Gamunex (Immune Globulin Intravenous Human) - Drug Interactions, Contraindications, Overdosage, etc

DRUG INTERACTIONS

Antibodies in GAMUNEX® may interfere with the response to live viral vaccines such as measles, mumps and rubella. Therefore, use of such vaccines should be deferred until approximately 6 months after GAMUNEX® administration. Please see DOSAGE AND ADMINISTRATION for other drug interactions.

CONTRAINDICATIONS

GAMUNEX®, Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, is contraindicated in individuals with known anaphylactic or severe systemic response to Immune Globulin (Human). Individuals with severe, selective IgA deficiencies (serum IgA <0.05 g/L) who have known antibody against IgA (anti-IgA antibody) should only receive GAMUNEX® with utmost cautionary measures, due to the risk of severe immediate hypersensitivity reactions including anaphylaxis. No experience is available on tolerability of GAMUNEX® in subjects with selective IgA deficiency since they were excluded from participation in the clinical trials with GAMUNEX®.

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08759262 (Issued August 2003)

Bayer

Manufactured by:

Bayer Corporation

Pharmaceutical Division

Elkhart, IN 46515 USA

U.S. License No. 8