Jubbonti contains denosumab, a protein (monoclonal antibody) that interferes with the action of another protein, to treat bone loss and osteoporosis. Treatment with Jubbonti makes bones stronger, making them less likely to break.

Bone is a living tissue that is constantly renewing itself. Estrogen helps maintain bone health.
After menopause, estrogen levels drop, which can cause bones to become thin and brittle. This can eventually lead to a condition called osteoporosis. Osteoporosis can also occur in men due to a number of causes including aging and/or low levels of the male hormone, testosterone. It can also occur in patients who are being treated for
administer glucocorticoids. Many patients with osteoporosis have no symptoms, but they are still at risk of bone fractures, especially in the spine, hips, and wrists.

Surgery or medications that interrupt the production of estrogen or testosterone, which are used to treat patients with breast cancer or prostate cancer, can also lead to bone loss. Bones become more fragile and more likely to fracture.

What are Jubbons used for?
Jubbonti is used for the treatment of:
• osteoporosis in women after menopause (postmenopausal) and in men at increased risk of fracture (breaking bones), reducing the risk of vertebral fractures, other than vertebral and hip fractures.
• bone loss resulting from decreased hormone (testosterone) concentration caused by surgery or drug treatment in patients with prostate cancer.
• bone loss resulting from long-term glucocorticoid treatment in patients at high risk of fracture.

Do not use Jubbonti:
• if you have low levels of calcium in your blood (hypocalcemia).
• if you are allergic to denosumab or any of the other ingredients of this medicine.

Talk to your doctor or pharmacist before using Jubbonti.

Pregnancy and breastfeeding:
Denosumab has not been tested 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. Jubbonti is not recommended if you are pregnant. Women of childbearing potential must use effective contraception during treatment with Jubbonti and for at least 5 months after stopping Jubbonti.

If you become pregnant during treatment with Jubbonti or for at least 5 months after stopping treatment with Jubbonti, 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 plan to breast-feed.

Your doctor will help you decide whether you should stop breast-feeding or whether to stop taking Jubbonti, taking into account the benefit of breast-feeding for the child and the benefit of Jubbonti for the mother.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

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

Jubbonti contains sorbitol:
This medicine contains 47 mg sorbitol per each ml of solution.

Jubbonti contains sodium:
This medicine contains less than 1 mmol sodium (23 mg) per ml of solution, that is to say essentially “sodium-free”.

Always use this medicine exactly as your doctor has told you. Talk to your doctor or pharmacist if you are not sure.

The recommended dose is one 60 mg pre-filled syringe, given once every 6 months as an injection under the skin (subcutaneously). The best places to inject are the upper thighs and the abdomen. Your caregiver can also use the outer arm. Please consult your doctor about when you should have another injection. Each pack of Jubbonti contains a calendar card with a sticker that can be used to mark the date of your next injection.

You should also take calcium and vitamin D supplements while you are taking Jubbonti. Your doctor will discuss this with you.

Your doctor may decide that it is best for you or your caregiver to inject Jubbonti. Your doctor or healthcare professional will show you or your caregiver how to use Jubbonti.

For instructions on how to administer the Jubbonti injection, please read section 7, “Instructions for use,” at the end of this leaflet.

Don't be agitated.

- The active substance is denosumab. Each 1 ml solution in the pre-filled syringe with protective device contains 60 mg denosumab (60 mg/ml).
- The other ingredients are glacial acetic acid, sorbitol (E 420), polysorbate 20, sodium hydroxide, hydrochloric acid 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 pre-filled syringe