mycophenolate mofetil hydrochloride: clinical use

Prescribing considerations

• Initiate and maintain treatment under an appropriately qualified transplant specialist.
• Assess infection burden, vaccination status, gastrointestinal disease, malignancy risk and interacting medicines.
• Provide pregnancy-prevention counselling and pregnancy testing where applicable.
• Avoid live attenuated vaccines; vaccine responses may be diminished.
• Do not permit blood donation during treatment or for six weeks afterwards, or semen donation during treatment or for 90 days afterwards.

Contraindications and cautions

• Hypersensitivity to mycophenolate mofetil, mycophenolic acid or an excipient
• Allergy to polysorbate 80
• Pregnancy unless no suitable alternative can prevent transplant rejection
• Breastfeeding
• A patient of childbearing potential without reliable contraception or the required negative pregnancy test

Monitoring

• Full blood count, including neutropenia and other cytopenias
• Renal function, liver function, albumin and blood pressure
• Infection, graft dysfunction, gastrointestinal toxicity and malignancy
• Pregnancy testing where relevant
• Serum immunoglobulins if recurrent infections develop

Clinical pharmacology

Mycophenolate mofetil is rapidly converted after intravenous administration to mycophenolic acid. It selectively and reversibly inhibits IMPDH and de novo guanosine nucleotide synthesis, with a comparatively strong cytostatic effect on T and B lymphocytes.

Formulation and product differences

• The selected vial contains the hydrochloride salt as a powder for intravenous concentrate.
• It requires aseptic reconstitution and dilution with glucose intravenous infusion.
• The prepared solution is for slow infusion only, not rapid or bolus administration.
• It is an intravenous alternative to oral formulations; transitions should remain specialist-directed.
• It contains polysorbate 80, which can cause allergic reactions.

Solution for infusion

Route: Intravenous

Strengths: 500 mg