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:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cyclosporine capsules (modified) is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine capsules (modified) has been used in combination with azathioprine and corticosteroids. Cyclosporine capsules (modified) is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Cyclosporine capsules (modified) can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone. Cyclosporine capsules (modified) is 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 (modified) as with other therapies upon cessation of treatment. Cyclosporine capsules (modified) is 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, (modified). Psoriasis patients who are treated with cyclosporine capsules (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, (modified). Although no adequate and well-controlled studies have been completed in children, transplant recipients as young as one year of age have received cyclosporine capsules (modified) with no unusual adverse effects. The safety and efficacy of cyclosporine capsules (modified) treatment in children with juvenile rheumatoid arthritis or psoriasis below the age of 18 have not been established. In rheumatoid arthritis clinical trials with cyclosporine, 17.5% of patients were age 65 or older. These patients were more likely to develop systolic hypertension on therapy, and more likely to show serum creatinine rises ≥ 50% above the baseline after 3 to 4 months of therapy. Clinical studies of cyclosporine capsules (modified) in transplant and psoriasis patients did not include a sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experiences have not identified differences in response 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:

Cyclosporine capsules, USP (modified) (Soft Gelatin Capsules) 25 mg Blue gray colored opaque oval shaped soft gelatin capsule imprinted as 'S 25' in red color ink, containing clear to cloudy pale yellow colored oily liquid. Packages of 30 unit-dose blisters (NDC 23155-837-30). 50 mg White colored opaque oblong shaped soft gelatin capsule imprinted as 'S 50' in red color ink, containing clear to cloudy pale yellow colored oily liquid Packages of 30 unit-dose blisters (NDC 23155-838-30). 100 mg Blue gray colored opaque oblong shaped soft gelatin capsule imprinted as 'S 100' in red color ink, containing clear to cloudy pale yellow colored oily liquid. Packages of 30 unit-dose blisters (NDC 23155-839-30). Store and Dispense In the original unit-dose container at controlled room temperature 68°F to 77°F (20°C to 25°C). Cyclosporine Capsules, USP (MODIFIED) (Soft Gelatin Capsules) All registered trademarks in this document are the property of their respective owners. Manufactured by: Strides Pharma Science Limited. Bengaluru – 562106, India Manufactured for: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) Revised: 09/2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYCLOSPORINE - CYCLOSPORINE CAPSULE, LIQUID FILLED
HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.
----------
CYCLOSPORINE, MODIFIED - CYCLOSPORINE CAPSULE, LIQUID FILLED
CYCLOSPORINE CAPSULES, USP (MODIFIED)
(SOFT GELATIN CAPSULES)
RX ONLY
PRESCRIBING INFORMATION
WARNING
Only physicians experienced in management of systemic
immunosuppressive
therapy for the indicated disease should prescribe cyclosporine
capsules,
(modified). At doses used in solid organ transplantation, only
physicians
experienced in immunosuppressive therapy and management of organ
transplant
recipients should prescribe cyclosporine capsules, (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, (modified), a systemic immunosuppressant, may
increase
the susceptibility to infection and the development of neoplasia. In
kidney, liver, and
heart transplant patients cyclosporine capsules, (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, (modified) have increased bioavailability in
comparison to
Sandimmune Soft Gelatin Capsules (cyclosporine capsules, USP) [NON-
MODIFIED]. Cyclosporine capsules, (modified) and Sandimmune are not
bioequivalent and cannot be used interchangeably without physician
supervision.
For a given trough concentration, cyclosporine exposure will be
greater with
cyclosporine capsules, (modified) than with Sandimmune . If a patient
who is
receiving exceptionally high doses of Sandimmune is converted to
cyclosporine
capsules, (modified), particular caution should be exercised.
Cyclosporine blood
concentrations should be monitored in transplant and r