XGEVA 120 mg Инъекционный Раствор

Содержание инструкции

1. XGEVA 120 mg injectable solution
   1. What is XGEVA and what it is used for
   2. What you need to know before you use XGEVA
   3. How to use XGEVA
   4. Possible side effects
   5. How to store XGEVA
   6. Contents of the pack and other information

XGEVA 120 mg injectable solution

denosumab

Read this leaflet carefully before taking 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 for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 XGEVA.

Contents of this leaflet

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

1. What is XGEVA and what it is used for

XGEVA 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 tumor.
XGEVA 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).
XGEVA is also used in the treatment of giant cell bone tumor, 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 XGEVA

Do not use XGEVA

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

The healthcare professional will not give you XGEVA if you have a very low level of calcium in your blood that has not been treated.
The healthcare professional will not give you XGEVA if you have wounds that have not healed from dental or oral surgery.

Warnings and precautions
Talk to your doctor before using XGEVA.
Calcium and Vitamin D Supplementation
You must take calcium and vitamin D supplements while you are being treated with XGEVA, 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 XGEVA.
Low Blood Calcium Levels
Tell your doctor immediately if you experience spasms, twitching, or muscle cramps during treatment with XGEVA, and/or numbness or tingling in your fingers or toes or around your mouth and/or convulsions, confusion, or loss of consciousness. You may have low calcium levels in your blood.
Kidney Impairment
Tell your doctor if you suffer from or have ever suffered from severe kidney problems, kidney impairment, or if you have been undergoing 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 XGEVA 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 should 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 examination before starting treatment with XGEVA.
• During treatment, it is necessary to maintain good oral hygiene and undergo periodic dental check-ups. If you wear dentures, you must ensure that they fit properly.
• If you are undergoing dental treatment or plan to have dental surgery (e.g., tooth extractions), tell your doctor about the dental treatment and inform your dentist that you are being treated with XGEVA.
• 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-angiogenic medicines (used for cancer treatment), who are undergoing dental surgery, who are not receiving routine dental care, who suffer from gum problems, or who are smokers 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 XGEVA.
Contact your doctor if you experience new or unusual pain in your hip, groin, or thigh.
High Calcium Levels in the Blood After Stopping Treatment with XGEVA
Some patients with giant cell bone tumor have developed high calcium levels 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 XGEVA.

Children and adolescents
XGEVA 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 XGEVA in children and adolescents with other cancers that have invaded the bones has not been studied.

Other medicines and XGEVA
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 tell your doctor if you are taking

• another medicine containing denosumab
• a bisphosphonate

You must not take XGEVA together with other medicines containing denosumab or bisphosphonates.

Pregnancy and breastfeeding
XGEVA has not been studied in pregnant women. It is important that you tell your doctor if you are pregnant, suspect you might be pregnant, or are planning to become pregnant. The use of XGEVA is not recommended if you are pregnant. Women of childbearing potential must use effective contraceptive methods while taking XGEVA and for at least 5 months after stopping treatment with XGEVA.
If you become pregnant during treatment with XGEVA or less than 5 months after stopping treatment with XGEVA, please inform your doctor.
It is not known whether XGEVA is excreted in breast milk. It is important that you tell your doctor if you are breastfeeding or are planning to breastfeed. Your doctor will then help you decide whether to stop breastfeeding or taking XGEVA, considering the benefit of breastfeeding for the baby and the benefit of taking XGEVA for the mother.
If you are breastfeeding during treatment with XGEVA, please inform your doctor.
Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
XGEVA does not alter or alters negligibly the ability to drive vehicles or use machines.

XGEVA contains sorbitol
This medicine contains 78 mg of sorbitol per vial.

XGEVA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 120 mg dose, that is to say
essentially ‘sodium-free’.

3. How to use XGEVA

XGEVA must be administered under the responsibility of a healthcare professional.
The recommended dose of XGEVA is 120 mg administered once every 4 weeks, as a single
injection under the skin (subcutaneous). XGEVA 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 XGEVA, 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 questions about the use of this medicine, 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 experience any of the following symptoms during treatment with XGEVA (may affect more than 1 in 10 people):

• spasms, contractions, muscle cramps, numbness or tingling in the fingers and toes 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 the following symptoms during treatment with XGEVA or after
stopping treatment with XGEVA (may affect up to 1 in 10 people):

• persistent pain in the mouth and/or jaw/lower jaw, and/or swelling or sores in the mouth that do not heal, or, in the jaw/lower jaw, the presence of discharge, numbness or a feeling of heaviness in the jaw/lower jaw, or a loose tooth, as these signs may indicate severe degeneration of the jaw bone (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),
• diarrhoea.

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 may 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 XGEVA

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 the 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 the drain 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 XGEVA 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, sodium hydroxide, sorbitol (E420), polysorbate 20 and water for injections.

Description of the appearance of XGEVA and contents of the pack
XGEVA is an injectable solution (injectable).
XGEVA is a clear solution, from colourless to slightly yellow. It may contain traces of
particles from clear to white.
Each pack contains one, three or four single-use vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Amgen Europe B.V.
Minervum 7061,
4817 ZK Breda,
Netherlands

Marketing Authorisation Holder
Amgen Europe B.V.
Minervum 7061,
4817 ZK Breda,
Netherlands

Manufacturer
Amgen Technology (Ireland) Unlimited Company
Pottery Road
Dun Laoghaire
Dublin
Ireland

Manufacturer
Amgen NV
Telecomlaan 5-7
1831 Diegem
Belgium
For further information on this medicinal product, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
s.a. Amgen n.v.
Tel/Tél: +32 (0)2 7752711

Lietuva
Amgen Switzerland AG Vilniaus filialas
Tel: +370 5 219 7474

България
Амджен България ЕООД
Тел.: +359 (0)2 424 7440

Luxembourg/Luxemburg
s.a. Amgen
Belgique/Belgien
Tel/Tél: +32 (0)2 7752711

Česká republika
Amgen s.r.o.
Tel: +420 221 773 500

Magyarország
Amgen Kft.
Tel.: +36 1 35 44 700

Danmark
Amgen, filial af Amgen AB, Sverige
Tlf: +45 39617500

Malta
Amgen S.r.l.
Italy
Tel: +39 02 6241121

Deutschland
Amgen GmbH
Tel.: +49 89 1490960

Nederland
Amgen B.V.
Tel: +31 (0)76 5732500

Eesti
Amgen Switzerland AG Vilniaus filialas
Tel: +372 586 09553

Norge
Amgen AB
Tlf: +47 23308000

Ελλάδα
Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε.
Τηλ.: +30 210 3447000

Österreich
Amgen GmbH
Tel: +43 (0)1 50 217

España
Amgen S.A.
Tel: +34 93 600 18 60

Polska
Amgen Biotechnologia Sp. z o.o.
Tel.: +48 22 581 3000

France
Amgen S.A.S.
Tél: +33 (0)9 69 363 363

Portugal
Amgen Biofarmacêutica, Lda.
Tel: +351 21 4220606

Hrvatska
Amgen d.o.o.
Tel: +385 (0)1 562 57 20

România
Amgen România SRL
Tel: +4021 527 3000

Ireland
Amgen Ireland Limited
Tel: +353 1 8527400

Slovenija
AMGEN zdravila d.o.o.
Tel: +386 (0)1 585 1767

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Amgen Slovakia s.r.o.
Tel: +421 2 321 114 49

Italia
Amgen S.r.l.
Tel: +39 02 6241121

Suomi/Finland
Amgen AB, sivuliike Suomessa/Amgen AB, filial
i Finland
Puh/Tel: +358 (0)9 54900500

Kύπρος
C.A. Papaellinas Ltd
Τηλ.: +357 22741 741

Sverige
Amgen AB
Tel: +46 (0)8 6951100

Latvija
Amgen Switzerland AG Rīgas filiāle
Tel: +371 257 25888

United Kingdom (Northern Ireland)
Amgen Limited
Tel: +44 (0)1223 420305
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu/ .
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The following information is intended exclusively for healthcare professionals:

• Before administration, the XGEVA solution must be visually inspected. The solution may contain traces of proteinaceous particles from translucent to white. Do not inject the solution if it is cloudy or has a change in colour.
• 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 should be disposed of in
accordance with local regulations.