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Anaphylaxis and other serious hypersensitivity reactions with rolapitant injectable emulsion

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The prescribing information for rolapitant injectable emulsion (Varubi—Tesaro) has been updated to alert prescribers that anaphylaxis, anaphylactic shock, and other serious hypersensitivity reactions have been reported in the postmarketing setting, some requiring hospitalization.

The prescribing information for rolapitant injectable emulsion (Varubi—Tesaro) has been updated to alert prescribers that anaphylaxis, anaphylactic shock, and other serious hypersensitivity reactions have been reported in the postmarketing setting, some requiring hospitalization. The majority of the reactions have occurred within the first few minutes of administration. Rolapitant injectable emulsion is approved to prevent delayed phase chemotherapy-induced nausea and vomiting. Health care professionals should be vigilant for signs of hypersensitivity or anaphylaxis in all patients receiving rolapitant injectable emulsion, both during and following the drug's administration. Health care professionals should consult with patients to determine if the individual is hypersensitive to any component of the product (including soybean oil). Patients with known allergies to legumes or other related allergens should be monitored closely. Individuals with a potential hypersensitivity should not be administered rolapitant injectable emulsion. The Dear Health Care Provider letter is available here.

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https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm592592.htm

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