Netupitant and palonosetron

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

Keep all appointments with your doctor.

Do not let anyone else take your medication.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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

Highly Emetogenic Chemotherapy, Including Cisplatin Based Chemotherapy:
-Day 1: One capsule (300 mg netupitant/0.5 mg palonosetron) orally approximately 1 hour prior to the start of chemotherapy along with 12 mg dexamethasone orally 30 minutes prior to chemotherapy
-Days 2 to 4: One capsule (300 mg netupitant/0.5 mg palonosetron) orally approximately 1 hour prior to the start of chemotherapy along with 8 mg dexamethasone orally once a day

Anthracyclines, Cyclophosphamide Based Chemotherapy, and Chemotherapy Not Considered Highly Emetogenic:
-Day 1: One capsule (300 mg netupitant/0.5 mg palonosetron) orally approximately 1 hour prior to the start of chemotherapy along with 12 mg dexamethasone orally 30 minutes prior to chemotherapy
-Days 2 to 4: One capsule (300 mg netupitant/0.5 mg palonosetron) orally approximately 1 hour prior to the start of chemotherapy; dexamethasone administration not necessary

Comments:
-Can be taken with or without food

Use: Prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy

Check with your doctor if severe nausea and vomiting continue after leaving the hospital or cancer treatment center.

netupitant and palonosetron may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, a fast heartbeat, fever, hives, itching, irritation, hoarseness, joint pain, stiffness or swelling, rash, redness of the skin, swelling of the eyelids, face, lips, hands, or feet, tightness in the chest, or trouble breathing or swallowing after using netupitant and palonosetron.

netupitant and palonosetron may cause a serious condition called serotonin syndrome if taken together with some medicines such as fentanyl (Abstral®, Duragesic®), lithium (Eskalith®, Lithobid®), a MAO inhibitor (such as methylene blue injection, Eldepryl®, Marplan®, Nardil®, Parnate®), medicine to treat migraine headaches (such as tramadol, Ultram®), or medicine to treat depression (eg, fluoxetine, mirtazapine, paroxetine, Celexa®, Effexor®, Lexapro®, Paxil®, Zoloft®). Check with your doctor first before taking any other medicines with netupitant and palonosetron combination.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• A very bad and sometimes deadly health problem called serotonin syndrome may happen. The risk may be greater if you take this medicine with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.

• Antiemetic
• Selective 5-HT3 Receptor Antagonist
• Substance P/Neurokinin 1 Receptor Antagonist

For netupitant, Cmax was 35% higher in females than in males while the AUC was similar between males and females. For palonosetron, mean AUC was 35% higher and the mean Cmax was 26% higher in females than in males.

1% to 10%:

Central nervous system: Headache (9%), fatigue (4% to 7%)

Dermatologic: Erythema (3%)

Gastrointestinal: Dyspepsia (4%), constipation (3%)

Neuromuscular & skeletal: Weakness (8%)

Adverse events were observed in some animal reproduction studies using the components of this combination product.

Applies to netupitant / palonosetron: oral capsule

Along with its needed effects, netupitant / palonosetron may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking netupitant / palonosetron:

• Agitation
• confusion
• dizziness
• fever
• hearing or seeing things that are not there
• muscle twitching
• overactive reflexes
• poor coordination
• shivering
• sweating
• trembling or shaking

Some side effects of netupitant / palonosetron may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Headache
• fatigue
• unusual tiredness or weakness

• constipation
• flushing or redness of the skin
• heartburn
• indigestion
• stomach discomfort, upset, or pain