Aloxi

Generic Name: palonosetron (Intravenous route)

pal-oh-NOE-se-tron

Commonly used brand name(s):

In the U.S.

• Aloxi

Available Dosage Forms:

• Solution

Therapeutic Class: Antiemetic

Pharmacologic Class: Serotonin Receptor Antagonist, 5-HT3

Uses For Aloxi

Palonosetron is used to prevent nausea and vomiting that is caused by cancer therapy or surgery. It works by blocking the hormone (serotonin) that causes vomiting.

This medicine is available only with your doctor's prescription.

Before Using Aloxi

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of palonosetron in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of palonosetron in the elderly.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Apomorphine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of Aloxi

You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.

Precautions While Using Aloxi

This medicine may cause a serious allergic reaction. Call your doctor or nurse right away if you have any of the following symptoms after using this medicine: a fast heartbeat; fever; hives; itching; irritation; hoarseness; joint pain, stiffness or swelling; rash; redness of the skin; shortness of breath; swelling of the eyelids, face, lips, hands, or feet; tightness in the chest; trouble with breathing or swallowing; or wheezing.

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

Aloxi Side Effects

Along with its needed effects, a medicine 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:

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

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

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

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

Some side effects 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

• Abdominal pain
• acid or sour stomach
• belching
• bloated full feeling
• blood in 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
• diarrhea
• difficult breathing
• difficulty in passing urine
• drowsiness
• dry mouth
• excess air or gas in stomach or intestines
• excessive sleeping
• eye irritation
• fear
• feeling happy
• feeling of warmth
• fever
• 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 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
• restlessness
• runny nose
• shivering
• sore throat
• stomach discomfort, upset, or pain
• sugar in the urine
• swelling or protruding veins
• trembling
• troubled breathing
• trouble sleeping
• unexplained noise in ears
• unexplained weight loss
• unusually deep sleep
• unusually long duration of sleep
• vein discoloration
• weakness or heaviness of legs

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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