SANDIMMUNE- cyclosporine capsule, liquid filled SANDIMMUNE- cyclosporine injection SANDIMMUNE- cyclosporine solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CYCLOSPORINE (UNII: 83HN0GTJ6D) (CYCLOSPORINE - UNII:83HN0GTJ6D)

Available from:

Novartis Pharmaceuticals Corporation

INN (International Name):

CYCLOSPORINE

Composition:

CYCLOSPORINE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sandimmune (cyclosporine) is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. It is always to be used with adrenal corticosteroids. The drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents. Because of the risk of anaphylaxis, Sandimmune Injection (cyclosporine injection, USP) should be reserved for patients who are unable to take the soft gelatin capsules or oral solution. Sandimmune Injection (cyclosporine injection, USP) is contraindicated in patients with a hypersensitivity to Sandimmune (cyclosporine) and/or Cremophor® EL (polyoxyethylated castor oil). Although no adequate and well-controlled studies have been conducted in children, patients as young as 6 months of age have received the drug with no unusual adverse effects. Clinical studies of Sandimmune (cyclosporine) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Product summary:

Sandimmune® Soft Gelatin Capsules (cyclosporine capsules, USP) 25 mg: Oval, pink, branded “ 78/240”. Unit dose packages of 30 capsules,       3 blister cards of 10 capsules………………………………………………………….NDC 0078-0240-15 100 mg: Oblong, dusty rose, branded “ 78/241”. Unit dose packages of 30 capsules,       3 blister cards of 10 capsules………………………………………………………….NDC 0078-0241-15 Store and Dispense: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature] . An odor may be detected upon opening the unit dose container, which will dissipate shortly thereafter. This odor does not affect the quality of the product. Sandimmune ® Oral Solution (cyclosporine oral solution, USP) Supplied in 50 mL bottles containing 100 mg of cyclosporine per mL       NDC 0078-0110-22 A dosage syringe is provided for dispensing. Store and Dispense: In the original container at temperatures below 30°C (86°F). Do not store in the refrigerator. Protect from freezing. Once opened, the contents must be used within 2 months. Sandimmune ® Injection (cyclosporine injection, USP) FOR INTRAVENOUS INFUSION Supplied as a 5 mL sterile ampul containing 50 mg of cyclosporine per mL,       in boxes of 10 ampuls…………………………………………………………………..NDC 0078-0109-01 Store and Dispense: At temperatures below 30°C (86°F). Protect from light. FOR INFUSION ONLY *Cremophor® is the registered trademark of BASF Aktiengesellschaft. Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 © Novartis Revised: September 2023 T2023-72

Authorization status:

New Drug Application

Summary of Product characteristics

SANDIMMUNE- CYCLOSPORINE CAPSULE, LIQUID FILLED
SANDIMMUNE- CYCLOSPORINE INJECTION
SANDIMMUNE- CYCLOSPORINE SOLUTION
NOVARTIS PHARMACEUTICALS CORPORATION
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SANDIMMUNE SOFT GELATIN CAPSULES
_(CYCLOSPORINE CAPSULES, USP)_
SANDIMMUNE ORAL SOLUTION
_(CYCLOSPORINE ORAL SOLUTION, USP)_
SANDIMMUNE INJECTION
_(CYCLOSPORINE INJECTION, USP)_
_FOR INFUSION ONLY_
RX ONLY
PRESCRIBING INFORMATION
WARNING
ONLY PHYSICIANS EXPERIENCED IN IMMUNOSUPPRESSIVE THERAPY AND
MANAGEMENT OF ORGAN TRANSPLANT PATIENTS SHOULD PRESCRIBE SANDIMMUNE
(CYCLOSPORINE). PATIENTS RECEIVING THE DRUG SHOULD BE MANAGED IN
FACILITIES EQUIPPED AND STAFFED WITH ADEQUATE LABORATORY AND
SUPPORTIVE
MEDICAL RESOURCES. THE PHYSICIAN RESPONSIBLE FOR MAINTENANCE THERAPY
SHOULD HAVE COMPLETE INFORMATION REQUISITE FOR THE FOLLOW-UP OF THE
PATIENT.
SANDIMMUNE (CYCLOSPORINE) SHOULD BE ADMINISTERED WITH ADRENAL
CORTICOSTEROIDS BUT NOT WITH OTHER IMMUNOSUPPRESSIVE AGENTS.
INCREASED SUSCEPTIBILITY TO INFECTION AND THE POSSIBLE DEVELOPMENT OF
LYMPHOMA MAY RESULT FROM IMMUNOSUPPRESSION.
SANDIMMUNE SOFT GELATIN CAPSULES (CYCLOSPORINE CAPSULES, USP) AND
SANDIMMUNE ORAL SOLUTION (CYCLOSPORINE ORAL SOLUTION, USP) HAVE
DECREASED BIOAVAILABILITY IN COMPARISON TO NEORAL SOFT GELATIN
CAPSULES
(CYCLOSPORINE CAPSULES, USP) MODIFIED AND NEORAL ORAL SOLUTION
(CYCLOSPORINE ORAL SOLUTION, USP) MODIFIED.
SANDIMMUNE AND NEORAL ARE NOT BIOEQUIVALENT AND CANNOT BE USED
INTERCHANGEABLY WITHOUT PHYSICIAN SUPERVISION.
THE ABSORPTION OF CYCLOSPORINE DURING CHRONIC ADMINISTRATION OF
SANDIMMUNE SOFT GELATIN CAPSULES AND ORAL SOLUTION WAS FOUND TO BE
ERRATIC. IT IS RECOMMENDED THAT PATIENTS TAKING THE SOFT GELATIN
CAPSULES
OR ORAL SOLUTION OVER A PERIOD OF TIME BE MONITORED AT REPEATED
INTERVALS
FOR CYCLOSPORINE BLOOD CONCENTRATIONS AND SUBSEQUENT DOSE ADJUSTMENTS
BE MADE IN ORDER TO AVOID TOXICITY DUE TO HIGH CONCENTRATIONS AND
POSSIBLE ORGAN REJECTION DUE TO LOW ABSORPTION OF CYCLOSPORINE. THIS
IS OF
SPECIAL IMPORTANCE IN LIVER TRANSPLANTS. NUMEROUS ASSAYS ARE BEING
DEVELOPED TO MEASURE