Mycophenolate Mofetil: Brands, Price & Uses in Bangladesh

Mycophenolate Mofetil is indicated for the following uses:

Established / FDA-approved uses

• Prophylaxis of organ rejection in patients receiving allogeneic kidney transplants, in combination with cyclosporine (or tacrolimus) and corticosteroids.
• Prophylaxis of organ rejection in patients receiving allogeneic heart transplants, in combination with other immunosuppressants.
• Prophylaxis of organ rejection in patients receiving allogeneic liver transplants, in combination with other immunosuppressants.

Guideline-supported / commonly used off-label uses

• Induction and maintenance therapy of lupus nephritis (Class III-V), as part of a combination immunosuppressive regimen, based on treatment guidelines.
• Other autoimmune and inflammatory conditions (e.g., certain forms of vasculitis, autoimmune hepatitis, some dermatologic autoimmune disorders) where used off-label under specialist supervision.

Mycophenolate Mofetil is always used in combination with other immunosuppressive agents and must be prescribed and monitored by a physician experienced in transplant medicine or the relevant autoimmune condition.

Dosage of Mycophenolate Mofetil must be individualized according to indication, organ transplanted, and clinical/laboratory response, and should only be adjusted by the treating physician.

Renal transplantation (adults)

• 1 g orally twice daily (total 2 g/day), usually started within 72 hours of transplantation.

Cardiac transplantation (adults)

• 1.5 g orally twice daily (total 3 g/day).

Hepatic transplantation (adults)

• 1.5 g orally twice daily (total 3 g/day).

Lupus nephritis (off-label, per guideline use)

• Induction phase: approximately 1-1.5 g twice daily, individualized.
• Maintenance phase: lower doses (e.g., 0.5-1 g twice daily), individualized by response.

Pediatric renal transplant (3 months of age and older)

• Body-surface-area-based dosing: approximately 600 mg/m² orally twice daily, up to a maximum of 2 g/day, using the oral suspension or tablets as appropriate.

Administration

• Take on an empty stomach when possible for consistency, though it may be taken with food if gastrointestinal upset occurs.
• Swallow tablets/capsules whole; do not crush, chew, or open capsules, and avoid inhaling any powder from broken tablets/capsules due to teratogenic potential.
• Space doses evenly (e.g., every 12 hours).
• Take exactly as prescribed by your physician; do not stop, change, or skip doses without medical advice, given the risk of organ rejection.

Renal impairment

In patients with severe chronic renal impairment (GFR less than 25 mL/min/1.73 m²) outside the immediate post-transplant period, doses above 1 g twice daily should be avoided, and patients should be monitored closely.

Hepatic impairment

No dose adjustment is required for hepatic transplant recipients with hepatic parenchymal disease, but clinical monitoring is advised.

Common and serious side effects of Mycophenolate Mofetil include:

Very common

• Diarrhea and other gastrointestinal disturbances (nausea, vomiting, abdominal pain) - can be severe and dose-limiting.
• Leukopenia and other blood count abnormalities.
• Increased susceptibility to bacterial, viral (including CMV, herpes), fungal, and opportunistic infections.

Common

• Headache, tremor, insomnia.
• Hypertension, peripheral edema.
• Elevated liver enzymes.

Serious (less common but important)

• Severe neutropenia, anemia, thrombocytopenia (requires regular blood monitoring).
• Increased risk of lymphoma and other malignancies (particularly skin cancers) due to chronic immunosuppression.
• Progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection.
• Gastrointestinal bleeding or perforation (rare).
• Pure red cell aplasia (rare).

Patients should promptly report fever, unusual bruising/bleeding, persistent diarrhea, or signs of infection to their physician.