Netupitant & Palonosetron

Netupitant/palonosetron is a prescription medication used to prevent nausea and vomiting in patients receiving cancer chemotherapy.

Netupitant/palonosetron is available in capsule form and is taken 1 hour before the start of chemotherapy. It can be taken with or without food.

This medication comes in a single capsule that contains two medications: netupitant and palonosetron. Palonosetron is a serotonin receptor antagonist. This drug prevents nausea and vomiting during the first 24 hours after the start of cancer chemotherapy. Netupitant is a substance P/neurokinin 1 receptor antagonist. This drug prevents nausea and vomiting during both the acute phase(first 24 hours) and delayed phase (from 25 to 120 hours) after the start of cancer chemotherapy.

Common side effects of netupitant/palonosetron include headache, weakness, fatigue, indigestion and constipation.

Netupitant/palonosetron can also cause dizziness. Do not drive or operate heavy machinery until you know how netupitant/palonosetron affects you.

Netupitant/palonosetron is a prescription medication used to prevent nausea and vomiting in patients receiving cancer chemotherapy.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Netupitant & Palonosetron may be found in some form under the following brand names:

• Akynzeo

Serious side effects have been reported with netupitant/palonosetron. See the “Netupitant/palonosetron Precautions” section.

Common side effects of netupitant/palonosetron include

• headache
• weakness
• fatigue
• indigestion
• constipation

This is not a complete list of side effects netupitant/palonosetron side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• benzodiazepines including alprazolam (Xanax), midazolam, and triazolam (Halcion)
• certain chemotherapy medications such as cyclophosphamide (Cytoxan), docetaxel (Docefrez, Taxotere), etoposide, ifosfamide (Ifex), imatinib (Gleevec), irinotecan (Camptosar), paclitaxel (Taxol), vinblastine, vincristine, and vinorelbine (Navelbine)
• dexamethasone
• erythromycin (E.E.S., Ery-tab, others)
• fentanyl (Abstral, Actiq, Duragesic, Fentora, Lazanda, Onsolis, Subsys)
• ketoconazole (Nizoral)
• lithium (Lithobid)
• medications to treat migraines such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex), and zolmitriptan (Zomig)
• methylene blue
• mirtazapine (Remeron)
• monoamine oxidase (MAO) inhibitors including isocarboxazid (Marplan), linezolid (Zyvox), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate)
• phenobarbital
• rifampin (Rifadin, Rimactane, in Rifater, in Rifamate)
• selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Paxil, Pexeva), and sertraline (Zoloft)
• tramadol (Conzip, Ultram, in Ultracet)

This is not a complete list of netupitant/palonosetron drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with netupitant/palonosetron including the following:

• hypersensitivity reactions, including anaphylaxis
• serotonin syndrome. Tell your healthcare provider right away if you have some or all of the following symptoms of serotonin syndrome:
  • changes in mental status, including agitation, hallucination, delirium, or coma
  • increased heart rate
  • changes in blood pressure
  • dizziness
  • flushing
  • neuromuscular symptoms, including tremor, muscle rigidity, or incoordination
  • seizures

Netupitant/palonosetron can cause dizziness. Do not drive or operate heavy machinery until you know how netupitant/palonosetron affects you.

Do not take netupitant/palonosetron if you:

• are allergic to netupitant/palonosetron or to any of its ingredients

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of netupitant/palonosetron, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking netupitant/palonosetron, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to netupitant/palonosetron or to any of its ingredients
• have or have had liver disease
• have or have had kidney disease
• are pregnant or breastfeeding

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

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Netupitant/palonosetron falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if netupitant/palonosetron crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using netupitant/palonosetron .

Take netupitant/palonosetron exactly as prescribed.

Netupitant/palonosetron is available in capsule form and is taken 1 hour before the start of chemotherapy. It can be taken with or without food.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated

The recommended dose of netupitant/palonosetron is one capsule (300 mg netupitant/0.5mg palonosetron) approximately 1 hour before chemotherapy. It is usually administered with dexamethasone.

If you take too much netupitant/palonosetron, call your healthcare provider or local Poison Control Center or seek emergency medical attention right away.

If netupitant/palonosetron is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store netupitant/palonosetron at room temperature.
• Keep this and all medications out of the reach of children.