Safety Information on Rolapitant Injectable Emulsion

The Oncology Center of Excellence of the U.S. Food and Drug Administration (FDA) is informing health-care providers about new safety information for rolapitant (Varubi) injectable emulsion, a substance P/neurokinin (NK-1) receptor antagonist indicated for the prevention of delayed nausea and vomiting associated with cancer chemotherapy in adults.

Hypersensitivity and Anaphylaxis Reported

Anaphylaxis, anaphylactic shock, and other serious hypersensitivity reactions have been reported in the postmarketing setting, some requiring hospitalization, according to a letter to health-care providers from the manufacturer, Tesaro Inc. These reactions have occurred during or soon after the infusion of rolapitant, and most have occurred within the first few minutes of administration.

The company is advising health-care professionals to watch for signs of hypersensitivity or anaphylaxis in all patients receiving rolapitant injectable emulsion—both during and following its administration—and consult with patients to determine if they are hypersensitive to any component of the product (including soybean oil). Patients with known allergies to legumes or other related allergens should be monitored closely. Patients with a potential hypersensitivity should not be administered rolapitant injectable emulsion.

If anaphylaxis or any other serious hypersensitivity/infusion reaction occurs:

  • Administration of rolapitant injectable emulsion should be stopped immediately
  • Appropriate medical management (including epinephrine and or antihistamines) should be initiated.
  • Rolapitant injectable emulsion should be permanently discontinued 

For further information, see the related MedWatch Safety Alert.

Health-care professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA's MedWatch Reporting System by completing a form online, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.




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