amethasone 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.
EMEND* 125 mg orally 80 mg orally 80 mg orally
Dexamethasone† 12 mg orally none none
Ondansetron‡ 2 x 8 mg orally none none
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2 Registered trademark of MERCK & CO., Inc.
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.
Rx only
Manufactured for:
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA
Manufactured by:
DSM Pharmaceuticals, Inc., 5900 Martin Luther King Jr. Highway, Greenville, NC 27834
U.S. Patent Nos.: 5,512,570; 5,691,336
Issued February 2009
Printed in USA
9840002
PATIENT PACKAGE INSERT
Patient Information
EMEND®
(fosaprepitant dimeglumine)
for Injection
You should read this information before you start taking EMEND1 (fosaprepitant dimeglumine) for Injection. Also, read the le |
