NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
PEMETREXED APOTEX POWDER FOR INJECTION
Contains the active ingredient pemetrexed (as disodium)
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about this medicine. 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 taking this medicine against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What this medicine is used for
The name of your medicine is Pemetrexed APOTEX Powder for Injection, which is given as an intravenous infusion. It contains the active ingredient pemetrexed, as the disodium salt.
Pemetrexed is used to treat:
mesothelioma, a rare cancer of the lungs often related to exposure to asbestos
non-small cell lung cancer, a type of lung cancer.
Pemetrexed belongs to a group of medicines called cytotoxic or antineoplastic agents. They may also be called chemotherapy medicines.
It affects enzymes within cancer cells to kill cancer cells or prevent them growing and multiplying.
Pemetrexed may be used in combination with other chemotherapy drugs.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor’s prescription.
There is no evidence that this medicine is addictive.
This medicine should not be used in children under the age of 18.
Before you are given this medicine
When you must not be given it
Do not use this medicine if you have an allergy to:
any medicine containing pemetrexed
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 or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Do not use this medicine if you are pregnant.
This medicine should not be given during pregnancy. You and your doctor should discuss the risks and benefits involved.
Do not breastfeed if you are using this medicine.
This medicine should not be given whilst breastfeeding. You and your doctor should discuss the risks and benefits involved.
Before you are given it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding.
Your doctor can discuss with you the risks and benefits involved.
If you have not told your doctor about any of the above, tell them before you start using this medicine.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may interact with pemetrexed. These include:
medicines used to treat arthritis or pain from inflammation such as ibuprofen or other non-steroidal anti-inflammatory medicines (NSAIDs).
If you are taking any of these, you may need a different dose, or you may need to take different medicines.
Other medicines not listed above may also interact with pemetrexed.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while using this medicine.
Your doctor should advise you to take certain medicines or vitamin while using pemetrexed.
These may help to minimise side effects.
Your doctor should advise you to take a folate supplement or a multivitamin containing folate once daily for at least five days in the week before your first pemetrexed dose. This should be continued throughout your therapy cycles and for at least three weeks following completion of pemetrexed treatment.
Your doctor should also advise you to have a vitamin B12 injection during the week before your first dose of pemetrexed. A vitamin B12 injection should be given once every three treatment cycles.
Your doctor may also advise you to take an oral corticosteroid such as dexamethasone to reduce the likelihood and severity of skin rashes.
Ask your doctor if you have any questions about why these other medicines have been prescribed for you.
How this medicine will be given
Follow carefully all directions given to you by your doctor.
Their instructions may be different to the information in this leaflet.
How much will be given
Your doctor will decide the dosage of Pemetrexed APOTEX you will be given. This will depend on your condition and other factors, such as your weight.
How it is given
Pemetrexed is given as an infusion (drip) into your veins over a 10-minute period.
When treating certain cancers, you may also be given other chemotherapy medicines.
Your doctor or nurse will inject pemetrexed for you.
Never inject pemetrexed yourself. Always let your doctor or nurse do this.
How often it is given
Pemetrexed is given once every three weeks (1 treatment cycle). Your doctor will advise how many treatment cycles you need.
Before each infusion you will have samples of your blood taken to check that you have enough blood cells to receive pemetrexed. Your doctor may decide to change your dose or delay treating you depending on your general condition and if your blood cell counts are too low.
If you are given too much (overdose)
As pemetrexed is given to you under the supervision of your doctor, it is unlikely that you will have too much.
However, if you experience any side effects after being given pemetrexed, immediately tell your doctor or nurse or telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively, go to the Accident and Emergency department at your nearest hospital.
You may need urgent medical attention.
While you are being treated with this medicine
Things you must do
Always take your daily folate supplement until your doctor tells you to stop.
Always check with your doctor that your vitamin B12 injections are up to date.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are be treated with pemetrexed.
Tell any other doctors, dentists and pharmacists who treat you that you are being treated with this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are being treated with this medicine.
It may affect other medicines used during surgery.
If you become pregnant while receiving this medicine, tell your doctor immediately.
If you are about to have any blood tests, tell your doctor that you are receiving this medicine.
Keep all of your doctor’s appointments so that your progress can be checked.
Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.
Things to be careful of
Be careful when driving or operating machinery until you know how this medicine affects you.
This medicine may cause tiredness or drowsiness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.
Tell your doctor as soon as possible if you do not feel well while you are being treated with pemetrexed or if you have any questions or concerns.
All medicines can have side effects. Sometimes they are serious but most of the time they are not.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Tell your doctor if you notice any of the following:
fatigue, drowsiness, fainting
pain in the stomach, upset stomach, nausea, loss of appetite, vomiting
diarrhoea, constipation or dark urine
skin irritation, burning or prickling sensation
conjunctivitis (red and itchy eyes with or without discharge and crusty eyelids)
coughing, difficulty breathing, wheezing caused by inflammation of the lung
abdominal, chest, back or leg pain.
The above lists include the more common side effects of your medicine.
Additional side effects when used in combination with other chemotherapy agents include:
loss of feeling
kidney problems where you pass little or no urine.
When used in combination with other chemotherapy medicine, also refer to the other product’s consumer medicine information leaflet for a list of other possible side effects.
Tell your doctor as soon as possible if you notice any of the following:
fever or infection with a temperature, sweating or other signs of infection
pain, redness, swelling or sores in your mouth
sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips or tongue or other parts of the body, shortness of breath, wheezing or trouble breathing
tiredness, feeling faint or breathless, if you look pale
bleeding or bruising more easily than normal.
These may be serious side effects and you may need medical attention.
In rare cases pemetrexed can cause inflammation of the colon (large bowel). Tell your doctor as soon as possible if you experience any of the following symptoms:
diarrhoea with blood and mucus
If you experience any of the following, contact your doctor immediately or go to the Accident and Emergency department at your nearest hospital:
chest pain or fast heartbeat
bleeding from the gums, nose or mouth, any bleeding that will not stop, reddish or pinkish urine, unexpected bruising
symptoms of an allergic reaction including cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin
These are very serious side effects and you may need urgent medical attention or hospitalisation.
Tell your doctor if you notice anything that is making you feel unwell.
Other side effects not listed above may occur in some patients.
Some of these side effects (for example, abnormal blood tests showing low cell counts) can only be found when your doctor does tests to check your progress.
Storage and disposal
This medicine will be stored in the hospital pharmacy or on the ward.
It will be kept in a cool dry place where the temperature will stay below 25°C.
What Pemetrexed APOTEX Powder for Injection looks like
500 mg strength
White to either light yellow or green-yellow powder. AUST R 210440.
Pack of 1 vial.
Each vial contains 500 mg of pemetrexed as the active ingredient.
Each vial also contains the following inactive ingredients:
hydrochloric acid and/or sodium hydroxide may have been added to both strengths to adjust pH.
This medicine is free from gluten, lactose, sucrose, tartrazine and other azo dyes.
Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW2113
16 Giffnock Avenue
Macquarie Park NSW2113
APO and APOTEX are registered trademarks of Apotex Inc.
This leaflet was last updated in
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