GENGRAF cyclosporine capsule

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Cardinal Health

INN (Internationale Bezeichnung):

CYCLOSPORINE

Zusammensetzung:

CYCLOSPORINE 25 mg

Verschreibungstyp:

PRESCRIPTION DRUG

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

GENGRAF- CYCLOSPORINE CAPSULE
CARDINAL HEALTH
----------
GENGRAF® CAPSULES
(CYCLOSPORINE CAPSULES
USP [MODIFIED])
WARNING
Only physicians experienced in the 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
c