May 1, 2016
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Emend Injection

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Emend Injection




Indications
Dosage
How Supplied

INDICATIONS

EMEND® for injection, in combination with other antiemetic agents, is indicated in adults 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.

DOSAGE AND ADMINISTRATION

Prevention Of Nausea And Vomiting Associated With HEC And MEC

The recommended dosage of EMEND for injection, dexamethasone, and a 5-HT 3 antagonist in adults for the prevention of nausea and vomiting associated with administration of HEC or MEC 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 approximately 30 minutes prior to chemotherapy.

Table 1 : Recommended Dosing for the Prevention of Nausea and Vomiting Associated with HEC

  Day 1 Day 2 Day 3 Day 4
EMEND for injection 150 mg intravenously over 20 to 30 minutes approximately 30 minutes prior to chemotherapy 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-HT 3 antagonist prescribing information for the recommended dosage none none none
*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].

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

  Day 1
EMEND for injection 150 mg intravenously over 20 to 30 minutes approximately 30 minutes prior to chemotherapy
Dexamethasone* 12 mg orally
5-HT3 antagonist See selected 5-HT3 antagonist prescribing information for the recommended dosage
*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].

Preparation Of EMEND For Injection

Table 3 : Preparation Instructions for EMEND for Injection

Step 1 Aseptically inject 5 mL 0.9% Sodium Chloride Injection, USP into the vial. Assure that 0.9% Sodium Chloride Injection, USP is added to the vial along the vial wall in order to prevent foaming. Swirl the vial gently. Avoid shaking and jetting 0.9% Sodium Chloride Injection, USP into the vial.
Step 2 Aseptically prepare an infusion bag filled with 145 mL of 0.9% Sodium Chloride Injection, USP.
Step 3 Aseptically withdraw the entire volume from the vial and transfer it into the infusion bag containing 145 mL of 0.9% Sodium Chloride Injection, USP to yield a total volume of 150 mL and a final concentration of 1 mg/mL.
Step 4 Gently invert the bag 2 to 3 times.
Step 5 Before administration, inspect the bag for particulate matter and discoloration. Discard the bag if particulate and/or discoloration are observed.

Caution: Do not mix or reconstitute EMEND for injection with solutions for which physical and chemical compatibility have not been established. EMEND for injection is incompatible with any solutions containing divalent cations (e.g., Ca2+ , Mg2+), including Lactated Ringer's Solution and Hartmann's Solution.

Storage

The reconstituted final drug solution is stable for 24 hours at ambient room temperature [at or below 25°C (77°F)].

HOW SUPPLIED

Dosage Forms And Strengths

EMEND for injection: 150 mg, white to off-white lyophilized powder in single-dose glass vial for reconstitution

Storage And Handling

No. 3941 — One 150-mg W hite to off-white lyophilized powder in single-dose glass vial, for reconstitution. Supplied as follows:

NDC 0006-3941-32 1 vial per carton.

Storage

Emend for injection vials must be refrigerated, store at 2°C-8°C (36°F-46°F).

The reconstituted final drug solution is stable for 24 hours at ambient room temperature [at or below 25°C (77°F)].

Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., W hitehouse Station, NJ 08889, USA. Manufactured by: Patheon Manufacturing Services LLC, 5900 Martin Luther King Jr. Highway, Greenville, NC 27834, USA. Revised: Jan 2016

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

Last reviewed on RxList: 2/16/2016

Indications
Dosage
How Supplied

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