MedPath
HSA Approval

AKYNZEO CAPSULES 300MG/0.5MG

SIN15031P

AKYNZEO CAPSULES 300MG/0.5MG

AKYNZEO CAPSULES 300MG/0.5MG

June 8, 2016

JUNIPER BIOLOGICS PTE LTD

JUNIPER HEALTHCARE PTE LTD

Regulatory Information

JUNIPER BIOLOGICS PTE LTD

JUNIPER HEALTHCARE PTE LTD

Therapeutic

Prescription Only

Formulation Information

CAPSULE, GELATIN COATED

**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 _\[see Clinical Studies (14), Table 5)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_. \[From **14 CLINICAL STUDIES**\] ![Akynzeo Dosage Table 5](https://cdn.medpath.com/drug/dosage/20240520/509a164c016ca624064bf17a6d5cff1f.png) Anthracyclines and Cyclophosphamide Based Chemotherapy and Chemotherapy Not Considered Highly Emetogenic 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 _\[see Clinical Studies (14), Table 7_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_. \[From **14 CLINICAL STUDIES**\] ![Akynzeo Dosage Table 7](https://cdn.medpath.com/drug/dosage/20240520/e622f8f5e906ae6f364c72f8c8273008.png) AKYNZEO can be taken with or without food.

ORAL

Medical Information

**1 INDICATIONS AND USAGE** AKYNZEO is indicated 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.

**4 CONTRAINDICATIONS** None.

A04AA55

palonosetron, combinations

Manufacturer Information

juniper healthcare pte ltd

Helsinn Birex Pharmaceuticals Ltd. (Intermediate Netupitant Tablets and final drug product)

CATALENT PHARMA SOLUTIONS LLC (Intermediate Palonosetron softgels)

Active Ingredients

Palonosetron HCl 0.56mg eqv to Palonosetron

0.50mg

Palonosetron

Netupitant

300mg

Netupitant

Documents

Package Inserts

Akynzeo Capsules PI.pdf

Approved: March 17, 2022

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