This is to provide you with important new prescribing recommendations for GamaSTAN S/D when used for prophylaxis for Hepatitis A. GamaSTAN S/D, manufactured by Grifols Therapeutics Incorporated, is an intramuscularly administered Immune Globulin preparation used for prevention of several viral diseases. This notification reflects a change only in dosing for prevention of Hepatitis A virus (HAV) disease.
The increase in dosage is based on recently observed decreasing concentrations of antibodies to HAV in GamaSTAN S/D, attributed to the decreasing prevalence of previous HAV infection among plasma donors. This change in the dosage recommendations for HAV prophylaxis is a precautionary measure, to ensure continued effectiveness of GamaSTAN S/D.
New Dosing Recommendations
GamaSTAN S/D prescribing information has been updated with the following changes to the dosing instructions for the HAV prophylaxis indication:
- GamaSTAN® S/D for household and institutional hepatitis A case contacts.
Prior Dose New Dose
0.02 mL/kg 0.1 mL/kg
- The following doses of GamaSTAN® S/D are recommended for persons who plan to travel in areas where hepatitis A is common.
Length of Stay Prior Dose New Dose
Up to 1 month ---------- 0.1 mL/kg
Up to 2 months ---------- 0.2 mL/kg
More than 2 months ---------- repeat dose of 0.2 mL/kg every 2 months
Less than 3 months 0.02 mL/kg ----------
3 months or longer 0.06 mL/kg; ----------
(repeat every 4-6 months)
Alternative Therapies – Vaccine for Pre-exposure Prevention of HAV Disease
VAQTA, HAVRIX and TWINRIX vaccines are approved in the U.S. for prevention of disease caused by HAV. VAQTA and HAVRIX are indicated for persons 12 months of age or older. TWINRIX is licensed for persons 18 years of age or older. The Hepatitis A vaccines are highly effective and are licensed to be administered at least two weeks prior to the anticipated exposure to HAV.