CellCept®
GoodRxMycophenolate Mofetil · oral capsule
Misc.
Approved uses
Prophylaxis of organ rejection in kidney transplantation
1 g twice daily orally in adults; 600 mg/m2 twice daily in children
Prophylaxis of organ rejection in heart or liver transplantation
1.5 g twice daily orally in adults
Any patient on this is meaningfully immunosuppressed, which changes how an ocular infection should be read
OFF-LABELNot in the FDA label for this product
Non-infectious uveitis, as a corticosteroid-sparing agent
3 g orally daily in the trial
RCT · n=216 · not superior
The FAST trial randomised 216 adults with non-infectious uveitis to methotrexate 25 mg weekly or mycophenolate 3 g daily. Treatment success at 6 months was 57.1% on mycophenolate against 66.7% on methotrexate, a difference that did not reach significance (odds ratio 1.50, 95% CI 0.81 to 2.81, p=0.20), so mycophenolate was not the better first-line drug overall. Where the two separated was by anatomy: in posterior uveitis and panuveitis methotrexate did better (74.4% against 55.3%, p=0.02), while in intermediate uveitis mycophenolate did (63.6% against 33.3%, p=0.07), with the interaction itself significant at p=0.004. Raised liver enzymes affected 7.4% on mycophenolate.
Non-infectious ocular inflammation, including scleritis and mucous membrane pemphigoid
Oral, as the sole non-corticosteroid agent
Cohort · n=236 · 73% at 1 yr
A retrospective cohort of 236 patients on mycophenolate monotherapy for non-infectious ocular inflammation reached sustained complete control of inflammation in 53% by 6 months and 73% by 1 year, and reduced prednisone to 10 mg a day or less while holding that control in 41% and 55% over the same points. 12% stopped within the first year for side effects, which were typically reversible. The authors' framing is that it works in about half of patients given enough time, so it is a slow agent rather than a rescue one.
Contraindications
Mycophenolate mofetil capsule is contraindicated in patients with a history of hypersensitivity, including anaphylaxis, to mycophenolate mofetil (MMF), mycophenolic acid (MPA) or any component of the drug product.
Available FormsMycophenolate mofetil 250 mg capsules and 500 mg tablets, plus an oral suspension and an intravenous form.
Mechanism of ActionMycophenolate mofetil (MMF) is absorbed following oral administration and hydrolyzed to mycophenolic acid (MPA), the active metabolite. MPA is a selective uncompetitive inhibitor of the two isoforms (type I and type II) of inosine monophosphate dehydrogenase (IMPDH) leading to inhibition of the de novo pathway of guanosine nucleotide synthesis and blocks DNA synthesis. The mechanism of action of MPA is multifaceted and includes effects on cellular checkpoints responsible for metabolic programming of lymphocytes. MPA shifts transcriptional activities in lymphocytes from a proliferative state to catabolic processes.
Warnings & Precautions
- Embryofetal toxicity: use during pregnancy causes first-trimester pregnancy loss and congenital malformations. This carries a boxed warning, and pregnancy must be excluded before starting.
- Increased risk of lymphoma and other malignancies, particularly of the skin. This carries a boxed warning.
- Increased susceptibility to serious infection, including opportunistic infection, sepsis, and progressive multifocal leukoencephalopathy. This carries a boxed warning.
- CMV reactivation, BK virus-associated nephropathy and hepatitis B or C reactivation have been reported.
- Blood dyscrasias, including neutropenia and pure red cell aplasia, can occur.
Common Side Effects
The most common adverse reactions in clinical trials (20 % or greater) include diarrhea, leukopenia, infection, vomiting, and there is evidence of a higher frequency of certain types of infections e.
Pregnancy & LactationPregnancy: Contraindicated. Use causes first-trimester pregnancy loss and congenital malformations, including of the external ear, face, heart, oesophagus and kidney. Females of reproductive potential must use effective contraception before, during, and for 6 weeks after therapy.
Lactation: Unknown whether it is present in human milk; because of the potential for serious adverse reactions, advise against breastfeeding.
Pediatric UseSafety and effectiveness have been established in pediatric patients 3 months and older for the prophylaxis of organ rejection of allogenic kidney, heart or liver transplants.