Jubereq

Package leaflet: Information for the patient

Jubereq 120 mg solution for injection

denosumab
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• 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 may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
• Your doctor will give you a patient reminder card containing important safety information that you must know before and during treatment with Jubereq.

Contents of this leaflet

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

1. What Jubereq is and what it is used for

Jubereq contains denosumab, a protein (monoclonal antibody) that works by reducing bone destruction caused by the spread of tumour to the bone (bone metastases) or by giant cell tumour of bone.
Jubereq 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 for radiotherapy or surgery).
Jubereq is also used to treat giant cell tumour of bone that 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 using Jubereq Do not use Jubereq

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

The healthcare provider will not administer Jubereq to you if you have very low levels of calcium in the blood that have not been treated.
The healthcare provider will not administer Jubereq if you have unhealed wounds following dental or oral surgery.

Warnings and precautions
Talk to your doctor before using Jubereq.

Calcium and vitamin D supplementation
You must take calcium and vitamin D supplements while being treated with Jubereq, except if 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 Jubereq.

Low calcium levels in the blood
Tell your doctor immediately if, during treatment with Jubereq, you experience muscle spasms, twitching or cramps, and/or numbness or tingling in the fingers of your hands and feet or around the mouth, and/or seizures, confusion or loss of consciousness. You may have low levels of calcium in the blood.

Kidney problems
Inform your doctor if you currently have or have ever had severe kidney problems, kidney failure, or if you have undergone dialysis, as these conditions may increase the risk of low calcium levels in the blood, especially if you are not taking calcium supplements.

Problems with mouth, teeth or jaw
A side effect called osteonecrosis of the jaw/mandible (severe deterioration of the jaw/mandible bone tissue) has been commonly reported (may occur in up to 1 in 10 people) in patients receiving Jubereq injections for tumor-related conditions.
Osteonecrosis of the jaw/mandible may also occur after discontinuation of treatment.
It is important to try to prevent the development of osteonecrosis of the jaw/mandible, as it is a painful condition that may be difficult to treat. To reduce the risk of developing osteonecrosis of the jaw/mandible, you should take the following precautions:

• Before receiving treatment, inform your doctor/nurse (healthcare provider) if you have any mouth or dental problems. Your doctor should 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 undergo a dental examination before starting treatment with Jubereq.
• During treatment, it is necessary to maintain good oral hygiene and undergo regular dental check-ups. If you wear dentures, ensure they are properly fitted.
• If you are currently undergoing dental treatment or are scheduled to have dental surgery (e.g., tooth extractions), inform your doctor about the dental treatment and inform your dentist that you are being treated with Jubereq.
• Contact your doctor and dentist immediately if you notice any new mouth or dental problems, such as loose teeth, pain or swelling, or failure of mouth sores to heal, or presence of discharge, as these could be signs of osteonecrosis of the jaw/mandible.

Patients who are undergoing chemotherapy and/or radiotherapy, taking steroids or anti-angiogenic medicines (used to treat cancer), undergoing dental surgery, not receiving routine dental care, suffering from gum problems, or who smoke may have an increased risk of developing osteonecrosis of the jaw/mandible.

Unusual fractures of the thigh bone (femur)
Some people have developed unusual femur fractures during treatment with Jubereq.
Contact your doctor if you experience new or unusual pain in your hip, groin, or thigh.

High calcium levels in the blood after stopping Jubereq treatment
Some patients with giant cell tumor of bone have developed high calcium levels in the blood weeks to months after stopping treatment. Your doctor will monitor you for signs and symptoms of high calcium levels after you stop taking Jubereq.

Children and adolescents
Jubereq is not recommended for children and adolescents under 18 years of age, except for adolescents with giant cell tumor of bone whose bones have stopped growing. The use of Jubereq in children and adolescents with other tumors that have invaded the bones has not been studied.

Other medicines and Jubereq
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 that you inform your doctor if you are taking:

• another medicine containing denosumab
• a bisphosphonate

You must not take Jubereq together with other medicines containing denosumab or bisphosphonates.

Pregnancy and breastfeeding
Jubereq has not been studied in pregnant women. It is important that you inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy. The use of Jubereq is not recommended during pregnancy. Women of childbearing potential must use effective contraception while taking Jubereq and for at least 5 months after stopping treatment with Jubereq.
If you become pregnant during treatment with Jubereq or within 5 months after stopping treatment with Jubereq, please inform your doctor.
It is not known whether Jubereq is excreted in human milk. It is important that you inform your doctor if you are breastfeeding or planning to breastfeed. Your doctor will then help you decide whether to discontinue breastfeeding or discontinue Jubereq, taking into account the benefits of breastfeeding for the child and the benefits of taking Jubereq for the mother.
If you are breastfeeding during treatment with Jubereq, please inform your doctor.

Ask your doctor or pharmacist for advice before taking this 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 of 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. If you have any known allergy, inform your doctor.

Jubereq contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 120 mg dose, i.e., essentially ‘sodium-free’.

3. How to use Jubereq

Jubereq must be administered under the supervision of a healthcare professional.
The recommended dose of Jubereq is 120 mg given once every 4 weeks, as a single
subcutaneous injection. Jubereq will be injected into the thigh, abdomen, or upper arm. If you are being treated for giant cell bone tumour, you will receive additional doses 1 week and 2 weeks after the first dose.
Do not shake.
During treatment with Jubereq, you must also take calcium and vitamin D supplements unless you have high levels of calcium in your blood. Your doctor will discuss this with you.
If you have any questions about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if, during treatment with Jubereq, you notice any of the following symptoms (may affect more than 1 in 10 people):

• muscle spasms, contractions, cramps, numbness or tingling in the fingers of the hands and feet or around the mouth and/or seizures, confusion or loss of consciousness. These signs could indicate low levels of calcium in the blood. Low calcium levels in the blood may also lead to changes in heart rhythm known as QT prolongation, which is detected by electrocardiogram (ECG).

Contact your doctor and dentist immediately if, during treatment with Jubereq or after stopping treatment with Jubereq, you notice any of the following symptoms (may occur in up to 1 in 10 people):

• persistent pain in the mouth and/or jaw, and/or swelling or failure of sores in the mouth or jaw to heal, presence of discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth, as these signs could indicate a severe deterioration of the jawbone (osteonecrosis).

Very common side effects (may occur in more than 1 in 10 people):

• bone, joint and/or muscle pain, sometimes severe,
• shortness of breath (dyspnea),
• diarrhoea.

Common side effects (may occur in up to 1 in 10 people):

• low levels of phosphate in the blood (hypophosphatemia),
• tooth extraction,
• excessive sweating,
• in patients with advanced tumour: development of another type of tumour.

Uncommon side effects (may occur in up to 1 in 100 people):

• high levels of calcium in the blood (hypercalcemia) after stopping treatment in patients with giant cell tumour of the bone,
• new or unusual pain in the hip, groin or thigh (this could be an early sign of a possible fracture of the thigh bone),
• skin rash or sores in the mouth (drug-induced lichenoid eruptions).

Rare side effects (may occur in 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; skin rash, itching or hives). In rare cases, allergic reactions may be severe.

Not known (frequency cannot be estimated from the available data):
inform your doctor if you experience ear pain, ear discharge, and/or an ear infection. These could be signs of damage to the ear bone.

Reporting of side effects
If you get any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Jubereq

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
carton 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 removed from the refrigerator and allowed to reach room temperature (up to 25°C) before injection. This will make the injection more comfortable. Once the vial has reached room temperature (up to 25°C), it must not be returned to the refrigerator and should be used within 30 days.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information What Jubereq contains

• The active substance is denosumab. Each vial contains 120 mg in 1.7 mL of solution (equivalent to 70 mg/mL).
• The other components are glacial acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 20 and water for injections (see section 2, Jubereq contains sorbitol, Jubereq contains sodium and Jubereq contains polysorbate 20).

Description of the appearance of Jubereq and contents of the pack
Jubereq is an injectable solution (injectable).
Jubereq is a clear, colourless to slightly yellow solution.
Each pack contains one, three or four single-use vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n
Edifici Est, 6a Planta
08039 Barcelona
Spain

Manufacturer
Accord Healthcare Polska Sp. z.o.o.
Ul. Lutomierska 50, 95-200,
Pabianice, Poland

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
AT / BE / BG / CY / CZ / DE / DK / EE / ES / FI / FR / HR / HU / IE / IS / IT / LT / LV / LU / MT /
NL / NO / PL / PT / RO / SE / SI / SK
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64

EL
Win Medica Α.Ε.
Τηλ: +30 210 74 88 821

More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu/.

The following information is intended exclusively for healthcare professionals:

• Before administration, the Jubereq solution should be inspected visually. The solution may contain traces of translucent to white proteinaceous particles. Do not inject the solution if it is cloudy or shows discoloration.
• Do not shake.
• To minimize discomfort at the injection site, allow the vial to reach room temperature (up to 25°C) before injection and inject slowly.
• The entire content of the vial must be administered.
• A 27-gauge steel needle is recommended for denosumab administration.
• The vial must not be reused.

Any unused medicine and waste material arising from this medicine must be disposed of in accordance with
local applicable regulations.