AKYNZEO

AKYNZEO- netupitant and palonosetron capsule
AKYNZEO- fosnetupitant and palonosetron hydrochloride injection
Helsinn Therapeutics (U.S.), Inc.

1 INDICATIONS AND USAGE

  • AKYNZEO capsules is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. AKYNZEO capsules is a combination of palonosetron and netupitant: palonosetron prevents nausea and vomiting during the acute phase and netupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy.
  • AKYNZEO for injection and AKYNZEO injection are indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. AKYNZEO for injection is a combination of palonosetron and fosnetupitant, a prodrug of netupitant: palonosetron prevents nausea and vomiting during the acute phase and fosnetupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy.

    Limitations of Use

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

The recommended dosages of AKYNZEO and dexamethasone in adults for the prevention of nausea and vomiting associated with administration of emetogenic chemotherapy are shown in Table 1.

AKYNZEO capsules can be taken with or without food.

Table 1: Antiemetic Treatment Regimen

Treatment Regimen

Day 1

Days 2 to 4

Highly Emetogenic Chemotherapy, including Cisplatin-Based Chemotherapy

AKYNZEO capsules

1 capsule of AKYNZEO

1 hour before chemotherapy

Dexamethasone 8 mg once a day

Dexamethasone 12 mg

30 minutes before chemotherapy

AKYNZEO for injection and AKYNZEO injection

1 vial of AKYNZEO

Infuse over 30 minutes starting 30 minutes before chemotherapy [see Dosage and Administration (2.2)]

Dexamethasone 8 mg once a day

Dexamethasone 12 mg

30 minutes before chemotherapy

Anthracyclines and Cyclophosphamide-Based Chemotherapy and Chemotherapy Not Considered Highly Emetogenic

AKYNZEO capsules

1 capsule of AKYNZEO

1 hour before chemotherapy

None

Dexamethasone 12 mg

30 minutes before chemotherapy

2.2 Preparation and Administration of AKYNZEO Injection (Ready-to-Use and To-be-Diluted)

AKYNZEO injection is supplied as either a Ready-to-Use (with hanger) vial or a To-be-Diluted vial.

AKYNZEO injection (Ready-to-Use; with hanger)See Table 2 for preparation instructions of AKYNZEO injection (Ready-to-Use) for intravenous infusion. AKYNZEO injection (Ready-to-Use) does not require dilution prior to administration.

Table 2: Preparation and Administration of AKYNZEO Injection (Ready-to-Use) for Intravenous Infusion
Step 1 Before administration, inspect the solution for particulate matter and discoloration. Discard the vial if particulates and/or discoloration are observed.
Step 2 Using aseptic technique, insert a vented intravenous set through the septum of the vial. Once the stopper is punctured, use immediately.
Step 3 To administer, invert and hang the vial utilizing the strap affixed to the bottom of the vial.
Step 4 Administer over 30 minutes as an intravenous infusion. At the end of the infusion, flush the infusion line with 0.9% Sodium Chloride Injection, USP or with 5% Dextrose injection, USP to ensure complete drug administration.

AKYNZEO injection (Ready-to-Use) contains no antimicrobial preservatives and is intended for single use only.

Compatibility

AKYNZEO injection (Ready-to-Use) is compatible with intravenous dexamethasone sodium phosphate which can be infused simultaneously. Do not add dexamethasone sodium phosphate to the AKYNZEO injection (Ready-to-Use) vial.

Stability and Storage

Use immediately once the stopper is punctured.

AKYNZEO Injection (To-be-Diluted)

Table 3: Preparation and Administration of AKYNZEO Injection (To-be-Diluted) for Intravenous Infusion
Step 1 Before administration, inspect the solution for particulate matter and discoloration. Discard the vial if particulates and/or discoloration are observed.
Step 2 Aseptically prepare an infusion vial or bag filled with 30 mL of 5% Dextrose injection, USP or 0.9% Sodium Chloride injection, USP.
Step 3 Aseptically withdraw the entire volume of solution from the AKYNZEO vial (20 mL) and transfer it into the infusion vial or bag containing 30 mL of 5% Dextrose injection, USP or 0.9% Sodium Chloride injection, USP to yield a total volume of 50 mL.
Step 4 Gently invert the vial or bag until complete dissolution.
Step 5 Before administration, inspect the final diluted solution for particulate matter and discoloration. Discard the vial or bag if particulates and/or discoloration are observed.
Step 6 Administer over 30 minutes as an intravenous infusion. At the end of the infusion, flush the infusion line with the same carrier solution to ensure complete drug administration.

AKYNZEO injection (To-be-Diluted) contains no antimicrobial preservatives and is intended for single use only.

Compatibility

AKYNZEO injection (To-be-Diluted) is compatible with intravenous dexamethasone sodium phosphate which can be added to the infusion bag containing AKYNZEO solution or infused simultaneously.

Stability and Storage

The total time from dilution to the start of the infusion, with or without intravenous dexamethasone sodium phosphate, should not exceed 24 hours.

Store the final diluted solution at room temperature, 20ºC to 25ºC (68Fº to 77ºF).

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.