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:

Actavis Pharma, Inc.

INN (International Name):

CYCLOSPORINE

Composition:

CYCLOSPORINE 25 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYCLOSPORINE- CYCLOSPORINE CAPSULE, LIQUID FILLED
CYCLOSPORINE- CYCLOSPORINE SOLUTION
ACTAVIS PHARMA, INC.
----------
CYCLOSPORINE CAPSULES, USP [MODIFIED] (SOFT GELATIN)
CYCLOSPORINE ORAL SOLUTION, USP [MODIFIED]
REVISED: JANUARY 2015
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 tran