The Safety Profile of APONVIE

Similar Safety Profile to That of IV Ondansetron

Aprepitant has been used for PONV since 2006.¹

In 2 studies of more than 560 patients undergoing general anesthesia, there were no significant differences in the incidence of adverse events between oral aprepitant and IV ondansetron.^2-4

Aprepitant is not associated with QT prolongation, urinary retention, blurred vision, cognitive issues including sedation, or instances of serotonin syndrome.²

Aprepitant is well tolerated, with an established safety profile.²

IV aprepitant has been administered, even at a higher dose (130 mg), in more than 2.5 million doses to treat chemotherapy-induced nausea and vomiting.⁵

Pooled Analysis: Adverse Reactions²

Events included adverse reactions with an incidence ≥3% and at a greater incidence than IV ondansetron.

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References: 1. Korvick J; Center for Drug Evaluation and Research. Supplemental NDA approval letter: NDA 21-549/S-010 (Emend). Rockville, MD: US Food and Drug Administration; June 30, 2006. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021549s010LTR.pdf. Accessed March 14, 2022. 2. APONVIE [package insert]. San Diego, CA: Heron Therapeutics Inc; 2022. 3. Diemunsch P, Gan TJ, Philip BK, et al. Single-dose aprepitant vs ondansetron for the prevention of postoperative nausea and vomiting: a randomized, double-blind Phase III trial in patients undergoing open abdominal surgery. Brit J Anaesth. 2007;99(2):202-211. doi:10.1093/bja/aem133. 4. Gan TJ, Apfel CC, Kovac A, et al. A randomized, double-blind comparison of the NK1 antagonist, aprepitant, versus ondansetron for the prevention of postoperative nausea and vomiting. Anesth Analg. 2007;104(5):1082-1089. doi:10.1213/01.ane.0000263277.35140.a3. 5. Data on file. CINVANTI quantity sold data. San Diego, CA: Heron Therapeutics Inc; 2021.

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Important Safety Information!

Contraindications

APONVIE is contraindicated in patients with a history of hypersensitivity to aprepitant or any component of the product, and in patients taking pimozide. Increased pimozide levels may cause serious or life-threatening reactions, such as QT prolongation.

Warnings and Precautions

Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, during or soon after administration of aprepitant have occurred. Symptoms including dyspnea, eye swelling, flushing, pruritus, and wheezing have been reported. Monitor patients during and after administration. If hypersensitivity reactions occur, administer appropriate medical therapy. Do not administer APONVIE in patients who experienced these symptoms with previous use of aprepitant.

Clinically Significant CYP3A4 Drug Interactions: Aprepitant is a substrate, weak-to-moderate (dose-dependent) inhibitor, and an inducer of CYP3A4. Use of pimozide, a CYP3A4 substrate, with APONVIE is contraindicated. Use of APONVIE with strong CYP3A4 inhibitors (eg, ketoconazole) may increase plasma concentrations of aprepitant and result in an increased risk of adverse reactions related to APONVIE. Use of APONVIE with strong CYP3A4 inducers (eg, rifampin) may result in a reduction in aprepitant plasma concentrations and decreased efficacy of APONVIE.

Decrease in INR with Concomitant Warfarin: Use of aprepitant with warfarin, a CYP2C9 substrate, may result in a clinically significant decrease in the International Normalized Ratio (INR) of prothrombin time. Monitor the INR in patients on chronic warfarin therapy in the 2-week period particularly at 7 to 10 days, following administration of APONVIE.

Risk of Reduced Efficacy of Hormonal Contraceptives: The efficacy of hormonal contraceptives may be reduced for 28 days following administration of APONVIE. Advise patients to use effective alternative or back-up methods of non-hormonal contraception for 1 month following administration of APONVIE.

Use in Specific Populations

Avoid use of APONVIE in pregnant women as alcohol is an inactive ingredient in APONVIE. There is no safe level of alcohol exposure in pregnancy.

Adverse Reactions

Most common adverse reactions (incidence ≥3%) for APONVIE are constipation, fatigue, and headache and for oral aprepitant are constipation and hypotension.

Report side effects to Heron at 1-844-437-6611 or to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Indication

APONVIE is a substance P/neurokinin-1 (NK₁) receptor antagonist, indicated for the prevention of postoperative nausea and vomiting (PONV) in adults.

Limitations of Use: APONVIE has not been studied for treatment of established nausea and vomiting.

Please see full Prescribing Information.

Full Prescribing Information

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