Approved Use/Important Safety Considerations

AKYNZEO (netupitant and palonosetron) capsules/(fosnetupitant and palonosetron) for injection is a prescription medicine called an “antiemetic.” AKYNZEO is used in combination with the medicine dexamethasone in adults 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.

Important Safety Considerations

• AKYNZEO may cause serious allergic reactions, such as anaphylaxis. Get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction: hives, swollen face, trouble breathing, or chest pain
• Serotonin syndrome can happen with AKYNZEO particularly with certain other medicines such as anti‑depressants and anti‑migraine medicines and can be life‑threatening. Stop taking AKYNZEO capsules and go to the nearest hospital emergency room right away if you get any of the following symptoms: 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
• Tell your doctor or nurse about all your medical conditions including if you are taking other medications or if you are pregnant or breastfeeding or plan to become pregnant or breastfeed

Only take AKYNZEO as prescribed by your doctor. For additional information about AKYNZEO, talk to your doctor or see the full Full Prescribing Information.

You may report side effects to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.