GENGRAF- cyclosporine capsule

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

AbbVie Inc.

INN (Международно Name):

CYCLOSPORINE

Композиция:

CYCLOSPORINE 50 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Gengraf® Capsules (cyclosporine capsules, USP [MODIFIED ]) is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine (MODIFIED ) has been used in combination with azathioprine and corticosteroids. Gengraf® Capsules (cyclosporine capsules, USP [MODIFIED ]) is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Gengraf® can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone. Gengraf® Capsules (cyclosporine capsules, USP [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 Gengraf® as with other therapies upon cessation of treatment. Gengraf® Capsules (cyclosporine capsules, USP [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 Gengraf® Capsules (cyclosporine capsules, USP [MODIFIED ]). Psoriasis patients who are treated with Gengraf® Capsules (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 Gengraf® .

Каталог на резюме:

25 mg Oval, white imprinted in blue, 25 mg, and the code OR. Packages of 30 unit-dose blisters. (NDC 0074-3108-32). 100 mg Oval, white, with two blue stripes, imprinted in blue, 100 mg, and the code OT. Packages of 30 unit-dose blisters. (NDC 0074-3109-32). In the original unit-dose container at controlled room temperature 68°-77°F (20°-25°C). (See USP Controlled Room Temperature). Sandimmune® is a registered trademark of Novartis Pharmaceuticals Corporation. © AbbVie Inc. 2000-2021  AbbVie Inc., North Chicago, IL 60064, U.S.A. 20067177 February, 2021 

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

GENGRAF- CYCLOSPORINE CAPSULE
ABBVIE INC.
----------
GENGRAF CAPSULES
(CYCLOSPORINE CAPSULES, USP [MODIFIED])
WARNING
ONLY PHYSICIANS EXPERIENCED IN MANAGEMENT OF SYSTEMIC
IMMUNOSUPPRESSIVE THERAPY FOR THE INDICATED DISEASE SHOULD PRESCRIBE
GENGRAF CAPSULES (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 GENGRAF
. 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.
GENGRAF
, A SYSTEMIC IMMUNOSUPPRESSANT, MAY INCREASE THE
SUSCEPTIBILITY TO INFECTION AND THE DEVELOPMENT OF NEOPLASIA. IN
KIDNEY,
LIVER, AND HEART TRANSPLANT PATIENTS GENGRAF 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.
GENGRAF CAPSULES (CYCLOSPORINE CAPSULES, USP [MODIFIED]) HAS
INCREASED BIOAVAILABILITY IN COMPARISON TO SANDIMMUNE SOFT GELATIN
CAPSULES (CYCLOSPORINE CAPSULES, USP). GENGRAF AND SANDIMMUNE ARE
NOT BIOEQUIVALENT AND CANNOT BE USED INTERCHANGEABLY WITHOUT PHYSICIAN
SUPERVISION. FOR A GIVEN TROUGH CONCENTRATION, CYCLOSPORINE EXPOSURE
WILL BE GREATER WITH GENGRAF THAN WITH SANDIMMUNE . IF A PATIENT WHO
IS RECEIVING EXCEPTIONALLY HIGH DOSES OF SANDIMMUNE IS CONVERTED TO
GENGRAF
, PARTICULAR CAUTION SHOULD BE EXERCISED. CYCLOSPORINE BLOOD
CONCENTRATIONS SHOULD BE MONITORED IN TRANSPLANT AND RHEUMATOID
ARTHRITIS PATIENTS TAKING GENGRAF TO AVOID TOXICITY DUE TO HIGH
CONCENTRATIONS. DOSE ADJUSTMENTS SHOULD BE MADE IN TRANSPLANT PATIENTS
TO MINIMIZE POSSIBLE ORGAN REJECTION DUE TO LOW CONCENTRATIONS.
COMPARISON OF BLOOD CONCENTRATIONS IN THE PUBLISHED LITERATURE WITH
BLOOD CONCENTRAT