Dosage & Administration
For intramuscular use only. Do not administer intravenously.
| Indication | Dosage | Instruction |
| Hepatitis A | 0.1 mL/kg | Administer within two weeks of prior exposure to hepatitis A. |
| Administer before departure to persons traveling to areas with endemic hepatitis A: | ||
| 0.1 mL/kg | if the length of stay will be up to 1 month | |
| 0.2 mL/kg | if the length of stay will be up to 2 months; repeat every 2 months for longer stays. | |
| Measles | 0.25 mL/kg | Administer within 6 days of exposure. |
| 0.5 mL/kg | Immediately administer (maximum dose, 15 mL) to an immunocompromised child. | |
| Varicella | 0.6 mL/kg to 1.2 mL/kg | Administer promptly if Varicella-Zoster Immune Globulin (Human) is unavailable. |
| Rubella | 0.55 mL/kg | Only administer to exposed pregnant women who will not consider a therapeutic abortion. |
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Gamastan Prescribing Information
- Thrombosis may occur with immune globulin products, including GAMASTAN. 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. [see Warnings and Precautions (5.2), Patient Counseling Information (17)]
- 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. [ Warnings and Precautions (5.2)]
GAMASTAN is a human immune globulin indicated for:
Hepatitis A
GAMASTAN is indicated for prophylaxis following exposure to hepatitis A. The prophylactic value of GAMASTAN is greatest when given before or soon after exposure to hepatitis A. GAMASTAN is not indicated in persons with clinical manifestations of hepatitis A or in those exposed more than 2 weeks previously.
Measles (Rubeola)
GAMASTAN is indicated to prevent or modify measles in a susceptible person exposed fewer than 6 days previously. A susceptible person is one who has not been vaccinated and has not had measles previously.
- GAMASTAN may be especially indicated for susceptible household contacts of measles patients, particularly contacts under 1 year of age, for whom the risk of complications is highest. (3)
- GAMASTAN is also indicated for pregnant women without evidence of immunity.
- Do not give GAMASTAN and measles vaccine at the same time. If a child is older than 12 months and has received GAMASTAN, give measles vaccine about five months later when the measles antibody titer will have disappeared. (3,4) [see Drug Interactions (7)] If a susceptible child exposed to measles is immunocompromised, give GAMASTAN immediately.
Varicella
GAMASTAN is indicated to modify varicella.
- Passive immunization against varicella in immunosuppressed patients is best accomplished by use of Varicella Zoster Immune Globulin (Human). If unavailable, GAMASTAN, promptly given, may also modify varicella.
Rubella
GAMASTAN is indicated to modify rubella in exposed women who will not consider a therapeutic abortion.
- Some studies suggest that the use of GAMASTAN in exposed, susceptible women can lessen the likelihood of infection and fetal damage; therefore, GAMASTAN may benefit those women who will not consider a therapeutic abortion.
- Do not give GAMASTAN for routine prophylaxis of rubella in early pregnancy to an unexposed woman.
Limitations of Use
- GAMASTAN is not standardized with respect to antibody titers against hepatitis B surface antigen (HBsAg) and must not be used for prophylaxis of viral hepatitis type B. Prophylactic treatment to prevent hepatitis B can best be accomplished with use of Hepatitis B Immune Globulin (Human), often in combination with Hepatitis B Vaccine.
- GAMASTAN is not indicated for routine prophylaxis or treatment of rubella, poliomyelitis, mumps, or varicella.
For intramuscular use only.
Do not administer intravenously.
Dose
| Indication | Dosage | Instruction |
| ||
| Prophylaxis for exposure to hepatitis A | 0.1 mL/kg * | Administer within two weeks of prior exposure for household and institutional hepatitis A case contacts. |
| Administer before departure to persons traveling to areas with endemic hepatitis A: | ||
| 0.1 mL/kg | if the length of stay will be up to 1 month | |
| 0.2 mL/kg | if the length of stay will be up to 2 months | |
| 0.2 mL/kg | if the length of stay will be 2 months or longer; repeat every 2 months. | |
| Prevent or modify measles in a susceptible person exposed fewer than six days previously | 0.25 mL/kg † | Administer to a susceptible person within 6 days of exposure. |
| 0.5 mL/kg | Immediately administer (maximum dose, 15 mL) to an immunocompromised child. | |
| Modify varicella | 0.6 mL/ kg to 1.2 mL/kg | Administer promptly only if Varicella-Zoster Immune Globulin (Human) is unavailable. |
| Modify rubella only in an exposed woman who will not consider a therapeutic abortion | 0.55 mL/kg | Only administer to an exposed pregnant woman who will not consider a therapeutic abortion. |
Preparation and Handling
- If the product shows any sign of tampering, do not use it and notify Grifols Therapeutics LLC immediately [1-800-520-2807].
- Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. GAMASTAN is a clear or slightly opalescent, and colorless to pale yellow sterile solution.
Administration
- Administer GAMASTAN intramuscularly, preferably in the anterolateral aspects of the upper thigh and the deltoid muscle of the upper arm. Do not use the gluteal region as an injection site because of the risk of injury to the sciatic nerve. [see Warnings and Precautions (5.3)]
- Draw back on the plunger of the syringe before injection in order to be certain that the needle is not in a blood vessel. [see Warnings and Precautions (5.3)]
- Divide and inject doses greater than 10 mL into several muscle sites to reduce local pain and discomfort. An individual decision as to which muscle is injected must be made for each patient based on the volume of material to be administered.
- If Hepatitis A Vaccine is recommended along with GAMASTAN, administer simultaneously but at separate anatomical sites.
GAMASTAN is a sterile, 16.5% protein solution supplied in 2 mL and 10 mL single-dose vials.
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 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.
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 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.
Pediatric Use
Safety and effectiveness in the pediatric population have not been established.
Geriatric Use
Safety and effectiveness in the geriatric population have not been established.
GAMASTAN is contraindicated in:
- Anaphylactic or severe systemic hypersensitivity reactions to Immune Globulin (Human). [see Warnings and Precautions (5.1)]
- IgA deficient patients with antibodies against IgA and a history of hypersensitivity.