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Emend

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Emend Capsules




Indications
Dosage
How Supplied

INDICATIONS

Prevention Of Chemotherapy Induced Nausea And Vomiting (CINV)

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).

Prevention Of Postoperative Nausea And Vomiting (PONV)

EMEND capsules are indicated in adults for the prevention of postoperative nausea and vomiting.

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.

DOSAGE AND ADMINISTRATION

Prevention Of Chemotherapy Induced Nausea And Vomiting (CINV)

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
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]†
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
*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].

Table 2: Recommended Dosing for the Prevention of Nausea and Vomiting Associated with MEC

  Population Day 1 Day 2 Day 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 coadministered, administer 50% of the recommended corticosteroid dose on Days 1 through 4 [see Clinical Studies]†
5-HT3 antagonist Adults and Pediatric Patients 12 Years and Older See the selected 5-HT3 antagonist prescribing information for recommended dosage none none
*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].

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
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]†
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
*After preparation, the final concentration of EMEND for oral suspension is 25 mg/mL [see Preparation Instructions for EMEND for Oral Suspension -- for Healthcare Providers]. 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].

Prevention Of Postoperative Nausea And Vomiting (PONV)

The recommended oral dosage of EMEND capsules in adults is 40 mg within 3 hours prior to induction of anesthesia.

Preparation Instructions For EMEND For Oral Suspension -For Healthcare Providers

EMEND for oral suspension should be prepared by a healthcare provider. Once prepared, it may be administered either by a healthcare provider, patient, or caregiver.

Before you prepare EMEND

  • Do not open the pouch of EMEND until ready to prepare the medicine.
  • Store the pouch at room temperature [between 68°F-77°F (20°C-25°C)].

Table 4: Instructions for Healthcare Providers on How to Prepare EMEND for Oral Suspension

EMEND for oral suspension is packaged as a kit with one 1 mL oral dosing dispenser, one 5 mL oral dosing dispenser, one cap and one mixing cup.

1. Fill the mixing cup with room temperature drinking water.

Fill the mixing cup with room temperature drinking water - Illustration

2. Fill the 5 mL oral dosing dispenser with 4.6 mL of water from the mixing cup. Make sure no air is in the dispenser - if air is present, remove.

Fill the 5 mL oral dosing dispenser with 4.6 mL of water - Illustration

3. Discard all the unused water remaining in the mixing cup.

4. Add the 4.6 mL of water from the dispenser back into the mixing cup.

Add the 4.6 mL of water from the dispenser back into the mixi -ng cup Illustration

5. Each pouch of EMEND for oral suspension contains 125 mg of aprepitant which is to be suspended in 4.6 mL of water giving a final concentration of 25 mg/mL. Hold the EMEND for oral suspension pouch upright and shake the contents to the bottom before opening the pouch.

6. Pour the entire contents of the pouch into the 4.6 mL of water in the mixing cup and snap the lid shut.

Pour the entire contents of the pouch into the 4.6 mL of water in the mixing cup - Illustration

7. Mix the EMEND suspension gently by swirling 20 times; then gently invert the mixing cup 5 times. To prevent foaming, do not shake the mixing cup. The mixture will be cloudy pink to light pink.

Mix the EMEND suspension gently by swirling 2 -0 times  Illustration

8. Check the EMEND mixture for any clumps or foaming:

  • If any clumps are present, repeat Step 7 until there are no clumps.
  • If there is any foam, wait for the foam to disappear before going on to Step 9.

Check the EMEND mixture for any clumps or foaming - Illustration

9. Fill the dispenser with the prescribed dose shown above in Table 3.

  • Choose the dispenser based on dose:
    • Use 1 mL dispenser if dose is 1 mL or less.
    • Use 5 mL dispenser if dose is more than 1 mL.
  • Fill the dispenser with the prescribed dose from the cup.

If the dose is less than 1 mL round to the nearest 0.1 mL.

If the dose is more than 1 mL round to the nearest 0.2 mL.

It is common to have medicine leftover in the cup.

Make sure no air is in the dispenser - if air is present, remove.

Make sure the dispenser contains the prescribed dose.

Make sure no air is in the dispenser - Illustration

10. Place the cap on the dispenser until it clicks.

11. If the dose is not administered immediately after measuring, store filled oral dosing dispenser(s) in the refrigerator [between 36°F-46°F (2°C-8°C)] for up to 72 hours prior to use. When dispensing dose(s) to the patient or caregiver, instruct them to refrigerate the oral dosing dispenser(s) until they are ready to administer the dose.

12. When ready to use, the mixture can be kept at room temperature [between 68°F-77°F (20°C-25°C)] for up to 3 hours.

The mixture can be kept at room temperature - Illustration

13. Discard the mixing cup along with any remaining suspension.

Administration Instructions

EMEND capsules and EMEND for oral suspension can be administered with or without food.

EMEND Capsules
  • Swallow capsules whole.
EMEND for Oral Suspension
  • The dose will be prepared by the healthcare provider and dispensed to the patient or caregiver in an oral dispenser.
  • Keep the dispenser in the refrigerator until administered to the patient. The dose can be stored at room temperature for up to 3 hours before use.
  • When ready to use, take the cap off the dispenser, place the dispenser in the patient's mouth along the inner cheek on either the right or left side. Slowly dispense the medicine.
  • The dose must be used within 72 hours of preparation.
  • Discard any doses remaining after 72 hours.

HOW SUPPLIED

Dosage Forms And Strengths

EMEND Capsules
  • 40 mg: white body and mustard yellow cap with “464” and “40 mg” printed radially in black ink on the body.
  • 80 mg: white body and cap with “461” and “80 mg” printed radially in black ink on the body.
  • 125 mg: white body and pink cap with “462” and “125 mg” printed radially in black ink on the body.
EMEND for Oral Suspension
  • 125 mg as a pink to light pink powder in a single-use pouch with one 1 mL oral dosing dispenser, one 5 mL oral dosing dispenser, one cap and mixing cup.

No. 3855 — 125-mg capsules: Opaque, hard gelatin capsule with white body and pink cap with “462” and “125 mg” printed radially in black ink on the body. They are supplied as follows:

NDC 0006-0462-06 unit-dose package of 6.

No. 3854 — 80-mg capsules: White, opaque, hard gelatin capsule with “461” and “80 mg” printed radially in black ink on the body. They are supplied as follows:

NDC 0006-0461-02 unit-of-use BiPack of 2
NDC 0006-0461-06 unit-dose package of 6.

No. 3862 — Unit-of-use TriPack containing one 125-mg capsule and two 80-mg capsules.

NDC 0006-3862-03.

No. 6741 — 40-mg capsules: Opaque, hard gelatin capsule with white body and mustard yellow cap with “464” and “40 mg” printed radially in black ink on the body. They are supplied as follows:

NDC 0006-0464-10 unit-of-use package of 1
NDC 0006-0464-05 unit-dose package of 5.

No. 3066 — 125 mg for oral suspension: Pink to light pink powder, in a single-use pouch, packaged as a kit with one 1 mL oral dosing dispenser, one 5 mL oral dosing dispenser, one cap and one mixing cup. It is supplied as follows:

NDC 0006-3066-03 – unit of use carton.

Storage And Handling

Capsules

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

For Oral Suspension

Store unopened pouch at 20-25°C (68-77°F); excursions permitted between 15-30°C (between 59-86°F). Store in the original container. Do not open pouch until ready for use.

Once prepared, if suspension is not used immediately, store refrigerated [between 36°F-46°F (2°C-8°C)] for up to 72 hours prior to use. When ready to use, the mixture can be kept at room temperature [between 68°F-77°F (20°C-25°C)] for up to 3 hours.

Distributed by: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA. Revised: Dec 2015.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 12/26/2015

Indications
Dosage
How Supplied

Emend Capsules - User Reviews

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