Afinitor is used in the treatment of renal cell carcinoma, a type of kidney cancer; pancreatic neuroendocrine tumours (pNET), a type of cancer located in the pancreas; tuberous sclerosis complex (TSC) with angiomyolipoma of the kidney (a kidney tumour) not requiring immediate surgery; or TSC with subependymal giant cell astrocytoma (sometimes called 'SEGA'), a specific type of brain tumour not requiring immediate surgery.
Afinitor is also used in the treatment of hormone receptor-positive HER2 negative advanced breast cancer in postmenopausal women, in conjunction with exemestane after failure of letrozole or anastrozole.
It is only used in patients whose tumour has tested negative to HER2.
Everolimus is the active substance in Afinitor.
Treatment of kidney cancer
Afinitor stops the cancer from making new cells and cuts off the blood supply. This slows the growth and spread of the cancer.
Treatment of pNET
Afinitor is used to control the growth of these tumours located in the pancreas.
Treatment of SEGA
Afinitor reduces the size of brain tumours (SEGA) that are caused by a genetic disorder called tuberous sclerosis. This may stop the tumours from causing problems as they grow, such as hydrocephalus (excessive accumulation of fluid within the brain).
Treatment of TSC with angiomyolipoma of the kidney
Afinitor may reduce the size of angiomyolipoma of the kidney that is associated with a genetic disorder called TSC. This may lower the risk of the tumour(s) causing bleeding complications and may help to preserve kidney function.
Treatment of hormone receptor-positive, HER2 negative advanced breast cancer
Growth of this type of breast cancer is stimulated by oestrogens which are female sex hormones. Oestrogen inhibitors such as letrozole, anastrozole and exemestane reduce the amount of oestrogen and can slow the growth of breast cancers. After failure of letrozole or anastrozole, exemestane is used in combination with Afinitor to prevent the breast cancer cells from becoming resistant to the exemestane.
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.
Children and adolescents
AFINITOR is not to be used in children or adolescents for the treatment of hormone receptor-positive, HER2 negative advanced breast cancer, advanced neuroendocrine tumours or advanced kidney cancer.
AFINITOR is not to be used in children less than 1 years of age for treatment of SEGA associated with TSC.
Do not take Afinitor if you have an allergy to:
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.
Tell your doctor if you have or have had any of the following medical conditions:
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 or dispersible 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.
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:
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 are taking anti-seizure medications and your dose changes.
A change in the dose of your medication (up or down) may require a change in Afinitor dose.
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.
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.
Treatment of kidney cancer, pancreatic neuroendocrine tumours, hormone receptor positive, HER2 negative advanced breast cancer and TSC with angiomyolipoma of the kidney
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).
Treatment of SEGA
Your doctor will tell you the dose that you need to take depending on your body size and other medicines you are taking.
Blood tests are necessary during treatment with Afinitor to measure the amount of Afinitor in your blood and find the appropriate daily dose for you.
Take it consistently on an empty stomach or consistently 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 or dispersible tablet and stop it working properly.
Do not take it with grapefruit juice.
Grapefruit juice can interfere with the absorption of the tablet or dispersible tablet.
Swallow the tablet whole with a glass of water. Do not crush or chew it.
If you cannot swallow Afinitor tablets whole, you can stir them into a glass of water:
Afinitor Dispersible Tablets
Do not chew, crush, or swallow the Afinitor Dispersible Tablets whole.
Take Afinitor Dispersible Tablets as a suspension only. You can prepare the suspension in an oral syringe or in a small drinking glass.
If you have any questions, contact your doctor or pharmacist.
Small drinking glass
Instructions for use and handling of tablets and dispersible tablets
Caregivers are advised to avoid contact with suspensions of Afinitor tablets or dispersible tablets. Wash hands thoroughly before and after preparation of either suspension.
Take the tablet or dispersible 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.
Keep taking this medicine for as long as your doctor tells you.
If it is more than 6 hours after you normally take it, skip the tablet or dispersible 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 or dispersible 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.
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.
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.
You will have regular blood tests during treatment. These will monitor the amount of blood cells (white blood cells, red blood cells and platelets) in your body to see if Afinitor is having an unwanted effect on these cells. Blood tests will also be carried out to monitor your kidney function (levels of creatinine, blood urea nitrogen or urinary protein), liver function (level of transaminases) and your blood sugar levels, because these can also be affected by Afinitor.
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, chest pain, shortness of breath or wheezing.
Patients may develop lung or breathing problems, such as pneumonitis, pulmonary embolism or acute respiratory distress syndrome.
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.
Afinitor can make you more likely to get an infection (like pneumonia, infection of the urinary tract, fungal infection or viral infection such as hepatitis B reactivation).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 do not 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.
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.
Be careful driving or operating machinery until you know how Afinitor affects you.
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:
If any of the following happen, tell your doctor immediately:
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( for example, high levels of cholesterol and lipids in the blood).
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.
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.
Afinitor tablets are white to yellowish and elongated with no score. Afinitor tablets are available in three different strengths, supplied in packs of 30, 50#, 60#, 100# and 120# tablets:
#not currently marketed
Afinitor Dispersible Tablets
The dispersible tablets are white to slightly yellowish, round, flat tablets with a bevelled edge and no score.
Afinitor tablets contain 2.5, 5 and 10 mg of everolimus as the active ingredient. They also contain:
Afinitor Dispersible Tablets
Afinitor dispersible tablets contain 2, 3 and 5 mg of everolimus as the active ingredient. They also contain:
This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.