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Emend Injection

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Emend Injection

Indications
Dosage
How Supplied

INDICATIONS

EMEND® for Injection is a substance P/neurokinin-1 (NK1) receptor antagonist indicated in adults for use in combination with other antiemetic agents 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 [see DOSAGE AND ADMINISTRATION]

  • prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) [see DOSAGE AND ADMINISTRATION].

Limitations of Use

EMEND for Injection 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 Nausea And Vomiting Associated With Highly Emetogenic Chemotherapy (HEC)

EMEND for Injection 150 mg (Single Dose Regimen of EMEND)

EMEND for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. No capsules of EMEND are administered on Days 2 and 3. EMEND for Injection should be administered in conjunction with a corticosteroid and a 5-HT3 antagonist as specified in Table 1. The recommended dosage of dexamethasone with EMEND for Injection 150 mg differs from the recommended dosage of dexamethasone with EMEND for Injection 115 mg on Days 3 and 4. The package insert for the coadministered 5-HT3 antagonist must be consulted prior to initiation of treatment with EMEND for Injection.

Table 1 : Recommended dosing (Single Dose Regimen of EMEND) for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy

  Day 1 Day 2 Day 3 Day 4
EMEND 150 mg intravenous none none none
Dexamethasone* 12 mg orally 8 mg orally 8 mg orally twice daily 8 mg orally twice daily
5-HT3 antagonist See the package insert for the selected 5-HT3 antagonist for appropriate dosing information. none none none
*Dexamethasone should be administered 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 through 4. The dose of dexamethasone accounts for drug interactions.

EMEND for Injection 115 mg (3-Day Dosing Regimen of EMEND)

EMEND for Injection 115 mg is administered on Day 1 only as an infusion over 15 minutes initiated 30 minutes prior to chemotherapy. Capsules of EMEND 80 mg should be administered on Days 2 and 3. EMEND for Injection 115 mg should be administered in conjunction with a corticosteroid and a 5-HT3 antagonist as specified in Table 2. The recommended dosage of dexamethasone with EMEND for Injection 115 mg differs from the recommended dosage of dexamethasone with EMEND for Injection 150 mg on Days 3 and 4. The package insert for the co-administered 5-HT3 antagonist must be consulted prior to initiation of treatment with EMEND for Injection.

Capsules of EMEND 125 mg may be substituted for EMEND for Injection 115 mg on Day 1.

Table 2 : Recommended dosing (3-Day Dosing Regimen of EMEND) for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy

  Day 1 Day 2 Day 3 Day 4
EMEND 115 mg intravenous 80 mg orally 80 mg orally none
Dexamethasone* 12 mg orally 8 mg orally 8 mg orally once daily 8 mg orally once daily
5-HT3 antagonist See the package insert for the selected 5-HT3 antagonist for appropriate dosing information. none none none
*Dexamethasone should be administered 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 through 4. The dose of dexamethasone accounts for drug interactions.

Prevention Of Nausea And Vomiting Associated With Moderately Emetogenic Chemotherapy (MEC)

EMEND for Injection 115 mg (3-Day Dosing Regimen of EMEND)

EMEND for Injection 115 mg is administered on Day 1 only as an infusion over 15 minutes initiated 30 minutes prior to chemotherapy. Capsules of EMEND 80 mg should be administered on Days 2 and 3. EMEND for Injection 115 mg should be administered in conjunction with a corticosteroid and a 5-HT3 antagonist as specified in Table 3. The recommended dosage of dexamethasone with EMEND for Injection 115 mg differs from the recommended dosage of dexamethasone with EMEND for Injection 150 mg on Days 3 and 4. The package insert for the co-administered 5-HT3 antagonist must be consulted prior to initiation of treatment with EMEND for Injection.

Capsules of EMEND 125 mg may be substituted for EMEND for Injection 115 mg on Day 1.

Table 3 : Recommended dosing (3-Day Dosing Regimen of EMEND) for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy

  Day 1 Day 2 Day 3
EMEND 115 mg intravenous 80 mg orally 80 mg orally
Dexamethasone* 12 mg orally none none
5-HT3 antagonist See the package insert for the selected 5-HT3 antagonist for appropriate dosing information. none none
*Dexamethasone should be administered 30 minutes prior to chemotherapy treatment on Day 1. The dose of dexamethasone accounts for drug interactions.

Preparation Of EMEND For Injection

Table 4 : Preparation Instructions for EMEND for Injection (115 mg and 150 mg)

  115 mg 150 mg
Step 1 Aseptically inject 5 mL 0.9% Sodium Chloride for Injection (normal saline) into the vial. Assure that normal saline is added to the vial along the vial wall in order to prevent foaming. Swirl the vial gently. Avoid shaking and jetting saline into the vial. Aseptically inject 5 mL 0.9% Sodium Chloride for Injection (normal saline) into the vial. Assure that normal saline is added to the vial along the vial wall in order to prevent foaming. Swirl the vial gently. Avoid shaking and jetting saline into the vial.
Step 2 Aseptically prepare an infusion bag filled with 110 mL of normal saline. Aseptically prepare an infusion bag filled with 145 mL of normal saline.
Step 3 Aseptically withdraw the entire volume from the vial and transfer it into the infusion bag containing 110 mL of normal saline to yield a total volume of 115 mL and a final concentration of 1 mg/1 mL. Aseptically withdraw the entire volume from the vial and transfer it into the infusion bag containing 145 mL of normal saline to yield a total volume of 150 mL and a final concentration of 1 mg/1 mL.
Step 4 Gently invert the bag 2-3 times. Gently invert the bag 2-3 times.
Note: The differences in preparation for each dose are displayed as bolded text.

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

Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

Caution: EMEND for Injection should not be mixed or reconstituted 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.

HOW SUPPLIED

Dosage Forms And Strengths

One 150-mg single dose glass vial: W hite to off-white lyophilized solid (Sterile lyophilized powder for intravenous use only after reconstitution and dilution).

One 115-mg single dose glass vial: W hite to off-white lyophilized solid (Sterile lyophilized powder for intravenous use only after reconstitution and dilution).

Storage And Handling

No. 3884 — One 115-mg single dose glass vial: W hite to off-white lyophilized solid. Supplied as follows:

NDC 0006-3884-32 1 vial per carton.

No. 3941 — One 150-mg single dose glass vial: W hite to off-white lyophilized solid. Supplied as follows:

NDC 0006-3941-32 1 vial per carton. Storage

Vials: Store at 2-8°C (36-46°F).

Sterile lyophilized powder for intravenous use only after reconstitution and dilution.

Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., W hitehouse Station, NJ 08889, USA. Manufactured by: DSM Pharmaceuticals, Inc., 5900 Martin Luther King Jr. Highway, Greenville, NC 27834, USA. Revised: Aug 2014

Last reviewed on RxList: 8/27/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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