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

Source: FDA, National Drug Code (US) Revision Year: 2020

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 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.

1.2 Measles (Rubeola)

GAMASTAN is indicated to prevent or modify measles in a susceptible person exposed fewer than 6 days previously.(3) 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.

1.3 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.(5,6)

1.4 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.(7)
Do not give GAMASTAN for routine prophylaxis of rubella in early pregnancy to an unexposed woman.(7)

1.5 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.(8)
GAMASTAN is not indicated for routine prophylaxis or treatment of rubella, poliomyelitis, mumps, or varicella.

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 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(9,10)
	0.2 mL/kg	if the length of stay will be up to 2 months(9,10)
	0.2 mL/kg	if the length of stay will be 2 months or longer; repeat every 2 months.(9,10)
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.

^* 0.05 milliliter per pound
^† 0.11 milliliter per pound

2.2 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 or light brown sterile solution.

2.3 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(4) [see Warnings and Precaution (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.

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.

< Previous: Overview

Next: Precautions >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.