EMEND

EMEND- fosaprepitant dimeglumine injection, powder, lyophilized, for solution
Merck Sharp & Dohme Corp.

1 INDICATIONS AND USAGE

EMEND® for injection, 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

  • EMEND has not been studied for the treatment of established nausea and vomiting.

2 DOSAGE AND ADMINISTRATION

2.1 Prevention of Nausea and Vomiting Associated with HEC and MEC in Adult Patients

The recommended dosage of EMEND for injection, dexamethasone, and a 5-HT3 antagonist 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 EMEND for injection as an intravenous infusion on Day 1 over 20 to 30 minutes, completing the infusion approximately 30 minutes prior to chemotherapy.

Table 1 Recommended Adult Dosing for the Prevention of Nausea and Vomiting Associated with HEC
Day 1 Day 2 Day 3 Day 4
*
Administer 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 EMEND [see Clinical Pharmacology (12.3)].
EMEND for injection 150 mg intravenously over 20 to 30 minutes none none none
Dexamethasone * 12 mg orally 8 mg orally 8 mg orally twice daily 8 mg orally twice daily
5-HT3 antagonist See selected 5-HT3 antagonist prescribing information for the recommended dosage none none none
Table 2 Recommended Adult Dosing for the Prevention of Nausea and Vomiting Associated with MEC
Day 1
*
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 EMEND [see Clinical Pharmacology (12.3)].
EMEND for injection 150 mg intravenously over 20 to 30 minutes
Dexamethasone * 12 mg orally
5-HT3 antagonist See selected 5-HT3 antagonist prescribing information for the recommended dosage

2.2 Prevention of Nausea and Vomiting Associated with HEC and MEC in Pediatric Patients

The recommended pediatric dose regimens of EMEND, to be administered with a 5-HT3 antagonist, 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.

EMEND Dosage Regimens for Use with Single-Day Chemotherapy Regimens

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

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

Administer EMEND for injection 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.

Table 3 Single Dose Regimen of EMEND for injection for Pediatric Patients 6 Months * to 17 Years for the Prevention of Nausea and Vomiting Associated with Single-Day Regimens of HEC or MEC
Drug Age Regimen
*
Dosing in pediatric patients less than 6 kg is not recommended
Administer dexamethasone 30 minutes prior to chemotherapy treatment on Day 1
EMEND for injection 12 Years to 17 Years 150 mg intravenously over 30 minutes
2 Years to less than 12 Years 4 mg/kg (maximum dose 150 mg) intravenously over 60 minutes
6 Months to less than 2 Years 5 mg/kg (maximum dose 150 mg) intravenously over 60 minutes
Dexamethasone 6 Months to 17 Years If a corticosteroid, such as dexamethasone, is co-administered, administer 50% of the recommended corticosteroid dose on Days 1 and 2.
5-HT3 antagonist 6 Months to 17 Years See selected 5-HT3 antagonist prescribing information for the recommended dosage

EMEND 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 EMEND on Days 1, 2, and 3. Administer EMEND for injection as an intravenous infusion through a central venous catheter on Day 1 and EMEND capsules or EMEND for oral suspension on Days 2 and 3, as shown in Table 4.

Administer EMEND for injection 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.

Table 4 Pediatric Patients 6 Months * to 17 Years Recommended 3-Day EMEND Dosage Regimen for Prevention of Nausea and Vomiting Associated with Single or Multi-day Regimens of HEC or MEC
Age Group Drug Day 1 Day 2 Day 3
*
Dosing in pediatric patients less than 6 kg is not recommended
For patients 12 years to 17 years who cannot swallow oral capsules, EMEND for oral suspension can be used instead.
Administer dexamethasone 30 minutes prior to chemotherapy treatment on Day 1
12 Years to 17 Years EMEND for injection 115 mg intravenously over 30 minutes
EMEND capsules 80 mg orally 80 mg orally
6 Months to Less than 12 Years EMEND for injection 3 mg/kg (maximum dose 115 mg) intravenously over 60 minutes
EMEND for oral suspension 2 mg/kg orally (maximum 80 mg) 2 mg/kg orally (maximum 80 mg)
6 Months to 17 Years Dexamethasone If a corticosteroid, such as dexamethasone, is co-administered, administer 50% of the recommended corticosteroid dose on Days 1 through 4
6 Months to 17 Years 5-HT3 antagonist See selected 5-HT3 antagonist prescribing information for the recommended dosage

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