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Emend Injection

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Emend Injection

INDICATIONS

EMEND (fosaprepitant dimeglumine injection) 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 (fosaprepitant dimeglumine injection) 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 (fosaprepitant dimeglumine injection) for Injection 150 mg (Single Dose Regimen of EMEND (fosaprepitant dimeglumine injection) )

EMEND (fosaprepitant dimeglumine injection) 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 (fosaprepitant dimeglumine injection) are administered on Days 2 and 3. EMEND (fosaprepitant dimeglumine injection) 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 (fosaprepitant dimeglumine injection) for Injection 150 mg differs from the recommended dosage of dexamethasone with EMEND (fosaprepitant dimeglumine injection) for Injection 115 mg on Days 3 and 4.

Table 1 : Recommended dosing (Single Dose Regimen of EMEND (fosaprepitant dimeglumine injection) ) 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
Ondansetron† 32 mg intravenous 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.
†Ondansetron should be administered 30 minutes prior to chemotherapy treatment on Day 1.

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

EMEND (fosaprepitant dimeglumine injection) 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 (fosaprepitant dimeglumine injection) 80 mg should be administered on Days 2 and 3. EMEND (fosaprepitant dimeglumine injection) 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 (fosaprepitant dimeglumine injection) for Injection 115 mg differs from the recommended dosage of dexamethasone with EMEND (fosaprepitant dimeglumine injection) for Injection 150 mg on Days 3 and 4.

Capsules of EMEND (fosaprepitant dimeglumine injection) 125 mg may be substituted for EMEND (fosaprepitant dimeglumine injection) for Injection 115 mg on Day 1.

Table 2 : Recommended dosing (3-Day Dosing Regimen of EMEND (fosaprepitant dimeglumine injection) ) 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
Ondansetron† 32 mg intravenous 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.
†Ondansetron should be administered 30 minutes prior to chemotherapy treatment on Day 1.

Prevention of Nausea and Vomiting Associated with Moderately Emetogenic Chemotherapy (MEC)

EMEND (fosaprepitant dimeglumine injection) for Injection 115 mg (3-Day Dosing Regimen of EMEND (fosaprepitant dimeglumine injection) ):

EMEND (fosaprepitant dimeglumine injection) 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 (fosaprepitant dimeglumine injection) 80 mg should be administered on Days 2 and 3. EMEND (fosaprepitant dimeglumine injection) 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 (fosaprepitant dimeglumine injection) for Injection 115 mg differs from the recommended dosage of dexamethasone with EMEND (fosaprepitant dimeglumine injection) for Injection 150 mg on Days 3 and 4.

Capsules of EMEND (fosaprepitant dimeglumine injection) 125 mg may be substituted for EMEND (fosaprepitant dimeglumine injection) for Injection 115 mg on Day 1.

Table 3 : Recommended dosing (3-Day Dosing Regimen of EMEND (fosaprepitant dimeglumine injection) ) 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
Ondansetron† 8 mg orally twice daily none none
**Dexamethasone should be administered 30 minutes prior to chemotherapy treatment on Day 1. The dose of dexamethasone accounts for drug interactions.
†Ondansetron 8-mg capsule should be administered 30 to 60 minutes prior to chemotherapy treatment and one 8-mg capsule should be administered 8 hours after the first dose on Day 1.

Preparation of EMEND (fosaprepitant dimeglumine injection) for Injection

Table 4 : Preparation Instructions for EMEND (fosaprepitant dimeglumine injection) for Injection (115-mg and 150-mg)

  115 mg 150 mg
Step1 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.
Step2 Aseptically prepare an infusion bag filled with 110 mL of normal saline. Aseptically prepare an infusion bag filled with 145 mL of normal saline.
Step3 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 (fosaprepitant dimeglumine injection) for Injection should not be mixed or reconstituted with solutions for which physical and chemical compatibility have not been established. EMEND (fosaprepitant dimeglumine injection) 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: White to off-white lyophilized solid (Sterile lyophilized powder for intravenous use only after reconstitution and dilution).

One 115 mg single dose glass vial: White 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: White 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: White 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., Whitehouse Station, NJ 08889, USA. Manufactured by: DSM Pharmaceuticals, Inc., 5900 Martin Luther King Jr. Highway, Greenville, NC 27834, USA. Issued November 2010

Last reviewed on RxList: 12/15/2010
This monograph has been modified to include the generic and brand name in many instances.

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