- U.S. Food and Drug Administration (FDA) (https://voice.ons.org/topic/us-food-and-drug-administration-fda)
- Treatment side effects (https://voice.ons.org/topic/treatment-side-effects)
- Clinical practice (https://voice.ons.org/topic/clinical-practice)
- Symptom management (https://voice.ons.org/topic/symptom-management)
FDA Approves Rolapitant IV for CINV
On October 25, 2017, the U.S. Food and Drug Administration (FDA) approved the use of rolapitant (Varubi®) IV in combination with other antiemetic agents for adults experiencing delayed chemotherapy therapy-induced nausea and vomiting (CINV).
Rolapitant through oral administration had been approved through the FDA in September 2015. The new IV administration route is expected to offer the same results at a lower cost to patients with CINV.
Delayed nausea and vomiting typically occurs 25–120 hours post treatment and can be especially debilitating.
According to the Varubi press release, “Varubi IV is supplied in ready-to-use vials and does not require refrigerated storage or mixing. As a result, utilization in busy chemotherapy clinics is straightforward and easily adopted into existing practice patterns for administration of antiemetic regimens associated with emetogenic chemotherapy. Varubi IV is to be administered up to two hours before chemotherapy administration in combination with a 5-HT3 receptor antagonist and dexamethasone. No dosage adjustment is required for dexamethasone, a CYP3A4 substrate, and Varubi is the first intravenously administered NK-1 receptor antagonist approved by the FDA that does not contain polysorbate 80.”
For more information, visit the Varubi website (http://www.varubirx.com/en).
Prescribing information is also available (http://www.varubirx.com/application/files/9515/0897/2736/VARUBI_rolapitant_Full_Prescribing_Information-October2017.pdf).