Frequently Asked Questions

APONVIE Efficacy

Why utilize an IV version of aprepitant versus an oral?

APONVIE is administered via a single, 30-second IV push. Therapeutic plasma concentrations associated with ≥97% receptor occupancy in the brain are achieved within 5 minutes for APONVIE—unlike oral aprepitant, which was taken 1 to 3 hours prior to induction of general anesthesia in clinical trials and does not reach maximum concentration until 4 hours after administration.1-5,a

Plasma concentrations of APONVIE (aprepitant) were higher than those of the oral formulation for approximately 3 hours. By the 4-hour timepoint, the plasma concentrations for the 2 formulations converged and remained similar.5

IV administration allows the drug to enter directly into systemic circulation without the delay associated with absorption processes. This results in 100% bioavailability, making it the best way to deliver a drug rapidly and accurately, and bypassing first-pass metabolism.6

Learn more about how IV administration affects plasma concentrations.

Why are your studies based on oral aprepitant data?

The FDA allows for bioequivalent submissions of drugs to be based on previously approved drug labels. APONVIE was approved via a 505(b)(2) pathway.5

APONVIE 32 mg administered as a single, 30-second IV injection demonstrated bioequivalenceb to oral aprepitant 40 mg, supporting its efficacy for the prevention of PONV.5

Results also showed APONVIE was well-tolerated, with a safety profile similar to that of oral aprepitant and ondansetron.1

Learn more about how APONVIE was proven bioequivalent to oral aprepitant.

Why was the 40 mg dose selected to be used as the comparator in the Phase 1 bioequivalence study rather than the 125 mg dose?

There were no clinically meaningful differences between the 40 mg dose of oral aprepitant and the 125 mg dose. In the combined study population, more patients taking aprepitant achieved complete response compared with patients taking ondansetron.7,8

Why was “no vomiting 0 to 24 hours” added as a co-primary endpoint in Study 1?

In Study 2, which occurred prior to Study 1, complete response was not statistically significant. However, no vomiting 0 to 24 was statistically significant as a secondary endpoint. Therefore, no vomiting 0 to 24 hours was added to Study 1 as a co-primary endpoint.7,8

Is APONVIE the same product as CINVANTI? Why did you market APONVIE as a new product instead of an expanded indication for CINVANTI?

While APONVIE is the same formulation (7.2 mg/mL of aprepitant) as Heron’s approved drug CINVANTI, the aprepitant dose in APONVIE is about 1/4th the dose needed in CINVANTI for CINV. APONVIE is supplied in a 5 mL vial containing 32 mg (4.4 mL) of aprepitant, the dose approved for PONV. CINVANTI is supplied in a 20 mL vial containing 130 mg (18 mL) of aprepitant, the maximum dose approved for CINV.

Our pipeline is divided into acute care and oncology care solutions. Through this division of acute care and oncology care solutions, we are also able to clearly differentiate APONVIE from CINVANTI to help reduce medication errors due to the different dose and duration of dosing. The two drugs also have very distinctly different patient populations. We intentionally market APONVIE and CINVANTI as two separate products to reach specific audiences more effectively, ensuring healthcare providers and patients understand what medical options are available to them.

Will Heron be conducting additional studies to support an expanded label that covers the treatment of PONV?
In the future, Heron may assess the need to conduct a study for use of APONVIE for treatment of established PONV.


What are the reported side effects with APONVIE?1

A total of 51 healthy subjects received a single 32 mg dose of APONVIE as a single, 30-second intravenous injection. Adverse reactions reported in at least 3% of subjects were constipation (8%), fatigue (6%), and headache (4%).

In a pooled analysis of PONV studies, less common adverse reactions reported in more than 0.5% of patients treated with oral aprepitant and at a greater incidence than ondansetron were: dizziness and urticaria. In addition, 2 serious adverse reactions were reported in PONV clinical studies of oral aprepitant in patients taking a higher than recommended dose: 1 case of constipation, and 1 case of sub-ileus.

The following adverse reactions have been identified during post-approval use of aprepitant. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Skin and subcutaneous tissue disorders: pruritus, rash, urticaria, Stevens-Johnson syndrome/toxic epidermal necrolysis.

Immune system disorders: hypersensitivity reactions including anaphylaxis and anaphylactic shock.

Nervous system disorders: ifosfamide-induced neurotoxicity reported after aprepitant and ifosfamide coadministration.

Learn more about the safety profile of APONVIE.

Can you use APONVIE in patients who are pregnant?1

There is no available data on APONVIE in pregnant women. Avoid use of APONVIE in pregnant women due to the alcohol content.

Do you have any data on the presence of aprepitant in human milk?1

There are no data on the presence of aprepitant in human milk, the effects on the breastfed infant, or the effects on milk production. Aprepitant is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for APONVIE and any potential adverse effects on the breastfed infant from APONVIE or from the underlying maternal condition.

Can you use APONVIE with patients on dialysis or with renal impairment?1

Yes, aprepitant is not renally excreted. Aprepitant was eliminated primarily by metabolism.

The pharmacokinetics of aprepitant in patients with severe renal impairment and those with end stage renal disease (ESRD) requiring hemodialysis were similar to those of healthy subjects with normal renal function.

No dosage adjustment is necessary for patients with any degree of renal impairment or for patients with ESRD undergoing hemodialysis.

Is APONVIE safe for those under 18?1

The safety and effectiveness of APONVIE have not been established in pediatric patients. Heron is in the process of conducting a pediatric study for APONVIE.

Can you use APONVIE in patients with hepatic impairment?1
The pharmacokinetics of oral aprepitant in mild to moderately hepatically impaired patients (Child-Pugh score 5 to 9) was similar to those of healthy subjects with normal hepatic function. There are no clinical or pharmacokinetic data in patients with severe hepatic impairment (Child-Pugh score greater than 9).

APONVIE Ordering, Pricing, Reimbursement, and Storage

How do I order APONVIE?

APONVIE is available through authorized wholesalers and specialty distributors. To order APONVIE, contact your preferred distributor. APONVIE is packaged in cartons of 10 single-use vials.

How much does APONVIE cost?

APONVIE is priced to support broad access. Heron offers 340B pricing to eligible institutions, which allows purchases at a minimum discount of 23.1%. GPO, sub-WAC, and prime vendor discounts are also available. In addition, reimbursement for APONVIE may offset the cost of the product for many patients.

See more detail on APONVIE pricing.

How is APONVIE reimbursed?

Medicare: APONVIE is separately reimbursed by Medicare at ASP + 6% in HOPDs and ASCs under 3-year transitional pass-through status effective April 1, 2023.c APONVIE is the only product in its class separately reimbursed by Medicare in HOPDs and ASCs. Use C9145 when billing for APONVIE.

Generic PONV medications like oral aprepitant and other drugs without pass-through status are packaged across all settings of care.d

Commercial: Some commercial payers reimburse separately for APONVIE as a percentage of billed charges. However, most will reimburse APONVIE as part of the surgical supply package across all sites of care. Contact payers to verify coverage.

Learn more about reimbursement for APONVIE.

What are the recommended storage conditions for APONVIE?

Refrigerate APONVIE at 2°C to 8°C (36°F to 46°F) up to 36 months. APONVIE can remain at room temperature (20°C to 25°C; 68°F to 77°F) up to 60 days. Do not freeze.

Can APONVIE be stored in our automated dispensing system?

Yes, the carton of 10 single-use vials is approximately 5.8" x 2.7" x 1.9". Individual vials of APONVIE are controlled-room-temperature stable (68° F to 77°F; 20°C to 25°C) for up to 60 days and will fit into automated dispensing systems.

aThe relationship between receptor occupancy and efficacy has not been established.

bTwo drugs are considered by FDA to be bioequivalent if the rate and extent of absorption of the proposed drug do not show a significant difference from the rate and extent of absorption of the therapeutic/approved drug when administered.

cAPONVIE will be reimbursed at WAC + 3% until ASP is established. Medicare reimbursement is subject to CMS updates, co-pay amounts, sequestration, and other factors.

dReimbursement comparisons do not imply safety or efficacy.

References: 1. APONVIE [package insert]. San Diego, CA: Heron Therapeutics Inc; 2022. 2. Data on file. Summary of clinical pharmacology studies. San Diego, CA: Heron Therapeutics Inc. 2021. 3. 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. 4. EMEND [package insert]. Whitehouse Station, NJ: Merck & Co Inc: 2019. 5. Data on file. Study HTX-019-111. San Diego, CA: Heron Therapeutics Inc; 2021. 6. Ruiz ME, Scioli Montoto S. Routes of drug administration. In: Talevi A, Quiroga P, eds. ADME Processes in Pharmaceutical Sciences. Springer, Cham. Published December 1, 2018. doi:10.1007/978-3-319-99593-9_6. 7. 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. 8. 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.

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Important Safety Information!


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


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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