Pronunciation:

pal-oh-NOE-se-tron

Brand Names:

• Aloxi

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antiemetic

Pharmacologic—

Serotonin Receptor Antagonist, 5-HT3

Uses of This Medicine:

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 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 geriatrics-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:

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 This Medicine:

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.

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 or nurse immediately if any of the following side effects occur:

Less common

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

Rare

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:

Symptoms of Overdose

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:

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

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.