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Announcing the only IV NK1 RA newly approved with the operational flexibility of 2-minute IV Push1-4
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 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.
CINVANTI is the first and only synthetic–surfactant-free IV NK1 RA approved for prevention of acute and delayed CINV due to both HEC and MEC1,2
 
CINVANTI has been FDA approved for a new method of administration—a 2-minute IV Push1
 
CINVANTI delivers the trusted efficacy of aprepitant in a unique emulsion formulation1,5
 
 
 
When given as a 30-minute infusion, proven bioequivalent to fosaprepitant for injection5
 
CINVANTI is free of the synthetic surfactant polysorbate 80 (PS 80)1
 
 
 
PS 80 is associated with adverse events and infusion site reactions6,7
 
CINVANTI 30-minute IV infusion demonstrated fewer treatment-emergent adverse events (TEAEs) within 30 minutes of infusion vs fosaprepitant in healthy subjects5
 
CINVANTI 2-minute IV Push rate of TEAEs was comparable to IV infusion8
 
CINVANTI 2-minute IV Push provides operational advantages over longer IV infusions by
 
REDUCING preparation and administration time1,3,4
 
 
 
Decreases pharmacy workload, requires fewer preparation steps, and allows for storage in automated dispensing devices
 
REDUCING patient time required for treatment4,9
 
 
 
Gives patients time back in their day
 
REDUCING use of infusion supplies1,10,11
 
 
 
Eliminates the need for materials such as tubing and bags of parenteral solution
Benefits of CINVANTI
To learn more about CINVANTI 2-minute IV Push or schedule an appointment with a representative, please visit CINVANTI.com
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 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
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 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 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 reinstate 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 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. 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.
Please see accompanying full Prescribing Information.
References: 1. CINVANTI [package insert]. Heron Therapeutics, Inc., San Diego, CA; February 2019. 2. Emend IV [package insert]. Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ; September 2018. 3. Grissinger M. Some IV medications are diluted unnecessarily in patient-care areas, creating undue risk. P&T. 2017;42(8):490-508. 4. Tsao NW, Lo C, Babich M, Shah K, Bansback NJ. Decentralized automated dispensing devices: systematic review of clinical and economic impacts in hospitals. Can J Hosp Pharm. 2014;67(2):138-148. 5. Data on file [Clinical Summary] Heron Therapeutics, Inc., San Diego, CA. 6. Coors EA, Seybold H, Merk HF, Mahler V. Polysorbate 80 in medical products and nonimmunologic anaphylactoid reactions. Ann Allergy Asthma Immunol. 2005;95(6):593-599. 7. Pritchett W, Kinsley K. Benefits and risks of fosaprepitant in patients receiving emetogenic regimens. Clin J Oncol Nurs. 2016;20(5):555-556. 8. Ottoboni T, Lauw M, Keller MR, et al. HTX-019 via 2-min injection or 30-min infusion in healthy subjects. [Epub ahead of print Dec 21, 2018]. Future Oncol. doi: 10.2217/fon-2018-0809. 9. Raajasekar AKA, Barola S, Tehrani L, Chandra AB. To push or not to push: the benefit of administering anti-emetics by intravenous push. Blood. 2015;126(23):3314. 10. Intermountain Healthcare. Fact sheet for patients and families. https://intermountainhealthcare.org/ext/Dcmnt?incid=520977298. Accessed February 8, 2019. 11. DeBernardo, Christina. Medication administration via intravenous piggyback (IVPB). KLA education services. https://www.ivyleaguenurse.com/courses/IVPB.pdf. Accessed February 9, 2019. 12. AKYNZEO [package insert]. Helsinn Healthcare SA., Lugano, Switzerland; April 2018.
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© 2019 Heron Therapeutics, Inc. All rights reserved. 02/19 PP-CV-0153

 

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