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FDA approved Focinvez (fosaprepitant) for Prevention of Chemotherapy-Induced Nausea and VomitingFDA approved a new intravenous drug to help prevent nausea and vomiting from chemotherapy

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Key Takeaway
Consider for CINV prophylaxis with HEC/MEC in patients aged 6 months and older.

The FDA has approved Focinvez (fosaprepitant), a substance P/neurokinin-1 (NK1) receptor antagonist, for the prevention of chemotherapy-induced nausea and vomiting (CINV). The approval covers its use, in combination with other antiemetics, for preventing acute and delayed nausea and vomiting associated with highly emetogenic chemotherapy (HEC), including high-dose cisplatin, and for delayed nausea and vomiting associated with moderately emetogenic chemotherapy (MEC) in adults and pediatric patients aged 6 months and older. This provides an intravenous NK1 receptor antagonist option for integration into standard antiemetic regimens, particularly for patients undergoing highly emetogenic treatments where control of delayed-phase symptoms is critical. The label notes the drug has not been studied for the treatment of established nausea and vomiting.

Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

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

Indication & Patient Population

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.

Dosing & Administration

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.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

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.

The U.S. Food and Drug Administration (FDA) has approved a new medication called Focinvez (fosaprepitant). It is designed to help prevent nausea and vomiting that can be a side effect of chemotherapy, a common cancer treatment. This drug works by blocking a specific pathway in the body that triggers these symptoms. It is approved for use alongside other anti-nausea medicines.

This drug is for adults and children 6 months and older who are receiving certain types of chemotherapy known to cause severe nausea. It is specifically for preventing symptoms, both right after treatment and in the days that follow. The approval is particularly important for patients undergoing the strongest types of chemotherapy, where controlling delayed symptoms is a major challenge.

The approval means that doctors and hospitals now have a new intravenous (IV) option to include in their standard plans for preventing chemotherapy-related sickness. For some patients who cannot take pills or need a specific type of medicine, this provides another tool to help them get through their treatment with fewer side effects.

It is important to note that this drug has not been studied for treating nausea and vomiting that has already begun. As with any new treatment, patients should talk with their doctor to understand if this option is appropriate for their specific treatment plan and overall health.

What this means for you:
A new IV option is available to help prevent chemotherapy-related sickness, but it's for prevention, not treatment.

Study Details

Study typeFda approval
PublishedAug 2023
View Original Abstract ↓
1 INDICATIONS AND USAGE 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. 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. FOCINVEZ is a substance P/neurokinin-1 (NK 1 ) receptor antagonist, indicated in adults and pediatric patients 6 months of age and older, in combination with other antiemetic agents, for the prevention of (1) : acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). Limitations of Use (1) FOCINVEZ has not been studied for treatment of established nausea and vomiting.
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