Palonosetron (Systemic)

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Palonosetron (Systemic)

US Brand Names

• Aloxi

Description

Palonosetron (pal-oh-NOE-se-tron) is a substance that is used to treat the nausea and vomiting that is sometimes associated with cancer therapy.

This medicine is available only with your doctor's prescription, in the following dosage forms:

Parenteral

• Injection (U.S.)

Special Considerations

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to palonosetron, dolasetron, granisetron, or ondansetron. Also tell your doctor if you are allergic to any other substances such as foods, preservatives, or dyes.

Pregnancy

Palonosetron has not been studied in pregnant women. However palonosetron has not been shown to cause birth defects or other problems in animal studies.

Breast-feeding

It is not known if palonosetron passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast feeding. Due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug

Children

Studies on this medicine have only been done in adult patients, and there is no specific information comparing use of palonosetron in children with use in other age groups.

Older adults

This medicine has been tested in a limited number of patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any prescription or nonprescription (over-the-counter [OTC]) medicine.

Other medical problems

The presence of other medical problems may affect the use of palonosetron. Make sure you tell your doctor if you have any other medical problems, especially:

• Irregular heartbeats-May increase the risk of certain side effects

• Kidney problems-May increase the amount of palonosetron in the body

Administration

Dosing

The dose of palonosetron will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of palonosetron. If your dose is different, do not change it unless your doctor tells you to do so.

• For parenteral dosage form (injection):

o For prevention of nausea and vomiting after anticancer medicine:

� Adults and adolescents 18 years of age or older-0.25 mg as a single dose injected into a vein, over a period of thirty seconds, beginning approximately 30 minutes before the start of chemotherapy. Dose should not be repeated within seven consecutive days.

� Children up to 18 years of age-Use and dose must be determined by your doctor.

Storage

To store this medicine:

• Keep out of the reach of children.

• Store at room temperature

• Keep the medicine away from light

Precautions

Check with your doctor if severe nausea and vomiting occur after receiving the anticancer medicine.

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.

Symptoms of Overdose

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.

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome.

More Common

Difficulty having a bowel movement (stool); headache.

Less common

abdominal pain; acid or sour stomach; belching; bloated full feeling; blood in urine; bloody or black, tarry stools; blurred vision; burning, crawling, itching, numbness, prickling, "pins and needles" , or tingling feelings; change in vision; chest pain or discomfort; chills; confusion; continuing ringing or buzzing; cough; decrease in frequency of urination; decrease in urine volume; deep breathing; diarrhea; difficult breathing; difficulty in passing urine; dizziness; dizziness, faintness, or light-headedness when getting up from a lying or sitting position suddenly; [dribbling] painful urination; drowsiness; dry mouth; excess air or gas in stomach or intestines; excessive sleeping; eye irritation; fainting; fast, pounding heartbeat or pulse; fear; feeling of warmth; fever; flushed dry skin; fruit-like breath odor; general feeling of discomfort or illness; happy; heartburn; hearing loss; hiccups; impaired vision; increased hunger; increased thirst; increased urination; indigestion; irregular heartbeat; joint pain; large, flat, blue or purplish patches in the skin; light-headedness; loss of appetite; muscle aches and pains; muscle tremors; nausea or vomiting; nervousness; numbness or tingling in hands, feet, or lips; painful knees and ankles; pain or discomfort in arms, jaw, back or neck; passing gas; pounding in the ears; 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; seizures; shivering; shortness of breath; slow heartbeat; sore throat; stomach discomfort, upset, or pain; sugar in the urine; sweating; swelling or protruding veins; trembling; troubled breathing; trouble sleeping; unexplained noise in ears; unexplained weight loss; unusual tiredness; unusually deep sleep; unusually long duration of sleep; vein discoloration; weakness or heaviness of legs.

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

May 24, 2004