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Frequently Asked Questions
APONVIE Efficacy
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.
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
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.
There were no clinically meaningful differences between the
40 mg dose of oral aprepitant and the
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
While APONVIE is the same formulation (7.
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.
APONVIE Safety
A total of 51 healthy subjects received a single
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.
There is no available data on APONVIE in pregnant women. Avoid use of APONVIE in pregnant women due to the alcohol content.
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.
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.
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.
APONVIE Ordering, Pricing, Reimbursement, and Storage
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.
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.
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.
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.
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
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.
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
Risk of Reduced Efficacy of Hormonal Contraceptives: The efficacy of
hormonal contraceptives may be reduced for
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
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.
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