenolate sodium therapy should be undertaken only under appropriate supervision in transplant recipients in order to minimize the risk of graft rejection.27
GI bleeding (requiring hospitalization), ulceration, and perforations have been reported with mycophenolate mofetil.1, 27, 600
Clinicians should be aware of these serious adverse GI effects when administering mycophenolate mofetil to patients with GI disease.1, 600 Use mycophenolate sodium with caution in patients with active serious digestive system disease.27
Hypoxanthine-Guanine Phosphoribosyl-Transferase Deficiency
Because mycophenolic acid inhibits inosine monophosphate dehydrogenase, mycophenolate mofetil and mycophenolate sodium should be avoided in patients with hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT), including Kelley-Seegmiller or Lesch-Nyhan syndrome.1, 27, 600 In such patients, the drug may cause an exacerbation of disease symptoms characterized by the overproduction and accumulation of uric acid leading to symptoms associated with gout, such as acute arthritis, tophi, nephrolithiasis or urolithiasis and renal disease, including renal failure.1, 27, 600
Cases of acute inflammatory syndrome, some resulting in hospitalization, have been reported with the use of mycophenolate mofetil and mycophenolate products.1, 27, 600 Acute inflammatory syndrome is a paradoxical proinflammatory reaction characterized by fever, arthralgias, arthritis, muscle pain, and elevated inflammatory markers (e.g., C-reactive protein, erythrocyte sedimentation rate) without evidence of infection or underlying disease recurrence.1, 27, 600 Symptoms occur within weeks to months of drug initiation or a dosage increase; improvement of symptoms and inflammatory markers are usually observed within 24—48 hours following treatment discontinuation.1, 27, 600
Monitor patients for symptoms and laboratory parameters of acute inflammatory syndrome when initiating treatment with mycophenolate products or when increasing the dosage.1, 27, 600 Discontinue treatment and consider treatment alternatives based on the risks and benefits for the patient.1, 27, 600
Avoid the use of live attenuated vaccines (e.g., intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, TY21a typhoid vaccines) during treatment with mycophenolate mofetil.1, 27, 600 Advise patients that vaccinations may be less effective.1, 27, 600 Advise patients to discuss with the clinician before seeking any immunizations.1, 27, 600
Local Adverse Reactions with Rapid IV Administration
Do not administer mycophenolate mofetil IV solution by rapid or bolus IV injection as rapid infusion increases the risk of local adverse reactions (e.g., phlebitis, thrombosis).1
Mycophenolate mofetil oral suspension (CellCept®, not Myhibbin®) contains aspartame, which is a source of phenylalanine (0.56 mg of phenylalanine/mL of the suspension).1 Phenylalanine can be harmful to patients with phenylketonuria.1 Before prescribing mycophenolate mofetil oral suspension to a patient with phenylketonuria, consider the combined daily amount of phenylalanine from all sources, including mycophenolate mofetil.1
Patients should not donate blood during therapy with mycophenolate mofetil or mycophenolate sodium and for ≥6 weeks following discontinuation of the drug because their blood or blood products might be administered to pregnant women or females of reproductive potential.1, 27, 600
Based on findings from animal studies, men should not donate semen during therapy and for at least 90 days following discontinuation of mycophenolate mofetil or mycophenolate sodium.1, 27, 600
Effect on Mycophenolic Acid Concentrations of Concomitant Drugs
Several drugs, when used concomitantly with mycophenolate mofetil, have the potential to alter systemic mycophenolic acid exposure.1, 600
To ensure mycophenolic acid concentrations remain stable, it may be appropriate to measure plasma mycophenolic acid concentrations before and after making any changes to immunosuppressive therapy, or when adding or discontinuing concomitant drugs.1, 600
Potential Impairment of Ability to Drive or Operate Machinery
Mycophenolate mofetil may impact the ability to drive or operate machinery.1, 600
Advise patients to avoid driving or using machines if they experience somnolence, confusion, dizziness, tremor, or hypotension during treatment with mycophenolate mofetil.1, 600
A pregnancy exposure registry is available that monitors pregnancy outcomes in women exposed to mycophenolate during pregnancy and those becoming pregnant within 6 weeks of discontinuing the drug.1, 27, 600 To report a pregnancy or obtain information about the registry, visit [Web] or call 1-800-617-8191.1, 27, 600
Mycophenolate may cause fetal toxicity when administered to pregnant women.1, 27, 600 Use of mycophenolate has been associated with increased risk of first-trimester pregnancy loss and serious congenital malformations in multiple organ systems, based on published data from pregnancy registries.1, 27, 600 Documented malformations include external ear and other facial abnormalities (e.g., cleft lip and palate) and anomalies of the distal limbs, heart, esophagus, kidney, and nervous system.1, 27, 600
Congenital malformations and pregnancy loss have been observed in rats and rabbits receiving mycophenolate at doses less than the recommended human dose; maternal toxicity was not observed.1, 27, 600
Apprise females of reproductive potential and pregnant women of the potential hazard.1, 27, 600 Consider alternative immunosuppressants with less potential for embryofetal toxicity.1, 27, 600
Perform a blood or urine pregnancy test (i.e., having a sensitivity of at least 25 mIU/mL for HCG) immediately prior to beginning mycophenolate therapy, and repeat the pregnancy test with the same sensitivity 8—10 days later.1, 27, 600 Perform repeat pregnancy tests during routine follow-up visits.1, 27, 600
There are no data on the presence of mycophenolate in human milk or the effects of the drug on milk production.1, 27, 600 Limited data are available from the National Transplantation Pregnancy Registry on the effects of mycophenolate on breast-fed children.1, 27, 600 Mycophenolic acid is distributed into milk in rats.1, 27, 600
It is not possible to exclude potential risks to nursing infants.1, 27, 600 Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for mycophenolate and any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.1, 27, 600
Females and Males of Reproductive Potential
Advise females of reproductive potential of the potential risks of fetal toxicity and counsel them regarding pregnancy prevention and planning.1, 27, 600
If pregnancy is being considered, discuss risks and benefits of mycophenolate therapy and consider alternative immunosuppressants with less potential for embryofetal toxicity.1, 27, 600
In females of reproductive potential, perform a blood or urine pregnancy test (i.e., having a sensitivity of at least 25 mIU/mL for HCG) immediately prior to beginning mycophenolate therapy, and repeat the pregnancy test with the same sensitivity 8—10 days later.1, 27, 600 Perform repeat pregnancy tests during routine follow-up visits, and discuss the results of all pregnancy tests with the patient.1, 27, 600 If a pregnancy test is positive, consider alternative immunosuppressants with less potential for embryofetal toxicity whenever possible.1, 27, 600
Counsel patients of reproductive potential regarding use of acceptable contraception; refer to the prescribing information for specific, acceptable contraceptive methods.1, 27, 600 Advise female patients to use acceptable forms of contraception throughout the entire therapy and for 6 weeks after discontinuance of mycophenolate, unless the patient commits to complete abstinence from heterosexual contact.1, 27, 600 Advise patients that concomitant use of mycophenolate and certain oral hormonal contraceptives may result in decreased concentrations of the oral hormonal contraceptive.1, 27, 600
The risk of genotoxic effects on sperm cells cannot be excluded based on animal findings.1, 27, 600 Therefore, sexually active male patients and/or their female partners are recommended to use effective contraception during treatment of the male patient and for ≥90 days after discontinuation of treatment.1, 27, 600 Male patients should not donate sperm during treatment with mycophenolate and for ≥90 days after discontinuation of treatment.1, 27, 600
Safety and effectiveness of mycophenolate mofetil have been established in pediatric patients ≥3 months of age for the prophylaxis of organ rejection of allogenic renal, cardiac, or hepatic transplants.1, 600 Use of mycophenolate mofetil in the kidney transplant population is supported by evidence from adequate and well-controlled studies in adults with additional data from one open-label, pharmacokinetic and safety study in pediatric patients.1, 600 Use of mycophenolate mofetil in the pediatric cardiac or hepatic transplant population is supported by adequate and well-controlled studies and pharmacokinetic data in adult cardiac or hepatic transplant patients.1, 600 Additional supportive data include pharmacokinetic data in pediatric kidney and liver transplant patients and published findings of the drug's clinical efficacy and safety in pediatric cardiac or hepatic transplant patients.1, 600
The combination of inactive ingredients (e.g., simethicone, sodium phosphate monobasic dihydrate, sodium phosphate dibasic dihydrate, glycerin) in mycophenolate mofetil oral suspension (Myhibbin®) may impact GI tolerability; monitor pediatric patients receiving the drug for signs and symptoms of GI intolerance.600
Safety and efficacy of mycophenolate sodium (e.g., Myfortic® ) in stable renal transplant pediatric patients 5-16 years of age who were initiated on the drug ≥6 months posttransplant is based on evidence from adequate and well-controlled studies in a similar population of adult renal transplant patients with additional pharmacokinetic data in stable renal transplant pediatric patients.27 Safety and efficacy of mycophenolate sodium have not been established in pediatric de novo renal transplant patients or in pediatric renal transplant patients <5 years of age.27 A mycophenolate sodium dosage form suitable for providing an appropriate dosage for pediatric patients with a body surface area less than 1.19 m2 is not commercially available in the US.27
Limited data are available concerning use of mycophenolate sodium in pediatric patients.27 Following administration of a single dose of mycophenolate sodium (mycophenolic acid 450 mg/m2) delayed-release tablets in stable pediatric renal transplant patients 5-16 years of age, peak plasma concentrations and AUC of mycophenolic acid were 33 and 18% higher, respectively, than those reported in adults receiving the same dose based on body surface area (720 mg).27 The clinical importance of these findings remains to be determined.27 Pharmacokinetic data are not available in pediatric patients younger than 5 years of age.27
Pharmacokinetic parameters, including AUC, in children 1-18 years of age receiving mycophenolate mofetil 600 mg/m2 (oral suspension) twice daily following renal transplantation, are similar to values in adult renal transplant recipients receiving 1 g twice daily.1, 600
Clinical studies of mycophenolate did not include sufficient numbers of patients 65 years of age or older to determine whether they respond differently than younger adults.1, 27, 600 While other clinical experience has not revealed differences in response, drug dosages should be selected cautiously in geriatric patients.1, 27, 600 The greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant diseases and drug therapy observed in the elderly also should be considered.1, 27, 600 Geriatric patients may be at increased risk of developing GI hemorrhage, pulmonary edema, or certain infections (e.g., invasive CMV infection) than younger patients.1, 600
The pharmacokinetics of mycophenolate mofetil and its metabolites have not been found to be altered in geriatric transplant patients compared to younger transplant patients.1, 600 Pharmacokinetics of mycophenolate sodium in geriatric patients have not been formally studied.27
No dosage adjustment for mycophenolate preparations is necessary for renal transplant recipients with severe hepatic parenchymal disease; it is not known whether dosage adjustment is needed for other hepatic diseases.1, 600 No data are available for cardiac transplant recipients with severe hepatic parenchymal disease.1, 600
Specific studies evaluating the pharmacokinetics of mycophenolate sodium have not been conducted in patients with hepatic impairment.27 Pharmacokinetic studies in patients with alcoholic cirrhosis indicate that hepatic mycophenolic acid glucuronidation is not affected by hepatic parenchymal disease.1, 27, 600 Hepatic disease with other etiologies (e.g., biliary cirrhosis) may show a different effect.27
Dosage adjustment of mycophenolate mofetil preparations is not necessary in renal transplant recipients experiencing postoperative delayed graft function; however, these patients should be closely monitored.1, 600 Patients receiving mycophenolate mofetil who experience posttransplant delay in graft function generally have AUC values for mycophenolic acid that are similar to those not experiencing graft function delay; however, the AUC for MPAG (the inactive phenolic glucuronide metabolite of mycophenolic acid) is increased twofold to threefold in patients experiencing delayed graft function compared with those not experiencing delayed function.1, 600
Mycophenolate mofetil dosages exceeding 1 g twice daily should be avoided in renal transplant recipients with severe chronic impairment of the graft (glomerular filtration rate less than 25 mL/minute per 1.73 m2).1, 600 Administration of a single dose of mycophenolate mofetil in individuals with severe long-term renal impairment (glomerular filtration rate less than 25 mL/minute per 1.73 m2) has resulted in higher AUC values for mycophenolic acid and MPAG than values in individuals with less severe impairment or no impairment.1, 600
No data are available on the use of mycophenolate mofetil in cardiac or hepatic transplant recipients with severe chronic renal impairment; mycophenolate mofetil may be used in these patients if the potential benefits outweigh the potential risks.1, 600
Specific studies evaluating the pharmacokinetics of mycophenolate sodium have not been conducted in patients with renal impairment.27 AUC values for mycophenolic acid in patients with renal impairment receiving mycophenolate sodium are not expected to increase appreciably relative to values in patients with normal renal function; however, AUC values for MPAG are expected to increase substantially with decreased renal function.27
The most common adverse effects (≥20%) with mycophenolate mofetil therapy are diarrhea, leukopenia, infection, and vomiting; there is evidence of a higher frequency of certain types of infections (e.g., opportunistic infection).1, 600
The most common adverse effects (≥20%) with mycophenolate sodium therapy are anemia, leukopenia, constipation, nausea, diarrhea, vomiting, dyspepsia, urinary tract infection, cytomegalovirus infection, insomnia, and postoperative pain.27
Anti-infective agents that eliminate beta-glucuronidase-producing bacteria in the intestine (e.g., aminoglycosides, cephalosporins, fluoroquinolones, penicillins) may interfere with the enterohepatic recirculation of mycophenolic acid and the phenolic glucuronide of mycophenolic acid (MPAG, the predominant inactive metabolite of mycophenolic acid), thus leading to reduced systemic mycophenolic acid exposure.1, 600
Ciprofloxacin or Amoxicillin plus Clavulanic acid: Concomitant administration of mycophenolate mofetil and oral ciprofloxacin or amoxicillin plus clavulanic acid decreased median trough concentrations of mycophenolic acid (active metabolite of mycophenolate mofetil) by approximately 50% in 3 days following initiation of antibiotic therapy in one study in renal transplant recipients.1, 27, 600 Interference of hydrolysis of MPAG may lead to less mycophenolic acid available for absorption when mycophenolate sodium is administered concomitantly with ciprofloxacin or amoxicillin plus clavulanic acid.27 The clinical importance of this interaction is unclear; however, no dose adjustment of mycophenolate sodium is necessary when coadministered with these drugs.27
Norfloxacin and Metronidazole: Concomitant use of mycophenolate mofetil and the anti-infective combination of norfloxacin and metronidazole decreased the systemic exposure to mycophenolic acid.1, 27, 600 However, there is no effect on mycophenolate acid plasma concentrations when mycophenolate mofetil is concomitantly administered with norfloxacin or metronidazole given separately.27 Concomitant use of mycophenolate sodium with the combination of norfloxacin and metronidazole is not recommended.27
Rifampin: Concomitant use of rifampin with mycophenolate mofetil decreased the systemic exposure to mycophenolic acid.1, 600 Concomitant use of mycophenolate sodium with rifampin is not recommended unless the benefits outweigh the risks.27
Trimethoprim/Sulfamethoxazole: Following concomitant use of mycophenolate mofetil and trimethoprim/ sulfamethoxazole (co-trimoxazole), no effect on the bioavailability of mycophenolic acid was observed.1, 600
Decreased plasma concentrations/systemic exposure of mycophenolic acid (and consequently reduced efficacy of the drug) may occur with concomitant use with antacids containing aluminum and magnesium hydroxides.1, 27, 600
Absorption of mycophenolate mofetil was decreased when administered to patients also taking Maalox® TC; the peak plasma concentration and AUC for mycophenolic acid were 33% and 17% lower, respectively, than when mycophenolate mofetil was administered alone under fasting conditions.1, 600
Absorption of mycophenolate sodium was decreased when administered to patients also taking magnesium-aluminum-containing antacids; the peak plasma concentration and AUC for mycophenolic acid were 25 and 37% lower, respectively, than when mycophenolate sodium was administered alone under fasting conditions.27
Administer antacids containing magnesium or aluminum hydroxide at least 2 hours after administration of mycophenolate mofetil.1, 600
Do not administer mycophenolate sodium simultaneously with antacids.27
Azathioprine and mycophenolate mofetil inhibit purine metabolism.27 Concomitant use of mycophenolate sodium and azathioprine or mycophenolate mofetil is not recommended.27
Concomitant use of mycophenolate mofetil without cyclosporine results in increased systemic exposure to mycophenolic acid compared with use of mycophenolate mofetil with cyclosporine.1, 600 The lower systemic exposure to mycophenolic acid when mycophenolate mofetil is used with cyclosporine has been attributed to cyclosporine-induced inhibition of multidrug-resistance-associated protein 2 transporter in the biliary tract; inhibition of this transporter prevents excretion of MPAG into bile (MPAG is converted to mycophenolic acid via enterohepatic recirculation).1, 27, 600 Cyclosporine interferes with mycophenolic acid enterohepatic recirculation.1, 600 Consider this information when mycophenolate mofetil is used without cyclosporine.1, 600
Clinicians should be aware that there is also a potential change of mycophenolic acid plasma concentrations after switching from cyclosporine to other immunosuppressive drugs or from other immunosuppressive drugs to cyclosporine in patients concomitantly receiving mycophenolate sodium.27
Drugs Modulating Glucuronidation
Concomitant use of mycophenolate mofetil with drugs inducing glucuronidation (e.g., telmisartan) decreases the systemic exposure of mycophenolic acid, potentially reducing efficacy of mycophenolate mofetil.1, 600 Concomitant use of telmisartan and mycophenolate mofetil resulted in an approximately 30% decrease in mycophenolic acid concentrations.1, 600
Concomitant use of mycophenolate mofetil with drugs inhibiting glucuronidation (e.g., isavuconazole) increases the systemic exposure of mycophenolic acid, which may increase the risk of related adverse reactions.1, 600 An increase in mycophenolic acid AUC by 35% was observed with concomitant administration of isavuconazole.1, 600
Monitor patients for alterations in efficacy or mycophenolate mofetil related-adverse reactions when these drugs are used concomitantly with mycophenolate mofetil.1, 27, 600
Drugs that Interfere with Enterohepatic Recirculation
Decreased systemic exposure of mycophenolic acid (and consequently reduced efficacy of the drug) may occur with concomitant use with drugs that directly interfere with enterohepatic recirculation or indirectly interfere with enterohepatic recirculation by altering the GI flora.1, 27, 600 Examples of such drugs include cyclosporine, trimethoprim/sulfamethoxazole, bile acid sequestrants (cholestyramine), rifampin, aminoglycosides, cephalosporins, fluoroquinolones, and penicillins.1, 600
Concomitant use with mycophenolate mofetil with cholestyramine decreased the AUC of mycophenolic acid by approximately 40%.1, 27, 600
Monitor patients for alterations in efficacy or mycophenolate mofetil related-adverse reactions when these drugs are used concomitantly with mycophenolate mofetil.1, 600
Do not administer mycophenolate sodium with drugs that may interfere with enterohepatic recirculation or drugs that may bind bile acids (e.g., bile acid sequestrants such as cholestyramine, oral activated charcoal), because of the potential to reduce the efficacy of mycophenolate sodium.27
Drugs that Undergo Renal Tubular Secretion
MPAG, the predominant inactive metabolite of mycophenolic acid, may compete for renal tubular secretion with other drugs (e.g., acyclovir, ganciclovir, probenecid, valacyclovir, valganciclovir) when these drugs are used concomitantly with mycophenolate mofetil or mycophenolate sodium; this may result in increased plasma concentrations for both MPAG and these other drugs and/or adverse reactions associated with these drugs.1, 27, 600
Concentrations of acyclovir (valacyclovir [prodrug]) or ganciclovir (valganciclovir [prodrug]) and MPAG will also be increased in the presence of renal impairment.27
Concomitant use of acyclovir with mycophenolate mofetil increased plasma concentrations of acyclovir and MPAG.1, 27, 600
Following single-dose administration to stable kidney transplant patients, no pharmacokinetic interaction was observed between mycophenolate mofetil and IV ganciclovir.1, 600
Monitor for drug-related adverse reactions in patients with renal impairment.1, 600 Monitor blood cell counts if used concomitantly with mycophenolate sodium.27
Concomitant use of ethinyl estradiol and levonorgestrel with mycophenolate mofetil resulted in decreased plasma concentrations of levonorgestrel;1, 27, 600 however, the systemic exposure to ethinyl estradiol was not affected.1, 600 There is a possibility of decreased effectiveness of the combined oral contraceptive.1, 600
In a drug-drug interaction trial, mean AUCs for ethinyl estradiol and norethindrone were similar when coadministered with mycophenolate mofetil as compared to administration of the oral contraceptives alone.27 When ethinyl estradiol and desogestrel were administered with mycophenolate mofetil, AUCs for ethinyl estradiol and 3-keto desogestrel were not affected.1, 600
Use additional barrier contraceptive methods.1, 27, 600
Concomitant administration of calcium-free phosphate binders (e.g., sevelamer) and mycophenolate mofetil decreases systemic exposure of mycophenolic acid (and consequently reduces efficacy of the drug).1, 27, 600
Concomitant administration of sevelamer and mycophenolate mofetil decreased the mean peak plasma concentration and AUC of mycophenolic acid by 36 and 26%, respectively.1, 27, 600
Administer sevelamer or other non-calcium-containing phosphate binders ≥2 hours after the administration of mycophenolate mofetil.1, 600
Do not administer sevelamer or other non-calcium-containing phosphate binders simultaneously with mycophenolate sodium.27
Decreased systemic exposure of mycophenolic acid (and consequently reduced efficacy of the drug) may occur with concomitant use with proton pump inhibitors (PPIs).1, 600 Coadministration of PPIs (e.g., lansoprazole, pantoprazole) in single doses to healthy volunteers and multiple doses to transplant patients receiving mycophenolate mofetil resulted in 30-70% reductions in maximum plasma concentration and 25-35% reductions in the AUC of mycophenolic acid, possibly due to decreased mycophenolic acid solubility at an increased gastric pH.1, 600 Monitor patients for alterations in efficacy when PPIs are used concomitantly with mycophenolate mofetil.1, 600
Administration of pantoprazole (40 mg twice daily for 4 days) to healthy volunteers did not alter the pharmacokinetics of a single dose of mycophenolate sodium.27
Vaccinations may be less effective during mycophenolate therapy.1, 27, 600 Avoid use of live virus vaccines in patients receiving mycophenolate mofetil or mycophenolate sodium.1, 27, 600
Mycophenolate mofetil, the 2-morpholinoethyl ester of mycophenolic acid, is an antimetabolite immunosuppressive agent.1, 600 Following oral administration, mycophenolate mofetil is absorbed and hydrolyzed in vivo to the pharmacologically active metabolite, mycophenolic acid.1, 600 Mycophenolic acid exhibits a cytostatic and reversible effect on T- and B-cells.1, 27, 600 Mycophenolic acid is a selective, noncompetitive, reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), an essential enzyme in de novo guanosine synthesis.1, 27, 600 Because T- and B-cells are very dependent on de novo synthesis of purines (e.g., guanosine) for their proliferation, mycophenolic acid inhibits de novo guanosine nucleotide synthesis and blocks DNA synthesis.1, 27, 600
The mechanism of action of mycophenolic acid is multifaceted.1, 600 Mycophenolic acid alters cellular checkpoints responsible for metabolic programming of lymphocytes; it shifts transcriptional activities in lymphocytes from a proliferative state to catabolic processes.1, 600 In vitro, mycophenolic acid modulates transcriptional activities in human CD4+ T-lymphocytes by suppressing the Akt/mTOR and STAT5 pathways, which causes the T-cells to become less responsive to antigenic stimulation.1, 600 Mycophenolic acid also enhances the expression of negative co-stimulators such as CD70, programmed death-1 (PD-1), cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), and transcription factor FoxP3, in addition to decreasing the expression of positive co-stimulators CD27 and CD28.1, 600 The drug inhibits proliferative responses of T- and B-cells to both mitogenic and allospecific stimulation, antibody responses, as well as the production of cytokines from lymphocytes and monocytes (e.g., granulocyte-macrophage colony-stimulating factor, interferon-gamma, interleukin-17, and tumor necrosis factor-alpha).1, 600 By preventing glycosylation of lymphocyte and monocyte glycoproteins involved in intercellular adhesion to endothelial cells, mycophenolic acid may inhibit recruitment of leukocytes to sites of inflammation and graft rejection.1, 600
Mycophenolate sodium also is an immunosuppressive agent.27 Following oral administration of mycophenolate sodium delayed-release tablets, mycophenolic acid (the active moiety) is released.27 Mycophenolate sodium has been shown to prevent acute rejection in rat models of kidney and heart allotransplantation; the drug also decreases antibody production in mice.27
Mycophenolate mofetil is well absorbed following oral administration, having an absolute bioavailability of 94% relative to IV mycophenolate mofetil.1, 600 Following oral and IV administration, mycophenolate mofetil undergoes rapid and complete metabolism to mycophenolic acid, the active metabolite.1, 600 Mycophenolate mofetil (CellCept®) tablets, capsules, and oral suspension are bioequivalent.1 The mycophenolic acid AUC appears to increase in a dosage-proportional manner in kidney transplant patients receiving multiple oral doses of mycophenolate mofetil up to a daily dosage of 3 g.1, 600 In the early posttransplant period (i.e., <40 days posttransplant), kidney, heart, and liver transplant patients had mean mycophenolic acid AUCs and peak plasma concentrations approximately 20—41% and 32%—44% lower, respectively, compared to the late transplant period (i.e., 3—6 months posttransplant).1, 600 Following administration of mycophenolate mofetil IV 1 g twice daily over 2 hours to kidney transplant patients for 5 days, mean mycophenolic acid AUCs were approximately 24% higher than those observed after oral administration of a similar dose in the immediate posttransplant phase.1, 600 In liver transplant patients, administration of mycophenolate mofetil IV 1 g twice daily followed by 1.5 g orally twice daily resulted in mean mycophenolic acid AUC estimates similar to those found in kidney transplant patients administered 1 g twice daily.1, 600
Mycophenolate sodium exhibits linear and dose-proportional pharmacokinetics over the dosage range of 360—2160 mg.27 Following oral administration of mycophenolate sodium delayed-release, enteric-coated tablets, mycophenolic acid is released in the intestine.27 The absolute bioavailability of mycophenolic acid following oral administration of mycophenolate sodium delayed-release tablets in stable renal transplant patients has been reported to be 72%.27 Following oral administration of mycophenolate sodium delayed-release tablets, the median time to peak plasma concentrations of the drug is 1.5-2.75 hours compared with 0.5-1 hour reported with conventional preparations of mycophenolate mofetil.27 Administration of mycophenolate sodium (as delayed-release tablets) or mycophenolate mofetil with food does not affect the AUC of mycophenolic acid; however, decreases by about 33 or 40%, respectively, of the peak plasma concentrations of mycophenolic acid have been observed.1, 27, 600 Mycophenolate sodium delayed-release tablets cannot be used interchangeably with mycophenolate mofetil tablets or capsules without clinician supervision because the rate of absorption following the administration of these two agents is not equivalent.27
Mycophenolic acid is ≥97-98% bound to plasma protein (mainly albumin).1, 27, 600 Mycophenolate mofetil undergoes complete metabolism to mycophenolic acid; metabolism occurs presystemically following oral administration.1, 27, 600 Mycophenolic acid is metabolized by glucuronyl transferase to form the phenolic glucuronide of mycophenolic acid (MPAG), the predominant metabolite, which is not pharmacologically active.1, 27, 600 In vivo, MPAG is converted back to mycophenolic acid via enterohepatic recirculation; concurrent administration of drugs that interfere with such recirculation (e.g., cholestyramine) may decrease plasma concentrations of mycophenolic acid.1, 27, 600
Ninety-three percent of an orally administered dose of mycophenolate mofetil is excreted in urine (mainly [about 87%] as MPAG) and 6% is excreted in feces.1, 600 Following administration of mycophenolate sodium, most of the dose (greater than 60%) of mycophenolic acid is excreted in urine as MPAG, and 3% is excreted in urine as unchanged mycophenolic acid.27 Following administration of mycophenolate mofetil, the mean apparent half-life of mycophenolic acid is 17.9 hours following oral administration and 16.6 hours following IV administration.1, 600 Following administration of mycophenolate sodium, the mean elimination half-lives of mycophenolic acid and MPAG ranged between 8—16 hours and 13—17 hours, respectively.27 Mycophenolic acid and MPAG usually are not removed by dialysis.1, 27, 600
Additional Information
The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Capsules | 250 mg* | Mycophenolate Mofetil Capsules | |
Genentech | ||||
For oral suspension | 200 mg/mL* | Mycophenolate Mofetil Oral Suspension | ||
CellCept® | Genentech | |||
Tablets, film-coated | 500 mg* | Mycophenolate Mofetil Tablets | ||
CellCept® | Genentech | |||
Oral Suspension | 200 mg/mL | Myhibbin® |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | For injection, for IV infusion only | 500 mg (of mycophenolate mofetil)* | Mycophenolate Mofetil Hydrochloride for Injection | |
CellCept® Intravenous | Genentech |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets, delayed-release, (enteric-coated) film-coated | 180 mg (of mycophenolic acid)* | Mycophenolate Sodium Delayed-release Tablets | |
360 mg (of mycophenolic acid)* | Mycophenolate Sodium Delayed-release Tablets | |||
Myfortic® | Novartis |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
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