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Sandimmune Injection Generic Name & Formulations
Legal Class
Rx
General Description
Cyclosporine 50mg/mL; soln for IV infusion; contains alcohol, Cremophor EL (polyoxyethylated castor oil).
Pharmacological Class
Immunosuppressant.
See Also
How Supplied
Caps—3x10 blister cards; Soln—50mL; Inj (5mL)—10
Manufacturer
Sandimmune Injection Indications
Indications
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.
Sandimmune Injection Dosage and Administration
Adult
Observe continuously for the first 30mins after start of infusion and frequently thereafter. Give by slow IV infusion over 2–6hrs. Administer IV at ⅓ oral dose. Initially 5–6mg/kg/day as a single dose given 4–12hrs prior to transplantation; continue same IV dose post-op until capsules or oral soln can be tolerated. Switch to oral dosage forms as soon as possible after surgery. Adjunct corticosteroid therapy is recommended. Conversion from Neoral, blood concentration monitoring: see full labeling.
Children
See full labeling.
Sandimmune Injection Contraindications
Contraindications
IV: hypersensitivity to Cremophor EL.
Sandimmune Injection Boxed Warnings
Boxed Warning
Prescribe only by physicians experienced in immunosuppressive therapy. May increase risk of infections, lymphomas and other malignancies. Decreased bioavailability compared to Neoral; do not use interchangeably.
Sandimmune Injection Warnings/Precautions
Warnings/Precautions
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.
Sandimmune Injection Pharmacokinetics
See Literature
Sandimmune Injection Interactions
Interactions
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.
Sandimmune Injection Adverse Reactions
Adverse Reactions
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.
Sandimmune Injection Clinical Trials
See Literature
Sandimmune Injection Note
Not Applicable
Sandimmune Injection Patient Counseling
See Literature
