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EMEND is indicated for prevention of postoperative nausea and vomiting.
SELECTED IMPORTANT RISK INFORMATION
EMEND is a weak to moderate (dose-dependent) CYP3A4 inhibitor. EMEND should not be used concurrently with pimozide, terfenadine, astemizole, or cisapride. Inhibition of cytochrome P450 isoenzyme 3A4 (CYP3A4) by aprepitant could result in elevated plasma concentrations of these drugs, potentially causing serious or life-threatening reactions.
EMEND, a dose-dependent inhibitor of CYP3A4, should be used with caution in patients receiving concomitant orally administered medicinal products that are primarily metabolized through CYP3A4. Weak inhibition of CYP3A4 by a single 40-mg dose of aprepitant is not expected to alter the plasma concentrations of these concomitant medicinal products to a clinically significant degree. The effect of EMEND on the pharmacokinetics of orally administered CYP3A4 substrates is greater than the effect of EMEND on the pharmacokinetics of intravenously administered CYP3A4 substrates.
Coadministration of EMEND with warfarin may result in a clinically significant decrease in international normalized ratio (INR) of prothrombin time. In patients on chronic warfarin therapy, the INR should be closely monitored in the 2-week period, particularly at 7 to 10 days, following administration of a single 40-mg dose of EMEND for prevention of postoperative nausea and vomiting.
The efficacy of hormonal contraceptives may be reduced during coadministration with EMEND and for 28 days after the last dose of EMEND. Alternative or backup methods of contraception should be used during treatment with EMEND and for 1 month after the last dose of EMEND.
Although studies have not been done with the 40-mg single dose, the timing of administration of EMEND relative to ovulation could cause contraceptive failure.
Chronic continuous use of EMEND for prevention of nausea and vomiting is not recommended because it has not been studied and because the drug interaction profile may change during chronic continuous use.
The most frequent adverse events reported in clinical trials of EMEND for postoperative nausea and vomiting were constipation (8.5%), nausea (8.5%), pruritus (7.6%), pyrexia (5.9%), hypotension (5.7%), headache (5.0%), and bradycardia (4.4%).
The recommended oral dosage of EMEND is 40 mg within 3 hours before induction of anesthesia.
Before prescribing EMEND, please read the Prescribing Information and Patient Product Information.
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