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Important Safety Information
Gamunex, Immune Globulin Intravenous
(Human), 10% Caprylate/Chromatography
Purified, is indicated for the
treatment of primary humoral
immunodeficiency disease (PI),
idiopathic thrombocytopenic purpura
(ITP), and chronic inflammatory
demyelinating polyneuropathy (CIDP).
Gamunex is contraindicated in
individuals with known anaphylactic
or severe systemic response to
Immune Globulin (Human).
Immune Globulin Intravenous (Human)
(IGIV) products have been reported
to be associated with renal
dysfunction, acute renal failure,
osmotic nephrosis and death.
Patients should be instructed to
immediately report symptoms of
decreased urine output, sudden
weight gain, fluid retention/edema,
and/or shortness of breath (which
may suggest kidney damage) to their
physicians.
While these
reports of renal dysfunction and
acute renal failure have been
associated with the use of many of
the licensed IGIV products, those
containing sucrose as a stabilizer
accounted for a disproportionate
share of the total number. Gamunex
does not contain sucrose. Glycine, a
natural amino acid, is used as a
stabilizer.
There have been
reports of noncardiogenic pulmonary
edema [Transfusion-Related Lung
Injury (TRALI)], hemolytic anemia,
and aseptic meningitis in patients
administered with IGIV. Thrombotic
events have been reported in
association with IGIV. Patients at
risk for thrombotic events may
include those with a history of
atherosclerosis, multiple
cardiovascular risk factors,
advanced age, impaired cardiac
output, and/or known or suspected
hyperviscosity. Hyperproteinemia,
increased serum viscosity, and
hyponatremia may occur in patients
receiving IGIV therapy.
Gamunex is made
from human plasma. As with all
plasma-derived therapeutics, the
potential to transmit infectious
agents, such as viruses and
theoretically, the Creutzfeldt-Jakob
(CJD) agent that can cause disease,
cannot be totally eliminated. There
is also the possibility that unknown
infectious agents may be present in
such products.
Please speak to your doctor and refer to
Gamunex Prescribing Information for full details.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch or call 1-800-FDA-1088.
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