Ask the Experts - Anaphylactoid Reaction to Basiliximab?
Ask the Experts - Anaphylactoid Reaction to Basiliximab?
My patient had a severe anaphylactoid reaction (capillary leak syndrome) to basiliximab during renal transplantation. What is the treatment? I would like to know of similar experiences.
K.K. Narani , MB, BS, MD
Anaphylaxis or cytokine release syndrome appears to be very rare in association with the use of basiliximab (Simulect; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey). There were no reported cases in the initial kidney trials using basiliximab. However, the package insert for basiliximab includes a warning that during postmarketing experience, severe hypersensitivity reactions have been reported. These reactions are of variable severity, include a number of different clinical manifestations and are not specific for basiliximab. At the University of Wisconsin, we have treated over 700 kidney transplant recipients with basiliximab without any postinfusion complications.
In a personal communication on July 19, 2001 with Lawrence Chodoff, PharmD, a representative of Novartis, the following information was conveyed. Basiliximab has been administered to over 2000 organ transplant recipients in controlled trials without any reports of postinfusion reactions thought by the investigator to be related to the drug. Based on cumulative sales figures, basiliximab has been administered to more than 20,000 patients worldwide. There have been 17 spontaneous reports of hypersensitivity-type reactions after the administration of basiliximab. If all of these reactions were related to basiliximab, this would result in an incidence of approximately 1 in 1000 recipients developing postinfusion reactions.
Editor's Note:
In a letter from Novartis Pharmaceuticals Corporation to healthcare providers and an FDA MedWatch Alert dated October 6, 2000, it was stated that:
"Severe acute (onset within 24 hours) hypersensitivity reactions including anaphylaxis have been observed both on initial exposure to Simulect and/or following re-exposure after several months. These reactions may include hypotension, tachycardia, cardiac failure, dyspnea, wheezing, bronchospasm, pulmonary edema, respiratory failure, urticaria, rash, pruritus, and/or sneezing. If a severe hypersensitivity reaction occurs, therapy with Simulect should be permanently discontinued. Medications for the treatment of severe hypersensitivity reactions including anaphylaxis should be available for immediate use. Patients previously administered Simulect should only be re-exposed to a subsequent course of therapy with extreme caution. The potential risks of such re-administration, specifically those associated with immunosuppression, are not known."
This statement is available on Medscape.
My patient had a severe anaphylactoid reaction (capillary leak syndrome) to basiliximab during renal transplantation. What is the treatment? I would like to know of similar experiences.
K.K. Narani , MB, BS, MD
Anaphylaxis or cytokine release syndrome appears to be very rare in association with the use of basiliximab (Simulect; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey). There were no reported cases in the initial kidney trials using basiliximab. However, the package insert for basiliximab includes a warning that during postmarketing experience, severe hypersensitivity reactions have been reported. These reactions are of variable severity, include a number of different clinical manifestations and are not specific for basiliximab. At the University of Wisconsin, we have treated over 700 kidney transplant recipients with basiliximab without any postinfusion complications.
In a personal communication on July 19, 2001 with Lawrence Chodoff, PharmD, a representative of Novartis, the following information was conveyed. Basiliximab has been administered to over 2000 organ transplant recipients in controlled trials without any reports of postinfusion reactions thought by the investigator to be related to the drug. Based on cumulative sales figures, basiliximab has been administered to more than 20,000 patients worldwide. There have been 17 spontaneous reports of hypersensitivity-type reactions after the administration of basiliximab. If all of these reactions were related to basiliximab, this would result in an incidence of approximately 1 in 1000 recipients developing postinfusion reactions.
Editor's Note:
In a letter from Novartis Pharmaceuticals Corporation to healthcare providers and an FDA MedWatch Alert dated October 6, 2000, it was stated that:
"Severe acute (onset within 24 hours) hypersensitivity reactions including anaphylaxis have been observed both on initial exposure to Simulect and/or following re-exposure after several months. These reactions may include hypotension, tachycardia, cardiac failure, dyspnea, wheezing, bronchospasm, pulmonary edema, respiratory failure, urticaria, rash, pruritus, and/or sneezing. If a severe hypersensitivity reaction occurs, therapy with Simulect should be permanently discontinued. Medications for the treatment of severe hypersensitivity reactions including anaphylaxis should be available for immediate use. Patients previously administered Simulect should only be re-exposed to a subsequent course of therapy with extreme caution. The potential risks of such re-administration, specifically those associated with immunosuppression, are not known."
This statement is available on Medscape.
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