Mycophenolate Mofetil

Source: UK SPC (eMC) for CellCept 1 g/5 mL powder for oral suspension, §4.2 (https://www.medicines.org.uk/emc/product/1569/smpc). Treatment should be initiated and maintained by appropriately qualified transplant specialists, in combination with ciclosporin and corticosteroids. HEPATIC TRANSPLANT: intravenous mycophenolate mofetil should be administered for the first 4 days following hepatic transplant, with oral mycophenolate mofetil initiated as soon after this as it can be tolerated (IV dosing is not given in this oral-suspension SPC — source the IV product SPC separately if needed). ELDERLY: the recommended dose of 1 g twice a day for renal transplant patients and 1.5 g twice a day for cardiac or hepatic transplant patients is appropriate for the elderly. TREATMENT DURING REJECTION EPISODES: renal transplant rejection does not lead to changes in mycophenolic acid (MPA) pharmacokinetics, so dose reduction or interruption is not required; there is no basis for dose adjustment following cardiac transplant rejection; no pharmacokinetic data are available during hepatic transplant rejection, and no data are available for treatment of first or refractory rejection in paediatric transplant patients. HANDLING: mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits — avoid inhalation or direct contact of the dry powder with skin or mucous membranes, and direct contact of the reconstituted suspension with skin; if contact occurs wash thoroughly with soap and water and rinse eyes with plain water. PAEDIATRIC (dosing is per BODY SURFACE AREA, not per kg, so paedDose is null — verify against a children's formulary before any under-18 use): for paediatric renal, cardiac and hepatic transplant patients aged 1 to 18 years the recommended initial dose is 600 mg/m2 BSA orally twice daily, with an initial total daily dose not to exceed 2 g (or 10 mL of the oral suspension); the dose and product form should be individualised on clinical assessment. If the recommended initial dose is well tolerated but does not achieve clinically adequate immunosuppression in paediatric cardiac and hepatic transplant patients, the dose can be increased to 900 mg/m2 BSA twice daily (maximum total daily dose 3 g, or 15 mL of the oral suspension). The recommended maintenance dose for paediatric renal transplant patients remains 600 mg/m2 twice daily (maximum total daily dose 2 g, or 10 mL). The powder for oral suspension should be used in patients unable to swallow capsules and tablets and/or with a BSA lower than 1.25 m2 due to the increased risk of choking; patients with a BSA of 1.25 to 1.5 m2 may be prescribed capsules at 750 mg twice daily (1.5 g daily dose), and patients with a BSA greater than 1.5 m2 capsules or tablets at 1 g twice daily (2 g daily dose). BSA is calculated with the Mosteller formula, and the SPC Table 1 gives the mg-to-mL conversions using the oral dispenser (graduations of 0.25 mL, corresponding to 50 mg increments; doses above 5 mL to be composed from two draws of at least 1 mL each). Different oral formulations should not be substituted without clinical supervision. Some adverse reactions occur with greater frequency in this age group, so temporary dose reduction or interruption may be required. The eMC bundle did not include §4.5, so the interactions listed below are taken from the US FDA label §7 (openFDA), which was truncated at the source-fetch limit — verify against the UK SPC §4.5.