Pregnancy and infection precautions are essential
Boxed embryo-fetal, malignancy and serious-infection risks require specialist monitoring. Arrange pregnancy prevention/planning and never independently interrupt transplant immunosuppression.
Warnings and precautionsIndications
Prescription transplant immunosuppression with specialist supervision.
Labeled uses
With other immunosuppressants, prevents rejection after allogeneic kidney, heart or liver transplantation in adults and children from three months. This focused label reference does not provide autoimmune-disease or rejection-rescue protocols.
Formulation boundary
Oral mofetil products must not be exchanged unsupervised with delayed-release mycophenolic acid tablets. Absorption differs; salt-name similarity is not a milligram conversion.
Dosage and administration
Transplant type, route and pediatric BSA determine dosing.
Adult transplant doses
Give twice daily; every IV dose requires an infusion lasting at least two hours, never a bolus. Use IV temporarily when oral treatment cannot be tolerated, starting within 24 hours after transplant for up to 14 days; switch as soon as feasible. Specialist preparation is required.
| Adult transplant | Dose per administration, twice daily |
|---|---|
| Kidney | 1 g oral or IV |
| Heart | 1.5 g oral or IV |
| Liver | 1.5 g oral; 1 g IV |
Pediatric oral doses
From three months: kidney 600 mg/m² twice daily, maximum 2 g/day. Heart/liver start 600 mg/m² twice daily; if tolerated, may increase to 900 mg/m² twice daily, maximum 3 g/day. BSA 1.25 to under 1.5 m² permits 750 mg capsules twice daily; BSA ≥ 1.5 m² permits 1 g capsule/tablet twice daily (heart/liver starting doses). No pediatric IV dose is inferred.
Renal and hematologic adjustment
For severe chronic kidney-graft impairment, GFR < 25 mL/min/1.73 m², avoid more than 1 g twice daily and monitor closely. Delayed kidney-graft function alone needs no adjustment. If ANC falls below 1,300/µL, interrupt/reduce with diagnostic assessment. These boundaries do not establish a universal renal algorithm for heart/liver recipients.
Oral administration
Prefer an empty stomach; stable recipients may take with food if needed. Swallow tablets/capsules intact. Pharmacist prepares 200 mg/mL suspension; shake and use calibrated dispenser, without mixing into other liquids. Missed dose: take when remembered unless next dose is less than two hours away; then skip, never double.
IV preparation boundary
Aseptic reconstitution and further dilution use 5% dextrose according to the full pharmacy instructions. No concurrent same-catheter admixtures; initiate infusion within four hours after preparation. Hazardous-drug handling and exact dose-dependent preparation remain pharmacy responsibilities.
Safety
Pregnancy loss, malignancy and fatal infections are major risks.
Warnings and precautions
Monitor serious/opportunistic infections, including BK, CMV, PML and viral hepatitis reactivation; balance any reduction against graft loss. Cytopenias/PRCA and GI bleeding/perforation occur. Evaluate acute inflammatory syndrome after initiation/escalation; discontinue if confirmed after benefit/risk assessment. Avoid HGPRT-deficiency syndromes and live vaccines. Suspension contains phenylalanine; assess PKU.
Contraindications
Hypersensitivity to mofetil, mycophenolic acid or ingredients contraindicates treatment; IV formulation also contraindicated with polysorbate 80 allergy. Serious allergy requires discontinuation and urgent treatment.
Boxed-warning status
Boxed warning covers embryo-fetal toxicity, lymphoma/other cancers and serious infections. Avoid pregnancy exposure when safer alternatives are available; prevention/planning counseling is essential.
Adverse reactions
Diarrhea, vomiting, abdominal symptoms, leukopenia/anemia and infections are prominent. Combination-regimen trial rates cannot isolate causation. Serious postmarketing marrow, pulmonary, allergy and congenital events have uncertain frequencies.
Drug interactions
Review changes to all immunosuppressive and concurrent medicines.
Absorption and recirculation
Give aluminum/magnesium hydroxide antacids and calcium-free phosphate binders such as sevelamer at least two hours AFTER CellCept. PPIs, bile sequestrants, cyclosporine, rifampin and certain antimicrobials can lower exposure; monitor effectiveness. Glucuronidation modifiers such as telmisartan/isavuconazole can alter exposure.
Renal secretion and contraception
Acyclovir-related antivirals/probenecid can compete with metabolite secretion, especially with renal impairment; monitor adverse effects. Oral contraceptive effectiveness may decrease; additional barrier contraception is required. Do not use absence of a numerical dose rule as permission to combine unsupervised.
Exposure monitoring
MPA concentrations may be useful before/after regimen or interacting-drug changes. No universal therapeutic target, empiric multiplier or fixed interaction-adjustment algorithm is supplied here.
Use in specific populations
Pregnancy prevention and transplant-specific organ assessment are essential.
Reproductive potential
Pregnancy testing immediately before starting and 8–10 days later, then routine follow-up. Acceptable contraception throughout treatment and six weeks afterward; oral pills need a barrier method. Sexually active men and/or female partners should use effective contraception through 90 days after cessation. No blood donation through six weeks or semen donation through 90 days afterward.
Pregnancy and breastfeeding
Pregnancy exposure markedly increases miscarriage and congenital-malformation risk. Report pregnancy immediately, but do not independently stop graft-protective therapy. Human lactation data are limited and cannot exclude infant risk; weigh feeding benefits, maternal need and alternatives with specialists.
Organ impairment and older adults
Severe renal impairment increases metabolite exposure; heart/liver evidence is limited. Kidney recipients with severe hepatic parenchymal disease need no adjustment, but other etiologies and heart-recipient hepatic disease lack adequate data. Older recipients require comorbidity/drug review and may face greater infection/GI risks. No dialysis replacement dose is established.
Clinical pharmacology
A prodrug generates the active IMPDH inhibitor mycophenolic acid.
Mechanism
MPA inhibits de-novo guanosine synthesis and lymphocyte proliferation; the immunosuppressive effect is reversible and increases infection risk.
Disposition
Rapid conversion to MPA; glucuronidation and enterohepatic recirculation influence exposure. MPA is strongly protein bound and elimination mainly occurs as urinary glucuronide. Typical study mean MPA half-life is about 18 hours after oral dosing; dialysis usually removes neither MPA nor metabolite effectively. No plasma half-life determines an individual safe interruption interval.
Monitoring and counseling
Monitor graft function, blood counts, infection and pregnancy prevention.
Monitoring
Label suggests CBC weekly in month one, twice monthly in months two/three, then monthly for the rest of year one. Follow graft/organ function, infection, GI tolerance, inflammatory symptoms and indicated exposure measurements; tailor thereafter. Repeat pregnancy testing/counseling.
Counseling
Read Medication Guide; preserve the prescribed schedule. Seek urgent care for allergy or severe bleeding/abdominal pain and contact the team for infection or new neurologic symptoms. Limit ultraviolet exposure with clothing/sunscreen. Avoid live vaccines, hazardous powder contact and driving when impaired.
Product identification
Verify mofetil strength, route and dispensing preparation.
Representative product identity
CellCept 500 mg lavender caplet engraved CELLCEPT 500/Roche: 100-tablet bottle NDC 0004-0260-01. Other formulations/brands have distinct identifiers.
Dosage forms and strengths
250 mg capsules; 500 mg tablets; 35 g powder for 200 mg/mL suspension; 500 mg-equivalent IV single-dose vial (hydrochloride salt). No unsupervised delayed-release mycophenolic-acid substitution.
Storage and handling
Selected products: 25°C with permitted 15–30°C excursions; tablets in light-resistant containers. Constituted suspension lasts 60 days, may refrigerate 2–8°C, never freeze. IV prepared solutions must begin infusion within four hours; discard leftovers. Use hazardous-drug handling procedures.
References
Original sources for the clinical and product information.
- Genentech / DailyMedCellCept · Current full prescribing information
PI/Medication Guide July 2026; SPL 51 effective August 5, 2026; published August 10, 2026.