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U.S. Department of Health and Human Services

Safety

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Simulect (basiliximab)

Postmarketing reports of seventeen cases of severe acute hypersensitivity reactions, including anaphylaxis, occurring in patients following the administration of Simulect. Other reactions may include hypotension, tachycardia, cardiac failure, dyspnea, wheezing, bronchospasm, pulmonary edema, respiratory failure, urticaria, rash, pruritus, and/or sneezing. The onset of these reactions occurred within 24 hours following initial exposure and/or following re-exposure to Simulect.

[October 6, 2000 - Letter - Novartis]