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Akynzeo: Uses, Side Effects and Dosage

Status:
Prescription (Rx) Facts
Strength:
300 mg, 0.5 mg, 260 mg, 0.28 mg, 260 mg/20 mL, 0.28 mg/20 mL
Drug class:
Active ingredients:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Akynzeo

What is AKYNZEO?

AKYNZEO is a prescription medicine called an antiemetic. AKYNZEO is used in combination with the medicine dexamethasone in people to help prevent the nausea and vomiting that happens right away or later with certain anti-cancer medicines (chemotherapy).

It is not known if AKYNZEO is safe and effective in children under 18 years of age.

Before you take or receive AKYNZEO, tell your doctor about all of your medical conditions, including if you:

  • have had an allergic reaction to palonosetron or another medicine for nausea or vomiting.
  • have liver problems.
  • have kidney problems.

  • are pregnant or plan to become pregnant. AKYNZEO may harm your unborn baby.

  • are breastfeeding or plan to breastfeed. It is not known if AKYNZEO passes into your breast milk. You and your doctor should decide if you will take AKYNZEO or breastfeed. You should not do both.

Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

AKYNZEO and certain other medicines can affect each other, causing serious side effects.

How will I take or receive AKYNZEO?

  • Take AKYNZEO exactly as your doctor tells you to take it.
  • Take 1 AKYNZEO capsule by mouth, about 1 hour before you get your anti-cancer medicine (chemotherapy).
  • AKYNZEO for injection will be given to you in your vein by I.V. (intravenous) infusion about 30 minutes before you start your chemotherapy treatment.

  • Take AKYNZEO capsule with or without food.

  • If you take too much AKYNZEO, call your doctor or go to the nearest hospital emergency room right away.

What are the possible side effects of AKYNZEO?

AKYNZEO may cause serious side effects, including:

  • allergic reactions, such as anaphylaxis. Get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction with AKYNZEO: hives, swollen face, trouble breathing, or chest pain.

  • serotonin syndrome which can happen with AKYNZEO particularly with certain other medicines such as anti-depressants and anti-migraine medicines and can lead to death.

    • Stop taking AKYNZEO capsules and go to the nearest hospital emergency room right away if you get any of the following symptoms of serotonin syndrome: agitation, hallucinations or other changes in mental status, dizziness, fast heartbeat, sweating, high body temperature, shaking (tremors), unsteady movements, muscle twitching (overactive reflexes), or seizures with or without nausea, vomiting, and diarrhea.

The most common side effects of AKYNZEO capsules and injection include: headache, weakness, fatigue, upset stomach, constipation, and skin redness.

These are not all the possible side effects of AKYNZEO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store AKYNZEO capsules?

Store AKYNZEO at room temperature between 68°F to 77°F (20°C to 25°C).

General information about the safe and effective use of AKYNZEO

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use AKYNZEO for a condition for which it was not prescribed. Do not give AKYNZEO to other people, even if they have the same symptoms that you have. It may harm them. You can ask your doctor or pharmacist for information about AKYNZEO that is written for health professionals.

What are the ingredients in AKYNZEO capsules?

Active ingredients: netupitant and palonosetron hydrochloride

Inactive ingredients: butylated hydroxyanisole (BHA), croscarmellose sodium, gelatin, glycerin, magnesium stearate, microcrystalline cellulose, mono- and di-glycerides of capryl/capric acid, polyglyceryl dioleate, povidone K-30, purified water, red iron oxide, silicon dioxide, sodium stearyl fumarate, sorbitol, sucrose fatty acid esters, titanium dioxide and yellow iron oxide. It may contain traces of medium-chain triglycerides, lecithin, and denatured ethanol. AKYNZEO may contain small amounts of medium-chain triglycerides, lecithin, and denatured ethanol.

What are the ingredients in AKYNZEO for injection?

Active ingredients: fosnetupitant chloride hydrochoride and palonosetron hydrochloride

Inactive ingredients: mannitol, edetate disodium, sodium hydroxide, and hydrochloric acid may be added for pH adjustment.

What are the ingredients in AKYNZEO injection?

Active ingredients: fosnetupitant chloride hydrochloride and palonosetron hydrochloride

Inactive ingredients: edetate disodium, mannitol and water for injection; sodium hydroxide and hydrochloric acid may be added for pH adjustment.

Manufactured by Helsinn Birex Pharmaceuticals, Dublin, Ireland

for Helsinn Healthcare SA, Switzerland

Distributed by Helsinn Therapeutics (U.S.), Inc. Iselin, NJ 08830 under license of Helsinn Healthcare SA, Switzerland

AKYNZEO is a registered trademark of Helsinn Healthcare SA, Lugano, Switzerland

For more information, go to www.akynzeo.com

This Patient Information has been approved by the U.S. Food and Drug Administration. Approved: May 2022

Instructions for opening the AKYNZEO pack of one capsule in one blister:

  1. 1. Press buttons A and B together with one hand.
  1. 2. Pull the tab card on the right hand side with other hand.
  1. 3. Release buttons A and B while pulling the tab card.
  1. 4. Keep pulling the tab card until the pack is fully open.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 205718 · View the label on DailyMed

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Akynzeo

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Serotonin-3 Receptor Antagonist, Substance P/Neurokinin-1 Receptor Antagonist
Active ingredients Netupitant, Palonosetron
Dosage form Capsule, Injection
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) HELSINN HLTHCARE
FDA approval NDA 205718New Drug Application (NDA) Approved October 10, 2014
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
300 mg, 0.5 mg – 1 in 1 blister pack / 1 in 1 carton NDC 69639-101-01
300 mg, 0.5 mg – 2 in 1 blister pack / 2 in 1 carton NDC 69639-101-04
260 mg, 0.28 mg – 1 in 1 vial / 1 in 1 carton NDC 69639-102-01
260 mg/20 mL, 0.28 mg/20 mL – 20 ml in 1 vial / 1 in 1 carton NDC 69639-105-01
260 mg/20 mL, 0.28 mg/20 mL – 20 ml in 1 vial, single-dose / 1 in 1 carton NDC 69639-106-01

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.