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.

aThe concentration of FOCINVEZ is 3 mg/mL
bAdminister dexamethasone 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 through 4. Also administer dexamethasone in the evenings on Days 3 and 4. A 50% dosage reduction of dexamethasone on Days 1 and 2 is recommended to account for a drug interaction with FOCINVEZ .

a The concentration of FOCINVEZ is 3 mg/mL.
b Administer dexamethasone 30 minutes prior to chemotherapy treatment on Day 1. A 50% dosage reduction of dexamethasone is recommended to account for a drug interaction with FOCINVEZ .

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.

aDosing in pediatric patients less than 6 kg is not recommended
bThe concentration of FOCINVEZ is 3mg/mL.
cAdminister dexamethasone 30 minutes prior to chemotherapy treatment on Day 1

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.

aDosing in pediatric patients less than 6 kg is not recommended
bThe concentration of FOCINVEZ is 3 mg/mL.
cFor patients 12 years to 17 years who cannot swallow oral capsules, aprepitant for oral suspension can be used instead.
dFor patients less than 12 years of age who weigh at least 40 kg and who are able to swallow oral capsules, aprepitant capsules can be used on Days 2 and 3.
eAdminister dexamethasone 30 minutes prior to chemotherapy treatment on Day 1.

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.

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
• 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.
• Allow FOCINVEZ to come to room temperature before use if the injection is NOTstored at room temperature.
• Use a vented infusion set when FOCINVEZ is infused from the bottle.
• The vial hanger can be separated from the vial label.

• Gently invert the bottle and hang the bottle using the attached hanger and start infusion.

• 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.