01/16/2018

New safety information for Varubi® (rolapitant) injectable emulsion

The Oncology Center of Excellence of the Food and Drug Administration is informing health care 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 health care providers from the manufacturer, Tesaro Inc. These reactions have occurred during or soon after the infusion of Varubi 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 Varubi 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 Varubi injectable emulsion.

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

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

For further information, see the related MedWatch Safety Alert.