everolimus
Consumer Medicine Information
NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about . It does not contain all the information that is known about . It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.
What Afinitor is used for
Afinitor is used in the treatment of renal cell carcinoma, a type of kidney cancer.
Everolimus, the active substance in Afinitor, stops the cancer from making new cells and cuts off the blood supply. This slows the growth and spread of the cancer.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
Afinitor is available only with a doctor's prescription and is not addictive.
There is not enough information to recommend the use of this medicine in children and adolescents.
Before you take Afinitor
When you must not take it
Do not take Afinitor if you have an allergy to:
everolimus, the active ingredient in Afinitor
a medicine called Rapamune which contains the active ingredient sirolimus
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 take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have or have had any of the following medical conditions:
problems with your liver
diabetes or high levels of blood sugar
Tell your doctor if you have any infections.
It may be necessary to treat your infections before starting Afinitor.
Tell your doctor if you have previously had hepatitis B, because it may be reactivated during your treatment with Afinitor.
Tell your doctor if you are pregnant or plan to become pregnant.
Afinitor is not recommended for use during pregnancy. Your doctor can discuss with you the risks and benefits involved.
Tell your doctor if you are breast-feeding.
Breastfeeding is not recommended while you are taking Afinitor. It is not known whether Afinitor passes into breast milk and could affect your baby.
Tell your doctor if you have lactose intolerance.
Afinitor tablets contain lactose.
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Your doctor will want to know if you are prone to allergies.
If you have not told your doctor about any of the above, tell him/her before you start taking Afinitor.
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 and Afinitor may interfere with each other. These include:
antibiotics such as rifampicin, rifabutin, clarithromycin and erythromycin
antifungal medicines such as ketoconazole, voriconazole, fluconazole and itraconazole
medicines for high blood pressure or heart problems such as diltiazem and verapamil
drugs used to treat HIV/AIDS such as ritonavir, amprenavir, fosamprenavir, efavirenz and nevirapine
epilepsy medicines such as carbamazepine, phenibarbitone and phenytoin
St John's wort
drugs used to stop the body from rejecting organ transplants such as cyclosporin
drugs used to prevent vomiting such as aprepitant
midazolam, a medicine used to treat acute seizures, or used as a sedative before or during surgery or a medical procedure
Such medicines may be affected by Afinitor or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Tell your doctor if you need to receive a vaccination.
Some vaccines may be less effective if given when taking Afinitor.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.
How to take Afinitor
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the label ask your doctor or pharmacist for help.
How much to take
Your doctor will tell you the dose that you should take. The usual dose is 10 mg taken once a day.
A higher or lower dose may be recommended in some situations (e.g. if you have liver problems).
How to take it
Take it on an empty stomach or after a light fat-free meal. Do not take it with a meal that is high in fat.
Dietary fats can interfere with the absorption of the tablet and stop it working properly.
Swallow the tablet whole with a glass of water. Do not crush or chew it.
Take the tablet at the same time each day, preferably in the morning.
Taking it at the same time each day will help you remember when to take it. It will also help to keep a steady amount of the medicine in your bloodstream.
Do not take it with grapefruit juice.
Grapefruit juice can interfere with the absorption of the tablet.
How long to take it
Keep taking this medicine for as long as your doctor tells you.
If you forget to take it
If it is more than 6 hours after you normally take it, skip the tablet you missed and take your next tablet when you are meant to.
If it is less than 6 hours after you normally take it, you may still have the tablet. Then go back to taking your medicine as you would normally.
Do not take a double dose to make up for the dose that you missed.
This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Afinitor. Do this even if there are no signs of discomfort or poisoning.
While you are taking Afinitor
Things you must do
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor will do tests from time to time to make sure the medicine is working and to prevent unwanted side effects.
Kidney failure has been observed in some patients receiving Afinitor. Your doctor will monitor your kidney function during your treatment with Afinitor.
Tell your doctor if you experience new or worsening cough, difficulty breathing or wheezing.
Your doctor may need to change the amount of Afinitor you have, or add another medicine to help with this side effect.
Tell your doctor if you have a temperature or chills, or another sign of an infection.
You may need medical treatment.
Tell your doctor if you experience pain or discomfort in the mouth or have open sores in the mouth.
You might need treatment with a mouthwash or gel. Some mouthwashes and gels can make ulcers worse, so don't try anything without checking with your doctor first.
Make sure you use a contraceptive to prevent pregnancy during treatment with Afinitor. If you become pregnant while taking this medicine, tell your doctor immediately.
If you want to be vaccinated, tell your doctor you are taking Afinitor before you have the vaccination.
Afinitor may affect your response to vaccination. Some vaccines may not be suitable for you.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Afinitor.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.
Things you must not do
Do not take Afinitor to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.
Things to be careful of
Be careful driving or operating machinery until you know how Afinitor affects you.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Afinitor.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
sore mouth, cold sores or mouth ulcers
dry mouth
dehydration
fatigue or unusual weakness
trouble sleeping (insomnia)
nausea, vomiting, diarrhoea, abdominal pain
difficulty swallowing, loss of appetite, disturbance of taste, weight loss
heartburn
headache
nose bleeds
swelling of hands, feet or limbs due to fluid retention
dry or red skin
rash and pain on the palms of your hands or soles of your feet.
If any of the following happen, tell your doctor immediately:
symptoms of an allergic reaction such as 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
constant "flu-like" symptoms such as fever, chills, sore throat, aching joints and inflammation, swollen glands, cough, or any other signs of infection such as infection of a cut or scratch
burning sensation on urination or increased urgency to urinate
coughing or shortness of breath, which could be signs of a lung problem
shortness of breath, swelling of the feet or legs which could be a sign of heart failure
sudden onset of shortness of breath, chest pain or coughing up blood which could be a sign of one or more blocked arteries in your lungs
symptoms of hepatitis B: The first symptoms may be nonspecific, including fever, skin rash, joint pain and inflammation. Other symptoms may include fatigue, loss of appetite, nausea, jaundice (yellowing of the skin), and pain in the upper right abdomen. Pale stool or dark urine may also be signs of hepatitis.
The above list includes serious side effects. You may need urgent medical attention or hospitalisation.
Tell your doctor if you notice anything else that is making you feel unwell.
Other side effects not listed here or not yet known may happen in some people. Some of these side effects can only be found by laboratory testing.
After taking Afinitor
Storage
Keep the tablets in the original packet and foils until it is time to take them.
Store the tablets in a cool, dark and dry place at room temperature.
Do not store Afinitor or any other medicine in the bathroom or near a sink.
Do not leave it in the car or on window sills.
Keep the medicine where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
Product description
What it looks like
Afinitor tablets are white to yellowish and elongated with no score. Afinitor tablets are available in two different strengths, supplied in packs of 30, 50#, 60#, 100# and 120# tablets:
#not currently marketed
5 mg: with "5" on one side and "NVR" on the other
10 mg: with "UHE" on one side and "NVR" on the other
Ingredients
Afinitor tablets contain 5 and 10 mg of everolimus as the active ingredient. They also contain:
butylated hydroxytoluene
magnesium stearate
lactose
hypromellose
crospovidone
lactose anhydrous
This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.
Sponsor
Afinitor is supplied in Australia by:
Novartis Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
North Ryde NSW 2113
Telephone 1 800 671 203
® = Registered Trademark
This leaflet was prepared in
September 2011.
Australian Registration Number:
5 mg - (AUST R 154661)
10 mg - (AUST R 154663)
