Denbrayce 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.

Denbrayce 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).

Denbrayce is also used to treat giant cell tumour of bone that 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 Denbrayce:
- if you are allergic to denosumab or any of the other ingredients of this medicine (listed in section 6).
drug.

Talk to your doctor before using Denbrayce.

Pregnancy and breastfeeding:
Denbrayce has not been studied in pregnant women. If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine. Denosumab is not recommended for use if you are pregnant. Women of childbearing potential should use effective contraception during treatment with denosumab and for at least 5 months after stopping denosumab.

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

It is not known whether denosumab is excreted in human milk. It is important to tell 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 denosumab, taking into account the benefit of breast-feeding for the child and the benefit of denosumab for the mother.

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

Ask your doctor or pharmacist for advice before taking any medicine.

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

Denbrayce must be administered by a healthcare professional.
The recommended dose of Denbrayce is 120 mg given as a single injection under the skin (subcutaneously), once every 4 weeks. Denbrayce 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 denosumab 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 (E 420), polysorbate 20 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