Quick answers
- What is Netupitant and palonosetron used for?
- The FDA-approved label (Akynzeo, Helsinn Therapeutics (U.S.), Inc., June 23, 2026) says: “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 …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Netupitant and palonosetron have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Netupitant and palonosetron?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Netupitant and palonosetron been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Netupitant and palonosetron?
- 1 company lists prescription products of Netupitant and palonosetron in the FDA NDC Directory, including Helsinn Therapeutics (U.S.), Inc..
What Netupitant and palonosetron is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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 …
— FDA label: Akynzeo, Helsinn Therapeutics (U.S.), Inc., effective June 23, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Capsule |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Akynzeo |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Helsinn Therapeutics (U.S.), Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA205718 AKYNZEO | Helsinn Hlthcare | October 10, 2014 | 8, latest June 2, 2021 2021: Labeling · 2016: Labeling · 2016: Manufacturing (CMC) |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Akynzeo, Helsinn Therapeutics (U.S.), Inc., effective June 23, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →