GAMIMUNE

GAMIMUNE

What is Gamimune?

Gamimune (immune globulin intravenous injection) is a medication used to strengthen the body's natural defense system (immune system) to lower the risk of infection in persons with a weakened immune system. It is made from healthy human blood that has a high level of antibodies, which help fight infections. It is also used to increase platelets that may be needed to stop bleeding and form blood clots in certain individuals. IGIV is approved by the FDA for use in the treatment of Primary Immune Deficiency, Kawasaki’s disease, Chronic Lymphocytic Leukemia, bone marrow transplantation, Pediatric AIDS and Immune Thrombocytopenic Purpura.

What are Concerns related to Gamimune?

In 2002 the Bayer Corporation announced the discovery of apparent product tampering in vials of IGIV. Customer reports described a white precipitate in the solution or an uncharacteristically cloudy liquid. Bayer initiated a voluntary recall of two lots on February 1, 2002 (lot 648X078) and March 14, 2002 (lot 648X062).

Initial investigation of the returned vials identified unexpectedly low protein concentration, elevated chloride and the presence of bacteria. Several vials showed obvious signs of tampering.
Use of the tampered product could result in serious health consequences, such as bacterial infection, septic shock, and insufficient dosing of IGIV.

It is important before you administer IGIV, to look at the solution closely. It should be clear and free of floating material.

In 2006, additional lots were recalled due to an increased rate of allergic reactions.

What are the Side Effects Related to Gamimune?

Tell your health care provider if any of these symptoms are severe, or do not go away:
backache
headache
joint or muscle pain, leg cramps
rash
pain at the injection site
general feeling of discomfort

If you experience any of the following, or those listed in the Important Warning section, contact your healthcare provider immediately:
chest tightness
dizziness
hives or redness of the face
unusual tiredness
chills
fever or sweating
upset stomach or vomiting

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