Yaxwer contains denosumab, a protein (monoclonal antibody) that works by slowing down bone destruction caused by the spread of cancer to the bones (bone metastases) or giant cell tumor of bone.

Yaxwer is used in adults with advanced cancer to prevent serious complications caused by bone metastases (for example fractures, pressure on the spine or the need for radiotherapy or surgery).

Yaxwer is also used to treat giant cell tumor of the bone, which cannot be treated with surgery or for which surgery is not the best option, in adults and adolescents who have stopped growing.

Do not use Yaxwer:
- if you are allergic to denosumab or any of the other ingredients of this medicine (listed in section 6).
drug.

Before using Yaxwer, talk to your doctor.

Pregnancy and breastfeeding:
Yaxwer has not been studied in pregnant women. It is important to tell your doctor if you are pregnant, think you may be pregnant or are planning to become pregnant. Yaxwer is not recommended if you are pregnant. Women of childbearing potential must use effective contraception during treatment with Yaxwer and for at least 5 months after stopping Yaxwer.

If you become pregnant during treatment with Yaxwer or for at least 5 months after stopping treatment with Yaxwer, please tell your doctor.

It is not known whether Yaxwer is excreted in human milk. It is important to tell your doctor if you are breast-feeding.
your doctor if you are breast-feeding or intend to breast-feed. Your doctor will then help you decide whether you should stop breast-feeding or take Yaxwer, taking into account the benefit of breast-feeding for the child and the benefit of Yaxwer for the mother.

If you are breast-feeding during treatment with Yaxwer, please tell your doctor.

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

Yaxwer must be administered by a healthcare professional.

The recommended dose of Yaxwer is 120 mg given as a single injection under the skin (subcutaneously), once every 4 weeks. Yaxwer will be injected into the thigh, abdomen or upper arm. If you are being treated for giant cell tumor of bone you will receive an additional dose in the first and second weeks after the first dose.

Don't be agitated.

You should also take calcium and vitamin D supplements while taking Yaxwer unless you have too much calcium in your blood. Your doctor will discuss this with you.

If you have any further questions on this medicine, ask your doctor.
you, your pharmacist or nurse.

- The active substance is denosumab. Each vial contains 120 mg denosumab in 1.7 ml solution (corresponding to 70 mg/ml).
- The other ingredients are glacial acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 20 (E432) and water for injections.

Warning:
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

1 bottle