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:

Mayne Pharma Inc.

INN (International Name):

CYCLOSPORINE

Composition:

CYCLOSPORINE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cyclosporine capsules, USP [MODIFIED] and cyclosporine oral solution, USP [MODIFIED] are indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine capsules, USP [MODIFIED] and cyclosporine oral solution, USP [MODIFIED] have been used in combination with azathioprine and corticosteroids. Cyclosporine capsules, USP [MODIFIED] and cyclosporine oral solution, 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] and cyclosporine oral solution, 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] and cyclosporine oral solution, USP [MODIFIED] are indicated for the treatment of adult, nonimmunocompromised patients with severe (i.e., extensive and/or disabling), recalcitrant, plaque pso

Product summary:

A light yellow liquid supplied in 50 mL bottles containing 100 mg/mL and a 4 mL dosing syringe with case. In the original container at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Do not store in the refrigerator. Once opened, the contents must be used within two months. At temperatures below 68°F (20°C) the solution may gel; light flocculation or the formation of a light sediment or flakes may also form. Allow contents to reach room temperature to reverse these effects. There is no impact on product performance or dose.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYCLOSPORINE- CYCLOSPORINE CAPSULE, LIQUID FILLED
MAYNE PHARMA INC.
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CYCLOSPORINE CAPSULES, USP [MODIFIED](SOFT GELATIN)
CYCLOSPORINE ORAL SOLUTION, USP [MODIFIED]
REVISED: MARCH 2021
RX ONLY
PRESCRIBING INFORMATION
WARNING
ONLY PHYSICIANS EXPERIENCED IN MANAGEMENT OF SYSTEMIC
IMMUNOSUPPRESSIVE THERAPY FOR THE INDICATED DISEASE SHOULD PRESCRIBE
CYCLOSPORINE [MODIFIED]. AT DOSES USED IN SOLID ORGAN TRANSPLANTATION,
ONLY PHYSICIANS EXPERIENCED IN IMMUNOSUPPRESSIVE THERAPY AND
MANAGEMENT OF ORGAN TRANSPLANT RECIPIENTS SHOULD PRESCRIBE
CYCLOSPORINE [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 [MODIFIED], A SYSTEMIC IMMUNOSUPPRESSANT, MAY INCREASE
THE SUSCEPTIBILITY TO INFECTION AND THE DEVELOPMENT OF NEOPLASIA. IN
KIDNEY, LIVER, AND HEART TRANSPLANT PATIENTS, CYCLOSPORINE [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] AND CYCLOSPORINE ORAL SOLUTION
[MODIFIED] HAVE INCREASED BIOAVAILABILITY IN COMPARISON TO
SANDIMMUNE® SOFT GELATIN CAPSULES (CYCLOSPORINE CAPSULES) AND
SANDIMMUNE® ORAL SOLUTION (CYCLOSPORINE ORAL SOLUTION). CYCLOSPORINE
[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
[MODIFIED] THAN WITH SANDIMMUNE® . IF A PATIENT WHO IS RECEIVING
EXCEPTIONALLY HIGH DOSES OF SANDIMMUNE® IS CONVERTED TO CYCLOSPORINE
[MODIFIED], PARTICULAR CAUTION SHOULD BE EXERCISED. CYCLOSPORINE BLOOD
CONCENTRATIONS SHOULD BE MONITORED IN TRANSPLANT AND RHEUMATOID
ARTHRITIS PATIENTS TAKIN