APONVIE

AbsorptionFollowing administration of a single intravenous 32 mg dose of APONVIE administered as a 30 second injection to healthy subjects, mean (CV%) area under the plasma concentration-time curve (AUC 0-∞ ) was 7.8 (27.4%) mcg∙hr/mL and mean plasma concentration at 5 minutes post-dose was 2.1 (19%) mcg/mL. In healthy subjects, a single dose of 32 mg of APONVIE administered as a 30 second intravenous injection resulted in a 13% higher AUC 0-∞ of aprepitant compared to a single oral dose of 40 ...

The safety and efficacy of APONVIE have been established based on adequate and well-controlled studies of a single-dose of oral aprepitant in adults. Below is a description of the results of these adequate and well-controlled studies of oral aprepitant for the prevention of PONV. In two multicenter, randomized, double-blind, active comparator-controlled, parallel-group clinical studies (Studies 1 and 2), oral aprepitant was compared with ondansetron for the prevention of postoperative nausea and vomiting in 1658 patients undergoing open abdominal surgery. These two studies were of similar desi...

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Most common adverse reactions (incidence ≥3%) are ( 6.1 ): Single-dose APONVIE: constipation, fatigue, and headache. Single-dose oral aprepitant: constipation and hypotension. To report SUSPECTED ADVERSE REACTIONS, contact Heron Therapeutics, Inc. at 1-844-437-6611 and www.APONVIE.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6....

APONVIE is contraindicated in patients: with a history of hypersensitivity to aprepitant or any component of the product [see Description (11) ] . Hypersensitivity reactions have included anaphylaxis [see Warnings and Precautions (5.1) ] . taking pimozide. Inhibition of CYP3A4 by aprepitant could result in elevated plasma concentrations of pimozide, which is a CYP3A4 substrate, potentially causing...

Hypersensitivity Reactions (including anaphylaxis) : May occur during or soon after administration. If symptoms occur, administer appropriate medical therapy. ( 4 , 5.1 ) CYP3A4 Interactions : Aprepitant is a substrate, weak-to-moderate inhibitor, and inducer of CYP3A4; see full prescribing information. ( 5.2 , 7.2 ) Warfarin (a CYP2C9 substrate) : Risk of decreased INR of prothrombin time; monitor INR in 2-week period, particularly at 7 to 10 days, following administration of APONVIE. ( 5.3 , 7...

7 DRUG INTERACTIONS See full prescribing information for a list of clinically significant drug interactions. ( 4 , 5.2 , 5.3 , 5.4 , 7.1 , 7.2 ) 7.1 Effect of Aprepitant on the Pharmacokinetics of Other Drugs Aprepitant is a substrate, a weak-to-moderate (dose-dependent) inhibitor, and an inducer of CYP3A4. Aprepitant is also an inducer of CYP2C9 [see Clinical Pharmacology (12.3) ] . Table 2 inclu...