CYCLOSPORINE, MODFIED- 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:

Apotex Corp.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Kidney, Liver, and Heart Transplantation 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. Rheumatoid Arthritis 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. Psoriasis 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 tol

Product summary:

Cyclosporine capsules, USP (modified) (Soft Gelatin Capsules) 25 mg An oval, opaque grey colored soft gel capsule filled with liquid, printed with "C25" in black ink across one side. Packages of 30 unit-dose blisters (NDC 60505-4630-3). 50 mg An oblong, opaque off-white colored soft gel capsule filled with liquid, printed with "C50" in black ink across one side. Packages of 30 unit-dose blisters (NDC 60505-4631-3). 100 mg An oblong opaque grey colored soft gel capsule filled with liquid, printed with "C100" in black ink across one side. Packages of 30 unit-dose blisters (NDC 60505-4632-3). Store and Dispense Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in original unit-dose container. Cyclosporine Capsules, USP (MODIFIED) (Soft Gelatin Capsules) All registered trademarks in this document are the property of their respective owners. Revised: November 2023 Revision: 4

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYCLOSPORINE, MODFIED- CYCLOSPORINE CAPSULE, LIQUID FILLED
APOTEX CORP.
----------
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 rheumatoid
arthritis patients
taking cyclosporine capsules (modified) to avoid toxicity due to high
concentrati