Fosaprepitant

FOSAPREPITANT — fosaprepitant dimeglumine injection, powder, lyophilized, for solution
Lupin Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE

Fosaprepitant for injection is a substance P/neurokinin-1 (NK1 ) 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

  • Fosaprepitant for injection 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 fosaprepitant 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 fosaprepitant 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

* 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 fosaprepitant for injection [see CLINICAL PHARMACOLOGY (12.3) ].

Day 1 Day 2 Day 3 Day 4
Fosaprepitant 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

* 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 fosaprepitant for injection [see CLINICAL PHARMACOLOGY (12.3) ].

Day 1
Fosaprepitant 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 dosage regimens of fosaprepitant for injection, 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 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.
Fosaprepitant for injection Dosage Regimens for Use with Single-Day Chemotherapy Regimens
For pediatric patients weighing at least 6 kg receiving single-day HEC or MEC, fosaprepitant for injection may be administered as:

  • a single dose regimen of fosaprepitant for injection infused through a central venous catheter on Day 1, as shown in Table 3; or
  • as a 3-day fosaprepitant for injection regimen consisting of fosaprepitant 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 fosaprepitant 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: Fosaprepitant for injection Single Dose Regimen for the Prevention of Nausea and Vomiting Associated with Single-Day Regimens of HEC or MEC in Pediatric Patients 6 Months* to 17 Years

* Dosing in pediatric patients less than 6 kg is not recommended

Administer dexamethasone 30 minutes prior to chemotherapy treatment on Day 1

Drug Age Regimen
Fosaprepitant 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

Fosaprepitant for injection 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 fosaprepitant for injection on Days 1, 2, and 3. Administer fosaprepitant 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.
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.

Table 4: 3-Day fosaprepitant for injection Dosage Regimen for Prevention of Nausea and Vomiting Associated with Single or Multi-day Regimens of HEC or MEC Pediatric Patients 6 Months* to 17 Years

* Dosing in pediatric patients less than 6 kg is not recommended.

For patients 12 years to 17 years unable to swallow oral capsules, EMEND for oral suspension can be used instead on Days 2 and 3

For patients less than 12 years of age who weigh at least 40 kg and who are able to swallow oral capsules, EMEND capsules can be used instead on Days 2 and 3

§ Administer dexamethasone 30 minutes prior to chemotherapy treatment on Day 1.

Age of Pediatric Population Day 1 Day 2 Day 3
Fosaprepitant for injection* 12 years to 17 years 115 mg intravenously over 30 minutes 80 mg orally (EMEND capsules) 80 mg orally (EMEND capsules)
6 months to less than 12 years 3 mg/kg intravenously over 60 minutes (maximum dose 115 mg) 2 mg/kg orally (EMEND for oral suspension) (maximum dose 80 mg) 2 mg/kg orally (EMEND for oral suspension) (maximum dose 80 mg)
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 through 4.
5-HT3 antagonist 6 months to 17 years See selected 5-HT3 antagonist prescribing information for the recommended dosage.

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