Full Prescribing Information Important Safety Information

Time and motion results


CINVANTIā€”the IV NK1 RA that improved practice efficiencies in a time and motion study1

CINVANTI 2-minute IV Push streamlined nurse and pharmacy workflow vs 30-minute infusion, saving 33 minutes per dose1

CINVANTI 2-minute IV Push streamlined nurse and pharmacy workflow vs 30-minute infusions, saving 33 minute per dose CINVANTI 2-minute IV Push streamlined nurse and pharmacy workflow vs 30-minute infusions, saving 33 minute per dose
  EMR=electronic medical record; IV=intravenous; NK1 RA=neurokinin-1 receptor antagonist; Tx=treatment.
* Some common workflow steps for both methods of administration have not been included in this chart.

CINVANTI 2-minute IV Push eliminates key steps from the preparation and administration required for IV infusions1

Time saved with CINVANTI 2-minute IV Push from steps eliminated vs IV infusions

CINVANTI 2-minute IV Push saved time by eliminating key steps from the preparation and administration required for IV infusions
CINVANTI 2-minute IV Push saved nurses 30 minutes per administration1

Steps removed by using CINVANTI 2-minute IV Push vs 30-minute IV infusion*1:

Pharmacy Nurse
Mixing small-volume parenteral solution Verifying admixture is correct prior to administration
Delivering to the infusion area
Gathering and assembling infusion sets
Priming the pump/tubing
Hanging the IV bag
Programming the pump infusion rate
Infusing the product
Removing the IV bag when completed and disposing of waste appropriately

*Observational study with inputs from nurses, pharmacy leads, and pharmacy technicians.

CINVANTI 2-minute IV Push allows providers to save time otherwise spent preparing and administering IV infusions1

IV=intravenous.

CINVANTI 2-minute IV Push shortens infusion chair times1

  • Allows for savings on chair time that could be reused for other procedures1
  • Optimizes infusion schedules, allowing a greater number of patients to be treated in a more timely fashion1
  • Can help prevent unscheduled delays due to antiemetic preparation and complicated bottlenecking, helping to avoid frustration for employees and patients1

CINVANTI 2-minute IV Push may reduce administrative work1

Nurses are able to redirect time for enhanced patient care, thoroughly reviewing chemotherapy or other orders, and assisting other nurses1

Pharmacy is able to complete other tasks such as organizing and cleaning the pharmacy, performing inventory management, drug ordering, and correcting charge documentation1

IV=intravenous.

The need for materials such as tubing and bags of parenteral solution was eliminated with CINVANTI 2-minute IV Push1*

Supply item

Cost

CINVANTI
2-minute
IV Push

CINVANTI
30-minute
IV infusion

Single pair of gloves

$0.16

Yes Yes

20 mL Luer Lock plastic syringe (sterile)

$0.27

Yes Yes

18 g needle (sterile)

$0.04

Yes Yes

Alcohol swab (sterile)

$0.02

Yes Yes

100 mL NS infusion bag (sterile)

$1.22

N/A

Yes

Secondary tubing set (sterile)

$0.77

N/A

Yes

Patient label

$0.03

Yes Yes

Total

$0.52

$2.51

IV=intravenous; N/A=not applicable; NS=normal saline.
*Cost data was gathered between April 2018 and September 2019.

2-minute IV Push saved $1.99 per administration
CINVANTI 2-minute IV Push can be delivered with fewer steps and in less time compared to a 30-minute IV infusion1

IV=intravenous.

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. Burns D, Kula J, Marshall S, Ashworth E, Ornelas M. Best practice approach to successful conversion of fosaprepitant to aprepitant IV in a large multisite community oncology infusion center: a retrospective analysis. Adv Ther. 2020;37(7):3265-3277.