Myfortic 360 mg gastro-resistant tablets

Dosage

Children: Refer to specific drug information for detailed dosage recommendations.

Adults: Refer to specific drug information for detailed dosage recommendations.

Mechanism of action

The mechanism of action varies depending on the specific drug that 'contains' certain active ingredients. Each compound will have its own unique pharmacological pathway and target within the body, which can include receptor modulation, enzyme inhibition, or other biochemical interactions.

Pharmacodynamics

Pharmacodynamics will depend on the active ingredients in the formulation. It generally encompasses the biochemical and physiological effects of the drug and its mechanisms of action, including the relationship between drug concentration and effect.

Pharmacokinetics

Pharmacokinetics involves the absorption, distribution, metabolism, and excretion of the specific active ingredients within the formulation. This can vary significantly based on the drug's chemical properties, route of administration, and individual patient factors.

Pregnancy

Consult with a healthcare provider before use, as safety during pregnancy has not been established.

Breast-feeding

Consult with a healthcare provider before use, as it is not known if this drug is excreted in human milk.

Storage

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

Indications

• Prophylaxis of organ rejection in kidney transplantation
• Prophylaxis of organ rejection in heart transplantation
• Prophylaxis of organ rejection in liver transplantation
• Treatment of systemic lupus erythematosus
• Treatment of rheumatoid arthritis

Dosage

Children: Refer to BNF for Children for specific dosing guidelines.

Adults: Refer to BNF for specific dosing guidelines.

Mechanism of action

Mycophenolic acid exerts its effects primarily by inhibiting inosine monophosphate dehydrogenase (IMPDH), which is crucial in the de novo pathway of purine synthesis. This leads to decreased lymphocyte proliferation, particularly affecting T and B lymphocytes, which rely heavily on this pathway for their proliferation and function.

Pharmacodynamics

The inhibition of IMPDH results in reduced synthesis of purines, which are essential for the proliferation of lymphocytes. This immunosuppressive action helps to prevent graft rejection in transplant patients and controls autoimmune conditions. Mycophenolate mofetil (MMF), a prodrug of mycophenolic acid, is often used due to its enhanced bioavailability and safety profile.

Pharmacokinetics

Mycophenolic acid is rapidly absorbed after oral administration, with peak plasma concentrations occurring approximately 1 to 2 hours post-dose. It is extensively metabolized in the liver, primarily to its active form, mycophenolic acid. The drug has a half-life of approximately 16 to 18 hours, and its elimination is predominantly via the renal route. Dosing adjustments may be necessary in patients with renal impairment.

Contra-indications

• Hypersensitivity to mycophenolate mofetil or any component of the formulation
• Pregnant women, due to the risk of teratogenicity
• Active infections, particularly viral infections such as cytomegalovirus (CMV)

Adverse effects

• Gastrointestinal disturbances such as nausea, vomiting, and diarrhea
• Increased risk of infections due to immunosuppression
• Bone marrow suppression leading to leukopenia and thrombocytopenia
• Elevated liver enzymes
• Renal impairment

Interactions

• Antacids and cholestyramine may reduce absorption of mycophenolate
• Concomitant use with other immunosuppressants increases the risk of infections and malignancies
• Certain antibiotics, such as rifampicin, may affect mycophenolate metabolism

Precautions

• Monitor white blood cell counts regularly due to the risk of leukopenia
• Assess for signs of infection, especially in patients on long-term therapy
• Use caution in patients with a history of gastrointestinal disorders
• Avoid pregnancy during treatment and provide effective contraception

Pregnancy

Mycophenolate is contraindicated in pregnancy due to significant risks of fetal malformations and pregnancy loss. Women of childbearing potential must use effective contraception during treatment.

Breast-feeding

Mycophenolate is excreted in breast milk; caution is recommended when administering to breastfeeding mothers as potential adverse effects on the infant are possible.

Storage

Store at room temperature, away from moisture and light. Keep out of reach of children.

Formulations

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