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Emend

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Emend Capsules

Emend Capsules

INDICATIONS

Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)

EMEND®, in combination with other antiemetic agents, is indicated 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
  • prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) [see DOSAGE AND ADMINISTRATION].

Prevention of Postoperative Nausea and Vomiting (PONV)

EMEND is indicated for the prevention of postoperative nausea and vomiting [see DOSAGE AND ADMINISTRATION].

Limitations of Use

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

Chronic continuous administration is not recommended [see WARNINGS AND PRECAUTIONS].

DOSAGE AND ADMINISTRATION

Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)

Capsules of EMEND (aprepitant) are given for 3 days as part of a regimen that includes a corticosteroid and a 5-HT3 antagonist. The recommended dose of EMEND is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3.

EMEND may be taken with or without food.

EMEND (fosaprepitant dimeglumine) for Injection (115 mg) is a prodrug of aprepitant and may be substituted for oral EMEND (125 mg), 30 minutes prior to chemotherapy, on Day 1 only of the CINV regimen as an intravenous infusion administered over 15 minutes.

In clinical studies with EMEND, the following regimen was used for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy:

  Day 1 Day 2 Day 3 Day 4
EMEND* 125 mg orally 80 mg orally 80 mg orally none
Dexamethasone** 12 mg orally 8 mg orally 8 mg orally 8 mg orally
Ondansetront 32 mg I.V. none none none
*EMEND was administered orally 1 hour prior to chemotherapy treatment on Day 1 and in the morning on Days 2 and 3.
**Dexamethasone was administered 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 through 4. The dose of dexamethasone was chosen to account for drug interactions.
†Ondansetron was administered 30 minutes prior to chemotherapy treatment on Day 1.

In a clinical study with EMEND, the following regimen was used for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy:

  Day 1 Day 2 Day 3
EMEND* 125 mg orally 80 mg orally 80 mg orally
Dexamethasone** 12 mg orally none none
Ondansetront 2 x 8 mg orally none none
*EMEND was administered orally 1 hour prior to chemotherapy treatment on Day 1 and in the morning on Days 2 and 3.
**Dexamethasone was administered 30 minutes prior to chemotherapy treatment on Day 1. The dose of dexamethasone was chosen to account for drug interactions.
†Ondansetron 8-mg capsule was administered 30 to 60 minutes prior to chemotherapy treatment and one 8-mg capsule was administered 8 hours after the first dose on Day 1.

Prevention of Postoperative Nausea and Vomiting (PONV)

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

EMEND may be taken with or without food.

Geriatric Patients

No dosage adjustment is necessary for the elderly.

Patients with Renal Impairment

No dosage adjustment is necessary for patients with renal impairment or for patients with end stage renal disease (ESRD) undergoing hemodialysis.

Patients with Hepatic Impairment

No dosage adjustment is necessary for patients with mild to moderate hepatic impairment (Child-Pugh score 5 to 9). There are no clinical data in patients with severe hepatic impairment (Child-Pugh score > 9).

Coadministration with Other Drugs

For additional information on dose adjustment for corticosteroids when coadministered with EMEND, see DRUG INTERACTIONS.

Refer to the full prescribing information for coadministered antiemetic agents.

HOW SUPPLIED

Dosage Forms And Strengths

  • Capsules EMEND 40 mg are opaque, hard, gelatin capsules, with white body and mustard yellow cap with “464” and “40 mg” printed radially in black ink on the body.
  • Capsules EMEND 80 mg are white, opaque, hard, gelatin capsules, with “461” and “80 mg” printed radially in black ink on the body.
  • Capsules EMEND 125 mg are opaque, hard, gelatin capsules, with white body and pink cap with “462” and “125 mg” printed radially in black ink on the body.

Storage And Handling

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. 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. 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.

Storage

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

Distributed by: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA. Revised: 05/2012

Last reviewed on RxList: 7/12/2012
This monograph has been modified to include the generic and brand name in many instances.

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