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Full Prescribing Information Important Safety Information
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Heron Connect®—
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Learn more about programs and enrollment

Heron Connect provides support programs that meet the needs of patients and providers. Our access solutions include:

  • Convenient access for eligible patients through $0 copay,deductible assistance up to $200 per treatment, and patient assistance programs*†
  • Comprehensive support for practices to assist with patient benefit coordination
  • Dedicated Reimbursement Counselors to help with patient enrollment, appeals, product access, and more
  • The Heron Commitment Program®, which helps mitigate the financial burden of qualifying claim denials when program requirements are met‡§
  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.

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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.