CellCept

Treatment should be initiated and maintained by appropriately qualified transplant specialists. Posology Adults Renal transplant Treatment 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).

Cardiac transplant Treatment should be initiated within 5 days following transplantation. 5 g administered twice daily (3 g daily dose). Hepatic transplant Treatment of 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.

5 g administered twice daily (3 g daily dose). Paediatric population (1 to 18 years) The paediatric dosing information in this section applies to all oral formulations within the range of mycophenolate mofetil products, as appropriate.

Different oral formulations should not be substituted without clinical supervision. The recommended mycophenolate mofetil initial dose for paediatric renal, cardiac and hepatic transplant patients is 600 mg/m2 (of body surface area (BSA)), administered orally, twice daily (initial total daily dose not to exceed 2 g, or 10 ml of the oral suspension).

3 The dose and product form should be individualised based 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 of 3 g, or 15 ml of the oral suspension).

The recommended maintenance dose for paediatric renal transplant patients remains at 600 mg/m2 twice daily (maximum total daily dose of 2 g or 10 ml of the oral suspension). 25 m2 due to the increased risk of choking. 5 g daily dose).

5 m2 may be prescribed mycophenolate mofetil capsules or tablets at a dose of 1 g twice daily (2 g daily dose). 8) compared with adults, temporary dose reduction or interruption may be required; these will need to take into account relevant clinical factors including severity of reaction.

5 g twice a day for cardiac or hepatic transplant patients is appropriate for the elderly. 73 m2), outside the immediate post-transplant period, doses greater than 1 g administered twice a day should be avoided. These patients should also be carefully observed.

1%) were among the most common and/or serious adverse reactions associated with the administration of mycophenolate mofetil in combination with ciclosporin and corticosteroids. 4). Tabulated list of adverse reactions The adverse reactions from clinical trials and post-marketing experience are listed in Table 1, by MedDRA system organ class (SOC) along with their frequencies.

The corresponding frequency category for each adverse reaction is based on the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1 000 to <1/100), rare (≥1/10 000 to <1/1 000), very rare (<1/10 000) and not known (cannot be estimated from the available data).

Due to the large differences observed in the frequency of certain adverse reactions across the different transplant indications, the frequency is presented separately for renal, hepatic and cardiac transplant patients. Table 1 Adverse reactions in studies investigating mycophenolate mofetil treatment in adults and adolescents, or through post-marketing surveillance Adverse reaction (MedDRA) System Organ Class Renal transplant Hepatic transplant Cardiac transplant Frequency Frequency Frequency Infections and infestations Bacterial infections Very Common Very Common Very Common Fungal infections Common Very Common Very Common 12 Adverse reaction (MedDRA) System Organ Class Renal transplant Hepatic transplant Cardiac transplant Protozoal infections Uncommon Uncommon Uncommon Viral infections Very Common Very Common Very Common Neoplasms benign, malignant and unspecified (including cysts and polyps) Benign neoplasm of skin Common Common Common Lymphoma Uncommon Uncommon Uncommon Lymphoproliferative disorder Uncommon Uncommon Uncommon Neoplasm Common Common Common Skin cancer Common Uncommon Common Blood and lymphatic system disorders Anaemia Very Common Very Common Very Common Aplasia pure red cell Uncommon Uncommon Uncommon Bone marrow failure Uncommon Uncommon Uncommon Ecchymosis Common Common Very Common Leukocytosis Common Very Common Very Common Leukopenia Very Common Very Common Very Common Pancytopenia Common Common Uncommon Pseudolymphoma Uncommon Uncommon Common Thrombocytopenia Common Very Common Very Common Metabolism and nutrition disorders Acidosis Common Common Very Common Hypercholesterolaemia Very Common Common Very Common Hyperglycaemia Common Very Common Very Common Hyperkalaemia Common Very Common Very Common Hyperlipidaemia Common Common Very Common Hypocalcaemia Common Very Common Common Hypokalaemia Common Very Common Very Common Hypomagnesaemia Common Very Common Very Common Hypophosphataemia Very Common Very Common Common Hyperuricaemia Common Common Very Common Gout Common Common Very Common Weight decreased Common Common Common Psychiatric disorders Confusional state Common Very Common Very Common Depression Common Very Common Very Common Insomnia Common Very Common Very Common Agitation Uncommon Common Very Common Anxiety Common Very Common Very Common Thinking abnormal Uncommon Common Common Nervous system disorders Dizziness Common Very Common Very Common Headache Very Common Very Common Very Common Hypertonia Common Common Very Common 13 Adverse reaction (MedDRA) System Organ Class Renal transplant Hepatic transplant Cardiac transplant Paresthesia Common Very Common Very Common Somnolence Common Common Very Common Tremor Common Very Common Very Common Convulsion Common Common Common Dysgeusia Uncommon Uncommon Common Cardiac disorders Tachycardia Common Very Common Very Common Vascular disorders Hypertension Very Common Very Common Very Common Hypotension Common Very Common Very Common Lymphocele Uncommon Uncommon Uncommon Venous thrombosis Common Common Common Vasodilatation Common Common Very Common Respiratory, thoracic and mediastinal disorders Bronchiectasis Uncommon Uncommon Uncommon Cough Very Common Very Common Very Common Dyspnoea Very Common Very Common Very Common Interstitial lung disease Uncommon Very Rare Very Rare Pleural effusion Common Very Common Very Common Pulmonary fibrosis Very Rare Uncommon Uncommon Gastrointestinal disorders Abdominal distension Common Very Common Common Abdominal pain Very Common Very Common Very Common Colitis Common Common Common Constipation Very Common Very Common Very Common Decreased appetite Common Very Common Very Common Diarrhoea Very Common Very Common Very Common Dyspepsia Very Common Very Common Very Common Esophagitis Common Common Common Eructation Uncommon Uncommon Common Flatulence Common Very Common Very Common Gastritis Common Common Common Gastrointestinal haemorrhage Common Common Common Gastrointestinal ulcer Common Common Common Gingival hyperplasia Common Common Common Ileus Common Common Common Mouth ulceration Common Common Common Nausea Very Common Very Common Very Common Pancreatitis Uncommon Common Uncommon Stomatitis Common Common Common Vomiting Very Common Very Common Very Common Immune system disorders Hypersenstivity Uncommon Common Common 14 Adverse reaction (MedDRA) System Organ Class Renal transplant Hepatic transplant Cardiac transplant Anaphylactic reactions Not known Not known Not known Hypogammaglobulinaemia Uncommon Very Rare Very Rare Hepatobiliary disorders Blood alkaline phosphatase increased Common Common Common Blood lactate dehydrogenase increased Common Uncommon Very Common Hepatic enzyme increased Common Very Common Very Common Hepatitis Common Very Common Uncommon Hyperbilirubinaemia Common Very Common Very Common Jaundice Uncommon Common Common Skin and subcutaneous tissue disorders Acne Common Common Very Common Alopecia Common Common Common Rash Common Very Common Very Common Skin hypertrophy Common Common Very Common Musculoskeletal and connective tissue disorders Arthralgia Common […]

8). The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent. As general advice to minimise the risk for skin cancer, exposure to sunlight and UV light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.

8). 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).

Cases of hepatitis due to reactivation of hepatitis B or hepatitis C have been reported in carrier patients treated with immunosuppressants. These infections are often related to a high total immunosuppressive burden and may lead to serious or fatal conditions that physicians should consider in the differential diagnosis in immunosuppressed patients with deteriorating renal function or neurological symptoms.

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 in patients receiving mycophenolate mofetil in combination with other immunosuppressants.

In some of these cases, switching mycophenolate mofetil to an alternative immunosuppressant resulted in serum IgG levels returning to normal. Patients on mycophenolate mofetil who develop recurrent infections should have their serum immunoglobulins measured.

In cases of sustained, clinically relevant hypogammaglobulinaemia, appropriate clinical action should be considered taking into account the potent cytostatic effects that mycophenolic acid has on T- and B-lymphocytes. There have been published reports of bronchiectasis in adults and children who received mycophenolate mofetil in combination with other immunosuppressants.

1. 8). 6). 6). 6). 6).