GamaSTAN Adverse Reactions

human normal immunoglobulin




Luen Cheong Hong
Full Prescribing Info
Adverse Reactions
The most common adverse reaction reported for GAMASTAN S/D (immune globulin (human)) during post-approval use was fatigue.
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 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. 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.
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $768 a year.
Sign up for free
Already a member? Sign in