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

AKYNZEO for injection and AKYNZEO injection have not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy.

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 for injection and AKYNZEO injection

AKYNZEO for injection and AKYNZEO injection are for use as an intravenous infusion after dilution. AKYNZEO for injection and AKYNZEO injection contain no antimicrobial preservatives and are intended for single use only.

Preparation

Table 2 for preparation instructions.

Table 2: Preparation of AKYNZEO for injection
Step 1 Aseptically inject 20 mL 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP into the vial. Ensure the solvent is added to the vial along the vial wall and not jetted in order to prevent foaming. Swirl the vial gently.
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 reconstituted solution from the AKYNZEO vial 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 till 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.

Storage

The total time from reconstitution to the start of the infusion should not exceed 24 hours. Store the reconstituted solution and the final diluted solution at room temperature.See Table 3 for preparation instructions of AKYZNEO injection.

Table 3: Preparation of AKYNZEO Injection

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.

Storage

The total time from dilution to the start of the infusion should not exceed 24 hours. Store the final diluted solution at room temperature.

Administration

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.

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