Included as part of the PRECAUTIONS section.
Administer GAMASTAN cautiously to patients with a history
of prior systemic allergic reactions following the administration of human immunoglobulin
preparations.11 Have epinephrine available for treatment of acute
allergic symptoms, should they occur.
Do not perform skin tests. In most patients the
intradermal injection of concentrated gamma globulin solution with its buffers
causes a localized area of inflammation which can be misinterpreted as a
positive allergic reaction. In actuality, this does not represent an allergy;
rather, it is localized tissue irritation of a chemical nature.
Misinterpretation of the results of such tests can lead the physician to
withhold beneficial human immunoglobulin from a patient who is not actually
allergic to this material.
Thrombosis may occur following treatment with immune
globulin products, including GAMASTAN.12-14 Risk factors may
include: advanced age, prolonged immobilization, hypercoagulable conditions, history
of venous or arterial thrombosis, use of estrogens, indwelling central vascular
catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may
occur in the absence of known risk factors.
Consider baseline assessment of blood viscosity in
patients at risk for hyperviscosity, including those with cryoglobulins,
fasting chylomicro - nemia/markedly high triacylglycerols (triglycerides), or
monoclonal gammopathies. For patients at risk of thrombosis, do not exceed the recommended
dose of GAMASTAN. Ensure adequate hydration in patients before administration.
Monitor for signs and symptoms of thrombosis and assess blood viscosity in
patients at risk for hyper - viscosity. [see BOXED WARNING, PATIENT INFORMATION]
Inject intramuscularly only. Do not administer GAMASTAN
intravenously because of the potential for serious reactions (e.g., Renal Dysfunction/Failure/Hemolysis,
Transfusion-Related Acute Lung Injury [TRALI]). Do not inject into a blood
vessel. [see DOSAGE AND ADMINISTRATION]
Transmissible Infectious Agents
GAMASTAN is made from human blood and may carry a risk of
transmitting infectious agents, e. g, viruses, the variant Creutzfeldt- Jakob
disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD)
agent. GAMASTAN is purified from human plasma obtained from healthy donors.
When medicinal biological products are administered, infectious diseases due to
transmission of pathogens cannot be totally excluded. However, in the case of
products prepared from human plasma, the risk of transmission of pathogens is
reduced by: (1) epidemiological controls on the donor population and selection of
individual donors by a medical interview and screening of individual donations
and plasma pools for viral infection markers; (2) testing of plasma for
hepatitis C virus (HCV), human immunodeficiency virus (HIV), hepatitis B virus
(HBV), HAV, and human parvovirus (B19V) genomic material; and (3) manufacturing
procedures with demonstrated capacity to inactivate/remove pathogens.
No cases of transmission of viral diseases, vCJD, or CJD
have ever been identified for products manufactured with the same core
manufacturing process as GAMASTAN® (immune globulin (human)). ALL infections suspected
by a physician possibly to have been transmitted by this product should be
reported by the physician or other healthcare provider to Grifols Therapeutics
Use In Specific Populations
There are no data with GAMASTAN use in pregnant women to
inform a drug-associated risk. Animal reproduction studies have not been conducted
with GAMASTAN. It is not known whether GAMASTAN can cause fetal harm when
administered to a pregnant woman or can affect reproduction capacity. In the
U.S. general population, the estimated backgrounds risk of major birth defect and
miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%,
There is no information regarding the presence of
GAMASTAN in human milk, the effect on the breastfed infant, or the effects on
milk production. The developmental and health benefits of breastfeeding should
be considered along with the mother's clinical need for GAMASTAN and any potential
adverse effects on the breastfed infant from GAMASTAN or from the underlying
Safety and effectiveness in the pediatric population have
not been established.
Safety and effectiveness in geriatric population have not
11. Fudenberg HH. Sensitization to immunoglobulins and
hazards of gamma globulin therapy. In: Merler E, editor. Immunoglobulins:
biologic aspects and clinical uses. Washington, DC: National Academy of
Sciences; 1970, p. 211-20.
12. Dalakas MC. High-dose intravenous immunoglobulin and
serum viscosity: risk of precipitating thromboembolic events. Neurology. 1994;44:223-6.
13. Woodruff RK, Grigg AP, Firkin FC, et al. Fatal
thrombotic events during treatment of autoimmune thrombocytopenia with
intravenous immunoglobulin in elderly patients. Lancet. 1986;2:217-8.
14. Wolberg AS, Kon RH, Monroe DM, et al. Coagulation
factor XI is a contaminant in intravenous immunoglobulin preparations. Am J Hematol.