Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
This medicine is new or being used differently. Please report side effects. See the
full CMI for further details.
1. Why am I using Afinitor?
Afinitor contains the active ingredient everolimus. Afinitor is used to treat various
types of cancer by slowing the growth of cancer-causing cells.
2. What should I know before I use Afinitor?
Do not use if you have ever had an allergic reaction to Afinitor or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with Afinitor and affect how it works.
4. How do I use Afinitor?
Your doctor will tell you the dose of Afinitor that you should take.
5. What should I know while using Afinitor?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using Afinitor.
Avoid becoming pregnant while using Afinitor and for up to 8 weeks after you stop
using it.
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Things you should not do
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Do not stop using this medicine suddenly.
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.
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Driving or using machines
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It is not known if Afinitor will influence your ability to drive and use machines.
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Drinking alcohol
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There are no known interactions between Afinitor and alcohol.
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Looking after your medicine
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Store below 30°C in the original packaging. Store it in a cool dry place away from
moisture, heat or sunlight.
Keep out of reach of children.
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6. Are there any side effects?
Common side effects include infections, rash, feeling weak or tired, diarrhoea, swelling
of arms, hands, feet, ankles, face or other parts of the body, abdominal pain, nausea,
fever, cough, headache, decreased appetite. For more information, including what to
do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information. You can help by reporting any side effects you may get.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems .
Active ingredient(s):
everolimus
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Afinitor. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Afinitor.
Where to find information in this leaflet:
1. Why am I using Afinitor?
Afinitor contains the active ingredient everolimus. Afinitor is classed as an inhibitor targeting mTOR (mammalian target of rapamycin).
Afinitor is used to treat various types of cancer by slowing the growth of cancer-causing
cells.
Afinitor is used in the treatment of:
Renal cell carcinoma, a type 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.
Neuroendocrine tumours (NETs)
Afinitor is used to control the growth of these tumours located in the stomach and
intestine, lung or pancreas.
Tuberous sclerosis complex (TSC) with angiomyolipoma of the kidney not requiring immediate
surgery
Afinitor may reduce the size of the tumour 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.
TSC with subependymal giant cell astrocytoma (sometimes called 'SEGA'), not requiring
immediate surgery
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).
TSC with seizures in patients 2 years and older
Afinitor may reduce the frequency of seizures in patients with a genetic disorder
called TSC.
Hormone receptor-positive, HER2 negative advanced breast cancer in postmenopausal
women
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. It is only used in patients whose tumour has tested negative to HER2.
2. What should I know before I use Afinitor?
Warnings
Do not use Afinitor if:
you are allergic to everolimus, or any of the ingredients listed at the end of this
leaflet. Always check the ingredients to make sure you can use this medicine
you have an allergy to everolimus-related medicines such as Rapamune, which contains
the active ingredient sirolimus
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.
Check with your doctor if you:
have or have had problems with your liver; It may be necessary to modify your dose
of Afinitor
have or have had diabetes or high levels of blood sugar
have previously had Hepatitis B
have received or about to receive radiation treatment
have lactose intolerance
have allergies to any other medicines, foods, preservatives or dyes
have had or about to have recent surgery, or have an unhealed wound following surgery
have any type of infection; it is important to treat your infection before starting
Afinitor
are scheduled to receive any vaccine
have any other medical conditions
take any medicines for any other condition
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Afinitor is not recommended for use during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Breastfeeding is not recommended while you are taking Afinitor and for two weeks after
the last dose of Afinitor. It is not known whether Afinitor passes into breast milk
and could affect your baby.
Contraception
To avoid becoming pregnant, you should use effective contraception while using Afinitor
and for up to 8 weeks after you stop using it.
Children and adolescents
Afinitor can be used in children or adolescents with normal liver function for the
treatment of:
TSC with SEGA (starting at 1 year of age)
TSC with seizures SEGA (starting at 2 years of age)
Afinitor is not to be used in children or adolescents for the treatment of cancer,
or TSC with angiomyolipoma of the kidney.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with Afinitor and affect how it works.
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
Medicines used to treat high blood pressure or other heart problems, known as ACE
inhibitors
Medicines used to treat HIV/AIDS such as ritonavir, amprenavir, fosamprenavir, efavirenz
and nevirapine
Medicines for epilepsy such as carbamazepine, phenobarbitone and phenytoin. If you
are taking a medicine to control seizures, any change in the dose of your medication
may require a change in your Afinitor dose
St John's wort, a herbal product used to treat depression and other conditions
Drugs used to stop the body from rejecting organ transplants such as ciclosporin
Medicines 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
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Afinitor.
Vaccines - tell your doctor if you need to get a vaccination. Some vaccines may be less effective if given while taking Afinitor.
4. How do I use Afinitor?
Afinitor is available as tablets and dispersible tablets. The tablets can be used
for the various cancers, TSC with SEGA, and TSC with kidney angiomyolipoma. It is
not recommended for use in TSC with seizures. The dispersible tablets can be used
for TSC with SEGA and TSC with seizures.
How much to take
Your doctor will tell you how many Afinitor tablets or dispersible tablets to take.
The dose will depend on the condition you are being treated for and your individual
treatment needs.
When to take Afinitor
Take Afinitor once a day, at the same time each day
It is best to take Afinitor in the morning, either consistently with or without food
Do not drink grapefruit juice or eat grapefruit, star fruit or Seville oranges while
taking Afinitor. These foods can stop Afinitor from working properly.
How to take Afinitor
Afinitor Tablets
Swallow the tablets whole with a glass of water. Do not chew or crush the tablets.
If you cannot swallow Afinitor tablets whole, you can stir the tablet into a glass
of water:
Put the required number of tablets into a glass containing approximately 30 mL of
water
Gently stir until the tablets break apart (approximately 7 minutes) then drink immediately
Rinse the glass with the same amount of water (approximately 30 mL) and drink the
contents to make sure that you get the full dose of Afinitor.
Afinitor Dispersible Tablets
Afinitor Dispersible Tablets must be made into a suspension in water first. Do not
use any other liquid. Do not chew, crush, or swallow the Dispersible Tablets whole.
You can prepare the suspension in an oral syringe or in a small drinking glass. The
suspension must be taken right away. If you do not take the dose within 60 minutes
after it has been prepared, throw away the dose and prepare a new dose of Afinitor
Dispersible Tablets.
Oral Syringe
Remove the plunger from a 10 mL oral syringe and put the prescribed number of dispersible
tablets inside the syringe
Re-insert the plunger and push it inward to make contact with the dispersible tablets
Pull up about 5 mL of water into the syringe to cover the dispersible tablets. Then
pull in about 4 mL of air.
Place the filled syringe into a container (tip up) for 3 minutes and allow the tablets
to disintegrate
Gently turn the oral syringe upside down 5 times immediately prior to taking the medicine
Carefully push the plunger to remove the excess air from the syringe and then immediately
dispense the full contents of the oral syringe directly into the mouth of the patient
so they can drink the medicine
After taking the medicine, pull up about 5 mL of water and 4 mL of air into the same
syringe and swirl the contents and then put the entire contents of the syringe into
the mouth of the patient.
Small drinking glass
Add approximately 25 mL (2 tablespoons) of water into a small drinking glass and add
the prescribed number of dispersible tablets. Do not add more than 10 mg of Afinitor
dispersible tablets to the glass. If you need to take more than 10 mg, prepare another
glass
Allow the dispersible tablets to disintegrate for 3 minutes
Stir the contents of the glass gently with a spoon and immediately drink the full
amount
Refill the glass with the same amount of water (about 25 mL), stir the contents with
the same spoon to suspend remaining particles, and drink the entire content of the
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 preparing either suspension.
If you forget to use Afinitor
Afinitor should be taken regularly at the same time each day. If you miss your dose
at the usual time, take it as soon as you remember, and then take the next tablet
as usual.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you use too much Afinitor
If you think that you have taken too much Afinitor, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using Afinitor?
Things you should do
Keep all of your doctor's appointments so that your progress can be checked
Tell your doctor if you plan to receive a vaccine
Avoid becoming pregnant while using Afinitor and for up to 8 weeks after you stop
using it
Tell your doctor if you are about to have surgery, have had recent surgery or if you
still have an unhealed wound following surgery.
Call your doctor straight away if you:
Experience new or worsening cough, difficulty breathing, chest pain, shortness of
breath or wheezing
Have a temperature or chills, or another sign of an infection
Experience pain or discomfort in the mouth or have open sores in the mouth
Experience shortness of breath, nausea, diarrhoea, skin rashes or soreness in the
mouth, gums or throat
Become pregnant while taking this medicine
Remind any doctor, dentist or pharmacist you visit that you are using Afinitor.
Things you should not do
Do not stop using this medicine suddenly
Do not change your dose, or switch between tablets and dispersible tablets unless
advised by your doctor
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.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Afinitor
affects you.
Looking after your medicine
Follow the instructions in the carton on how to take care of your medicine properly.
Keep the tablets or dispersible tablets in the original packet and foils until it
is time to take them.
Store below 30°C in the original packaging.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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Mouth, stomach, bowel problems:
Sore mouth or throat, cold sores or mouth ulcers
Nausea, vomiting, diarrhoea, constipation, tummy pain, excess gas
Dry mouth, difficulty swallowing
Loss of appetite, change in or loss of taste, weight loss
Cloudy urine, pain when urinating, wanting to urinate more often
General problems:
Feeling thirsty
Fatigue or unusual weakness
Trouble sleeping
Headache, dizziness
Ear ache
Runny nose, cough
Fever
Nose bleeds
Irregular, absent or heavy menstrual periods in females
Joint pain
Poor wound healing
Swelling of hands, feet or limbs due to fluid retention
Skin problems:
Bleeding or bruising more easily than normal
Small, solid pink or red bumps on the skin
Dry or red skin, rash
Nail disorders
Rash and pain on the palms of your hands or soles of your feet
Pimples
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
If these side effects become severe, tell your doctor, pharmacist or healthcare provider
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Serious side effects
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Serious side effects
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What to do
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Symptoms of an allergic reaction or infection 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
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
Painful skin rash with small fluid-filled blisters in a limited area on one side
of the body (left or right), often in a stripe (herpes zoster)
Lung or heart problems such as:
Coughing, breathing problems, rapid breath or shortness of breath
Sudden onset of shortness of breath, chest pain or coughing up blood
Other problems:
Difficulty breathing, nausea, diarrhoea, soreness in the mouth, gums or throat, skin
rashes or redness at site of radiation therapy
Symptoms of hepatitis B such as fever, skin rash, joint pain, inflammation, fatigue,
loss of appetite, nausea, jaundice (yellowing of the skin), pain in the upper right
abdomen, pale stool or dark urine
Swelling and/or pain in one of your legs, usually your calf, (redness or warm skin
in the affected area)
Swelling, feeling of heaviness or tightness, pain, limited movement of body parts
which could be a sign of fluid build-up and a problem with your lymphatic system
Vomiting blood, blood in your faeces
Signs of anger, easily irritated
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people. Some of these side effects
can only be found by laboratory testing (for example, high levels of cholesterol,
lipids, or sugar in the blood).
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Afinitor contains
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Active ingredient
(main ingredient)
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everolimus
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Other ingredients
(inactive ingredients)
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Afinitor Tablets
butylated hydroxytoluene
magnesium stearate
lactose monohydrate
hypromellose
crospovidone
lactose
Afinitor Dispersible Tablets
butylated hydroxytoluene
magnesium stearate
lactose monohydrate
hypromellose
crospovidone
mannitol
microcrystalline cellulose
colloidal anhydrous silica
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Potential allergens
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Lactose
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Do not take this medicine if you are allergic to any of these ingredients.
What Afinitor looks like
Afinitor Tablets
Afinitor tablets are available in three different strengths, supplied in packs of
30 tablets:
Afinitor 2.5 mg tablets are white to yellowish and elongated with no score, with "LCL"
on one side and "NVR" on the other (AUST R 177648)
Afinitor 5 mg tablets are white to yellowish and elongated with no score, with "5"
on one side and "NVR" on the other (AUST R 154661)
Afinitor 10 mg tablets are white to yellowish and elongated with no score, with "UHE"
on one side and "NVR" on the other (AUST R 154663)
Afinitor Dispersible Tablets
Afinitor dispersible tablets are available in three different strengths, supplied
in packs of 30 tablets:
Afinitor 2 mg dispersible tablets are white to slightly yellowish, round, flat tablets
with a bevelled edge and no score, with "D2" on one side and "NVR" on the other (AUST
R 200203)
Afinitor 3 mg dispersible tablets are white to slightly yellowish, round, flat tablets
with a bevelled edge and no score, with "D3" on one side and "NVR" on the other (AUST
R 200204)
Afinitor 5 mg dispersible tablets are white to slightly yellowish, round, flat tablets
with a bevelled edge and no score, with "D5" on one side and "NVR" on the other (AUST
R 200205)
Who distributes Afinitor
Afinitor is supplied in Australia by:
Novartis Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
Macquarie Park NSW 2113
Telephone 1 800 671 203
This leaflet was prepared in September 2021.
(afi021122c.doc) based on PI (afi021122i.doc)