fda-update

The Oncology Center of Excellence of the U.S. Food and Drug Administration (FDA) is informing healthcare providers about new safety information for Varubi® (rolapitant) 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.

Anaphylaxis, anaphylactic shock, and other serious hypersensitivity reactions have been reported in the postmarketing setting, some requiring hospitalization, according to a letter to healthcare 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 healthcare 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.

Healthcare 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 (800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (800-FDA-1088).

 

In collaboration with the FDA and as a service to our members, ONS provides updates on recent FDA approvals and other important FDA actions (e.g., updated safety information, new prescribing information) pertaining to therapies for patients with cancer. This allows the agency to inform oncologists and professionals in oncology-related fields in a timely manner. Included in the FDA updates is a link to the product label or to other sites for additional relevant clinical information. In supplying this information, ONS does not endorse any product or therapy and does not take any position on the safety or efficacy of the product or therapy described.

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