Full Prescribing Information Important Safety Information

Dosing, preparation, and storage for CINVANTI1

The only NK1 RA available with the added flexibility of IV Push1

  • CINVANTI is polysorbate-80 free
  • Administer CINVANTI 30 minutes prior to HEC or MEC in combination with other antiemetics to prevent nausea and vomiting1
  • Dosing is based on chemotherapy emetogenicity
HEC & MEC SINGLE-DOSE REGIMEN: CINVANTI IV 130 mg1
HEC & MEC HEC ONLY*
AGENT DAY 1 DAY 2 DAY 3 DAY 4
CINVANTI 130 mg None None None
Oral dexamethasone† 12 mg 8 mg 8 mg twice daily 8 mg twice daily
5-HT3 antagonist See selected
5-HT3 antagonist PI		 None None None
MEC 3-DAY DOSE REGIMEN: CINVANTI IV 100 mg1
AGENT DAY 1 DAY 2 DAY 3
CINVANTI 100 mg None None
Oral aprepitant None 80 mg 80 mg
Oral dexamethasone‡ 12 mg None None
5-HT3 antagonist See selected
5-HT3 antagonist PI		 None None
* Only HEC requires additional dosing of oral dexamethasone on Days 2-4.
† Administer dexamethasone 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 through 4. Also administer dexamethasone in the evenings on days 3 and 4. A 50% dosage reduction of dexamethasone on Days 1 and 2 is recommended to account for a drug interaction with aprepitant.1
‡ Administer dexamethasone 30 minutes prior to chemotherapy treatment on Day 1. A 50% dosage reduction of dexamethasone is recommended to account for a drug interaction with aprepitant.1


5-HT3=5-hydroxytryptamine 3; HEC=highly emetogenic chemotherapy; MEC=moderately emetogenic chemotherapy; PI=prescribing information.

Preparation and administration of CINVANTI for 2-minute IV Push
  • HEC or MEC (130 mg): Aseptically withdraw 18 mL from the vial and administer as 2-minute injection
  • MEC (100 mg): Aseptically withdraw 14 mL from the vial and administer as 2-minute injection
  • Flush infusion line with normal saline before and after administration of CINVANTI

Do not dilute

No reconstitution required

Preparation and administration of CINVANTI for 30-minute IV infusion
  • HEC or MEC (130 mg): Aseptically withdraw 18 mL from the vial
  • MEC (100 mg): Aseptically withdraw 14 mL from the vial
  • Transfer into an infusion bag filled with 100 mL of 0.9% Sodium Chloride Injection, USP or 5% Dextrose for Injection, USP
    • HEC or MEC (130 mg) dose total volume: 118 mL
    • MEC (100 mg) dose total volume: 114 mL
  • Gently invert the bag 4 to 5 times; avoid shaking
  • Inspect the bag for particulate and/or discoloration before 30-minute administration
  • Discard the bag if particulate and/or discoloration are observed

Use only non-DEHP tubing and non-PVC infusion bags

No reconstitution required

DEHP=Di(2-ethylhexyl) phthalate; HEC=highly emetogenic chemotherapy; IV=intravenous; MEC=moderately emetogenic chemotherapy; PVC=polyvinyl chloride; USP=United States Pharmacopeia.

Vial storage1

  • Each single glass vial contains 130 mg/18 mL aprepitant
  • Must be refrigerated, stored at 2°C-8°C (36°F-46°F)
  • Can remain at room temperature for up to 60 days
  • Do not freeze

Diluted solution storage1

N/A

Diluted drug solution remains stable:
  • At room temperature for 6 hours in 0.9% Sodium Chloride Injection, USP and 12 hours in 5% Dextrose for Injection, USP
  • Under refrigeration for 72 hours in 0.9% Sodium Chloride Injection, USP or 5% Dextrose for Injection, USP

N/A=not applicable; USP=United States Pharmacopeia.

IV=intravenous; NK1 RA=neurokinin-1 receptor antagonist.

Safety Profile with IV Push

See the data
Advantages of IV Push

Find out more
Operational Efficiencies with 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.

Reference:
  1. CINVANTI [prescribing information]. Heron Therapeutics, Inc., San Diego, CA; March 2022.