GAMASTAN Solution for injection (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

GRIFOLS USA, LLC

Λέξεις κλειδιά

13533-335 13533-635

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BOXED WARNING SECTION

WARNING: THROMBOSIS Thrombosis may occur with immune globulin products, including GAMASTAN. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history ...

1. Indications and Usage

GAMASTAN is a human immune globulin indicated for: 1.1 Hepatitis A GAMASTAN is indicated for prophylaxis following exposure to hepatitis A.(1,2) The prophylactic value of GAMASTAN is greatest when given ...

2. Dosage and Administration

For intramuscular use only. Do not administer intravenously. 2.1 Dose Indication Dosage Instruction Prophylaxis for exposure to hepatitis A 0.1 mL/kg* Administer within two ...

3. Dosage Forms and Strengths

GAMASTAN is a sterile, 16.5% protein solution supplied in 2 mL and 10 mL single-dose vials.

4. Contraindications

GAMASTAN is contraindicated in: Anaphylactic or severe systemic hypersensitivity reactions to Immune Globulin (Human)(11) [see Warnings and Precautions (5.1)]. IgA deficient patients with antibodies ...

5. Warnings and Precautions

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 ...

6. Adverse Reactions

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

6.2. Postmarketing Experience

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 ...

7. Drug Interactions

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 ...

8.1. Pregnancy

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 ...

8.2. Lactation

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 ...

8.4. Pediatric Use

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

8.5. Geriatric Use

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

11. Description

GAMASTAN is a clear or slightly opalescent, and colorless or pale yellow or light brown sterile solution of polyvalent human immune globulin for intramuscular administration. GAMASTAN contains no preservative. ...

12.1. Mechanism of Action

The polyclonal antibody in GAMASTAN is a passive immunizing agent to neutralize viruses, such as hepatitis A and measles viruses, to prevent or ameliorate disease.

12.2. Pharmacodynamics

The prophylactic value of GAMASTAN is greatest when given before or soon after exposure.

12.3. Pharmacokinetics

Peak levels of immunoglobulin G are obtained approximately two days after intramuscular injection of GAMASTAN.(16) The half-life of IgG in the circulation of individuals with normal IgG levels is 23 days.(17) ...

15. References

Centers for Disease Control and Prevention. Prevention of hepatitis A through active or passive immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2006;55(RR-07):1-23. ...

16.1. How Supplied

GAMASTAN is supplied in 2 mL and 10 mL single dose vials. GAMASTAN contains no preservative and is not made with natural rubber latex. NDC Number Size 13533-335-04 2 mL vial 13533-335-12 10 mL vial ...

16.2. Storage and Handling

Store GAMASTAN at 2°C to 8°C (36°F to 46°F). Do not freeze. Do not use after expiration date.

17. Patient Counseling Information

Discuss the risks and benefits of this product with the patient, before prescribing or administering it to the patient. Instruct the patient to immediately report symptoms of thrombosis. These symptoms ...