mycophenolic acid as mycophenolate sodium: clinical use

Prescribing considerations

• Initiation and maintenance should be under an appropriately qualified transplant specialist.
• Assess pregnancy potential, testing and contraception before initiation.
• Review vaccination status and avoid live attenuated vaccines during treatment.
• Consider cumulative immunosuppression, infection and malignancy risk; advise ultraviolet protection.
• Use caution with active serious gastrointestinal disease, severe renal impairment, recurrent infection or persistent respiratory symptoms.
• Patients should not donate blood during treatment or for six weeks afterwards; men should not donate semen during treatment or for 90 days afterwards.

Contraindications and cautions

• Hypersensitivity to mycophenolate sodium, mycophenolic acid, mycophenolate mofetil or an excipient
• Pregnancy unless no suitable alternative can prevent transplant rejection
• Women who could become pregnant without highly effective contraception or without pregnancy exclusion before initiation
• Breastfeeding
• Rare hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption because the tablets contain lactose

Monitoring

• Before treatment, assess pregnancy status where relevant, full blood count, renal and liver function, blood pressure, albumin and vaccination status.
• Continue regular full blood count and renal and liver biochemical monitoring.
• Investigate recurrent infections for hypogammaglobulinaemia when clinically appropriate.
• Monitor persistent cough or breathlessness for bronchiectasis or interstitial lung disease.
• Monitor patients with previous hepatitis B or C for clinical and laboratory evidence of reactivation.

Clinical pharmacology

Mycophenolate sodium releases mycophenolic acid, a selective, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase. Suppression of de novo guanosine nucleotide synthesis particularly restricts T- and B-lymphocyte proliferation.

Formulation and product differences

• The selected formulation is a gastro-resistant, enteric-coated tablet intended to delay release until beyond the stomach.
• Mycophenolate sodium and mycophenolate mofetil have different pharmacokinetic profiles and should not be substituted indiscriminately.
• The tablets contain lactose and sodium.

Gastro-resistant tablet

Route: Oral

Strengths: 180 mg, 360 mg