Palonosetron (Intravenous)

Palonosetron injection is used to stop nausea and vomiting caused by cancer medicines (chemotherapy). It is also used to stop nausea and vomiting that might happen 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.

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.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, like to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies conducted so far have not shown any specific problems in children that would limit the usefulness of palonosetron injection for preventing nausea and vomiting caused by cancer medicines. However, safety and effectiveness have not been established in children younger than 1 month of age.

No studies have been done to examine how age affects the use of palonosetron injection for preventing nausea and vomiting that may happen after surgery in children. Safety and effectiveness have not been established.

Geriatric

Studies conducted so far have not shown any specific problems in elderly patients that would limit the usefulness of palonosetron injection in older adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may want to adjust the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are highlighted for their potential significance and are not a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose 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 necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you take 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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or specific types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do, 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.

In the U.S.

• Aloxi

Available Dosage Forms:

• Solution

Therapeutic Class: Antiemetic

Pharmacologic Class: Serotonin Receptor Antagonist, 5-HT3

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.