Varubi injectable emulsion requires labelling change.

Tesaro Inc., announced that it has updated the Varubi (rolapitant) injectable emulsion package insert in collaboration with the FDA. Varubi injectable emulsion is a substance P/neurokinin (NK-1) receptor antagonist indicated for the prevention of delayed nausea and vomiting associated with chemotherapy in adults. The changes to the labeling include modifications to the CONTRAINDICATIONS, WARNINGS and PRECAUTIONS, and ADVERSE REACTIONS sections.

Following its introduction in late November 2017, Tesaro estimates that at least 7,000 doses of Varubi injectable emulsion have been administered to patients receiving emetogenic chemotherapy in the United States. Anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported in the postmarketing setting, some requiring hospitalization. These reactions have occurred during or soon after the infusion of Varubi injectable emulsion. Most reactions have occurred within the first few minutes of administration.

Tesaro has issued a Dear Healthcare Professional (DHCP) letter. This letter, as well as the updated full prescribing information, has been posted on the VARUBI website (www.varubirx.com). Additionally, members of the Tesaro field force will be calling on healthcare professionals to communicate this important new safety information.