Abbreviated Prescribing Information: Mycophenolate Mofetil 1g/5ml Oral Suspension
Consult Summary of Product Characteristics (SPC) before prescribing.
Presentation: White to off white Oral suspension; Each 5ml containing 1g of Mycophenolate Mofetil Therapeutic Indications: Mycophenolate mofetil is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in adult and paediatric (1 to 18 years) patients receiving allogeneic renal, cardiac or hepatic transplants. Posology and Method of Administration: Treatment with mycophenolate mofetil should be initiated and maintained by appropriately qualified transplant specialists. For Use in renal transplant in adults: Oral mycophenolate mofetil should be initiated within 72 hours following transplantation. The recommended dose in renal transplant patients is 1 g administered twice daily (2 g daily dose), i.e., 5 mL oral suspension twice daily. For use in hepatic transplant in adults: Intravenous mycophenolate mofetil should be administered for the first 4 days following hepatic transplant, with oral mycophenolate mofetil initiated as soon after this as can be tolerated. The recommended oral dose in hepatic transplant patients is 1.5 g administered twice daily (3 g daily dose). For cardiac transplant in adults: Oral mycophenolate mofetil should be initiated within 5 days following transplantation. The recommended dose in cardiac transplant patients is 1.5 g administered twice daily (3 g daily dose). Mycophenolate mofetil is intended for oral administration. Paediatric population (1 to 18 years): The recommended initial dose is 600 mg/m² administered twice daily (maximum total daily dose 2 g or 10 mL oral suspension). If clinically required and tolerated, the dose may be increased to 900 mg/m² twice daily (maximum total daily dose 3 g or 15 mL oral suspension). The dose and product form should be individualised based on clinical assessment. Oral suspension should be used in patients unable to swallow solid dosage forms or with a body surface area below 1.25 m². Temporary dose reduction or interruption may be required depending on clinical factors including severity of adverse reactions. Contra-indications: Mycophenolate mofetil should not be given to patients with hypersensitivity to mycophenolate mofetil, mycophenolic acid or to any of the excipients listed; women of childbearing potential who are not using highly effective contraception; Mycophenolate mofetil treatment should not be initiated in women of childbearing potential without providing a pregnancy test result to rule out unintended use in pregnancy; Mycophenolate mofetil should not be used in pregnancy unless there is no suitable alternative treatment to prevent transplant rejection; Mycophenolate mofetil should not be given to women who are breastfeeding. Special Warnings and Precautions for use: Patients receiving mycophenolate mofetil as part of immunosuppressive therapy are at increased risk of lymphomas and other malignancies, particularly of the skin, and should minimise exposure to sunlight and UV light; they are also at increased risk of serious, opportunistic and sometimes fatal infections, including viral reactivation (e.g. hepatitis B/C, BK virus, JC virus/PML), and should be monitored accordingly; haematological abnormalities such as neutropenia, anaemia and pure red cell aplasia may occur and regular blood count monitoring is required; gastrointestinal adverse reactions including ulceration, haemorrhage and perforation have been reported and caution is advised in patients with active serious gastrointestinal disease; mycophenolate is a potent teratogen associated with a high risk of miscarriage and congenital malformations and strict adherence to pregnancy prevention measures is essential; immunisation may be less effective and live vaccines should be avoided; drug interactions, particularly those affecting enterohepatic recirculation, may alter exposure and require monitoring; hypogammaglobulinaemia, bronchiectasis and pulmonary complications have been reported and persistent respiratory symptoms should be investigated; caution is required in paediatric and elderly patients, who may have an increased risk of adverse reactions, and patients should be instructed to report signs of infection, bleeding or bone marrow suppression immediately. Any warning from the MC, CHM CSM or MHRA. MHRA warning on teratogenic and genotoxic risks, particularly relating to use in pregnancy and in patients of childbearing potential. Please consult risk materials for further details. Black Triangle notice: Not applicable. Legal Category: POM. A list of very common, common, and serious adverse reactions: Very common and common: bacterial infections, fungal infections, viral infections, benign neoplasm of skin, neoplasm, skin cancer, anemia, leucopenia, hypercholesterolemia, ecchymosis, leukocytosis, pancytopenia, thrombocytopenia, acidosis, hyperglycemia, hyperkalemia, hyperlipidemia, hypocalcemia, hypokalemia, hypomagnesemia, hypophosphatemia, hyperuricaemia, gout, weight decreased, confusional state, depression, insomnia, anxiety, dizziness, headache, hypertonia, paresthesia, somnolence, tremor, convulsion, tachycardia, hypertension, hypotension, venous thrombosis, vasodilatation, cough, dyspnea, pleural effusion, abdominal distension, abdominal pain, colitis, constipation, decreased appetite, diarrhea, dyspepsia, esophagitis, eructation, flatulence, gastritis, gastrointestinal haemorrhage, gastrointestinal ulcer, gingival hyperplasia, ileus, mouth ulceration, nausea, stomatitis, vomiting, hypersensitivity, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, hepatic enzyme increased, hepatitis, hyperbilirubinaemia, jaundice, acne, alopecia, rash, skin hypertrophy, arthralgia, muscular weakness, blood creatinine increased, blood urea increased, hematuria, renal impairment, asthenia, chills, edema, hernia, malaise, pain, and pyrexia. Serious adverse reactions include: Lymphoproliferative disorders, lymphoma, hypogammaglobulinaemia, pulmonary fibrosis, bronchiectasis, pancreatitis, bone marrow failure, pure red cell aplasia, protozoal infections as well as some of the events listed above., Please refer to the SPC for full details of adverse events. Pack Size and NHS Price: 175ml – £115.16. Marketing Authorisation Number: PLGB 00427/0272 Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [May-2025]