Mycophenolate mofetil
Mycophenolate mofetil (CellCept)
Mycophenolate mofetil
( my-koh- FEN-oh-layt)
Pregnancy Category: C CellCept CellCept IV (Rx)

Classification: Immunosuppressant

Action/Kinetics: Rapidly absorbed after PO administration and hydrolyzed to the active mycophenolic acid (MPA). MPA has potent cytostatic effects on lymphocytes. Inhibits proliferative responses of T- and B-lymphocytes to both mitogenic and allospecific stimulation. MPA also suppresses antibody formation of B-lymphocytes. MPA and additional metabolites are excreted in the urine. t 1/2: 17.9 hr.

Uses: With cyclosporine and corticosteroids to prevent organ rejection in those receiving allogeneic renal or heart transplants. Investigational: Refractory uveitis.

Contraindications: Hypersensitivity to mycophenolate, mycophenolic acid, or polysorbate 80 (Tween). Lactation.

Special Concerns: Clients receiving immunosuppressant drugs have increased susceptibility to infection and are at a higher risk of developing lymphomas and other malignancies, especially of the skin. Higher blood levels are seen in those with severe impaired renal function. Use with caution in active serious digestive system disease. Safety and efficacy have not been determined in children.

Side Effects: Hematologic: Severe neutropenia, anemia, leukopenia, thrombocytopenia, hypochromic anemia, leukocytosis. GI: GI tract hemorrhage/perforations GI tract ulceration, diarrhea, constipation, nausea, dyspepsia, vomiting, oral moniliasis, anorexia, esophagitis, flatulence, gastritis, gastroenteritis, GI moniliasis, gingivitis, gum hyperplasia, hepatitis, ileus, infection, mouth ulceration, rectal disorder. CNS: Tremor, insomnia, dizziness, anxiety, depression, hypertonia, paresthesia, somnolence. GU: UTI, hematuria, kidney tubular necrosis, urinary tract disorder, albuminuria, dysuria, hydronephrosis, impotence, pain, pyelonephritis, urinary frequency. CV: Hypertension, angina pectoris, atrial fibrillation, cardiovascular disorder, hypotension, palpitation, peripheral vascular disorder, postural hypotension, tachycardia, thrombosis, vasodilation. Respiratory: Infection, dyspnea, increased cough, pharyngitis, bronchitis, pneumonia, asthma, lung disorder, lung edema, pleural effusion, rhinitis, sinusitis. Dermatologic: Acne, rash, alopecia, fungal dermatitis, hirsutism, pruritus, benign skin neoplasm, skin disorder, skin hypertrophy, skin ulcer, sweating. Metabolic/Endocrine: Peripheral edema, dehydration, hypercholesterolemia, hypophosphatemia, edema, hypokalemia, hyperkalemia, hyperglycemia, diabetes mellitus, parathyroid disorder. Musculoskeletal: Arthralgia, joint disorder, leg cramps, myalgia, myasthenia. Ophthalmologic: Amblyopia, cataract, conjunctivitis. Body as a whole: Pain, abdominal pain, fever, chills, headache, infection, malaise, sepsis asthenia, chest pain, back pain. Miscellaneous: Increased incidence of lymphoma/lymphoproliferative disease, nonmelanoma skin carcinoma, and other malignancies. Increased incidence of opportunistic infections, including herpes simplex, CMV, herpes zoster, Candida, Aspergillus/Mucor invasive disease, and Pneumocystis carinii. Enlarged abdomen, accidental injury, cyst, facial edema, flu syndrome, hemorrhage hernia, weight gain, pelvic pain, ecchymosis, polycythemia.

Laboratory Test Alterations: Alkaline phosphatase, creatinine, gamma glutamyl transpeptidase, LDH, AST, ALT. Also, hypercalcemia, hyperlipemia, hyperuricemia, hypervolemia, hypocalcemia, hypoglycemia, hypoproteinemia, acidosis.

Overdose Management: Symptoms: Nausea, vomiting, diarrhea, hematologic abnormalities, especially neutropenia. Treatment: Reduce dose of the drug. Removal of MPA by bile acid sequestrants (e.g., cholestyramine).

Drug Interactions: Acyclovir / Plasma levels of both drugs due to competition for renal tubular excretion Antacids containing aluminum/ magnesium / Absorption of mycophenolate Cholestyramine / Absorption of mycophenolate Echinacea / Do not give with mycophenolate Ganciclovir / Plasma levels of both drugs due to competition for renal tubular excretion Phenytoin / Plasma protein binding of phenytoin free phenytoin levels Probenecid / Significant plasma levels of MPA Salicylates / Free fraction of MPA Theophylline / Plasma protein binding of theophylline free theophylline levels

How Supplied: Capsules: 250 mg; Powder for Injection: 500 mg; Tablets: 500 mg

Dosage
?Capsules, IV, Tablets Prevent rejection following allogeneic renal transplants.
Adults: 1 g b.i.d. in combination with corticosteroids and cyclosporine.
Prevent rejection following allogeneic heart transplants.
Adults: 1.5 g b.i.d. with corticosteroids and cyclosporine.