Adult Dosing
Kidney transplant rejection prophylaxis
- 1 g IV bid
- Start IV within 24 hrs post transplant, switch to oral as soon as possible. IV not recommended >14 days
Heart transplant rejection prophylaxis
- 1.5 g IV bid
- Start IV within 24 hrs post transplant, switch to oral as soon as possible. IV not recommended >14 days
Liver transplant rejection prophylaxis
- 1 g IV bid
- Start IV within 24 hrs post transplant, switch to oral as soon as possible. IV not recommended >14 days
Notes:
- Insure negative serum or urine pregnancy test within 1 week prior to initiation in all women of childbearing age
- Do not administer by rapid or bolus intravenous injection. It is for IV infusion only
- Reconstitute and dilute to a concentration of 6 mg/mL using 5% dextrose injection. Administer as an IV infusion over a period of
2 hrs by either peripheral or central line
Pediatric Dosing
Kidney transplant rejection prophylaxis
- Oral susp is administered
Note:
- Safety and effectiveness in pediatric patients receiving allogeneic cardiac or hepatic transplants have not been established
[Outline]
Renal Dose Adjustment
Renal transplant patients,
- Delayed graft function immediate postop: No dose adjustments
- CrCl <25 mL/min, outside immediate post transplant period: Max: 1 g bid, monitor for adverse events
Cardiac or hepatic transplant
- Severe chronic renal impairment: Dose adjustments not defined, can use if potential benefits outweigh the potential risks
Hepatic Dose Adjustment
- Renal transplant with severe hepatic parenchymal disease: No dose adjustments
- Hepatic impairment with other etiologies: Dosage adjustment not defined
- Therapy may cause fetal harm and is associated with an increased risk of first trimester pregnancy loss and congenital malformations, especially external ear, facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, and kidney. Advise females of reproductive potential (FRP) regarding pregnancy prevention and planning [US Black Box Warning]
- Administer only under supervision of physicians experienced in immunosuppressive therapy and management of renal, cardiac, or hepatic transplant patients in an adequate medical facility. Physicians responsible for maintenance therapy should have all information needed for pt follow-up [US Black Box Warning]
- Increased risk of lymphomas and other malignancies, particularly of the skin have been reported following immunosuppressive regimen. The risk is related to the intensity and duration of immunosuppression [US Black Box Warning]
- Patients with increased risk for skin cancer, should be advised to avoid exposure to sunlight and UV light by wearing protective clothing and using a sunscreen with a high protection factor
- Mycophenolate in combination with cyclosporine and corticosteroids is indicated for prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac, or hepatic transplants
- Immunosuppressant can increase susceptibility to opportunistic infections, fatal infections and sepsis [US Black Box Warning]
- Activation of latent viral infections including progressive multifocal leukoencephalopathy (PML) and BK virus-associated nephropathy (BKVAN) have been observed in patients receiving immunosuppressants
- Severe neutropenia has been observed following the administration of mycophenolate, most frequently in the period from 31 to 180 days post transplant. Monitor the patient for neutropenia. Interrupt or reduce the dosage of mycophenola and manage appropriately if neutropenia develops
- Mycophenolate in combination with other immunosuppressive agents can cause pure red cell aplasia (PRCA)
- Perform pregnancy test < 1wk prior to starting therapy in women of childbearing potential. Women planning to conceive should consider immunosuppressants with less potential for embryofetal toxicity
- Use two reliable forms of contraception for 4 wks before therapy, during tx, and for 6 wks after discontinuation in women of childbearing potential
- Never administer mycophenolate intravenous solution as rapid or bolus intravenous injection
- Severe gastrointestinal adverse events including ulceration, hemorrhage, and perforation have been observed with mycophenolate administration. Use cautiously in patients with active serious digestive system disease
- Do not administer mycophenolate concomitantly with azathioprine, as both have the potential to cause bone marrow suppression
- Concomitant use with cholestyramine, norfloxacin, metronidazole not recommended
- Avoid the use of live attenuated vaccines during treatment with mycophenolate as vaccinations may be less effective
Cautions: Use cautiously in
- Severe chronic renal impairment
- Active GI diseases
- History of GI bleeding
- History of PUD
- Elderly patients
- Patients with childbearing potential
- Bone marrow depression
- Concomitant use of drug that interfere with enterohepatic recirculation
Pregnancy Category:D
Breastfeeding: Safety unknown, an alternate drug may be preferred, especially while nursing a newborn or preterm infant based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 6 April 2011).Because of the potential for possible serious adverse reactions in nursing infants, manufacturer recommends discontinuation of breastfeeding, or postponing of treatment (taking into account the importance of the drug to the mother).
Pricing data from www.DrugStore.com in U.S.A.
- CellCept 200 MG/ML SUSR [Bottle] (GENENTECH)
160 ml = $909.96
480 ml = $2705.93 - CellCept 250 MG CAPS [Bottle] (GENENTECH)
30 mg = $166
100 mg = $529.98 - CellCept 500 MG TABS [Bottle] (GENENTECH)
100 mg = $951.33
300 mg = $2822.58
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
