CINVANTI—the first and only polysorbate 80-free IV NK1 RA with the trusted efficacy of fosaprepitant1-3

Proven bioequivalent to fosaprepitant for injection4

In 2 pivotal studies (Study 104 and Study 106) conducted in healthy subjects who were not treated with chemotherapy, the bioequivalence of CINVANTI and fosaprepitant was evaluated with consistent results across both studies.4

Bioequivalence Information for Brand
  • Bioequivalence between CINVANTI and fosaprepitant was determined by pre-selected pharmacokinetic measurements that were found to be within the pre-defined statistical range†4
  • Drugs are considered bioequivalent if they have the same systemic exposure and, thus, should be comparably efficacious5
  • The secondary objective of both studies was to assess the safety and tolerability of CINVANTI and fosaprepitant4

NK1 RA=substance P/neurokinin-1 (NK1) receptor antagonist.
* Data presented are from Study 106.
Area under the curve0-t: Plasma concentration from time 0 to last measurement; Area under the curve0-inf: Plasma concentration from time 0 extrapolated to infinity; C12 hour: Plasma concentration at 12 hours.


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 and nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).

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

Important Safety Information


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 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 aprepitant.

Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylaxis and anaphylactic shock, have been reported with fosaprepitant, a prodrug of aprepitant, and with oral aprepitant. Symptoms including flushing, erythema, dyspnea, hypotension and syncope have been reported. If symptoms occur, discontinue CINVANTI. Do not reinstate if symptoms occur with first time 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 with the 3-day oral aprepitant regimen in conjunction with MEC (≥1% and greater than standard therapy) were fatigue and eructation.

The most common adverse reactions with the single-dose intravenous fosaprepitant regimen in conjunction with HEC were generally similar to that seen in prior HEC studies with oral aprepitant. In addition, infusion site reactions (3%) occurred.

The most common adverse reactions with single-dose CINVANTI (≥2%) were headache and fatigue.

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

  1. CINVANTI [package insert]. Heron Therapeutics, Inc., San Diego, CA; November 2017.
  2. Varubi [package insert]. Tesaro, Inc., Waltham, MA; October 2017.
  3. Emend IV [package insert]. Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ; August 2017.
  4. Data on file [Clinical Summary] Heron Therapeutics, Inc., San Diego, CA.
  5. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for industry bioavailability and bioequivalence studies for orally administered drug products—general considerations. 2003:1-23.