Pronunciation:

pal-oh-NOE-se-tron

Classifications:

Pharmacologic

Serotonin Receptor Antagonist, 5-HT3

Uses of This Medicine:

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

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

Before Using This Medicine:

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.

Children

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.

Older adults

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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.

Other 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

Other interactions

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 This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Palonosetron can be taken with or without food.

Dosing

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For prevention of nausea and vomiting:
    • Adults 0.5 milligram (mg) taken one hour before the start of cancer therapy.
    • Children Use and dose must be determined by your doctor.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

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

Side Effects of This Medicine:

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 immediately if any of the following side effects occur:

Rare

Bloody nose

blurred vision

chest pain

chills

difficult or labored breathing

dizziness

fainting

fast, slow, or irregular heartbeat

fever

headache

nausea and vomiting

nervousness

pale skin

pounding in the ears

pounding, slow heartbeat

shortness of breath

swelling of the eye

tightness in the chest

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

wheezing

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:

Less common

Difficulty having a bowel movement (stool)

Rare

Burning feeling in the chest or stomach

change in taste

cough

difficulty in moving

flushing, or redness of the skin

hair loss or thinning of hair

indigestion

itching skin

joint pain

loss of appetite

loss of taste

muscle aching or cramping

muscle pains or stiffness

pain or tenderness around the eyes and cheekbones

sleeplessness

stomach upset

stuffy or runny nose

swollen joints

tenderness in the stomach area

trouble sleeping

unable to sleep

unusually warm skin

weight loss

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.