EVEROLIMUS SANDOZ®

▼ 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.

EVEROLIMUS SANDOZ®

Active ingredient(s): everolimus

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Consumer Medicine Information (CMI)

This leaflet provides important information about using Everolimus Sandoz. 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 Everolimus Sandoz.

Where to find information in this leaflet:

1. Why am I using Everolimus Sandoz?
2. What should I know before I use Everolimus Sandoz?
3. What if I am taking other medicines?
4. How do I use Everolimus Sandoz?
5. What should I know while using Everolimus Sandoz?
6. Are there any side effects?
7. Product details

1. Why am I using Everolimus Sandoz?

Everolimus Sandoz contains the active ingredient everolimus. Everolimus Sandoz is classed as an inhibitor targeting mTOR (mammalian target of rapamycin). Everolimus Sandoz is used to treat various types of cancer by slowing the growth of cancer-causing cells.

Everolimus Sandoz is used in the treatment of:

• Renal cell carcinoma, a type of kidney cancer
  Everolimus Sandoz 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)
  Everolimus Sandoz 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
  Everolimus Sandoz 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
  Everolimus Sandoz 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).
• 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 Everolimus Sandoz 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 Everolimus Sandoz?

Warnings

Do not use Everolimus Sandoz 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 Everolimus Sandoz
• 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 Everolimus Sandoz
• 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.

Everolimus Sandoz 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 Everolimus Sandoz and for two weeks after the last dose of Everolimus Sandoz. It is not known whether Everolimus Sandoz passes into breast milk and could affect your baby.

Contraception

To avoid becoming pregnant, you should use effective contraception while using Everolimus Sandoz and for up to 8 weeks after you stop using it.

Children and adolescents

Everolimus Sandoz can be used in children or adolescents with normal liver function for treatment of TSC with SEGA (starting at 1 year of age).

Everolimus Sandoz 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 Everolimus Sandoz 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 Everolimus Sandoz 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 Everolimus Sandoz.

Vaccines – tell your doctor if you need to get a vaccination. Some vaccines may be less effective if given while taking Everolimus Sandoz.

4. How do I use Everolimus Sandoz?

How much to take

Your doctor will tell you how many Everolimus Sandoz tablets to take. The dose will depend on the condition you are being treated for and your individual treatment needs.

When to take Everolimus Sandoz

• Take Everolimus Sandoz once a day, at the same time each day
• It is best to take Everolimus Sandoz in the morning, either consistently with or without food
• Do not drink grapefruit juice or eat grapefruit, star fruit or Seville oranges while taking Everolimus Sandoz. These foods can stop Everolimus Sandoz from working properly.

How to take Everolimus Sandoz

Swallow the tablets whole with a glass of water. Do not chew or crush the tablets.

If you cannot swallow Everolimus Sandoz 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 Everolimus Sandoz.

Instructions for use and handling of tablets

Caregivers are advised to avoid contact with suspensions of Everolimus Sandoz tablets. Wash hands thoroughly before and after preparing the suspension.

If you forget to use Everolimus Sandoz

Everolimus Sandoz 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 Everolimus Sandoz

If you think that you have taken too much Everolimus Sandoz, 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 Everolimus Sandoz?

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 Everolimus Sandoz 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 Everolimus Sandoz.

Things you should not do

• Do not stop using this medicine suddenly
• Do not take Everolimus Sandoz 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 Everolimus Sandoz affects you.

Looking after your medicine

Follow the instructions in the carton on how to take care of your medicine properly.

Keep the 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

Less serious side effects

What to do

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

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

Serious side effects

Serious side effects

What to do

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

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.

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 Everolimus Sandoz contains

Active ingredient (main ingredient)	everolimus
Other ingredients (inactive ingredients)	butylated hydroxytoluene magnesium stearate lactose monohydrate hypromellose crospovidone lactose
Potential allergens	Lactose

Do not take this medicine if you are allergic to any of these ingredients.

What Everolimus Sandoz looks like

Everolimus Sandoz tablets are available in three different strengths, supplied in packs of 30 tablets:

• Everolimus Sandoz 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 297503)
• Everolimus Sandoz 5 mg tablets are white to yellowish and elongated with no score, with “5” on one side and “NVR” on the other (AUST R 297504)
• Everolimus Sandoz 10 mg tablets are white to yellowish and elongated with no score, with “UHE” on one side and “NVR” on the other (AUST R 297505).

Who distributes Everolimus Sandoz

Everolimus Sandoz 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
Website: www.novartis.com.au

This leaflet was prepared in September 2021.

(eve021122c_V2.doc) based on PI (eve021122i.doc)