YAXWER 120 mg Injectable Solution

Зміст інструкції

1. Yaxwer 120 mg injectable solution
   1. What is Yaxwer and what is it used for
   2. What you need to know before you use Yaxwer
   3. How to use Yaxwer
   4. Possible side effects
   5. How to store Yaxwer
   6. Package Contents and Other Information

Yaxwer 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 encountered during the use of this medicine. 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 or pharmacist.
• 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 could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. 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 Yaxwer.

Contents of this leaflet

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

1. What is Yaxwer and what is it used for

Yaxwer 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.
Yaxwer 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).
Yaxwer 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 Yaxwer

Do not use Yaxwer

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

Warnings and precautions
Talk to your doctor before using Yaxwer.
Calcium and vitamin D supplement
You must take calcium and vitamin D supplements while you are being treated with Yaxwer, 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 Yaxwer.
Low blood calcium levels
Tell your doctor immediately if you experience spasms, twitching or cramps of the muscles, and/or numbness or tingling in the fingers of your hands and feet or around the
mouth and/or convulsions, confusion or loss of consciousness while being treated with Yaxwer. 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 failure 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/mandible
An undesirable effect called osteonecrosis of the jaw/mandible (severe degeneration of the
bone tissue of the jaw/mandible) has been reported commonly (may occur in up to
1 in 10) in patients who received denosumab injections for conditions related to
cancer. Osteonecrosis of the jaw/mandible can also occur after stopping the
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. In order to reduce the risk of developing
osteonecrosis of the jaw/mandible you must take some precautions:

• Before receiving treatment, tell your doctor/nurse (healthcare professional) if you have any problems with your mouth or teeth. 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 examination before starting treatment with Yaxwer.
• 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 Yaxwer.
• 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/mandible.

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/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 the hip, groin, or thigh.
High blood calcium levels after stopping treatment with Yaxwer
Some patients with giant cell bone tumor have developed high blood calcium levels
weeks-months after stopping treatment. Your doctor will monitor you for signs and
symptoms of high calcium levels after you have stopped taking Yaxwer.

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

Other medicines and Yaxwer
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 Yaxwer together with other medicines containing denosumab or bisphosphonates.

Pregnancy and breastfeeding
If you are pregnant, or suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding, ask your doctor for advice before taking this medicine.
Yaxwer has not been studied in pregnant women. It is important that you tell your doctor if you are
pregnant, or suspect you may be pregnant, or are planning to become pregnant. The use of Yaxwer is not
recommended if you are pregnant. Women of childbearing potential must use effective methods of contraception
while taking Yaxwer and for at least 5 months after stopping treatment with
Yaxwer.
If you become pregnant during treatment with Yaxwer or less than 5 months after stopping the
treatment with Yaxwer, please inform your doctor.
It is not known whether Yaxwer 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 Yaxwer, considering the benefit of breastfeeding for the baby and the benefit of taking Yaxwer for the mother.
If you are breastfeeding during treatment with Yaxwer, please inform your doctor.

Driving and using machines
Yaxwer has no or negligible influence on the ability to drive and operate machines.

Yaxwer contains sorbitol, polysorbate 20 and sodium
This medicine contains 78 mg of sorbitol per dose (1.7 mL).
This medicine contains 0.17 mg of polysorbate 20 per dose (1.7 mL). Polysorbates can cause
allergic reactions. Tell your doctor if you or your child have any known allergies.
This medicine contains less than 1 mmol of sodium (23 mg) per dose (1.7 mL), that is to say, essentially
‘sodium-free’.

3. How to use Yaxwer

Yaxwer must be administered under the responsibility of a healthcare professional.
The recommended dose of Yaxwer is 120 mg administered once every 4 weeks, as a single
injection under the skin (subcutaneous). Yaxwer 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 Yaxwer, 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.

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 Yaxwer (they can 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 notice any of these symptoms during or after stopping treatment with Yaxwer (they can occur in up to 1 in 10 people):

• persistent pain in the mouth and/or jaw/lower jaw, and/or swelling or failure to heal of sores in the mouth or, in the jaw/lower jaw, presence of secretions, numbness or feeling of heaviness in the jaw/lower jaw, or loosening of a tooth as these signs may indicate a serious degeneration of the jaw/lower 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 (hypophosphatemia),
• 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 (hypercalcemia) 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, pharmacist or nurse. 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 Yaxwer

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 after Exp. and on the
pack 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 order to reach room temperature (up to 25°C) before injection. This will make the injection more comfortable.
Once removed from the refrigerator, Yaxwer can be stored at room temperature (up to 25 °C)
for a maximum of 30 days in the original packaging and in the outer packaging to protect the
medicine from light. It must be used within this 30-day period.
Do not dispose of any medicine in 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 Yaxwer 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, sodium hydroxide, sorbitol (E420), polysorbate 20 (E432) and water for injections.

Description of the appearance of Yaxwer and contents of the pack
Yaxwer is an injectable solution (injectable).
Yaxwer is a clear, colourless to slightly yellow solution, free from visible particles.
1.7 mL solution in a transparent glass injection vial (Ph. Eur. type I glass)
sealed with a bromobutyl rubber stopper coated with a fluorinated coating and a
flip-off plastic cap with an aluminium seal.
Each pack contains one, three or four single-use vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Hungary

Manufacturers
Chemical Works of Gedeon Richter Plc.
(Gedeon Richter Plc.)
Richter Gedeon utca 20.
4031 Debrecen
Hungary
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Hungary

Other sources of information
Detailed information on this product is also available by scanning with a smartphone
the QR code included below or on the outer packaging. The same information is also available
at the following address: www.yaxwerinfo.com
QR code to be included
More detailed information on this medicine is available on the website of the European
Medicines Agency, https://www.ema.europa.eu/.

The following information is intended for healthcare professionals only:

• Before administration, the Yaxwer solution must be visually inspected. Do not inject the solution if it contains visible particles, is cloudy or shows 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.

Any unused medicine or waste material should be disposed of in accordance with
current local regulations.