Mycophenolate Mofetil Abbreviated Prescribing Information

Abbreviated Prescribing Information: Mycophenolate Mofetil 1g/5ml Oral Suspension Consult Summary of Product Characteristics 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 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 it 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: For use in renal transplant in Paediatric population aged 2 to 18 years the recommended dose of mycophenolate mofetil is 600 mg/m2 administered twice daily (up to a maximum of 2 g/10 mL oral suspension daily). As some adverse reactions occur with greater frequency in this age group compared with adults, temporary dose reduction or interruption may be required; these will need to consider relevant clinical factors including severity of reaction. Paediatric population < 2 years there are limited safety and efficacy data in children below the age of 2 years. These are insufficient to make dosage recommendations and therefore use in this age group is not recommended. No data are available for paediatric cardiac transplant patients. No data are available for paediatric hepatic transplant patients. 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 negative 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 prescribed to women who are breastfeeding. Special Warnings and Precautions for use: Patients receiving immunosuppressive regimens involving combinations of medicinal products, including mycophenolate mofetil, are at increased risk of developing lymphomas and other malignancies, particularly of the skin; patients treated with mycophenolate mofetil are at increased risk for opportunistic infections (bacterial, fungal, viral and protozoal), fatal infections and sepsis. Such infections include latent viral reactivation, such as hepatitis B or hepatitis C reactivation and infections caused by polyomaviruses (BK virus-associated nephropathy, JC virus associated progressive multifocal leukoencephalopathy PML); Mycophenolic acid has a cytostatic effect on B- and T-lymphocytes, therefore an increased severity of COVID-19 may occur, and appropriate clinical action should be considered; There have been reports of hypogammaglobulinaemia in association with recurrent infections, bronchiectasis, pure red cell aplasia (PRCA) in patients receiving mycophenolate mofetil in combination with other immunosuppressants; There have also been isolated reports of interstitial lung disease and pulmonary fibrosis, some of which were fatal. Patients receiving mycophenolate mofetil should be monitored for neutropenia; Patients taking mycophenolate mofetil should have complete blood counts weekly during the first month, twice monthly for the second and third months of treatment, then monthly through the first year. Patients receiving mycophenolate mofetil should be instructed to report immediately any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow failure. Patients should be advised, that during treatment with mycophenolate mofetil, vaccinations may be less effective, and the use of live attenuated vaccines should be avoided; Mycophenolate mofetil has been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration, haemorrhage and perforation. Mycophenolate mofetil should be avoided in patients with Lesch-Nyhan and Kelley-Seegmiller syndrome; Caution should be exercised when switching combination therapy from regimens containing immunosuppressants (e.g. tacrolimus, sirolimus, belatacept, or vice versa), Drugs which interfere with Mycophenolate mofetil’s enterohepatic cycle (e.g. cholestyramine, antibiotics) should be used with caution due to their potential to reduce plasma levels and efficacy of mycophenolate mofetil. Therapeutic drug monitoring of MPA may be appropriate when switching combination therapy. It is recommended that mycophenolate mofetil should not be administered concomitantly with azathioprine; The risk/benefit ratio of mycophenolate mofetil in combination with sirolimus has not been established. Elderly patients may be at an increased risk of adverse events such as certain infections (including cytomegalovirus tissue invasive disease) and possibly gastrointestinal haemorrhage and pulmonary oedema, compared with younger individuals; Mycophenolate mofetil has teratogenic effects and is contraindicated in pregnancy unless there are no suitable alternative treatments to prevent transplant rejection. Spontaneous abortion (rate of 45% to 49%) and congenital malformations (estimated rate of 23% to 27%) have been reported following MMF exposure during pregnancy. Every effort to avoid pregnancy during treatment should be taken. Full patient information about the teratogenic risk and the pregnancy prevention measures should be given by the physician to women of childbearing potential, including those who inadvertently become pregnant during treatment, and, as appropriate, to male patients. Patients should not donate blood during therapy or for at least 6 weeks following discontinuation of mycophenolate. Men should not donate semen during therapy or for 90 days following discontinuation of mycophenolate. Any warning from the MC, CHM CSM or MHRA. No. Black Triangle notice: Not applicable. Legal Category: POM. The list of common and serious adverse reactions: Bacterial infections, Fungal infections, Protozoal infections, Viral infections, Benign neoplasm of skin, Lymphoma, Lymphoproliferative disorder, Neoplasm, Skin cancer, Anemia, Aplasia pure red cell, Bone marrow failure, Ecchymosis, Leukocytosis, Leucopenia, Pancytopenia, Pseudolymphoma, Thrombocytopenia, Acidosis, Hypercholesterolemia, Hyperglycemia, Hyperkalemia, Hyperlipidemia, Hypocalcaemia, Hypokalaemia, Hypomagnesemia, Hypophosphatemia, Hyperuricaemia, Gout, Weight decreased, Confusional state, Depression, Insomnia, Agitation, Anxiety, Thinking abnormal, Dizziness, Headache, Hypertonia, Paresthesia, Somnolence, Tremor, Convulsion, Dysgeusia,Tachycardia, Hypertension, Hypotension, Lymphocele, Venous thrombosis, Vasodilatation, Bronchiectasis, Cough, Dyspnea, Interstitial lung disease, Pleural effusion, Pulmonary fibrosis, Abdominal distension, Abdominal pain, Colitis, Constipation, Decreased appetite, Diarrhoea, Dyspepsia, Esophagitis, Eructation, Flatulence, Gastritis, Gastrointestinal haemorrhage, Gastrointestinal ulcer, Gingival hyperplasia, Ileus, Mouth ulceration, Nausea, Pancreatitis, Stomatitis, Vomiting, Hypersensitivity, Hypogammaglobulinaemia, 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, Pyrexia, and De novo purine synthesis inhibitors associated acute inflammatory syndrome. Refer to the SmPC for full details of other adverse reactions. 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: [August-2025].