Full Prescribing Information Important Safety Information

CINVANTI—the IV NK1 RA with the potential to improve practice efficiency, demonstrated by a time and motion study1

Selecting an NK1 RA should be driven by clinical considerations and supported by operational efficiencies

The importance of assessing the impact of operational advantages

  • Lower acquisition costs of generic antiemetics can provide short-term savings, but there is more to consider than just the cost of the product when determining the right NK1 RA for your practice
  • Product selection for CINV prophylaxis should also be driven by the desire to deliver efficient patient care

Limitations of other IV NK1 RAs1-3

Administered as IV infusions over longer durations of 20-30 minutes

Prepared and mixed in infusion bags

Require additional steps, time, and supplies

vs CINVANTI, the only IV NK1 RA approved as a 2-minute IV Push

Workflow benefits of CINVANTI 2-minute IV Push were supported by a retrospective study1

Study background1

  • A large multisite community oncology practice with more than 80 providers1
  • More than 700 employees who staff 13 infusion centers1
  • An OCM-based practice with the goal of improving patient care, increasing overall value, and reducing the impact on patient cost1,4

Study objectives

Time, motion, and cost evaluation1

A physician-owned community oncology practice conducted a time, motion, and cost evaluation to determine the overall impact and operational advantages of adopting CINVANTI 2-minute IV Push.*


The study focused on the precise timing of each step in the process of preparing and administering 30-minute IV infusions vs 2-minute IV Push, and how stakeholders were impacted in the separate workflow steps.†1

Key data points assessed were1:

Staff time saved/expended

Supplies saved/consumed

What could be accomplished with reallocated time for impacted disciplines

*This study was funded by Heron Therapeutics, Inc.

†Thirty-minute IV infusions of NK1 RAs included fosaprepitant or CINVANTI (aprepitant), as the practice was transitioning between the 2 products during the study period.1

CINV=chemotherapy-induced nausea and vomiting; IV=intravenous; NK1 RA=neurokinin-1 receptor antagonist; OCM=Oncology Care Model.

Operational Efficiencies with CINVANTI

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Indication

CINVANTI is a substance P/neurokinin-1 (NK1) receptor antagonist, indicated in adults, in combination with other antiemetic agents, for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen; delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen; and nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen.

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

Important Safety Information

Contraindications

CINVANTI is contraindicated in patients with hypersensitivity to any of the components of CINVANTI.

Concurrent use of pimozide with CINVANTI is contraindicated.

Warnings and Precautions

Clinically Significant CYP3A4 Drug Interactions

Aprepitant is a substrate, weak-to-moderate (dose-dependent) inhibitor, and an inducer of CYP3A4.

  • Use of CINVANTI with other drugs that are CYP3A4 substrates may result in increased plasma concentration of the concomitant drug.
    • Use of pimozide with CINVANTI is contraindicated due to the risk of significantly increased plasma concentrations of pimozide, potentially resulting in prolongation of the QT interval, a known adverse reaction of pimozide.
  • Use of CINVANTI with strong or moderate CYP3A4 inhibitors (e.g., ketoconazole, diltiazem) may increase plasma concentrations of aprepitant and result in an increased risk of adverse reactions related to CINVANTI.
  • Use of CINVANTI with strong CYP3A4 inducers (e.g., rifampin) may result in a reduction in aprepitant plasma concentrations and decreased efficacy of CINVANTI.

Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylaxis, during or soon after administration of CINVANTI have occurred. Symptoms including dyspnea, eye swelling, flushing, pruritus, and wheezing have been reported. If hypersensitivity reactions occur, discontinue CINVANTI. Do not reinitiate CINVANTI in patients who experience these symptoms with previous use.

Decrease in INR with Concomitant Warfarin

Co-administration of CINVANTI 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 initiation of CINVANTI with each chemotherapy cycle.

Risk of Reduced Efficacy of Hormonal Contraceptives

The efficacy of hormonal contraceptives may be reduced during administration of and for 28 days following the last dose of CINVANTI. Advise patients to use effective alternative or back-up methods of non-hormonal contraception during treatment with CINVANTI and for 1 month following administration of CINVANTI or oral aprepitant, whichever is administered last.

Use in Specific Populations

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

Adverse Reactions

The most common adverse reactions are:

  • Single-dose fosaprepitant with MEC (≥2%): fatigue, diarrhea, neutropenia, asthenia, anemia, peripheral neuropathy, leukopenia, dyspepsia, urinary tract infection, pain in extremity.
  • 3-day oral aprepitant with MEC (≥1% and greater than standard therapy): fatigue and eructation.
  • Single-dose fosaprepitant with HEC: generally similar to 3-day oral aprepitant. In addition, infusion site reactions (3%) occurred.
  • Single-dose CINVANTI (≥2%): headache and fatigue. The safety profile of CINVANTI in healthy subjects who received a single 2-minute injection was similar to that seen with a 30-minute infusion.

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

For more information about CINVANTI, please see full Prescribing Information.

References:
  1. Burns D, Kula J, Marshall S, Ashworth E, Ornelas M. Best practice approach to successful conversion of fosaprepitant to aprepitant IV in a large multisite community oncology infusion center: a retrospective analysis. Adv Ther. 2020;37(7):3265-3277.
  2. CINVANTI [prescribing information]. Heron Therapeutics, Inc., San Diego, CA; March 2022.
  3. Emend for injection [prescribing information]. Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ; April 2020.
  4. Oncology Care Model. Centers for Medicare & Medicaid Services website. Updated September 14, 2020. Accessed October 6, 2020. https://innovation.cms.gov/innovation-models/oncology-care.