MOFILET-S 360

Indications

• Prevention of organ rejection in kidney transplants
• Prevention of organ rejection in heart transplants
• Prevention of organ rejection in liver transplants

Dosage

Children: For paediatric patients, mycophenolate dosing is based on body surface area and typically starts at 600 mg/m² taken twice daily. Adjustments may be made according to clinical response. For specific paediatric dosing recommendations, refer to BNF for Children.

Adults: The usual initial dose of mycophenolate mofetil for adults is 1 g taken twice daily, which may be adjusted based on clinical response and tolerability. Dosage can vary based on the specific transplant type and patient condition. Refer to BNF for detailed dosing guidelines.

Mechanism of action

Mycophenolate works by inhibiting inosine monophosphate dehydrogenase (IMPDH), which is crucial for the de novo synthesis pathway of purine nucleotides in lymphocytes. This inhibition selectively affects lymphocytes, as they rely on this pathway for proliferation more than other cell types, leading to reduced lymphocyte counts and a suppressed immune response.

Pharmacodynamics

The pharmacodynamics of mycophenolate involve its selective inhibition of lymphocyte activation and proliferation, which is critical in preventing acute rejection in organ transplantation. By decreasing the number of activated T and B lymphocytes, mycophenolate effectively reduces the likelihood of graft rejection while maintaining some degree of immune function to protect against infections.

Pharmacokinetics

Mycophenolate is rapidly absorbed after oral administration, with peak plasma concentrations occurring within 1-2 hours. It undergoes extensive first-pass metabolism in the liver, resulting in the active metabolite mycophenolic acid. The drug is primarily eliminated via glucuronidation and is excreted in urine. Its plasma half-life is approximately 16-18 hours, although this can vary based on individual patient factors and concurrent medications.

Contra-indications

• Hypersensitivity to mycophenolate or any of its components
• Pregnancy (except in specific cases where benefits outweigh risks)

Adverse effects

• Gastrointestinal disturbances (nausea, vomiting, diarrhea)
• Increased risk of infections
• Hematological toxicity (such as leukopenia, anemia, thrombocytopenia)
• Headache
• Hypertension
• Elevated liver enzymes

Interactions

• rifampicin+mycophenolate: Moderate (decreases concentration)
• mycophenolate+aciclovir: Unknown (increases risk of haematological toxicity)
• isavuconazole+mycophenolate: Unknown (increases exposure)
• mycophenolate+ganciclovir: Unknown (increases risk of haematological toxicity)
• live vaccines+mycophenolate: Unknown (increases risk of generalised infection, possibly life-threatening)
• mycophenolate+valaciclovir: Unknown (increases risk of haematological toxicity)
• mycophenolate+valganciclovir: Unknown (increases risk of haematological toxicity)

Precautions

• Monitor for signs of infection due to immunosuppression
• Regular blood count monitoring to detect hematological toxicity
• Use with caution in patients with renal impairment
• Assess risk of malignancy and cardiovascular disease in long-term use

Pregnancy

Use in pregnancy should be avoided unless the potential benefits justify the risks to the fetus.

Breast-feeding

It is not known whether mycophenolate is excreted in human milk. Caution is advised when administered to nursing women.

Storage

Store in a cool, dry place, away from light. Keep out of reach of children.

Formulations

• Mycophenolate mofetil capsules
• Mycophenolate mofetil tablets
• Mycophenolate mofetil oral suspension