Fosnetupitant and palonosetron (injection)

Fosnetupitant and palonosetron is used along with other medications to stop nausea and vomiting that can occur during and after chemotherapy in adults.

Fosnetupitant and palonosetron is not used to treat nausea and vomiting that you currently have.

Fosnetupitant and palonosetron may also be used for reasons not mentioned in this medication guide.

Fosnetupitant and palonosetron is usually given before you begin chemotherapy treatment.

Fosnetupitant and palonosetron is given as an infusion into a vein. A healthcare provider will give you this injection.

You may receive other medicines to help prevent nausea and vomiting. Continue taking these medicines for as long as your doctor has prescribed.

You may need blood tests after receiving fosnetupitant and palonosetron if you also take a blood thinner called warfarin.

Use this medicine only as directed. Inform your doctor if you are taking other medicines or have any other medical conditions or allergies.

Tell your doctor if you have ever had:

• an allergic reaction to a similar medicine for nausea or vomiting, like dolasetron, ondansetron, palonosetron, or granisetron; or
• severe liver or kidney disease.

Tell your doctor if you also use stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with fosnetupitant and palonosetron could cause a serious condition called serotonin syndrome.

Fosnetupitant and palonosetron may harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using fosnetupitant and palonosetron.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty 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 side effects of fosnetupitant and palonosetron 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.

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

Fosnetupitant 235 mg-palonosetron 0.25 mg via IV infusion over 30 minutes ONCE, starting 30 minutes before chemotherapy on Day 1ADDITIONAL 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 dayUse: In combination with dexamethasone for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy

In a medical setting, it is unlikely that you will miss a dose.

In a medical setting, an overdose will be treated quickly.

Follow your doctor's instructions about any limits on food, drinks, or activities.

Sometimes it is not safe to use certain medicines together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medicines work less effectively.

Many drugs can affect fosnetupitant and palonosetron. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are mentioned here. Inform your doctor about all your current medicines and any medicine you begin or stop using.