Descriptions:

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.

This product is available in the following dosage forms:

Solution

Before Using:
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.

• Pediatric

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.

• Geriatric

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

• Breastfeeding

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.

• Drug Interactions

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
Oliceridine
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:
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:
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:
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.