Full Prescribing Information Important Safety Information
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Supporting your patients and your practice

Heron Connect® offers programs to help ensure CINVANTI<sup>®</sup> is financially accessible for your patients. Services are also provided to help streamline the access process for your practice.

Select the program and enrollment path that best meets the needs of individual patients.

Heron Connect Copay Assistance Program

Heron Connect Patient Assistance Program

Heron Commitment Program

Services For Your Practice

Heron Connect Copay Assistance Program

Commercially insured patients can benefit from $0 out-of-pocket costs for CINVANTI with the availability of copay assistance from Heron Therapeutics. When applicable, patients may also be eligible for deductible assistance up to $200 per treatment. You can enroll your patients in the following ways:

To verify benefits and enroll your patients:

Enroll patients online or download and complete the Insurance Verification and Program Enrollment Form. Fax form to 1-844-504-8652.

If your practice is not already enrolled:

Using the online application, you may enroll your practice at the same time that you enroll your patient.

Alternately, you may enroll your practice online here, or by faxing in a completed Practice Copay Assistance Program Enrollment Form .

Heron Connect Patient Assistance Program

Eligible patients may choose to enroll in the Heron Connect Patient Assistance Program (PAP).† This program is for patients with financial hardship who meet program eligibility criteria to receive CINVANTI at no cost.

To verify benefits and enroll your patients:

Enroll patients online here.

Alternately, you may complete the Insurance Verification and Program Enrollment Form. Fax this form and the prescription for CINVANTI to 1-844-504-8652.

Heron Commitment Program®‡

Heron Therapeutics is dedicated to ensuring patients and providers have access to CINVANTI. The Heron Commitment Program helps mitigate the economic burden of denials; in the event of a qualifying claim denial,§ the program will credit your practice for the cost of the administered medication, when program requirements are met.

More information on this program is available here.

To enroll your practice:

Complete a one-time Heron Commitment Program Enrollment Form. Fax this form to 1-844-504-8652.

Heron Connect services provide the access solutions you need

  • Dedicated Reimbursement Counselors: Your counselor will be a single point of contact for your practice
    • Help patients with enrollment in Heron Connect programs and insurance verification
    • Assist with prior authorization, appeals, billing, reimbursement, and coding
    • Track outcomes, and provide other services to support patients and help them secure product coverage
  • Prior Authorization and Appeals Support: Sample forms and letters are also available for download
  • Drug Replacement: In the event that CINVANTI is determined to be unfit for patient use, or has expired, Heron Therapeutics will replace the affected units. Call Heron Connect for more information at 1-844-HERON11 (1-844-437-6611)||
  • Product Information: Call if you have a clinical inquiry or would like to report an adverse event related to CINVANTI

For more information on Heron Connect, call 1-844-HERON11 (1-844-437-6611) from 8:30 am to 5 pm ET, Monday through Friday.

  1. Limitations apply. Offer not valid as follows: (a) patients covered under Medicare, Medicaid, or any federal or state program; (b) where plan covers treatment for the patient for the entire cost of the prescription drug. Patients pay $0 per copay per dose per 12-month calendar period. When applicable, deductible assistance up to $200 per treatment will be covered. For cash-paying patients, the program will cover $150 per prescription up to $1,800 per calendar year. Eligibility is for 12 months, after which patient will need to reapply for continued assistance. This offer expires 12/31/23.
  2. Heron Therapeutics, Inc., reserves the right, at its sole discretion, to discontinue the Heron Connect Patient Assistance Program or change the qualifications at any time. All patient information remains confidential. Product supply for the program depends on availability.
  3. The Heron Commitment Program and the other product support programs offered by Heron Therapeutics do not impose any purchase obligation at any time or in any manner. Use of CINVANTI and/or SUSTOL may be discontinued at any time, without penalty.
  4. A qualifying claim denial can be reviewed for the Heron Commitment Program when, for a patient covered under commercial insurance, the following criteria have been met, and documentation confirms: (a) the verification of benefits, conducted by the provider and/or Heron Connect, meets all of the payer criteria and/or policy requirements, (b) the submitted claim for the Heron product is denied, and (c) the claim has been denied again by the commercial payer after the first level of appeals process has been followed.
  5. Determination will be made by the manufacturer of 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, or visit www.CINVANTI.com.