EMEND

EMEND- aprepitant capsule
EMEND- aprepitant
EMEND- aprepitant powder, for suspension
Merck Sharp & Dohme LLC

1 INDICATIONS AND USAGE

EMEND® for oral suspension, in combination with other antiemetic agents, is indicated in 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.
  • nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).

EMEND® capsules, in combination with other antiemetic agents, is indicated in patients 12 years 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.
  • 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.
  • Chronic continuous administration of EMEND is not recommended because it has not been studied, and because the drug interaction profile may change during chronic continuous use.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

Adults and Pediatric Patients 12 Years of Age and Older

The recommended oral dosage of EMEND capsules, dexamethasone, and a 5-HT3 antagonist in adults and pediatric patients 12 years of age and older who can swallow oral capsules, for the prevention of nausea and vomiting associated with administration of HEC or MEC is shown in Table 1 or Table 2, respectively. For patients who cannot swallow oral capsules, EMEND for oral suspension can be used instead of EMEND capsules as shown in Table 3.

Table 1: Recommended Dosing for the Prevention of Nausea and Vomiting Associated with HEC
Population Day 1 Day 2 Day 3 Day 4
*
Administer EMEND capsules 1 hour prior to chemotherapy treatment on Days 1, 2, and 3. If no chemotherapy is given on Days 2 and 3, administer EMEND capsules in the morning.
Administer dexamethasone 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 through 4. A 50% dosage reduction of dexamethasone is recommended to account for a drug interaction with EMEND [see Clinical Pharmacology (12.3)].
EMEND capsules * Adults and Pediatric Patients 12 Years and Older 125 mg orally 80 mg orally 80 mg orally none
Dexamethasone Adults 12 mg orally 8 mg orally 8 mg orally 8 mg orally
Pediatric Patients 12 Years and Older If a corticosteroid, such as dexamethasone, is co-administered, administer 50% of the recommended corticosteroid dose on Days 1 through 4 [see Clinical Studies (14.3)].
5-HT3 antagonist Adults and Pediatric Patients 12 Years and Older See selected 5-HT3 antagonist prescribing information for the recommended dosage none none none
Table 2: Recommended Dosing for the Prevention of Nausea and Vomiting Associated with MEC
Population Day 1 Day 2 Day 3
*
Administer EMEND capsules 1 hour prior to chemotherapy treatment on Days 1, 2, and 3. If no chemotherapy is given on Days 2 and 3, administer EMEND capsules in the morning.
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 capsules * Adults and Pediatric Patients 12 Years and Older 125 mg orally 80 mg orally 80 mg orally
Dexamethasone Adults 12 mg orally none none
Pediatric Patients 12 Years and Older If a corticosteroid, such as dexamethasone, is co-administered, administer 50% of the recommended corticosteroid dose on Days 1 through 4 [see Clinical Studies (14.3)].
5-HT3 antagonist Adults and Pediatric Patients 12 Years and Older See the selected 5-HT3 antagonist prescribing information for recommended dosage none none

Pediatric Patients 6 Months to less than 12 Years of Age or Pediatric and Adult Patients Unable to Swallow Capsules

The recommended dose of EMEND for oral suspension to be administered with a 5-HT3 antagonist, with or without a corticosteroid, for the prevention of nausea and vomiting associated with administration of HEC or MEC is specified in Table 3. Dosing of EMEND for oral suspension is based on weight, to a maximum of 125 mg on Day 1 and 80 mg on Days 2 and 3. Dosing in pediatric patients less than 6 kg is not recommended.

Table 3: Recommended Dosing in Pediatric Patients 6 Months to Less than 12 Years of Age or Pediatric and Adult Patients Unable to Swallow Capsules
Population Day 1 Day 2 Day 3 Day 4
*
After preparation, the final concentration of EMEND for oral suspension is 25 mg/mL [see Dosage and Administration (2.3)]. Administer EMEND for oral suspension 1 hour prior to chemotherapy treatment on Days 1, 2, and 3. If no chemotherapy is given on Days 2 and 3, administer EMEND for oral suspension in the morning.
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 oral suspension * Pediatric Patients 6 Months to Less than12 Years or Pediatric and Adult Patients Unable to Swallow Capsules 3 mg/kg orally Maximum dose 125 mg 2 mg/kg orally Maximum dose 80 mg 2 mg/kg orally Maximum dose 80 mg none
Dexamethasone Adults Unable to Swallow Capsules See Table 1 or 2 See Table 1 or 2 See Table 1 or 2 See Table 1 or 2
Pediatric Patients 6 Months to Less than12 Years or Pediatric Patients Unable to Swallow Capsules If a corticosteroid, such as dexamethasone, is co-administered, administer 50% of the recommended corticosteroid dose on Days 1 through 4 [see Clinical Studies (14.3)].
5-HT3 antagonist Pediatric Patients 6 Months to Less than12 Years or Pediatric and Adult Patients Unable to Swallow Capsules See selected 5-HT3 antagonist prescribing information for the recommended dosage none none none

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.