Contraindications
Pregnancy, lactation. Rare hereditary deficiency of hypoxanthine-guanine phosphoribosyltransferase (HGPRT) (e.g. Kelley-Seegmiller or Lesch-Nyhan syndrome).
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Special Precautions
Patient with active serious gastrointestinal disease, active peptic ulcers. Renal impairment. Children. Avoid abrupt cessation of treatment. Mycophenolate mofetil and mycophenolate sodium are not interchangeable. Patient Counselling This drug may impair physical and mental ability, if affected, do not drive or operate machinery. Do not donate blood or blood products during treatment and for at least 6 months after the last dose. Monitoring Parameters Monitor CBC, LFT, renal function. Perform pregnancy test prior to initiation of therapy; then after 8-10 days in women of child-bearing potential, followed by repeat test during therapy. Monitor for signs and symptoms of infection, neurological symptoms, lymphoma, pure red cell aplasia, and autoimmune haemolytic anaemia.
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Adverse Reactions
Significant: CNS depression, new or reactivation of viral infection, neutropenia, pure red cell aplasia, gastric or duodenal ulcers, gastrointestinal bleeding and/or perforation, myasthenia gravis (abrupt discontinuation of treatment).
Blood and lymphatic system disorders: Leucopenia, thrombocytopenia, anaemia, pancytopenia, leukocytosis.
Cardiac disorders: Tachycardia.
Gastrointestinal disorders: Vomiting, abdominal pain, diarrhoea, nausea, dysgeusia.
General disorders and administration site conditions: Oedema, pyrexia, chills, pain, malaise, asthenia.
Infections and infestations: Sepsis, gastrointestinal candidiasis, UTI, herpes simplex, herpes zoster.
Investigations: Increased hepatic enzymes.
Metabolism and nutrition disorders: Acidosis, gout, anorexia.
Musculoskeletal and connective tissue disorders: Arthralgia.
Neoplasms benign, malignant and unspecified: Skin cancer, benign skin neoplasm.
Nervous system disorders: Convulsion, hypertonia, tremor, somnolence, dizziness, headache, paraesthesia.
Psychiatric disorders: Agitation, confusional state, depression, anxiety, abnormal thinking, insomnia.
Respiratory, thoracic and mediastinal disorders: Pleural effusion, dyspnoea, cough.
Skin and subcutaneous tissue disorders: Skin hypertrophy, rash, acne, alopecia.
Vascular disorders: Hypertension, hypotension, vasodilation.
Potentially Fatal: Infections (e.g. progressive multifocal leukoencephalopathy, meningitis, infectious endocarditis), pulmonary fibrosis. |
Drug Interactions
Mycophenolate mofetil may increase plasma concentration of aciclovir. Reduced absorption with antacids, polycarbophil calcium, sevelamer, colestyramine. Reduced MPA exposure with ciclosporin, antibiotics (e.g. aminoglycosides, cephalosporin, fluroquinolone, penicillins). Increased MPA exposure with isavuconazole, telmisartan. May reduce the efficacy of live attenuated vaccines.
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CIMS Class
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ATC Classification
L04AA06 - mycophenolic acid ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
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