NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
ALOXI®
Palonosetron 250 microgram per 5 mL solution for injection; Palonosetron 75 microgram per 1.5 mL solution for injection
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about ALOXI. 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 ALOXI 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 that happens:
with cancer chemotherapy
up to 24 hours while recovering from anaesthesia after surgery.
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 ALOXI
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
ALOXI 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, in particular if you have had an allergic reaction to another medicine for nausea or vomiting
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 ALOXI 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 or
right before anaesthesia for surgery.
Your doctor will decide how much of this medicine you will be given and for how long.
ALOXI is intended for single use in one patient.
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 ALOXI
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.
It is supplied in a pack of 5 glass vials, which each contain 1.5 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:
Mundipharma Pty Limited
88 Phillip Street
Sydney NSW 2000
AUSTRALIA
In New Zealand:
Mundipharma New Zealand Limited
C/Pharmaco (NZ) Limited
Auckland, NEW ZEALAND
Australian Registration Number
ALOXI 250 microgram per 5 mL injection
AUST R 114185
ALOXI 75 microgram per 1.5 mL injection
AUST R 281464
This leaflet was modified in August 2017.
® ALOXI is a registered trade mark of Helsinn Healthcare SA, Switzerland. Distributed under license of Helsinn Healthcare SA, Switzerland.
Orbis #RA-0130
Source: Read Full Article