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.
What should I tell my healthcare provider before taking or using Akynzeo?
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 should I take or use 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, low 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.
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 you have. It may harm them. You can ask your doctor or pharmacist for information about Akynzeo that is written for health professionals.
How should I store Akynzeo?
Store Akynzeo at room temperature between 68°F to 77°F (20°C to 25°C).
What are the ingredients in Akynzeo?
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.
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.
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.
For more information, go to www.akynzeo.com.