CYCLOSPORINE MODIFIED- cyclosporine capsule, liquid filled

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

CYCLOSPORINE

Composition:

CYCLOSPORINE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cyclosporine Capsules USP MODIFIED are indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine Capsules USP MODIFIED have been used in combination with azathioprine and corticosteroids. Cyclosporine Capsules USP MODIFIED are indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Cyclosporine Capsules USP MODIFIED can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone. Cyclosporine Capsules USP MODIFIED are indicated for the treatment of adult, nonimmunocompromised patients with severe (i.e., extensive and/or disabling), recalcitrant, plaque psoriasis who have failed to respond to at least one systemic therapy (e.g., PUVA, retinoids, or methotrexate) or in patients for whom other systemic therapies are contraindicated, or cannot be tolerated. While rebound rarely occurs, most patients will experience relapse with Cyclosporine Capsules USP MODIFIED as with other therapies upon cessation of treatment. Cyclosporine Capsules USP MODIFIED are contraindicated in patients with a hypersensitivity to cyclosporine or to any of the ingredients of the formulation. Rheumatoid arthritis patients with abnormal renal function, uncontrolled hypertension, or malignancies should not receive Cyclosporine Capsules USP MODIFIED. Psoriasis patients who are treated with Cyclosporine Capsules USP MODIFIED should not receive concomitant PUVA or UVB therapy, methotrexate or other immunosuppressive agents, coal tar or radiation therapy. Psoriasis patients with abnormal renal function, uncontrolled hypertension, or malignancies should not receive Cyclosporine Capsules USP MODIFIED.

Product summary:

Cyclosporine Capsules USP MODIFIED are available as yellow soft gelatin (oval 5) capsules, filled with yellowish to yellow-brown oily liquid, printed “Ivax hourglass logo” and “25 mg”, containing 25 mg Cyclosporine, USP MODIFIED and 15.8% v/v (12.4% wt./vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-9018-65). Cyclosporine Capsules USP MODIFIED are available as ochre-yellow soft gelatin (oblong 11) capsules, filled with yellowish to yellow-brown oily liquid, printed “Ivax hourglass logo” and “50 mg”, containing 50 mg Cyclosporine, USP MODIFIED and 15.8% v/v (12.4% wt./vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-9019-65). Cyclosporine Capsules USP MODIFIED are available as brown soft gelatin (oblong 20) capsules, filled with yellowish to yellow-brown oily liquid, printed “Ivax hourglass logo” and “100 mg”, containing 100 mg Cyclosporine, USP MODIFIED and 15.8% v/v (12.4% wt./vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 capsules (NDC 0093-9020-65). Store and Dispense PHARMACIST: Dispense in original unit-dose container. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA. Manufactured In Czech Republic By: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rev. K 3/2021

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYCLOSPORINE MODIFIED- CYCLOSPORINE CAPSULE, LIQUID FILLED
TEVA PHARMACEUTICALS USA, INC.
REFERENCE LABEL SET ID: 32B61EE9-A262-42E5-A878-F0D373B0AE76
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CYCLOSPORINE CAPSULES USP MODIFIED
(SOFT GELATIN CAPSULES)
RX ONLY
WARNING
ONLY PHYSICIANS EXPERIENCED IN MANAGEMENT OF SYSTEMIC
IMMUNOSUPPRESSIVE THERAPY FOR THE INDICATED DISEASE SHOULD PRESCRIBE
CYCLOSPORINE CAPSULES USP MODIFIED. AT DOSES USED IN SOLID ORGAN
TRANSPLANTATION, ONLY PHYSICIANS EXPERIENCED IN IMMUNOSUPPRESSIVE
THERAPY AND MANAGEMENT OF ORGAN TRANSPLANT RECIPIENTS SHOULD
PRESCRIBE CYCLOSPORINE CAPSULES USP MODIFIED. 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.
CYCLOSPORINE CAPSULES USP MODIFIED, A SYSTEMIC IMMUNOSUPPRESSANT,
MAY INCREASE THE SUSCEPTIBILITY TO INFECTION AND THE DEVELOPMENT OF
NEOPLASIA. IN KIDNEY, LIVER, AND HEART TRANSPLANT PATIENTS
CYCLOSPORINE
CAPSULES USP MODIFIED MAY BE ADMINISTERED WITH OTHER
IMMUNOSUPPRESSIVE AGENTS. INCREASED SUSCEPTIBILITY TO INFECTION AND
THE
POSSIBLE DEVELOPMENT OF LYMPHOMA AND OTHER NEOPLASMS MAY RESULT
FROM THE INCREASE IN THE DEGREE OF IMMUNOSUPPRESSION IN TRANSPLANT
PATIENTS.
CYCLOSPORINE CAPSULES USP MODIFIED HAVE INCREASED BIOAVAILABILITY IN
COMPARISON TO SANDIMMUNE (CYCLOSPORINE CAPSULES USP). CYCLOSPORINE
CAPSULES USP MODIFIED AND SANDIMMUNE (CYCLOSPORINE CAPSULES USP)
ARE NOT BIOEQUIVALENT AND CANNOT BE USED INTERCHANGEABLY WITHOUT
PHYSICIAN SUPERVISION. FOR A GIVEN TROUGH CONCENTRATION, CYCLOSPORINE
EXPOSURE WILL BE GREATER WITH CYCLOSPORINE CAPSULES USP MODIFIED THAN
WITH SANDIMMUNE (CYCLOSPORINE CAPSULES USP). IF A PATIENT WHO IS
RECEIVING EXCEPTIONALLY HIGH DOSES OF SANDIMMUNE (CYCLOSPORINE
CAPSULES USP) IS CONVERTED TO CYCLOSPORINE CAPSULES USP MODIFIED,
PARTICULAR CAUTION SHOULD BE EXERCISED. CYCLOSPORINE BLOOD
CONCENTRATIONS SHOULD BE MONITORED IN TRANSPLANT AND