Aloxi injection

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

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

Palonosetron is used in children only to prevent nausea and vomiting caused by cancer medicine.

Palonosetron may also be used for purposes not listed in this medication guide.

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

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

Call your doctor at once if you have:

• high levels of serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

Common side effects may include:

• constipation; 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 palonosetron 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:

• medicine to treat depression;

• medicine to treat a psychiatric disorder;

• a narcotic (opioid) medication; or

• 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.

Aloxi (palonosetron) 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 only to prevent nausea and vomiting caused by cancer medicine.

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.

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.

Call your doctor at once if you have:

• high levels of serotonin in the body - agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

Common Aloxi side effects may include:

• constipation; 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.

Applies to palonosetron: intravenous solution

Along with its needed effects, palonosetron (the active ingredient contained in Aloxi) 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 or nurse immediately if any of the following side effects occur while taking palonosetron:

• Blurred vision
• chest pain or discomfort
• confusion
• difficult breathing
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• fainting
• fever
• irregular heartbeats that continue
• sweating
• unusual tiredness or weakness

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• extra heartbeats
• nervousness
• pain in the shoulders, arms, jaw, or neck
• pounding in the ears
• slow or fast heartbeat

• Agitation
• diarrhea
• overactive reflexes
• poor coordination
• restlessness
• shivering
• talking or acting with excitement you cannot control
• trembling or shaking
• twitching

Get emergency help immediately if any of the following symptoms of overdose occur while taking palonosetron:

• Bluish color of the fingernails, lips, skin, palms, or nail beds
• collapse
• gasping to breathe
• paleness of the skin
• seizures

Some side effects of 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:

• Difficulty having a bowel movement (stool)
• headache

• Acid or sour stomach
• belching
• bloated or full feeling
• blood in the urine
• bloody or black, tarry stools
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in vision
• chills
• continuing ringing or buzzing
• cough
• decrease in frequency of urination
• decrease in urine volume
• deep breathing
• difficulty in passing urine
• drowsiness
• dry mouth
• excess air or gas in the stomach or intestines
• excessive sleeping
• eye irritation
• fear
• feeling happy
• feeling of warmth
• flushed dry skin
• fruit-like breath odor
• general feeling of discomfort or illness
• hearing loss
• heartburn
• hiccups
• impaired vision
• increased hunger
• increased thirst
• increased urination
• indigestion
• joint pain
• large, flat, blue or purplish patches in the skin
• loss of appetite
• muscle aches and pains
• muscle tremors
• numbness or tingling in the hands, feet, or lips
• painful knees and ankles
• painful urination
• passing gas
• raised red swellings on the skin, the buttocks, legs or ankles
• rash
• red, sore eyes
• redness of the face, neck, arms, and occasionally, upper chest
• runny nose
• sore throat
• stomach discomfort, upset, or pain
• sugar in the urine
• swelling or protruding veins
• trouble sleeping
• unexplained noise in the ears
• unexplained weight loss
• unusually deep sleep
• unusually long duration of sleep
• vein discoloration
• weakness or heaviness of the legs