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AKYNZEO® IV CONCENTRATE FOR SOLUTION FOR INFUSION 235 MG/0.25 MG/VIAL [SIN16899P]

Active ingredients: AKYNZEO® IV CONCENTRATE FOR SOLUTION FOR INFUSION 235 MG/0.25 MG/VIAL

Last updated 26 October 2025

Product Info

AKYNZEO® IV CONCENTRATE FOR SOLUTION FOR INFUSION 235 MG/0.25 MG/VIAL

[SIN16899P]

Product information

Active Ingredient and Strength

FOSNETUPITANT CHLORIDE HYDROCHLORIDE EQUIVALENT TO FOSNETUPITANT - 235 MG/VIAL
PALONOSETRON HYDROCHLORIDE EQUIVALENT TO PALONOSETRON - 0.25 MG/VIAL

Dosage Form

INFUSION, SOLUTION CONCENTRATE

Manufacturer and Country

BAXTER ONCOLOGY GMBH - GERMANY

Registration Number

SIN16899P

Licence Holder

JUNIPER BIOLOGICS PTE LTD

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

A04AA55

1 INDICATIONS AND USAGE
AKYNZEO IV is indicated in adults for the:

  • Prevention of acute and delayed nausea and vomiting associated with highly emetogenic chemotherapy, including cisplatin.

  • Prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
The recommended dosage of AKYNZEO IV and dexamethasone in adults for the prevention of nausea and vomiting associated with administration of emetogenic chemotherapy are shown in Table 1.

Akynzeo IV Dosage Table 1



2.2 Preparation and Administration of AKYNZEO IV
AKYNZEO IV is for use as an intravenous infusion after dilution. AKYNZEO IV contains no antimicrobial preservatives, is intended for single use only and is compatible with intravenous dexamethasone sodium phosphate which can be added to the AKYNZEO IV solution or infused simultaneously. See Table 2 for preparation instructions of AKYNZEO IV for intravenous infusion.

Akynzeo IV Dosage Table 2



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 below 25°C.

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.

2.3 Incompatibility of AKYNZEO IV
AKYNZEO IV is incompatible with any solution containing divalent cations (e.g., calcium, magnesium), including Lactated Ringer’s Injection and Hartmann’s Solution. Limited data are available on the compatibility of AKYNZEO IV with other intravenous substances, additives or other medications with the exception of intravenous dexamethasone sodium phosphate [see Dosage and Administration (2.2)], and they should not be added to the AKYNZEO solution or infused simultaneously. If the same intravenous line is used for sequential infusion of several different drugs, flush the line before and after infusion of AKYNZEO solution with 0.9% Sodium Chloride Injection, USP.

4 CONTRAINDICATIONS
Pregnancy