WYOST 120 mg INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the Patient

Wyost 120mg solution for injection

denosumab

This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you how to report side effects.

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
• Your doctor will provide you with a patient reminder card, which contains important safety information that you need to know before and during treatment with Wyost.

Contents of the pack

1. What is Wyost and what is it used for
2. What you need to know before you use Wyost
3. How to use Wyost
4. Possible side effects
5. Storage of Wyost
6. Contents of the pack and other information

1. What is Wyost and what is it used for

Wyost contains denosumab, a protein (monoclonal antibody) that slows down bone destruction that occurs when cancer spreads to the bone (bone metastases) or due to giant cell tumor of bone.

Wyost is used in adults with advanced cancer to prevent serious complications caused by bone metastases (e.g. fractures, spinal cord compression or the need for radiotherapy or surgery).

Wyost is also used to treat giant cell tumor of bone, which cannot be treated with surgery or when surgery is not the best option, in adults and adolescents whose bones have stopped growing.

2. What you need to know before you use Wyost

Do not use Wyost

• if you are allergic to denosumab or any of the other ingredients of this medicine (listed in section 6).

Your doctor will not give you Wyost if you have very low levels of calcium in your blood that have not been treated.

Your doctor will not give you Wyost if you have open wounds in your mouth or jaw due to dental or oral surgery.

Warnings and precautions

Consult your doctor before starting treatment with Wyost.

Calcium and vitamin D supplements

You must take calcium and vitamin D supplements during treatment with Wyost unless you have high levels of calcium in your blood. Your doctor will explain this to you. If your blood calcium levels are low, your doctor may decide to prescribe calcium supplements before starting treatment with Wyost.

Low blood calcium levels

Contact your doctor immediately if you experience muscle spasms, twitches or cramps and/or numbness or tingling in your fingers and toes or around your mouth and/or seizures, confusion or loss of consciousness during treatment with Wyost. It is possible that your blood calcium levels are low.

Kidney problems

Tell your doctor if you have or have had severe kidney problems, kidney failure or if you have needed dialysis, as this may increase the risk of low blood calcium levels, especially if you do not take calcium supplements.

Mouth, tooth and jaw problems

A common side effect (may affect up to 1 in 10 people) called osteonecrosis of the jaw (damage to the jaw bone) has been reported in patients receiving denosumab injection for cancer-related conditions. Osteonecrosis of the jaw can also occur after stopping treatment.

It is important to try to prevent the development of osteonecrosis of the jaw as it can be a painful condition that can be difficult to treat. To reduce the risk of developing osteonecrosis of the jaw, you must take some precautions:

• Before treatment, tell your doctor or nurse (healthcare professional) if you have any problems with your mouth or teeth. Your doctor should delay the start of your treatment if you have open wounds in your mouth or jaw due to dental or oral surgery. Your doctor will recommend a dental examination before starting treatment with Wyost.
• While being treated, you must maintain good oral hygiene and have regular dental check-ups. If you wear dental prostheses, you must ensure they fit properly.
• If you are undergoing dental treatment or are going to have dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and inform your dentist that you are being treated with Wyost.
• Contact your doctor and dentist immediately if you have any problems with your mouth or teeth, such as loose teeth, pain or swelling, ulcers that do not heal or are suppurating, as these could be signs of osteonecrosis of the jaw.

Patients undergoing chemotherapy and/or radiotherapy, taking steroids or anti-angiogenic medications (used to treat cancer), undergoing dental surgery, not having regular dental check-ups, having gum disease or being smokers, may have a higher risk of developing osteonecrosis of the jaw.

Unusual fractures of the thigh bone

Some people have developed unusual fractures of the thigh bone during treatment with denosumab. Contact your doctor if you experience new or unusual pain in the hip, groin or thigh.

High blood calcium levels after stopping treatment with Wyost

Some patients with giant cell tumors of bone have developed high blood calcium levels weeks or months after stopping treatment. Your doctor will monitor you for signs and symptoms of high blood calcium levels after stopping treatment with Wyost.

Children and adolescents

Wyost is not recommended for children and adolescents under 18 years of age except for adolescents with giant cell tumor of bone whose bones have stopped growing. The use of denosumab has not been studied in children and adolescents with other types of cancer that have spread to the bone.

Other medicines and Wyost

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription. It is very important that you inform your doctor if you are being treated with

• another medicine that contains denosumab
• a bisphosphonate

You should not take Wyost with other medicines that contain denosumab or bisphosphonates.

Pregnancy and breastfeeding

Denosumab has not been tested in pregnant women. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Wyost should not be used during pregnancy. Women of childbearing potential should use effective contraception during treatment with Wyost and for at least 5 months after stopping treatment with Wyost.

If you become pregnant during treatment with Wyost or less than 5 months after stopping treatment with Wyost, please inform your doctor.

It is not known whether denosumab is excreted in breast milk. It is important that you inform your doctor if you are breastfeeding or planning to breastfeed. Your doctor will help you decide whether to stop breastfeeding or stop taking Wyost, taking into account the benefit of breastfeeding for the child and the benefit of Wyost for the mother.

If you are breastfeeding during treatment with Wyost, please inform your doctor.

Ask your doctor or pharmacist for advice before taking any other medicine.

Driving and using machines

Wyost has no or negligible influence on the ability to drive and use machines.

Wyost contains sorbitol

This medicine contains 78.9 mg of sorbitol in each vial.

Wyost contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 120 mg; this is essentially “sodium-free”.

3. How to use Wyost

Wyost must be administered under the supervision of a healthcare professional.

The recommended dose of Wyost is 120 mg administered once every 4 weeks in a single injection under the skin (subcutaneously). Wyost will be injected into the thigh, abdomen or upper arm. If you are being treated for giant cell tumor of bone, you will receive an additional dose 1 and 2 weeks after the first dose.

Do not shake.

You must also take calcium and vitamin D supplements during treatment with Wyost unless you have high levels of calcium in your blood. Your doctor will explain this to you.

If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediatelyif you get any of these symptoms during treatment with Wyost (may affect more than 1 in 10 people):

• muscle spasms, twitches or cramps, numbness or tingling in your fingers and toes or around your mouth and/or seizures, confusion or loss of consciousness. These symptoms may be a sign that your blood calcium levels are low. Low blood calcium levels can also cause a change in heart rhythm called QT prolongation, which is seen on an electrocardiogram (ECG).

Tell your doctor and dentist immediatelyif you get any of these symptoms during treatment with Wyost or after stopping treatment (may affect up to 1 in 10 people):

• persistent pain in the mouth and/or jaw, swelling and/or ulcers that do not heal in the mouth or jaw, suppurating, numbness or a feeling of heaviness in the jaw or loosening of a tooth can be signs of bone damage in the jaw (osteonecrosis).

Very common side effects(may affect more than 1 in 10 people):

• bone, joint and/or muscle pain that can be severe,
• breathing difficulties,
• diarrhea.

Common side effects(may affect up to 1 in 10 people):

• low levels of phosphate in the blood (hypophosphatemia),
• tooth extraction,
• excessive sweating,
• in patients with advanced cancer: development of another type of cancer.

Uncommon side effects(may affect up to 1 in 100 people):

• high blood calcium levels (hypercalcemia) after stopping treatment in patients with giant cell tumor of bone,
• new or unusual pain in the hip, groin or thigh (can be an early sign of a possible fracture of the thigh bone),
• skin rash or mouth ulcers (drug-induced lichenoid eruptions).

Rare side effects(may affect up to 1 in 1,000 people):

• allergic reactions (e.g. wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; skin rash, itching or hives). In rare cases, allergic reactions can be severe.

Frequency not known(cannot be estimated from the available data):

• ask your doctor if you have ear pain, discharge from the ear and/or ear infection. These could be symptoms of damage to the bones of the ear.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Wyost

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the label after “EXP”. The expiry date refers to the last day of the month shown.

Store in a refrigerator (2°C - 8°C).

Do not freeze.

Keep the vial in the outer packaging to protect it from light.

Before injection, the vial may be left at room temperature (up to 25°C) for up to 30 days.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Wyost contains

• The active substance is denosumab. Each vial contains 120 mg of denosumab in 1.7 ml of solution (equivalent to 70 mg/ml).
• The other ingredients are glacial acetic acid, sorbitol (E420), polysorbate 20, sodium hydroxide, hydrochloric acid and water for injections.

Appearance and packaging of Wyost

Wyost is a solution for injection (injectable).

Wyost is a clear to slightly opalescent, colorless to slightly yellowish or slightly brownish solution.

Each pack contains 1, 3 or 4 single-use vials. Not all pack sizes may be marketed.

Marketing authorisation holder

Sandoz GmbH

Biochemiestr. 10

6250 Kundl

Austria

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova ulica 57

1526 Ljubljana

Slovenia

You can request more information about this medicine from the representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.

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This information is intended only for healthcare professionals:

• The Wyost solution should be inspected visually before administration. Do not inject the solution if it is cloudy or contains visible particles.
• Do not shake.
• To avoid discomfort at the injection site, before injecting, let the vial reach room temperature (up to 25°C) before injecting and inject slowly.
• The entire contents of the vial must be injected.
• For the administration of denosumab, it is recommended to use a 27 G needle.
• Do not reinsert the needle into the vial.

Disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.