Full Prescribing Information Important Safety Information

CINVANTI 2-minute IV Push as safe as 30-minute IV infusion, demonstrated by Study 1081

Shortages of IV fluid and bags have disrupted the ability to use IV infusions

IV fluid and bag shortages have a widespread and lasting impact

  • Events such as natural disasters and the COVID-19 pandemic have caused persistent interruptions to the supply chain for medical supplies.2-4
    • These shortages continue to be a challenge in the United States4

Heron completed Study 108 to evaluate CINVANTI given as a 2-minute IV Push1

  • Study 108 included a single-center, randomized, open-label, crossover evaluation of 50 healthy subjects to assess the pharmacokinetics, tolerability, and safety of CINVANTI administered by 2-minute IV Push vs 30-minute infusion
* Confinement lasted from the morning of Day 1 through the end of period 2, for a total of approximately 12 days (through the pharmacokinetics collection at 72 hours after dose 2).1
The American Society of Health-System Pharmacists (ASHP) recommends switching from IV infusion to IV Push whenever possible5

CINVANTI 2-minute IV Push demonstrated safety and tolerability comparable to 30-minute IV infusion in healthy subjects1

Incidence of any treatment-emergent adverse events within 30 minutes of administration (Study 108)
Graph demonstrating that the incidence of TEAEs within the first 30 minutes with CINVANTI IV Push was equal to CINVANTI infusion at a rate of 2%
  • In Study 108, incidence of TEAEs within the first 30 minutes with CINVANTI IV Push was comparable to CINVANTI infusion1

COVID-19=coronavirus disease 2019; IV=intravenous; TEAE=treatment-emergent adverse event.

Operational Efficiencies with CINVANTI

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Explore the Safety of Fosaprepitant vs CINVANTI

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Advantages of IV Push

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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. Ottoboni T, Lauw M, Keller MR, et al. HTX-019 via 2-min injection or 30-min infusion in healthy subjects. Future Oncol. 2019;15(8):865-874.
  2. Mazer-Amirshahi M, Fox ER. Saline shortages—many causes, no simple solution. N Engl J Med. 2018;378(16):1472-1474.
  3. Badreldin HA, Atallah B. Global drug shortages due to COVID-19: impact on patient care and mitigation strategies. Res Social Adm Pharm. 2021(17):1946-1949. doi:10.1016/j. sapharm.2020.05.017.
  4. FDA drug shortages. Current and resolved drug shortages and discontinuations reported to FDA. https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Dextrose+5per+Injection&st=c&tab=tabs-4&panels=0. Accessed March 1, 2022.
  5. ASHP fluid shortages. https://www.ashp.org/drug-shortages/shortage-resources/publications/fluid-shortages-suggestions-for-management-and-conservation#. Accessed March 28, 2022.