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

Talk to your doctor before using Jubereq.

Pregnancy and breastfeeding:
Jubereq 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. It is not recommended to use Jubereq if you are pregnant. Women of childbearing potential must use effective contraception during treatment with Jubereq and for at least 5 months after stopping Jubereq.
If you become pregnant during treatment with Jubereq or for at least 5 months after stopping treatment with Jubereq, please tell your doctor.
It is not known whether Jubereq 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 Jubereq, taking into account the benefit of breast-feeding for the child and the benefit of Jubereq for the mother.
If you are breast-feeding during treatment with Jubereq, please tell your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.

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

Jubereq contains sorbitol
This medicine contains 78.2 mg sorbitol per vial.

Jubereq contains polysorbate 20
This medicine contains 0.17 mg of polysorbate 20 in each 1.7 ml vial. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

Jubereq contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per 120 mg dose, that is to say essentially “sodium-free”.

Jubereq must be administered by a healthcare professional.
The recommended dose of Jubereq is 120 mg given as a single injection under the skin (subcutaneously), once every 4 weeks. Jubereq 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 Jubereq 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, 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 (see section 2, Jubereq contains sorbitol, Jubereq contains sodium and Jubereq contains polysorbate 20).

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