GAMASTAN Solution for injection Ref.[10819] Active ingredients: Human normal immunoglobulin G

5.1 Hypersensitivity Reactions

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.

5.2 Thrombosis

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 chylomicronemia/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 hyperviscosity [see Boxed Warning, Patient Counseling Information (17)].

5.3 Systemic Reactions

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 (2.3)].

5.4 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. 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 LLC [1-800-520-2807].

The most common adverse reaction reported for GAMASTAN S/D during post-approval use was fatigue.

The following adverse reactions have been identified during post-approval use with GAMASTAN made using the previous manufacturing process, GAMASTAN S/D. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Among patients treated with GAMASTAN S/D, cases of allergic/hypersensitivity reactions including anaphylaxis have been reported. Anaphylactic reactions, although rare, have been reported following the injection of human immune globulin preparations.(11) Anaphylaxis was more likely to occur if GAMASTAN S/D was given intravenously; therefore, GAMASTAN S/D and GAMASTAN must be administered only intramuscularly.

The following have been identified as the most frequently reported post-marketing adverse reactions.

Immune system disorders: Anaphylactic reaction*, hypersensitivity*

Nervous system disorders: Headache

Gastrointestinal disorders: Nausea

General disorders and administration site conditions: Injection site pain, injection site inflammation, fatigue, pyrexia

^* These reactions have been manifested by rash, flushing, and dyspnea

Antibodies in GAMASTAN may interfere with the response to live virus vaccines such as measles, mumps, polio, rubella, and varicella. Defer live vaccine administration for up to 6 months after GAMASTAN administration.

Risk Summary

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 background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Risk Summary

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 maternal condition.

Safety and effectiveness in the pediatric population have not been established.

Safety and effectiveness in the geriatric population have not been established.