New Formulation for Varubi
October 25, 2017 – The U.S. FDA has approved a new formulation for Varubi® (rolapitant), manufactured by Tesaro Pharmaceuticals. Varubi is indicated to prevent delayed nausea and vomiting caused by nausea-producing cancer chemotherapy when used in conjunction with dexamethasone and a 5-HT3 receptor antagonist. Varubi will now be available in an intravenous (IV) form, whereas it was previously available only as an oral tablet.
Varubi helps to prevent chemotherapy-induced nausea and vomiting (CINV) by blocking the receptors for human substance P/neurokinin 1 (NK-1). Recommended dosing is 166.5mg delivered over the course of 30 minutes no more than two hours before the administration of chemotherapy. Patients should not receive Varubi intravenous infusion if they have already had a dose within the previous two weeks.
Tesaro has already launched Varubi in intravenous form, available as single-dose vials that do not require reconstitution or dilution before use.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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