Aloxi blocks the actions of chemicals in the body that can trigger nausea and vomiting.

Aloxi is used in adults to prevent nausea and vomiting caused by surgery, or by receiving medicine to treat cancer (chemotherapy).

Aloxi is used in children as young as 1 month old only to prevent nausea and vomiting caused by cancer medicine.

Before you receive Aloxi, tell your doctor about all your medical conditions or allergies, and all the medicines you are using. Also make sure your doctor knows if you are pregnant or breast-feeding.

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.

Tell your doctor if you forget to take use Aloxi within 1 hour before chemotherapy. Do not use extra medicine to make up the missed dose.

Before receiving this medicine

You should not be treated with Aloxi if you are allergic to palonosetron.

To make sure Aloxi is safe for you, tell your doctor if you have ever had an allergic reaction to a similar medicine for nausea or vomiting, such as dolasetron (Anzemet) or ondansetron (Zofran).

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, serious infections, or prevention of nausea and vomiting. These medicines may interact with palonosetron and cause a serious condition called serotonin syndrome.

Tell your doctor if you are pregnant or breast-feeding.

Aloxi is injected into a vein through an IV. A healthcare provider will give you this injection.

Aloxi is usually given 30 minutes before chemotherapy, or right before you are given anesthesia for surgery.

Usual Adult Dose for Nausea/Vomiting - Chemotherapy Induced:

Oral: 0.5 mg orally administered approximately 1 hour prior to the start of chemotherapy
Uses: Moderately emetogenic cancer chemotherapy: Prevention of acute nausea and vomiting associated with initial and repeat courses.

Parenteral: 0.25 mg IV as a single dose 30 minutes before the start of chemotherapy

Uses: Prevention of acute nausea and vomiting in adults associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy.

Usual Adult Dose for Nausea/Vomiting - Postoperative:

Parenteral: 0.075 mg IV as a single dose immediately before induction of anesthesia

Uses: Prevention of postoperative nausea and vomiting (PONV) in adults for up to 24 hours following surgery. Efficacy beyond 24 hours has not been determined.

Usual Pediatric Dose for Nausea/Vomiting - Chemotherapy Induced:

Parenteral: 20 mcg/kg IV (maximum 1.5 mg x 1) infused over 15 minutes beginning 30 minutes before the start of chemotherapy

Uses: Prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy in patients 1 month to less than 17 years of age.

You should not be treated with Aloxi if you are allergic to palonosetron.

To make sure Aloxi is safe for you, tell your doctor if you have ever had an allergic reaction to a similar medicine for nausea or vomiting, such as dolasetron (Anzemet) or ondansetron (Zofran).

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, serious infections, or prevention of nausea and vomiting. These medicines may interact with palonosetron and cause a serious condition called serotonin syndrome.

Tell your doctor if you are pregnant or breast-feeding.

Because you will receive Aloxi in a clinical setting, you are not likely to miss a dose.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

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 Aloxi: 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 Aloxi side effects may include:

• nausea, vomiting;

• constipation;

• slow heartbeats; or

• headache.

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.

Using Aloxi while you are using certain other medicines can cause high levels of serotonin to build up in your body, a condition called "serotonin syndrome," which can be fatal. Tell your doctor if you also use:

• stimulant medicine;

• herbal products;

• medicine for depression or mental illness;

• migraine headache medicine;

• Parkinson's disease medication;

• medicine to treat a serious infections;

• opioid medication; or

• other medicine to prevent nausea and vomiting.

This list is not complete and many other drugs can interact with palonosetron. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.