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ALOXI

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):
  • 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

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.

• Irregular heartbeats May increase the risk of certain side effects

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