INDICATIONS
EMEND for Injection, 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 including high-dose cisplatin
- prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (see DOSAGE AND ADMINISTRATION).
DOSAGE AND ADMINISTRATION
EMEND for Injection is a sterile, lyophilized prodrug of aprepitant containing polysorbate 80 (PS80), to be administered intravenously as an infusion. Aprepitant is available as capsules (EMEND2) for oral administration.
EMEND for Injection (115 mg) may be substituted for EMEND (125 mg) 30 minutes prior to chemotherapy, on Day 1 only of the CINV regimen as an infusion administered over 15 minutes.
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.
The 3-day CINV regimen includes EMEND for Injection (115 mg) or EMEND (125 mg orally) on Day 1; EMEND (80 mg orally) on Days 2 and 3; in addition to a corticosteroid and a 5-HT3 antagonist as specified in the tables below.
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 |
| Ondansetron† | 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 ofdexamethasone was chosen to account for drug interactions. †Ondansetron was administered 30 minutes prior to chemotherapy treatment on Day 1. |
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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 |
| Ondansetron† | 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 fordrug interactions. †Ondansetron 8-mg capsule was administered 30 to 60 minutes prior to chemotherapy treatment and one 8-mg capsule was administered 8 hoursafter the first dose on Day 1. |
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Preparation of EMEND for Injection
- Aseptically inject 5 mL 0.9% Sodium Chloride for Injection (saline) into the vial. Assure that 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 prepare an infusion bag filled with 110 mL of saline.
- Aseptically withdraw the entire volume from the vial and transfer it into the infusion bag containing 110 mL of saline to yield a total volume of 115 mL and a final concentration of 1 mg/1 mL.
- Gently invert the bag 2-3 times.
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.
General Information
EMEND for Injection has not been studied for the treatment of established nausea and vomiting.
Chronic continuous administration is not recommended (see PRECAUTIONS).
See PRECAUTIONS: DRUG INTERACTIONS for additional information on dose adjustment for corticosteroids when coadministered with EMEND for Injection.
Refer to the full prescribing information for coadministered antiemetic agents.
EMEND for Injection may be administered with or without food.
No dosage adjustment is necessary for the elderly.
No dosage adjustment is necessary for patients with renal insufficiency or for patients with end stage renal disease undergoing hemodialysis.
No dosage adjustment is necessary for patients with mild to moderate hepatic insufficiency (Child- Pugh score 5 to 9). There are no clinical data in patients with severe hepatic insufficiency (Child-Pugh score >9).
HOW SUPPLIED
No. 3884 — One 115 mg single dose per 10 mL glass vial: White to off-white lyophilized solid. Supplied as follows:
NDC 0006-3884-32 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 & CO., INC., Whitehouse Station, NJ D8889, USA. Manufactured by: DSM Pharmaceuticals, Inc., 5900 Martin Luther King Jr. Highway, Greenville, NC 27834. Issued 2008. FDA rev date: 1/25/2008
Generic Name:
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