mycophenolate mofetil

ROUTE	ONSET	PEAK	DURATION
mycophenolate mofetil-PO	rapid	0.25–1.25 hr	N/A
mycophenolic acid	rapid	1.5–2.75 hr	N/A

Contraindicated in:

Hypersensitivity;
Hypersensitivity to polysorbate 80 (for IV mycophenolate mofetil);
OB: Pregnancy.

Use Cautiously in:

Active serious pathology of the GI tract (including history of ulcer disease or GI bleeding);
Phenylketonuria (oral suspension contains aspartame);
Severe chronic renal impairment (dose not to exceed 1 g twice daily [CellCept] if CCr <25 mL/min/1.73 m²); careful monitoring recommended;
Delayed graft function following transplantation (observe for ↑ toxicity);
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Rep: Women of reproductive potential and men with female partners of reproductive potential;
Pedi: Safety and effectiveness not established in children <3 mo (mycophenolate mofetil) or <5 yr (mycophenolic acid);
Geri: ↑risk of adverse reactions related to immunosuppression in older adults.

Adv. Reactions/Side Effects ⬆ ⬇

CV: edema, hypertension, hypotension, tachycardia

Derm: rash

Endo: hyperglycemia

F and E: hyperkalemia, hypocalcemia, hypokalemia, hypomagnesemia

GI: anorexia, constipation, diarrhea, nausea, vomiting, abdominal pain, GI BLEEDING

GU: renal impairment

Hemat: leukocytosis, leukopenia, thrombocytopenia, anemia, pure red cell aplasia

Metab: hypercholesterolemia

Neuro: anxiety, confusion, dizziness, headache, insomnia, paresthesia, sedation, tremor, PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML)

Resp: cough, dyspnea

Misc: fever, infection (including activation of latent viral infections such as Polyomavirus-associated nephropathy or Hepatitis B/C), acute inflammatory syndrome, MALIGNANCY

Interactions ⬆ ⬇

Drug-drug:

Combined use with azathioprine is not recommended (effects unknown).
Acyclovir and ganciclovir compete with MPA for renal excretion and, in patients with renal impairment, may ↑ each other’s toxicity.
Magnesium and aluminum hydroxide antacids ↓ the absorption of MPA; avoid concurrent use.
Proton pump inhibitors, including dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole, may ↓ levels and effectiveness.
Cholestyramine and colestipol↓ the absorption of MPA; avoid concurrent use.
May ↓ the effectiveness of oral contraceptives; additional contraceptive method should be used.
May ↓ the antibody response to and ↑ risk of adverse reactions from live-attenuated vaccines.
Amoxicillin/clavulanic acid or ciprofloxacin may ↓ MPA trough levels and effectiveness.
Cyclosporine may ↓ levels and effectiveness; use caution when discontinuing cyclosporine (may ↑ mycophenolate levels) or when switching from cyclosporine to another immunosuppressant, such as tacrolimus or belatacept.
Telmisartan may ↓ levels and effectiveness.

Route/Dosage ⬆ ⬇

Mycophenolate Mofetil

Kidney Transplantation
PO IV (Adults ): 1 g twice daily; IV should be started ≤24 hr after transplantation and switched to PO as soon as possible (IV not recommended for ≥14 days).
PO (Children ≥3 mo): 600 mg/m² twice daily (not to exceed 2 g/day).
Liver Transplantation
PO IV (Adults ): 1 g twice daily IV, or 1.5 g twice daily PO. IV should be started ≤24 hr after transplantation and switched to PO as soon as possible (IV not recommended for ≥14 days).
PO (Children ≥3 mo): 600 mg/m² twice daily; if well tolerated, can ↑ to 900 mg/m² twice daily (not to exceed 3 g/day).
Heart Transplantation
PO IV (Adults ): 1.5 g twice daily; IV should be started ≤24 hr after transplantation and switched to PO as soon as possible (IV not recommended for ≥14 days).
PO (Children ≥3 mo): 600 mg/m² twice daily; if well tolerated, can ↑ to 900 mg/m² twice daily (not to exceed 3 g/day).

Renal Impairment

PO IV (Adults ): CCr <25 mL/min: Daily dose should not exceed 2 g.

Mycophenolic Acid

Mycophenolate mofetil and mycophenolic acid should not be used interchangeably without the advice of a health care professional.
Kidney Transplantation
PO (Adults ): 720 mg twice daily.
PO (Children 5–16 yr and ≥1.19 m²): 400–450 mg/m² twice daily (not to exceed 720 mg twice daily).

Availability ⬆ ⬇

(Generic available)

Mycophenolate Mofetil

Tablets: 500 mg
Capsules: 250 mg
Oral suspensionfruit flavor: 200 mg/mL
Powder for injection : 500 mg/vial

Mycophenolic Acid

Delayed-release tablets: 180 mg; 360 mg

Assessment ⬆ ⬇

Assess for symptoms of organ rejection throughout therapy.
Assess for signs and symptoms of infection, including PML (hemiparesis, apathy, confusion, cognitive deficiencies, ataxia), periodically during therapy. If new infection or reactivated viral infection occurs, consider dose ↓, weighing risk to functioning allograft.
Monitor for symptoms and laboratory parameters of acute inflammatory syndrome when starting treatment with mycophenolate products or when ↑ dose. Discontinue mycophenolate and consider treatment alternatives based on risks and benefits.

Lab Test Considerations:

Verify negative urine pregnancy test with a specificity of 25 mIU/mL immediately prior to beginning therapy and again 8–10 days later. Repeat pregnancy tests should be performed during routine follow-up visits.
- Monitor CBC with differential weekly for 1st mo, twice monthly for the 2nd and 3rd mo of therapy, and then monthly during the 1st yr. Neutropenia occurs most frequently 31–180 days post-transplant. If ANC is <1300 × 10/mm³, interrupt or ↓ dose and manage appropriately.
- Monitor hepatic and renal function and electrolytes periodically during therapy. May cause ↑ alkaline phosphatase, AST, ALT, LDH, BUN, and serum creatinine. May also cause hyperkalemia, hypokalemia, hypocalcemia, hypomagnesemia, hyperglycemia, and hyperlipidemia.

Implementation ⬆ ⬇

The initial dose of mycophenolate should be given within 24 hr of transplant.
- Mycophenolate mofetil (Cellcept) and mycophenolic acid (Myfortic) are not interchangeable; rate of absorption is different.
REMS: Mycophenolate is administered under REMS requirements. Prescribers are encouraged to complete prescriber training program and patients are encouraged to complete the Information for Patients to mitigate the risk of embryofetal toxicity associated with the use of mycophenolate during pregnancy.
PO: Administer on an empty stomach, 1 hr before or 2 hr after meals. DNC: Swallow capsules and delayed-release tablets whole; do not open, crush, or chew. Oral suspension: Must be reconstituted by pharmacist. Do not mix with other medication. Can be administered by nasogastric tube (minimum size, 8 French) and is stable for 60 days refrigerated. Mycophenolate may be teratogenic; wear gloves and avoid contact with skin or mucous membranes or inhalation of contents of capsules or oral suspension powder.
- Do not administer mycophenolate concurrently with antacids containing magnesium or aluminum.

IV Administration:

IV: IV route should only be used for patients unable to take oral medication and should be switched to oral dose form as soon as tolerated.
Intermittent Infusion: Reconstitution: Reconstitute each vial with 14 mL of D5W. Shake gently to dissolve. Solution is slightly yellow.Diluent: Dilute contents of 2 vials (1-g dose) further with 140 mL of D5W or 3 vials (1.5-g dose) with 210 mL of D5W. Discard if solution is discolored or contains particulates. Solution is stable for 4 hr.Concentration: 6 mg/mL.
Rate: Administer via slow IV infusion over at least 2 hr. Do not administer as bolus or rapid infusion (↑ risk of phlebitis and thrombosis).
Y-Site Compatibility:
- alemtuzumab
- amikacin
- amiodarone
- anidulafungin
- argatroban
- atracurium
- bivalirudin
- bumetanide
- buprenorphine
- butorphanol
- calcium chloride
- caspofungin
- ceftolozane/tazobactam
- chlorpromazine
- ciprofloxacin
- cisatracurium
- daptomycin
- dexmedetomidine
- dexrazoxane
- digoxin
- diltiazem
- diphenhydramine
- dobutamine
- dopamine
- doxorubicin liposomal
- doxycycline
- droperidol
- enalaprilat
- ephedrine
- epinephrine
- erythromycin
- esmolol
- famotidine
- fentanyl
- fluconazole
- gentamicin
- glycopyrrolate
- granisetron
- haloperidol
- hydralazine
- hydromorphone
- hydroxyzine
- insulin, regular
- isavuconazonium
- isoproterenol
- labetalol
- leucovorin calcium
- levofloxacin
- lidocaine
- linezolid
- lorazepam
- magnesium sulfate
- mannitol
- meperidine
- mesna
- methadone
- metoclopramide
- metoprolol
- metronidazole
- midazolam
- milrinone
- morphine
- moxifloxacin
- nalbuphine
- naloxone
- nicardipine
- nitroglycerin
- norepinephrine
- 0.9% NaCl
- octreotide
- ondansetron
- oxytocin
- pamidronate
- pentamidine
- phentolamine
- phenylephrine
- potassium chloride
- procainamide
- prochlorperazine
- promethazine
- propranolol
- remifentanil
- rocuronium
- succinylcholine
- sufentanil
- tacrolimus
- theophylline
- tigecycline
- tirofiban
- tobramycin
- vancomycin
- vasopressin
- vecuronium
- verapamil
- voriconazole
- zidovudine
- zoledronic acid
Y-Site Incompatibility:
- acyclovir
- allopurinol
- amifostine
- aminocaproic acid
- aminophylline
- amphotericin B deoxycholate
- amphotericin B lipid complex
- amphotericin B liposomal
- ampicillin
- ampicillin/sulbactam
- azithromycin
- aztreonam
- calcium gluconate
- cangrelor
- cefazolin
- cefotaxime
- cefotetan
- cefoxitin
- ceftazidime
- ceftriaxone
- cefuroxime
- chloramphenicol
- clindamycin
- dantrolene
- defibrotide
- dexamethasone
- diazepam
- eptifibatide
- foscarnet
- fosphenytoin
- furosemide
- ganciclovir
- gemtuzumab ozogamicin
- heparin
- hydrocortisone
- imipenem/cilastatin
- ketorolac
- letermovir
- meropenem
- methotrexate
- methylprednisolone
- micafungin
- nafcillin
- nitroprusside
- pantoprazole
- pentobarbital
- phenobarbital
- phenytoin
- piperacillin/tazobacatam
- potassium acetate
- potassium phosphate
- sodium acetate
- sodium bicarbonate
- sodium phosphate
- trimethoprim/sulfamethoxazole

Patient/Family Teaching ⬆ ⬇

Instruct patient to take medication as directed, at the same time each day. Take missed dose as soon as remembered, but not if within 2 hr before next dose. Do not skip or double up on missed doses. Do not discontinue without consulting health care professional. Advise patient to read Medication Guide before starting therapy and with each Rx refill in case of changes.
REMS: Explain REMS program to patient.
Reinforce the need for lifelong therapy to prevent transplant rejection. Review symptoms of rejection for the transplanted organ, and stress need to notify health care professional immediately if signs of rejection or infection occur.
May cause somnolence, confusion, dizziness, tremor, or hypotension. Caution patient to avoid driving and other activities requiring alertness until response from medication is known.
Instruct patient to notify health care professional immediately if signs and symptoms of infection (temperature ≥100.5°F; cold symptoms [runny nose, sore throat]; flu symptoms [upset stomach, stomach pain, vomiting, diarrhea]; earache or headache; pain during urination; frequent urination; white patches in mouth or throat; unexpected bruising or bleeding; cuts, scrapes, or incisions that are red, warm, and oozing pus) or PML occur.
Advise patient to avoid contact with persons with contagious diseases.
Advise patient to avoid live-attenuated virus vaccines during therapy.
Inform patient of the ↑ risk of lymphoma and other malignancies. Advise patient to use sunscreen and wear protective clothing to ↓ risk of skin cancer.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Instruct patient to avoid donating blood during and for >6 wk after discontinuation of therapy.
Rep: Inform females of reproductive potential of potential for pregnancy loss and fetal harm. Discuss importance of simultaneously using two reliable nonhormonal forms of contraception or abstinence prior to beginning, during, and for 6 wk following discontinuation of therapy and to avoid breastfeeding. Discuss acceptable forms of contraception with health care professional. Mycophenolate may ↓ effectiveness of hormonal contraceptives. Encourage patients who become pregnant during or within 6 wk after therapy to enroll in the pregnancy registry by calling 1-800-617-8191 or www.mycophenolateREMS.com to monitor outcomes in women exposed to mycophenolate during pregnancy. Instruct male patients with female partners of reproductive potential to use effective contraception during and for ≥90 days after discontinuing therapy. Advise male patients to avoid semen donation during and for ≥90 days after discontinuing therapy.
Emphasize importance of routine follow-up laboratory tests.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇