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Submission: On December 02 via api from US — Scanned from US
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<fieldset class="fieldset"><label for="firstName" id="firstName-label" class="">First Name*</label>
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<option value="Administrator">Administrator</option>
<option value="Anesthesiology">Anesthesiology</option>
<option value="Bariatric Surgery">Bariatric Surgery</option>
<option value="CRNA">CRNA</option>
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<div class="grid__1/12 mobile:grid__1/10"><input type="checkbox" id="contact" class="input"></div><label for="contact" class="grid__11/12 mobile:grid__9/10 mobile:pl-0.5 label--alt">be contacted by a Heron representative</label>
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Therapeutics, Inc, about innovations regarding products, techniques, or research in postoperative care</label>
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Resource CenterFrequently Asked QuestionsImportant Safety InformationPrescribing Information US healthcare professionals only. Connect with Heron The Unmet Need Mechanism of Action Bioequivalence Bioequivalence Onset of Action Plasma Concentrations Efficacy Study Design Complete Response Vomiting Prevention Through 24 Hours Vomiting Prevention Through 48 Hours Pooled Analysis Post-Hoc Analysis Cochrane Meta-Analysis Multimodal Use Guidelines Plastic Surgery TKA and THA Craniotomy Laparoscopic Cholecystectomy Facial Plastic Surgery TKA Safety Preparation and Dosing Access FAQ APONVIE Efficacy APONVIE Safety APONVIE Ordering, Pricing, Reimbursement, and Storage Contact Heron Resource Center Frequently Asked Questions Important Safety Information Prescribing Information ONE PUSH FOR 48 HOURS OF PONV PREVENTION 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. Learn more: IV AdministrationMultimodal UseCochrane WHAT IS APONVIE? APONVIE is a proven, effective antiemetic for the prevention of postoperative nausea and vomiting (PONV) that is delivered via a single IV push and offers a 48-hour effective duration. APONVIE was created to help patients experience a smooth recovery with less risk of PONV-related symptoms and may help hospital staff with patient throughput by reducing PONV-related interruptions.1-3 First and only IV NK1 antagonist for prevention of PONV1 Superior vomiting prevention versus ondansetron through 48 hours1-3,a Single IV push1 Comparable safety profile to IV ondansetron without QT prolongation1 Reaches therapeutic plasma concentrations associated with ≥97% receptor occupancy within 5 minutes1,4,5,b aUnadjusted P value. bThe relationship between receptor occupancy and efficacy has not been established. Heron Therapeutics Heron is invested in and committed to developing innovative solutions for postoperative safety and comfort. Our Mission References: 1. APONVIE [package insert]. San Diego, CA: Heron Therapeutics Inc; 2022. 2. 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. 3. 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. 4. Data on file. Summary of clinical pharmacology studies. San Diego, CA: Heron Therapeutics Inc; 2021. 5. Van Laere K, De Hoon J, Bormans G, et al. Equivalent dynamic human brain NK1- receptor occupancy following single-dose i.v. fosaprepitant vs. oral aprepitant as assessed by PET imaging. Clin Pharmacol Ther. 2012;92(2):243-250. doi:10.1038/clpt.2012.62. [+] Expand[-] Collapse 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 Privacy Policy Terms of Use Contact Us Heron Therapeutics Do Not Sell My Personal Information © 2023 Heron Therapeutics, Inc. All Rights Reserved. PP-PONV-0068 | 04/23 CONNECT WITH HERON How could you incorporate APONVIE as the foundation of your institution's PONV management strategy? Connect with us to find out. Fields marked with an asterisk (*) are required. First Name* Last Name* Email* Healthcare Field Choose a Healthcare FieldAdministratorAnesthesiologyBariatric SurgeryCRNACardiothoracic SurgeryColorectal SurgeryENTsGeneral SurgeryNurse PractitionerNursingOB/GYNOrthopedic SurgeryNeurosurgeryPharmacyPhysician’s AssistantPodiatryOther Title Zip Code* I would like to*: be contacted by a Heron representative receive promotional communications from Heron Therapeutics, Inc, about innovations regarding products, techniques, or research in postoperative care set up a 15-minute virtual 1:1 program with an HCP in your area to discuss their experience with APONVIE and address any questions you may have about using it Submit To report an adverse event or product complaint: 844-HERON11 (844-437-6611) MedInfo@HeronTx.com For general information: 844-HERON11 (844-437-6611) Investors and Media: IR@HeronTx.com For all other inquiries, please visit the Heron Therapeutics corporate website. Go to Heron Website