Wyost

Patient Information Leaflet

Wyost 120 mg solution for injection

denosumab
This medicinal product is subject to additional monitoring. This will allow any new safety information to be rapidly identified. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.
• Your doctor will give you a patient reminder card containing important safety information that you must know before and during treatment with Wyost.

Contents of this leaflet

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 works to reduce bone destruction caused by the spread of tumour to the bone (bone metastases) or by giant cell tumour of bone.
Wyost is used in adults with advanced cancer to prevent serious complications caused by bone metastases (e.g. fracture, spinal cord compression, or the need for radiotherapy or surgery).
Wyost is also used to treat giant cell tumour of bone that cannot be treated surgically or where 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 provider will not administer Wyost to you if you have severely low levels of calcium in your blood that have not been treated.
Your healthcare provider will not administer Wyost if you have unhealed wounds following dental or oral surgery.

Warnings and precautions
Talk to your doctor before using Wyost.

Calcium and vitamin D supplementation
You must take calcium and vitamin D supplements while being treated with Wyost, unless your blood calcium levels are high. Your doctor will discuss this with you. If your blood calcium level is low, your doctor may decide to give you calcium supplements before starting treatment with Wyost.

Low levels of calcium in the blood
Tell your doctor immediately if, during treatment with Wyost, you experience muscle spasms, twitching, or cramps, and/or numbness or tingling in your fingers, toes, or around your mouth, and/or seizures, confusion, or loss of consciousness. You may have low levels of calcium in your blood.

Kidney problems
Tell your doctor if you currently have or have ever had severe kidney problems, impaired kidney function, or if you have been on dialysis, as these conditions may increase the risk of low blood calcium levels, especially if you are not taking calcium supplements.

Problems with mouth, teeth, or jaw
An adverse effect called osteonecrosis of the jaw/mandible (severe deterioration of the jaw/mandible bone tissue) has been commonly reported (may occur in up to 1 in 10 people) in patients who received denosumab injections for cancer-related conditions. Osteonecrosis of the jaw/mandible may also occur after stopping treatment.

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

• Before receiving treatment, inform your doctor/nurse (healthcare provider) if you have any problems with your mouth or teeth. Your doctor should delay starting treatment if you have unhealed wounds in your mouth following dental procedures or oral surgery. Your doctor may ask you to have a dental examination before starting treatment with Wyost.
• During treatment, you must maintain good oral hygiene and have regular dental check-ups. If you wear dentures, ensure they are properly fitted.
• If you are currently undergoing dental treatment or are scheduled to have dental surgery (e.g., tooth extractions), inform your doctor about the dental procedure and inform your dentist that you are being treated with Wyost.
• Contact your doctor and dentist immediately if you notice any new problems with your mouth or teeth, such as loose teeth, pain or swelling, or failure of mouth sores to heal, or if you have discharge, as these may be signs of osteonecrosis of the jaw/mandible.

Patients who are receiving chemotherapy and/or radiotherapy, taking steroids or anti-angiogenic medicines (used to treat cancer), undergoing dental surgery, not receiving routine dental care, suffering from gum disease, or who smoke may have a higher risk of developing osteonecrosis of the jaw/mandible.

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

High levels of calcium in the blood after stopping treatment with Wyost
Some patients with giant cell tumour of the bone have developed high levels of calcium in the blood weeks to months after stopping treatment. Your doctor will monitor you for signs and symptoms of high calcium levels after you stop taking 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 the bone whose bones have stopped growing. The use of denosumab in children and adolescents with other tumours that have spread to the bones has not been studied.

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. In particular, it is important that you inform your doctor if you are taking:

• another medicine containing denosumab
• a bisphosphonate

You must 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, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. The use of Wyost is not recommended during pregnancy. Women of childbearing potential must use effective contraception while taking 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 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 then help you decide whether to discontinue breastfeeding or discontinue Wyost, taking into account the benefits of breastfeeding for the child and the benefits of Wyost for the mother.

If you are breastfeeding while being treated with Wyost, please inform your doctor.
Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Wyost has no or negligible effect on the ability to drive vehicles or operate machinery.

Wyost contains sorbitol
This medicine contains 78.9 mg of sorbitol per vial.

Wyost contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium 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. Wyost will be injected into the thigh, abdomen, or upper arm. If you are being treated for giant cell bone tumour, you will receive additional doses 1 week and 2 weeks after the first dose.
Do not shake.
During treatment with Wyost, you must also take calcium and vitamin D supplements unless you have high levels of calcium in your blood. Your doctor will discuss this with you.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.
The information contained in this package leaflet is also available on the website and via the QR code shown below:
"Insert QR code" + www.wyost.eu

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if, during treatment with Wyost, you notice any of the following symptoms (may affect more than 1 in 10 people):

• muscle spasms, contractions, 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 signs could indicate low levels of calcium in the blood. Low calcium levels may also lead to a change in heart rhythm called QT interval prolongation, which is seen on an electrocardiogram (ECG).

Contact your doctor and dentist immediately if, during treatment with Wyost or after stopping treatment with Wyost, you notice any of the following symptoms (may occur in up to 1 in 10 people):

• persistent pain in the mouth and/or jaw, and/or swelling or failure of healing of sores in the mouth or jaw, discharge from the jaw, numbness or a feeling of heaviness in the jaw, or loosening of a tooth, as these signs could indicate a serious deterioration of the jawbone tissue (osteonecrosis).

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

• bone, joint and/or muscle pain, sometimes severe,
• shortness of breath (dyspnoea),
• diarrhoea.

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

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

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

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

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

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

Not known (frequency cannot be estimated from the available data):

• inform your doctor if you experience ear pain, ear discharge, and/or ear infection. These may be signs of damage to the ear bone.

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

5. How to store 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 label and carton after
Exp. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Keep the vial in the outer packaging to protect the medicine from light.
The vial may be removed from the refrigerator and allowed to reach room temperature (up to 25 °C) before injection. This will make the injection more comfortable. Once the vial has reached room temperature (up to 25 °C), it must be used within 30 days.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Wyost contains

• The active substance is denosumab. Each vial contains 120 mg in 1.7 mL of solution (corresponding to 70 mg/mL).
• The other ingredients are glacial acetic acid, sorbitol (E 420), polysorbate 20, sodium hydroxide, hydrochloric acid and water for injections.

Description of the appearance of Wyost and contents of the pack
Wyost is an injectable solution (injection).
Wyost is a solution ranging from clear to slightly opalescent, from colourless to slightly yellowish or
slightly brownish.
Each pack contains one single-use vial.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestr. 10
6250 Kundl
Austria

Manufacturer
Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana
Slovenia

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Sandoz nv/sa Sandoz Pharmaceuticals d.d filialas
Tél/Tel: +32 2 722 97 97 Tel: +370 5 2636 037

България Luxembourg/Luxemburg
Сандоз България КЧТ Sandoz nv/sa
Тел.: +359 2 970 47 47 Tél/Tel.: +32 2 722 97 97

Česká republika Magyarország
Sandoz s.r.o. Sandoz Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 430 2890

Danmark/Norge/Ísland/Sverige Malta
Sandoz A/S Sandoz Pharmaceuticals d.d.
Tlf: +45 63 95 10 00 Tel: +35699644126

Deutschland Nederland
Hexal AG Sandoz B.V.
Tel: +49 8024 908 0 Tel: +31 36 52 41 600

Eesti Österreich
Sandoz d.d. Eesti filiaal Sandoz GmbH
Tel: +372 665 2400 Tel: +43 5338 2000

Ελλάδα Polska
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε. Sandoz Polska Sp. z o.o.
Τηλ: +30 216 600 5000 Tel.: +48 22 209 70 00

España Portugal
Sandoz Farmacéutica, S.A. Sandoz Farmacêutica Lda.
Tel: +34 900 456 856 Tel: +351 21 000 86 00

France România
Sandoz SAS Sandoz Pharmaceuticals SRL
Tél: +33 1 49 64 48 00 Tel: +40 21 407 51 60

Hrvatska Slovenija
Sandoz d.o.o. Sandoz farmacevtska družba d.d.
Tel: +385 1 23 53 111 Tel: +386 1 580 29 02

Ireland Slovenská republika
Rowex Ltd. Sandoz d.d. - organizačná zložka
Tel: +353 27 50077 Tel: +421 2 48 200 60050 70 6111

Italia Suomi/Finland
Sandoz S.p.A. Sandoz A/S
Tel: +39 02 96541 Puh/Tel: +358 10 6133 400

Κύπρος United Kingdom (Northern Ireland)
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε. Sandoz GmbH
Sandoz Pharmaceuticals d.d. Tel: +43 5338 2000
Τηλ: +30 216 600 5000
Τηλ: +357 22 69 0690

Latvija
Sandoz d.d. Latvia filiāle
Tel: +371 67 892 006

More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu .

The following information is intended exclusively for healthcare professionals:

• Before administration, visually inspect the Wyost solution. Do not inject the solution if it is cloudy or contains visible particles.
• Do not shake.
• To minimize discomfort at the injection site, allow the vial to reach room temperature (up to 25 °C) before injection and inject slowly.
• The entire contents of the vial must be injected.
• A 27-gauge steel needle is recommended for the administration of denosumab.
• The vial must not be reused.

Any unused medicine and waste material derived from this medicine must be disposed of in accordance with
local regulations.