Wyost 120 mg solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Wyost 120 mg solution for injection

denosumab

This medicinal product is subject to additional monitoring, which will allow for quicker detection of new safety information. You can help by reporting any side effects you may experience. Section 4 at the end of this leaflet includes information on 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, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.
• Your doctor will provide you with a patient reminder card containing important safety information you should know before and during treatment with Wyost.

Leaflet contents

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

1. What Wyost is and what it is used for

Wyost contains denosumab, a protein (monoclonal antibody) that inhibits bone destruction occurring when cancer spreads to the bones (bone metastases) or in 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 radiation therapy or surgery).

Wyost is also used for the treatment of giant cell tumor of bone that 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 using Wyost

Do not use Wyost

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

Your healthcare professional will not administer Wyost to you if you have untreated low levels of calcium in your blood.

Your healthcare professional will not administer Wyost to you if you have unhealed wounds from dental or oral surgery.

Warnings and precautions

Talk to your doctor before starting to use Wyost.

Calcium and vitamin D supplements

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

Low calcium levels in the blood

Contact your doctor immediately if you experience muscle spasms, twitches, or cramps and/or numbness or tingling in your fingers, toes, or around your mouth and/or seizures, confusion, or loss of consciousness during treatment with Wyost. Your blood calcium level may be low.

Kidney problems

Inform your doctor if you have or have had severe kidney problems, kidney failure, or if you have required dialysis, as this may increase the risk of low calcium levels in the blood, especially if you are not taking calcium supplements.

Problems with the mouth, teeth, and jaw

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

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

• Before receiving treatment, inform 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 unhealed wounds in your mouth due to dental procedures or oral surgery. Your doctor will recommend a dental examination before starting treatment with Wyost.
• While being treated, you should maintain good oral hygiene and have regular dental check-ups. If you wear dentures, ensure they fit properly.
• If you are undergoing dental treatment or are scheduled for 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 experience any problems with your mouth or teeth, such as loose teeth, pain or swelling, non-healing or oozing sores, as these could be signs of osteonecrosis of the jaw.

Patients undergoing chemotherapy and/or radiotherapy, taking steroids or anti-angiogenic medicines (used to treat cancer), who have had dental surgery, who do not have regular dental check-ups, who have gum disease, or who smoke 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 your hip, groin, or thigh.

High calcium levels in the blood after stopping Wyost treatment

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

Other medicines and Wyost

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to 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 containing denosumab
• a bisphosphonate

You should not take Wyost together with other medicines containing denosumab or bisphosphonates.

Pregnancy and breastfeeding

Denosumab has not been studied in pregnant women. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Wyost is not recommended during pregnancy. Women of childbearing potential must 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 within 5 months after stopping treatment with Wyost, please inform your doctor.

It is unknown whether denosumab is excreted in human breast milk. It is important to inform your doctor if you are breastfeeding or plan to breastfeed. Your doctor will help you decide whether to discontinue breastfeeding or to discontinue Wyost, taking into account the benefits of breastfeeding for the child and the benefits of Wyost for the mother.

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

Consult your doctor or pharmacist before taking any other medicine.

Driving and using machines

The influence of Wyost on the ability to drive and use machines is none or negligible.

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 dose; i.e., 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 given once every 4 weeks as a single subcutaneous injection (under the skin). 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 additional doses 1 and 2 weeks after the first dose.

Do not shake.

You should also take calcium and vitamin D supplements during treatment with Wyost unless you have excess calcium in your blood. Your doctor will advise you on this matter.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Tell your doctor immediately if you experience any of the following symptoms while being treated with Wyost (may affect more than 1 in 10 people):

• muscle spasms, tics, cramps, numbness or tingling in the fingers of the hands and feet or around the mouth and/or seizures, confusion or loss of consciousness. These symptoms may be signs that your blood calcium levels are low. Low blood calcium levels may also cause a change in heart rhythm called QT prolongation, which is detected by an electrocardiogram (ECG).

Tell your doctor and dentist immediately if you experience any of the following 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 non-healing ulcers in the mouth or jaw, pus discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth, which may be signs of bone damage in the jaw (osteonecrosis).

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

• bone, joint and/or muscle pain, sometimes severe,
• breathing difficulties,
• diarrhoea.

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

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

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

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

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

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

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

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 stated on the carton and label after "CAD" or "EXP". The expiry date refers to the last day of the month indicated.

Store in a refrigerator (between 2 °C and 8 °C).

Do not freeze.

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

Before injection, the vial may be removed from the refrigerator and allowed to reach room temperature (up to 25 °C) to make the injection less uncomfortable. Once the vial has reached room temperature (up to 25 °C), it must be used within 30 days.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of Wyost

• 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 components are glacial acetic acid, sorbitol (E420), polysorbate 20, sodium hydroxide, hydrochloric acid, and water for injections.

Appearance of Wyost and contents of the pack

Wyost is an injectable solution.

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

Each pack contains 1, 3 or 4 single-use vials. Only certain pack sizes may be marketed.

Marketing Authorization Holder

Sandoz GmbH

Biochemiestr. 10

6250 Kundl

Austria

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova ulica 57

1526 Ljubljana

Slovenia

You can request further information about this medicinal product by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

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

This information is intended for healthcare professionals only:

• Wyost solution should be visually inspected 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, allow the vial to reach room temperature (up to 25 °C) before injection, and administer the injection slowly.
• The entire contents of the vial must be injected.
• A 27 G needle is recommended for the administration of denosumab.
• Do not reinsert the needle into the vial.

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