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National Drug Formulary

AKYNZEO CAPSULES 300MG/0.5MG [SIN15031P]

Active ingredients: AKYNZEO CAPSULES 300MG/0.5MG

View product's general information
Last updated 24 April 2026

Product Info

AKYNZEO CAPSULES 300MG/0.5MG

[SIN15031P]

Product information

Active Ingredient and Strength

NETUPITANT - 300 MG
PALONOSETRON HCL 0.56 MG EQV TO PALONOSETRON - 0.5 MG

Dosage Form

CAPSULE, GELATIN COATED

Manufacturer and Country

HELSINN BIREX PHARMACEUTICALS LTD. (INTERMEDIATE NETUPITANT TABLETS AND FINAL DRUG PRODUCT) - IRELAND
CATALENT PHARMA SOLUTIONS LLC (INTERMEDIATE PALONOSETRON SOFTGELS) - UNITED STATES

Registration Number

SIN15031P

Licence Holder

JUNIPER HEALTHCARE PTE LTD

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

A04AA55

Prescription-only Medicines with Exemptions for Supply without Prescription

NA

Indication

1 INDICATIONS AND USAGE

AKYNZEO 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.

Dosing

2 DOSAGE AND ADMINISTRATION

Administration
One AKYNZEO capsule administered approximately 1 hour prior to the start of chemotherapy.

Highly Emetogenic Chemotherapy, including Cisplatin Based Chemotherapy
The recommended dosage in adults is one capsule of AKYNZEO administered approximately 1 hour prior to the start of chemotherapy with dexamethasone 12 mg administered orally 30 minutes prior to chemotherapy on day 1 and 8 mg orally once daily on days 2 to 4 [see Clinical Studies (14), Table 5)].

[From 14 CLINICAL STUDIES]

Akynzeo Dosage Table 5



Moderately Emetogenic Chemotherapy / Anthracyclines and Cyclophosphamide-based Chemotherapy
The recommended dosage in adults is one capsule of AKYNZEO approximately 1 hour prior to the start of chemotherapy with dexamethasone 12 mg administered orally 30 minutes prior to chemotherapy on day 1. Administration of dexamethasone on days 2 to 4 is not necessary [see Clinical Studies (14), Table 7].

[From 14 CLINICAL STUDIES]

Akynzeo Dosage Table 7



AKYNZEO can be taken with or without food.

Contraindications

4 CONTRAINDICATIONS

Pregnancy