Focinvez Injection Dosage

2.1 Recommended Dosage for the Prevention of Nausea and Vomiting Associated with HEC and MEC in Adult Patients

The recommended dosage of FOCINVEZ, dexamethasone, and a 5-HT 3antagonist for the prevention of nausea and vomiting associated with administration of HEC or MEC in adults is shown in Table 1 or Table 2, respectively. Administer FOCINVEZ as an intravenous infusion on Day 1 over 20 to 30 minutes, completing the infusion approximately 30 minutes prior to chemotherapy.

2.2 Recommended Dosage for the Prevention of Nausea and Vomiting Associated with HEC and MEC in Pediatric Patients

The recommended pediatric dose regimens of FOCINVEZ, to be administered with a 5-HT 3antagonist, with or without a corticosteroid, for the prevention of nausea and vomiting associated with administration of single or multi-day chemotherapy regimens of HEC or MEC, are shown in Tables 3 and 4. Single-day chemotherapy regimens include those regimens in which HEC or MEC is administered for a single day only. Multi-day chemotherapy regimens include chemotherapy regimens in which HEC or MEC is administered for 2 or more days.

FOCINVEZ Dosage Regimens for Use with Single-Day Chemotherapy Regimens

For pediatric patients weighing at least 6 kg receiving single-day HEC or MEC, FOCINVEZ may be administered as:

• a single dose regimen of FOCINVEZ infused through a central venous catheter on Day 1, as shown in Table 3; or
• as a 3-day fosaprepitant/aprepitant regimen consisting of FOCINVEZ as an intravenous infusion through a central venous catheter on Day 1 and aprepitant capsules or aprepitant for oral suspension on Days 2 and 3, as shown in Table 4.

Administer FOCINVEZ on Day 1 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.

FOCINVEZ Dosage Regimen for Use with Multi-Day Chemotherapy Regimens

For pediatric patients weighing at least 6 kg receiving multi-day regimens of HEC or MEC, administer FOCINVEZ as an intravenous infusion through a central venous catheter on Day 1 and aprepitant capsules or aprepitant for oral suspension on Days 2 and 3, as shown in Table 4.

Administer FOCINVEZ 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.

Additional pediatric use information is approved for Merck Sharp & Dohme LLC’s EMEND (fosaprepitant) for injection. However, due to Merck Sharp & Dohme LLC’s marketing exclusivity rights, this drug product is not labeled with that information.

Preparation of FOCINVEZ

FOCINVEZ is ready-to-usefor intravenous infusion. The concentration of FOCINVEZ is 3 mg/mL.

Determine the volume to be administered from the injection vial directly based on the recommended dose [see Dosage and Administration ( 2.1, 2.2)].

Adults
The entire volume of the vial (50 mL) should be administered.

Pediatrics
In patients 12 years and older, the volume to be administered is calculated as follows:

• Volume to administer (mL) = the recommended dose (mg) / 3 (mg/mL) *

In patients 6 months to less than 12 years, the volume to be administered is calculated as follows:

• Volume to administer (mL) = the recommended dose (mg/kg) x weight (kg) / 3 (mg/mL)*

Note: Do not exceed the maximum dose [see Dosage and Administration ( 2.2)]

• In pediatric patients, the entire volume in vial may NOTbe required. Discard the unused portion.

• * The recommended dose of FOCINVEZ is based on the patient’s age and weight. The concentration of FOCINVEZ is 3 mg/mL.

• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use if solution is cloudy, contains precipitates, or if the red flip top cap is not intact.

• Vial may be inverted for use with a medical infusion set. The vial hanger can be seperated from the vial label and hanged from an IV pole.

• Allow FOCINVEZ to come to room temperature before use if the injection is NOTstored at room temperature.

• Caution:Do not mix FOCINVEZ with solutions for which physical and chemical compatibility have not been established. FOCINVEZ is incompatible with any solutions containing divalent cations (e.g., Ca 2+, Mg 2+), including Lactated Ringer’s Solution and Hartmann's Solution.

FOCINVEZ is compatible with 0.9% Sodium Chloride Injection.