FDA Approves Focinvez (fosaprepitant) for Prevention of Chemotherapy-Induced Nausea and Vomiting

FOCINVEZ is a substance P/neurokinin-1 (NK1) receptor antagonist.

FOCINVEZ, in combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin; and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). Limitations of Use: FOCINVEZ has not been studied for the treatment of established nausea and vomiting.

Recommended Adult Dosage: FOCINVEZ 150 mg on Day 1 as an intravenous infusion over 20 to 30 minutes, completed approximately 30 minutes prior to chemotherapy. For HEC, it is given with dexamethasone (with a 50% dosage reduction on Days 1 and 2 due to a drug interaction) and a 5-HT3 antagonist. For MEC, it is given with dexamethasone (with a 50% dosage reduction) and a 5-HT3 antagonist on Day 1 only. Recommended Dosage for Pediatric Patients (6 months to 17 years) Weighing at Least 6 kg: For single-day chemotherapy regimens, a single dose of FOCINVEZ on Day 1. For single or multi-day chemotherapy regimens, a 3-day regimen of FOCINVEZ on Day 1 and aprepitant capsules or aprepitant for oral suspension on Days 2 and 3. Administer FOCINVEZ through a central venous catheter on Day 1 as an intravenous infusion over 30 minutes (12 years to 17 years) or 60 minutes (6 months to less than 12 years), completing the infusion approximately 30 minutes prior to chemotherapy. Specific weight-based dosing for ages 2 to less than 12 years (4 mg/kg, max 150 mg) and 6 months to less than 2 years (5 mg/kg, max 150 mg) is provided.

Trial data not available in label.

Not reported in label.

FOCINVEZ is used in combination with other antiemetic agents (a 5-HT3 antagonist and a corticosteroid) for the prevention of CINV associated with HEC and MEC. For adult HEC regimens, it is part of a multi-day antiemetic plan. For adult MEC, it is part of a single-day regimen. In pediatrics, it can be used as a single intravenous dose or as part of a 3-day oral/intravenous regimen with aprepitant.