Cellcept (Mycophenolate Mofetil) – Professional Product Monograph
Brand Name: Cellcept
Generic Name (Active Ingredient): Mycophenolate Mofetil (MMF)
Other Common/International Names: Mycophenolate, MMF, Myfenax, Myfortic (enteric-coated mycophenolate sodium), Mycophenolate mofetil capsules/tablets/oral suspension
Drug Class: Immunosuppressant – Antimetabolite (Inosine Monophosphate Dehydrogenase Inhibitor)

What is Cellcept? Cellcept is an immunosuppressant containing mycophenolate mofetil, clinically proven to prevent organ rejection in kidney, heart, and liver transplant recipients by selectively inhibiting lymphocyte proliferation.

How does Cellcept work? It blocks inosine monophosphate dehydrogenase, suppressing T- and B-lymphocyte proliferation while sparing other rapidly dividing tissues.

Mode of Action:
Mycophenolate mofetil is a prodrug rapidly hydrolyzed to mycophenolic acid (MPA). MPA inhibits inosine monophosphate dehydrogenase (IMPDH), the key enzyme for de novo guanine nucleotide synthesis in lymphocytes. Since T and B cells rely heavily on this pathway, the drug selectively suppresses their proliferation, decreasing immune activation and preventing graft rejection.

Indications and Uses
Therapeutic Indication Clinical Evidence
Prevention of acute organ rejection (renal, cardiac, hepatic transplantation) Randomized trials (e.g., Sollinger et al., NEJM 1995) demonstrated significantly reduced biopsy-proven rejection rates vs. azathioprine
Off-label: Lupus nephritis, autoimmune hepatitis, myasthenia gravis, vasculitis, dermatologic autoimmune disorders Observational studies and guideline support (KDIGO, ACR)
Recommended Dosage (Typical Adult Transplant Recipient)
Formulation Standard Dose* Frequency
Oral capsule/tablet 1 g Twice daily
Intravenous infusion 1 g (over 2 hours) Every 12 hours (peri-operative)

*Dose adjustments may be required based on transplant type, renal impairment, or concomitant immunosuppressants (tacrolimus, cyclosporine, corticosteroids). Always individualize under specialist supervision.

Administration Notes:

Take on an empty stomach when possible to optimize absorption.

Do not crush or chew capsules; avoid inhalation of powder.

Maintain consistent dosing intervals to sustain immunosuppression.

Prescribing & Monitoring Information

Baseline tests: CBC, renal and hepatic function, pregnancy status.

Ongoing: CBC weekly for first month, biweekly for months 2–3, monthly thereafter; LFTs and renal profile periodically.

Vaccinations: Avoid live vaccines during therapy.

Pregnancy: Teratogenic—strict contraception required (REMS program in some regions).

Safety Information

Common Adverse Effects (≥10%)

Gastrointestinal: nausea, diarrhea, abdominal pain

Hematologic: leukopenia, anemia

Infectious risk: increased susceptibility to bacterial, viral, fungal infections (e.g., CMV, BK virus)

Serious/Uncommon

Progressive multifocal leukoencephalopathy (PML)

Sepsis, opportunistic infections

Malignancies (lymphoma, skin cancer) with long-term use

Warnings & Precautions

Black Box Warnings (US FDA): Embryofetal toxicity, increased risk of infection and malignancy.

Renal/Hepatic impairment: Dose modifications may be necessary.

Sun exposure: Use sunscreen; avoid tanning due to oncogenic risk.

Contraception: Two effective methods recommended during and for 6 weeks after therapy (women), 90 days after therapy (men).

Drug Interactions (Clinically Documented)
Interacting Agent Effect Management
Cyclosporine Decreases MPA exposure Monitor graft function; consider dose adjustment
Tacrolimus Minimal PK effect but additive immunosuppression Monitor for infection
Antacids/Cholestyramine Reduce absorption of MPA Separate administration by ≥2 hours
Acyclovir/Ganciclovir Increased hematologic toxicity risk CBC monitoring
Live vaccines May cause infection Avoid; use inactivated formulations
Evidence Base & Clinical Studies

Sollinger HW et al., NEJM 1995: Mycophenolate vs. azathioprine in renal transplant—significant reduction in acute rejection rates.

Mourad G et al., Transplantation 2001: Improved 1-year graft survival in cardiac transplant recipients.

KDIGO Guidelines 2020: Endorse mycophenolate as part of standard triple therapy (calcineurin inhibitor + steroid + MMF).

FAQs
Q1: Is Cellcept safe long term?
Long-term studies (>10 years) indicate stable graft outcomes, but ongoing monitoring for malignancy, infection, and hematologic toxicity is essential.

Q2: Can Cellcept be stopped abruptly?
Abrupt withdrawal may precipitate graft rejection; taper or substitute under transplant specialist supervision.

Q3: Can Cellcept be used in autoimmune diseases?
Yes, off-label use (lupus nephritis, vasculitis) is supported by clinical evidence, though not FDA-approved for all indications.

Q4: Is generic mycophenolate equivalent?
Regulatory bioequivalence studies confirm therapeutic equivalence when manufactured under GMP standards.

Q5: How should Cellcept be stored?
Keep at 15–30°C, protected from moisture and light. Once mixed, oral suspension should be refrigerated and discarded after 60 days.