Generic Name and Formulations:
Cyclosporine 25mg, 100mg; soft gel caps; contains alcohol.
Novartis Pharmaceuticals Corp
Indications for SANDIMMUNE:
Organ rejection prophylaxis in kidney, liver, and heart allogeneic transplants, in combination with corticosteroids. Treatment of chronic rejection in patients previously treated with other immunosuppressants. IV: reserved for patients who are unable to take caps or oral soln.
Give consistently with regard to meals and time of day. Initially 15mg/kg as a single dose given 4–12hrs prior to transplantation. Continue initial daily dose for 1–2wks post-op then taper by 5% per week to maintenance dose of 5–10mg/kg/day. Adjunct corticosteroid therapy is recommended. Oral soln: dilute with room temp milk, chocolate milk, or orange juice before administration; avoid switching diluents frequently. Conversion from Neoral, blood concentration monitoring: see full labeling.
See full labeling.
IV: hypersensitivity to Cremophor EL.
Be fully familiar with immunosuppressive therapy before prescribing. Not bioequivalent to all other forms of cyclosporine; do not interchange without physician supervision. Increased risk of infections, lymphomas and other malignancies (eg, skin). Monitor BP, renal and hepatic function. Control hypertension if develops. Malabsorption. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.
Avoid other nephrotoxic drugs (eg, ciprofloxacin, gentamicin, tobramycin, vancomycin, SMX/TMP, melphalan, amphotericin B, ketoconazole, cimetidine, ranitidine, tacrolimus, NSAIDs, colchicine), fibric acid derivatives, methotrexate. Cyclosporine levels increased by CYP3A inhibitors (eg, calcium channel blockers, amiodarone, azithromycin, azole antifungals, erythromycin, clarithromycin, quinupristin/dalfopristin, boceprevir, telaprevir, methylprednisolone, allopurinol, colchicine, bromocriptine, danazol, metoclopramide, probably indinavir, saquinavir, nelfinavir, ritonavir, imatinib, nefazodone, oral contraceptives). Avoid alcohol, grapefruit juice. Cyclosporine levels decreased by CYP3A inducers (eg, nafcillin, rifampin, carbamazepine, oxcarbazepine, bosentan (avoid), phenobarbital, phenytoin, octreotide, sulfinpyrazone, terbinafine, ticlopidine, St. John's wort), orlistat. Avoid potassium-sparing diuretics. Caution with concomitant rifabutin. Concomitant repaglinide: monitor blood glucose. Concomitant aliskiren: not recommended. Concomitant sirolimus: separate by 4 hours. May decrease effectiveness of vaccines; avoid live attenuated vaccines. May increase levels of digoxin (monitor), colchicine, statins (reduce dose), ambrisentan, and anthracycline antibiotics, dabigatran (avoid). Gingival hyperplasia with nifedipine. Convulsions with high-dose methylprednisolone.
Renal dysfunction, tremor, hirsutism, hypertension, gum hyperplasia, cramps, convulsions, headache, diarrhea, nausea, vomiting; increased risk of infections or malignancies, progressive multifocal leukoencephalopathy, polyoma virus-associated nephropathy, hypomagnesemia, hyperkalemia, hyperuricemia, thrombotic microangiopathy, hepatotoxicity, neurotoxicity; IV: anaphylactic reactions.
Caps—3x10 blister cards; Soln—50mL; Inj (5mL)—10