WYOST 120 mg Инъекционный Раствор

Содержание инструкции

1. Wyost 120 mg injectable solution
   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. How to store Wyost
   6. Contents of the pack and other information

Wyost 120 mg injectable solution

denosumab
Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicinal product. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before using this medicine as 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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
• Your doctor will give you a patient reminder card containing important safety information that you need to 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 you use 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 is Wyost and what is it used for

Wyost contains denosumab, a protein (monoclonal antibody) that works by decreasing the
destruction of bone caused by the spread of cancer to the bone (bone metastases) or for giant cell bone
tumour.
Wyost is used in adults with advanced cancer to prevent serious complications caused by bone
metastases (e.g. fracture, pressure on the spinal cord or need to receive radiotherapy or surgery).
Wyost is also used in the treatment of giant cell bone tumour, which 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 you use 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).

The healthcare professional will not give you Wyost if you have a very low level of calcium in your blood that has not been treated.
The healthcare professional will not give you Wyost if you have unhealed wounds from 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 you are 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 blood calcium levels
Tell your doctor immediately if you experience spasms, twitching or cramping of the muscles, and/or numbness or tingling in the fingers of your hands and feet or around your mouth and/or convulsions, confusion or loss of consciousness while being treated with Wyost. You may have low calcium levels in your blood.
Kidney problems
Tell your doctor if you suffer from or have ever suffered from severe kidney problems, kidney impairment or if you have been on dialysis, as these conditions may increase the risk of having low calcium levels in your blood, especially if you are not taking calcium supplements.
Problems with the mouth, teeth or jaw
An undesirable effect called osteonecrosis of the jaw/maxilla (severe degeneration of the bone tissue of the jaw/maxilla) has been reported commonly (may occur in up to 1 in 10 patients) in patients who received desonumab injections for conditions related to cancer. Osteonecrosis of the jaw/maxilla can also occur after stopping treatment.
It is important to try to prevent the development of osteonecrosis of the jaw/maxilla as it is a painful condition that can be difficult to treat. In order to reduce the risk of developing osteonecrosis of the jaw/maxilla you must take some precautions:

• Before receiving treatment, tell your doctor/nurse (healthcare professional) if you have any mouth or teeth problems. Your doctor may delay the start of treatment if you have unhealed wounds in your mouth following dental procedures or oral surgery. Your doctor may ask you to have a dental check-up before starting treatment with Wyost.
• During treatment, you must maintain good oral hygiene and have regular dental check-ups. If you wear dentures, you must make sure they fit properly.
• If you are undergoing dental treatment or are planning to have dental surgery (e.g. tooth extractions), tell your doctor about the dental treatment and tell your dentist that you are being treated with Wyost.
• Contact your doctor and dentist immediately if you notice the appearance of problems with your mouth or teeth, such as loosening of teeth, pain or swelling, or failure of mouth sores to heal or the presence of discharge, as these could be signs of osteonecrosis of the jaw/maxilla.

Patients who are undergoing chemotherapy and/or radiotherapy, who are taking steroids or anti-angiogenetic medicines (used for cancer treatment), who are undergoing dental surgery, who are not receiving routine dental care, who suffer from gum problems or who smoke may have a higher risk of developing osteonecrosis of the jaw/maxilla.
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 the hip, groin or thigh.
High blood calcium levels after stopping treatment with Wyost
Some patients with giant cell bone tumor 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 have stopped taking Wyost.

Children and adolescents
Wyost is not recommended for children and adolescents under the age of 18 years except for adolescents with giant cell bone tumor whose bones have stopped growing. The use of denosumab in children and adolescents with other cancers that have invaded 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 to tell 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 or are planning to become pregnant, or if you 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 contraceptive measures 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 of 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 are planning to breastfeed. Your doctor will then help you decide whether to stop breastfeeding or to stop taking Wyost, considering the benefit of breastfeeding for the baby and the benefit of taking 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 this medicine.

Driving and using machines
Wyost does not affect, or has a negligible effect on, the ability to drive and operate machines.

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 responsibility of a healthcare professional.
The recommended dose of Wyost is 120 mg administered once every 4 weeks, as a single
injection under the skin (subcutaneous). Wyost will be injected into the thigh, abdomen, or upper
arm. If you are being treated for giant cell bone tumor, you will receive an additional dose
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 an excess of calcium in your blood. Your doctor will discuss this with you.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist, or
nurse.
the QR code reported 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.

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

• spasms, contractions, muscle cramps, numbness or tingling in the fingers of the hands and feet or around the mouth and/or convulsions, confusion or loss of consciousness. These signs may indicate low levels of calcium in the blood. Low levels of calcium in the blood can also lead to a change in heart rhythm called prolonged QT interval, which is seen on an electrocardiogram (ECG).

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

• persistent pain in the mouth and/or jaw/mandible, and/or swelling or failure to heal sores in the mouth or, in the jaw/mandible, presence of secretions, numbness or feeling of heaviness in the jaw/mandible, or loosening of a tooth as these signs may indicate severe degeneration of the jaw bone tissue (osteonecrosis).

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

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

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

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

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

• high levels of calcium in the blood (hypercalcaemia) after stopping treatment in patients with giant cell bone tumor,
• new or unusual pain in the hip, groin or thigh (this could be an early sign of a possible fracture of the thigh bone),
• rash that may occur on the skin or sores in the mouth (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; rash, itching or hives on the skin). In rare cases, allergic reactions can be severe.

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

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

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 the package 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 left out of the refrigerator in such a way as 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 in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Wyost contains

• The active ingredient 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 (injectable).
Wyost is a solution 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 on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Sandoz nv/sa
Tél/Tel: +32 2 722 97 97

Lietuva
Sandoz Pharmaceuticals d.d filialas
Tel: +370 5 2636 037

България
Сандоз България КЧТ
Тел.: +359 2 970 47 47

Luxembourg/Luxemburg
Sandoz nv/sa
Tél/Tel.: +32 2 722 97 97

Česká republika
Sandoz s.r.o.
Tel: +420 225 775 111

Magyarország
Sandoz Hungária Kft.
Tel.: +36 1 430 2890

Danmark/Norge/Ísland/Sverige
Sandoz A/S
Tlf: +45 63 95 10 00

Malta
Sandoz Pharmaceuticals d.d.
Tel: +35699644126

Deutschland
Hexal AG
Tel: +49 8024 908 0

Nederland
Sandoz B.V.
Tel: +31 36 52 41 600

Eesti
Sandoz d.d. Eesti filiaal
Tel: +372 665 2400

Österreich
Sandoz GmbH
Tel: +43 5338 2000

Ελλάδα
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε.
Τηλ: +30 216 600 5000

Polska
Sandoz Polska Sp. z o.o.
Tel.: +48 22 209 70 00

España
Sandoz Farmacéutica, S.A.
Tel: +34 900 456 856

Portugal
Sandoz Farmacêutica Lda.
Tel: +351 21 000 86 00

France
Sandoz SAS
Tél: +33 1 49 64 48 00

România
Sandoz Pharmaceuticals SRL
Tel: +40 21 407 51 60

Hrvatska
Sandoz d.o.o.
Tel: +385 1 23 53 111

Slovenija
Sandoz farmacevtska družba d.d.

Tel: +386 1 580 29 02
Ireland
Rowex Ltd.
Tel: + 353 27 50077

Slovenská republika
Sandoz d.d. - organizačná zložka
Tel: +421 2 48 200 60050 70 6111

Italia
Sandoz S.p.A.
Tel: +39 02 96541

Suomi/Finland
Sandoz A/S
Puh/Tel: +358 10 6133 400

Κύπρος
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε.
Sandoz Pharmaceuticals d.d.
Τηλ: +30 216 600 5000
Τηλ: +357 22 69 0690

United Kingdom (Northern Ireland)
Sandoz GmbH
Tel: +43 5338 2000

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 .
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The following information is intended exclusively for healthcare professionals:

• Before administration, the Wyost solution must be visually inspected. 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 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.

Unused medicinal product and waste materials derived from such medicinal product must be disposed of in
accordance with current local regulations.