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 injection is used to prevent nausea and vomiting that is caused by cancer medicines (chemotherapy). It is also used to prevent nausea and vomiting that may occur after surgery. Palonosetron works by blocking the signals to the brain that cause nausea and vomiting.

This medicine is to be given only by or under the direct supervision of your doctor.

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of palonosetron injection to prevent nausea and vomiting that is caused by cancer medicines in children. However, safety and efficacy have not been established in children younger than 1 month of age.

Appropriate studies have not been performed on the relationship of age to the effects of palonosetron injection to prevent nausea and vomiting that may occur after surgery 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 injection in the elderly.

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—

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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfentanil
• Almotriptan
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amphetamine
• Benzhydrocodone
• Benzphetamine
• Brompheniramine
• Buprenorphine
• Buspirone
• Butorphanol
• Carbamazepine
• Chlorpheniramine
• Citalopram
• Clomipramine
• Cocaine
• Codeine
• Cyclobenzaprine
• Desipramine
• Desvenlafaxine
• Dextroamphetamine
• Dextromethorphan
• Dibenzepin
• Dihydrocodeine
• Doxepin
• Duloxetine
• Eletriptan
• Escitalopram
• Fenfluramine
• Fentanyl
• Fluoxetine
• Fluvoxamine
• Frovatriptan
• Furazolidone
• Gepirone
• Granisetron
• Hydrocodone
• Hydromorphone
• Hydroxyamphetamine
• Hydroxytryptophan
• Imipramine
• Iproniazid
• Isocarboxazid
• Lasmiditan
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lorcaserin
• Melitracen
• Meperidine
• Metaxalone
• Methadone
• Methamphetamine
• Methylene Blue
• Milnacipran
• Mirtazapine
• Moclobemide
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Naratriptan
• Nefazodone
• Nialamide
• Nortriptyline
• Ondansetron
• Opipramol
• Oxycodone
• Oxymorphone
• Paroxetine
• Pentazocine
• Phenelzine
• Procarbazine
• Protriptyline
• Rasagiline
• Remifentanil
• Rizatriptan
• Selegiline
• Sertraline
• Sibutramine
• St John's Wort
• Sufentanil
• Sumatriptan
• Tapentadol
• Tianeptine
• Tramadol
• Tranylcypromine
• Trazodone
• Trimipramine
• Tryptophan
• Venlafaxine
• Vilazodone
• Vortioxetine
• Zolmitriptan

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 or your child are in a hospital or cancer treatment center. A nurse or other trained health professional will give you or your child this medicine. This medicine is given through a needle placed in one of your veins.

This medicine is usually given about 30 minutes before the start of chemotherapy or right before you or your child receives anesthetic medicine for surgery.

This medicine should come with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Precautions While Using This Medicine:

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

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have a rash, a fast heartbeat, fever, hives, itching, irritation, hoarseness, joint pain, stiffness or swelling, rash, redness of the skin, swelling of the eyelids, face, lips, hands, or feet, tightness in the chest, or trouble breathing or swallowing after receiving this medicine.

Palonosetron may cause a serious condition called serotonin syndrome if taken together with some medicines such as fentanyl (Abstral®, Duragesic®), lithium (Eskalith®, Lithobid®), tramadol (Ultram®), or medicines to treat depression (such as mirtazapine, Remeron®). Check with your doctor first before taking any other medicines with palonosetron.

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

difficult breathing

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

fainting

fever

irregular heartbeats that continue

sweating

unusual tiredness or weakness

Rare

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

extra heartbeats

nervousness

pain in the shoulders, arms, jaw, or neck

pounding in the ears

slow or fast heartbeat

Incidence not known

Agitation

diarrhea

overactive reflexes

poor coordination

restlessness

shivering

talking or acting with excitement you cannot control

trembling or shaking

twitching

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Bluish color of the fingernails, lips, skin, palms, or nail beds

collapse

gasping to breathe

paleness of the 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

Acid or sour stomach

belching

bloated or full feeling

blood in the 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

difficulty in passing urine

drowsiness

dry mouth

excess air or gas in the stomach or intestines

excessive sleeping

eye irritation

fear

feeling happy

feeling of warmth

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 the 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

runny nose

sore throat

stomach discomfort, upset, or pain

sugar in the urine

swelling or protruding veins

trouble sleeping

unexplained noise in the ears

unexplained weight loss

unusually deep sleep

unusually long duration of sleep

vein discoloration

weakness or heaviness of the legs

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.