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USP DI Vol. II - PALONOSETRON (Systemic)

PALONOSETRON (Systemic)?


Some commonly used brand names are:

In the U.S.?

  • Aloxi

? Not commercially available in Canada.


Category

  • Antiemetic

Description

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

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

    Parenteral
  • Injection (U.S.)


Before Using This Medicine

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 followingshould be considered:

Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to palonosetron, dolasetron, granisetron, or ondansetron.Also tell your doctor if you are allergic to any other substances such asfoods, preservatives, or dyes.

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

Breast-feeding?It is not known if palonosetron passes into breastmilk. Although most medicines pass into breast milk in small amounts, manyof them may be used safely while breast feeding. Due to the potential forserious adverse reactions in nursing infants, a decision should be made whetherto discontinue nursing or discontinue the drug

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

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

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

Other medical problems?The presence of other medicalproblems may affect the use of palonosetron. Make sure you tell your doctorif you have any other medical problems, especially:

  • Irregular heartbeats?May increase the risk of certain sideeffects
  • Kidney problems?May increase the amount of palonosetron inthe body

Proper Use of This Medicine

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

  • For parenteral dosage form (injection):
    • For prevention of nausea and vomiting after anticancer medicine:
      • Adults and adolescents 18 years of age or older?0.25 mg asa single dose injected into a vein, over a period of thirty seconds, beginningapproximately 30 minutes before the start of chemotherapy. Dose should notbe repeated within seven consecutive days.
      • Children up to 18 years of age?Use and dose must be determinedby 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 While Receiving This Medicine

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


Side Effects of This Medicine

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

      Symptoms of Overdose

      Get emergency help immediately if any of the followingsymptoms 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 themedicine. However, check with your doctor if any of the following side effectscontinue or are bothersome.

      More Common

        Difficulty having a bowel movement (stool); headache

      Less common

        abdominal pain; acid or sour stomach; belching; bloated fullfeeling; 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 frequencyof urination ; decrease in urine volume; deep breathing; diarrhea; difficult breathing; difficulty in passingurine; dizziness; dizziness,faintness, or light-headedness when getting up from a lying or sitting positionsuddenly; [dribbling] painful urination; drowsiness; dry mouth; excess air or gas in stomach or intestines; excessive sleeping; eye irritation; fainting; fast, pounding heartbeat orpulse; fear; feeling ofwarmth; fever; flushed dryskin; 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 discomfortin arms, jaw, back or neck; passing gas; pounding in the ears; raised red swellingson 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 longduration of sleep; vein discoloration ; weakness or heaviness of legs

Other side effects not listed abovemay also occur in some patients. If you notice any other effects, check withyour doctor.


Developed: 05/24/2004