Palonosetron 250 µg per 5 mL solution for injection
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Palonosetron. It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits it is expected to have for you.
If you have any concerns about being given this medicine, ask your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
What Palonosetron is used for
This medicine belongs to a group of medicines known as serotonin (5-HT3) antagonists and is a colourless solution for injection into a vein.
It is used for the prevention of nausea and vomiting associated with cancer chemotherapy.
Your doctor, however, may prescribe this medicine for another purpose.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Before you are given Palonosetron
When you must not be given it
Do not use this medicine if you have an allergy to palonosetron or any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include:
- shortness of breath, wheezing, difficulty breathing or a tight feeling in your chest
- swelling of the face, lips, tongue or other parts of the body
- rash, itching, hives or flushed, red skin
It should not be used to prevent or treat nausea and vomiting in the days following chemotherapy if not associated with another chemotherapy administration.
Before you are given it
Your doctor must know about all of the following before you are given this medicine.
Tell your doctor or pharmacist if you have allergies to:
- any medicines
- any other substances, such as foods, preservatives or dyes
If you are pregnant or think you might be, your doctor will not use this medicine unless it is clearly necessary as it is not known whether it will cause any harmful effects when used during pregnancy. You should always ask your doctor or pharmacist for advice before using any medicine if you are pregnant or think you might be.
It is not known if this medicine is found in breast milk. You should ask your doctor or pharmacist for advice before using it if you are breast-feeding.
If you have not told your doctor about any of the above, tell them before you are given this medicine.
Taking or Being Given Other Medicines
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may affect the way other medicines work. Your doctor or pharmacist will be able to tell you what to do when being given this medicine with other medicines.
How Palonosetron is given
This medicine is given as an injection into a vein. A doctor or nurse will normally inject it about 30 minutes before the start of chemotherapy.
Your doctor will decide how much of this medicine you will be given and for how long.
Overdose
As this medicine is given to you under the supervision of your doctor, it is very unlikely that you will receive too much. However, if you experience any side effects after being given it, tell your doctor immediately.
While you are using Palonoseton
Things you must do
If the medicine starts to upset you or your symptoms become worse, tell your doctor.
Tell any other doctors, dentists, and pharmacists who are treating you that you are being treated with this medicine.
Tell your doctor, if you become pregnant during treatment with this medicine.
Things to be careful of
It is not known if this medicine has any effect on your ability to drive or use machines. You should be certain that you are able to drive and operate machines safely before you try.
Side Effects
Tell your doctor, nurse, or pharmacist as soon as possible if you do not feel well while you are being given this medicine.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
The following common side effects may occur.
- Headache
- Dizziness
- Constipation
- Diarrhoea
Tell your doctor, nurse or pharmacist if you notice any of the above reactions and they worry you.
The following uncommon side effects may also occur:
- Loss of appetite
- Anxiety or euphoria
- Sleep disturbances
- Change of sensation in your limbs
- Visual or hearing disturbances
- Motion sickness
- Change in heart rate
- Prominent or discoloured veins
- Hiccups, flatulence or dry mouth
- Upset stomach or stomach pain
- Rash
- Joint pain
- Difficulty passing water
- Weakness or tiredness
- Fever or a flu-like illness
You should tell your doctor if you notice any of the above effects.
Your doctor will tell you if the following uncommon side effects occur.
- Changes in the amounts of certain substances in your blood or urine
- Changes in your blood pressure
Other side effects not listed above may also occur in some patients.
Tell your doctor if you notice any other effects.
Storage
Keep out of the reach and sight of children
Store Below 25°C
Store in the original container
Keep the container in the outer carton in order to protect from light
Do not use this medicine if the expiry date printed on the pack has passed.
Product Description
What it looks like
This medicine is a colourless solution. It is supplied in a pack of one glass vial, which contains 5 mL of the solution. Each vial contains enough for one dose.
Ingredients
Active ingredient:
Palonosetron (as the hydrochloride)
Inactive ingredients:
- Mannitol
- Disodium edetate
- Sodium citrate
- Citric acid monohydrate
- Sodium hydroxide
- Hydrochloric acid
- Water for injections
Supplier
In Australia: Dr Reddy’s Laboratories Australia Pty Ltd
Level 3, 390 St Kilda Road, Melbourne VIC 3004 AUSTRALIA
Australian Registration Number
Palonosetron Dr Reddy’s Aust R 237484
Prepared on June 2022
Published by MIMS September 2022