Akynzeo contains a combination of netupitant and palonosetron.

Akynzeo is used to help prevent nausea and vomiting caused by chemotherapy. This medicine is given together with a steroid called dexamethasone.

Akynzeo helps prevent nausea and vomiting that occurs both during chemotherapy and later on (delayed nausea and vomiting).

Before you take Akynzeo, tell your doctor if you are pregnant or plan to become pregnant. Netupitant and palonosetron may harm your unborn baby. Tell your doctor if you are breastfeeding or plan to breastfeed. You and your doctor should decide if you will take Akynzeo or breastfeed. You should not do both.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

Akynzeo is not approved for use by anyone younger than 18 years old.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• liver or kidney disease; or

• an allergic reaction to a medicine for nausea or vomiting, such as dolasetron (Anzemet), ondansetron (Zofran), or palonosetron (Aloxi).

Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, or serious infections. These medicines may interact with netupitant and palonosetron and cause a serious condition called serotonin syndrome.

Netupitant and palonosetron may harm an unborn baby. Tell your doctor if you become pregnant.

You should not breast-feed while using this medicine.

Take Akynzeo exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Akynzeo is given ahead of time and will not treat nausea or vomiting you already have.

About 1 hour before chemotherapy, you will take Akynzeo with or without food.

You will take dexamethasone 30 minutes before chemotherapy, and you may need to keep taking it for 3 days afterward. Follow your doctor's dosing instructions very carefully.

Store the capsules at room temperature away from moisture and heat.

Usual Adult Dose for Nausea/Vomiting -- Chemotherapy Induced:

Netupitant 300 mg-palonosetron 0.5 mg orally ONCE, given 60 minutes before chemotherapy on Day 1

ADDITIONAL MEDICATIONS:
Highly Emetogenic Cancer Chemotherapy, Including Cisplatin-Based Chemotherapy:
-Day 1: Dexamethasone 12 mg orally 30 minutes prior to chemotherapy
-Days 2 to 4: Dexamethasone 8 mg orally once a day

Anthracyclines and Cyclophosphamide-Based Chemotherapy and Chemotherapy Not Considered Highly Emetogenic:
-Day 1: Dexamethasone 12 mg orally 30 minutes prior to chemotherapy

Use: In combination with dexamethasone 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 is not approved for use by anyone younger than 18 years old.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• liver or kidney disease; or

• an allergic reaction to a medicine for nausea or vomiting, such as dolasetron (Anzemet), ondansetron (Zofran), or palonosetron (Aloxi).

Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, or serious infections. These medicines may interact with netupitant and palonosetron and cause a serious condition called serotonin syndrome.

Netupitant and palonosetron may harm an unborn baby. Tell your doctor if you become pregnant.

You should not breast-feed while using this medicine.

Call your doctor for instructions if you have not taken Akynzeo at the correct time before your chemotherapy.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Akynzeo: hives; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common Akynzeo side effects may include:

• headache;

• feeling weak or tired;

• skin redness; or

• upset stomach, constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can interact with netupitant and palonosetron. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.