Description
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 for up to 24 hours 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 Aloxi® 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 Posfrea™ to prevent nausea and vomiting that may occur after surgery in children. Safety and efficacy have not been established. Use of Posfrea™ to prevent nausea and vomiting that is caused by cancer medicines is not indicated for use in children.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of palonosetron injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.
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
- Anileridine
- Benzhydrocodone
- Benzphetamine
- Brompheniramine
- Buprenorphine
- Buspirone
- Butorphanol
- Carbamazepine
- Chlorpheniramine
- Citalopram
- Clomipramine
- Cocaine
- Codeine
- Cyclobenzaprine
- Desipramine
- Desvenlafaxine
- Dextroamphetamine
- Dextromethorphan
- Dibenzepin
- Difenoxin
- Dihydrocodeine
- Diphenoxylate
- Dolasetron
- Doxepin
- Duloxetine
- Eletriptan
- Escitalopram
- Ethylmorphine
- Fenfluramine
- Fentanyl
- Fluoxetine
- Fluvoxamine
- Frovatriptan
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.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Allergy to selective 5-HT3 receptor antagonists (eg, alosetron [Lotronex®], dolasetron [Anzemet®], granisetron [Kytril®], or ondansetron [Zofran®])—Use with caution. It is likely you will also be allergic to palonosetron.
Proper Use
A nurse or other trained health professional will give you or your child this medicine. This medicine is given through an IV catheter that is placed into 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 anesthesia (medicine to put you to sleep) 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, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you or your child have chest tightness, 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, or trouble breathing or swallowing after receiving this medicine.
Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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
- slow or irregular heartbeat
- 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
- decrease in frequency of urination
- decrease in urine volume
- dry mouth
- difficulty in passing urine
- fast heartbeat
- flushed, dry skin
- fruit-like breath odor
- headache
- increased hunger
- increased thirst
- increased urination
- muscle tremors
- nervousness
- numbness or tingling in the hands, feet, or lips
- pain in the shoulders, arms, jaw, or neck
- pounding in the ears
- restlessness
- stomach pain or cramps
- sugar in the urine
- unexplained weight loss
- weakness or heaviness of legs
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
- Constipation
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
- deep breathing
- diarrhea
- drowsiness
- dry mouth
- excess air or gas in the stomach or intestines
- excessive sleeping
- eye irritation
- fear
- feeling happy
- feeling of warmth
- general feeling of discomfort or illness
- hearing loss
- heartburn
- hiccups
- impaired vision
- indigestion
- joint pain
- large, flat, blue or purplish patches in the skin
- loss of appetite
- muscle aches and pains
- 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 or upset
- swelling or protruding veins
- trouble sleeping
- unexplained noise in the ears
- unusually deep sleep
- unusually long duration of sleep
- vein discoloration
Rare
- Blistering, crusting, irritation, itching, or reddening of the skin
- cracked, dry, scaly skin
- difficulty in moving
- muscle stiffness
- swelling
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.
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