mycophenolate mofetil(redirected from RS-61443)
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mycophenolate mofetil hydrochloride
Pharmacologic class: Mycophenolic acid derivative
Therapeutic class: Immunosuppressant
Pregnancy risk category D
FDA Box Warning
• Increased susceptibility to infection and possible lymphoma development may result from immunosuppression. Give drug under supervision of physician experienced in immunosuppressive therapy and management of renal, cardiac, or hepatic transplant patients, in facility with adequate diagnostic and treatment resources. Physician responsible for maintenance therapy should have complete information needed for patient follow-up.
• Use of CellCept during pregnancy is associated with increased risk of pregnancy loss and congenital malformations. Female patients of childbearing potential who are taking CellCept must use contraception.
Inhibits binding of interleukin (IL)-1 to IL-1 receptors, preventing proliferation and differentiation of activated B and T cells. Binds to intracellular proteins to prevent T-cell activation, suppressing immune responses.
Capsules: 250 mg
Injection: 500 mg/vial
Oral suspension: 200 mg/ml (after constitution)
Tablets: 500 mg
Tablets (delayed-release): 180 mg, 360 mg
Indications and dosages
➣ To prevent organ rejection in patients receiving allogeneic kidney transplants
Adults: 1 g P.O. or I.V. b.i.d. or 720 mg P.O. b.i.d. (delayed-release), given with corticosteroids and cyclosporine
Children: 400 mg/m2 P.O. b.i.d. (delayed-release), up to a maximum of 720 mg b.i.d.; or 600 mg/m2 P.O. b.i.d., up to a maximum daily dosage of 2 g/10 ml (oral suspension). Given with corticosteroids and cyclosporine.
➣ To prevent organ rejection in patients receiving allogeneic heart transplants
Adults: 1.5 g P.O. or I.V. b.i.d., given with corticosteroids and cyclosporine. May start I.V. therapy less than 24 hours after transplantation; switch to P.O. dosing when tolerated.
➣ To prevent organ rejection in patients receiving allogeneic liver transplants
Adults: 1.5 g b.i.d. P.O. or 1 g I.V. b.i.d., given with corticosteroids and cyclosporine
• Severe chronic renal impairment
• Hypersensitivity to drug or its components, mycophenolic acid, or polysorbate 80 (I.V. form)
Use cautiously in:
• lymphoma, cancer, neutropenia, renal disease, or GI disorders
• elderly patients
• pregnant or breastfeeding patients
• children (indicated for kidney transplant only).
• Give P.O. form at least 1 hour before or 2 hours after meals. To enhance absorption, don't give with other drugs.
• Give delayed-released tablets whole. Don't let patient crush or chew them.
• Know that pharmacist should mix oral solution before dispensing.
☞ Be aware that drug is teratogenic. Avoid inhaling powder in capsules or letting powder contact skin, mucous membranes, or eyes. If contact occurs, wash skin thoroughly with soap and water or flush eyes with water.
• Know that delayed-release tablets aren't interchangeable with immediate-release tablets, capsules, or oral suspension.
• For I.V. use, reconstitute with dextrose 5% in water and dilute to 6 mg/ml. Administer over 2 hours.
☞ Don't give by rapid I.V. push or bolus.
CNS: headache, dizziness, insomnia, asthenia, tremor
CV: chest pain, hypertension, peripheral edema
EENT: pharyngitis, oral moniliasis
GI: nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, GI hemorrhage
GU: urinary tract infection, hematuria, renal tubular necrosis
Hematologic: anemia, hypochromic anemia, leukocytosis, leukopenia, thrombocytopenia
Metabolic: hypophosphatemia, hyperglycemia, hypokalemia, hyperkalemia
Musculoskeletal: back pain
Respiratory: dyspnea, cough, bronchitis, pneumonia
Skin: acne, rash
Other: pain, fever, opportunistic infections, fatal infections, sepsis, lymphoma and other cancers (especially of skin)
Drug-drug. Acyclovir, ganciclovir, other drugs that undergo renal tubular secretion: increased risk of toxicity from either drug
Antacids containing aluminum or magnesium: decreased mycophenolate absorption
Cholestyramine: reduced mycophenolate bioavailability
Hormonal contraceptives: reduced contraceptive efficacy
Phenytoin, theophylline: increased blood levels of both drugs
Probenecid, salicylates: increased mycophenolate blood level
Drug-diagnostic tests. Cholesterol: increased level
Drug-herbs. Astragalus, echinacea, melatonin: interference with immunosuppressant effect
• Monitor CBC with white cell differential, electrolyte levels, lipid panel, blood chemistry, and liver function tests frequently.
• Evaluate vital signs. Assess cardiovascular and respiratory status carefully. Watch for signs and symptoms of bronchitis and pneumonia.
☞ Assess all body systems carefully for signs and symptoms of infection.
☞ Monitor patient closely for bleeding tendency.
• Advise patient to take oral drug at least 1 hour before or 2 hours after meals. Tell him not to crush, break, or chew tablets, not to open or chew capsules, and not to take with other drugs.
☞ If capsule breaks, tell patient not to inhale powder or let it contact skin, mucous membranes, or eyes. If contact occurs, tell him to wash skin thoroughly with soap and water or flush eyes with water.
☞ Instruct patient to take his temperature and promptly report fever or other signs or symptoms of infection. Tell him to immediately report unusual bleeding or bruising.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• Instruct patient to avoid crowds and people with known infections.
• Advise patient not to take herbs without consulting prescriber.
• Tell patient to avoid live-virus vaccines.
☞ Instruct patient to avoid excessive exposure to sunlight and ultraviolet light, because of increased risk of skin cancer.
☞ Tell female patient to use abstinence or two other contraceptive methods during and for 6 weeks after therapy (even if she has a history of infertility). Urge her to report suspected pregnancy immediately.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and herbs mentioned above.
mycophenolate mofetilA mycophenolic ester used as a therapeutic immunosuppressant, which is similar to, but less toxic than, azathioprine. Mycophenolate mofetil inhibits purine metabolism in T and B cells, and lymphocyte proliferation in vitro.
Prevent or manage GVHD, rejection of heart, kidney, lung and other allograft transplants, autoimmune disorders (e.g., Behçet disease, pemphigus vulgaris, systemic lupus erythematosus).
Hyperglycaemia, hypercholesterolaemia, increased BUN, potassium, leukopaenia, anaemia, diarrhoea, emesis.