JUBEREQ 120 mg INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the Patient

Jubereq120 mg solution for injection

denosumab

This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you how to report side effects.

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
• Your doctor will provide you with a patient reminder card, which contains important safety information that you need to know before and during treatment with Jubereq.

Contents of the pack

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

1. What is Jubereq and what is it used for

Jubereq contains denosumab, a protein (monoclonal antibody) that slows down bone destruction that occurs when cancer spreads to the bones (bone metastases) or due to giant cell tumor of bone.

Jubereq is used in adults with advanced cancer to prevent serious complications caused by bone metastases (e.g., fractures, spinal cord compression, or the need for radiation or surgery).

Jubereq is also used to treat giant cell tumor of bone that cannot be treated with surgery or when surgery is not the best option, in adults and adolescents whose bones have stopped growing.

2. What you need to know before you use Jubereq

Do not use Jubereq

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

Your healthcare professional will not give you Jubereq if you have very low levels of calcium in your blood that have not been treated.

Your healthcare professional will not give you Jubereq if you have open wounds in your mouth or jaw due to dental or oral surgery.

Warnings and precautions

Consult your doctor before startingJubereq.

Calcium and vitamin D supplements

You should take calcium and vitamin D supplements during treatment with Jubereq unless you have high levels of calcium in your blood. Your doctor will explain this to you. If your blood calcium levels are low, your doctor may decide to prescribe calcium supplements before starting treatment with Jubereq.

Low blood calcium levels

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

Kidney problems

Tell your doctor if you have or have had severe kidney problems, kidney failure, or if you have needed dialysis, as this may increase the risk of low blood calcium levels, especially if you do not take calcium supplements.

Mouth, tooth, and jaw problems

A common side effect (affecting up to 1 in 10 people) called osteonecrosis of the jaw (damage to the jawbone) has been reported in patients receiving Jubereq injection for cancer-related conditions. Osteonecrosis of the jaw can also occur after stopping treatment.

It is essential to try to prevent the development of osteonecrosis of the jaw, as it can be a painful condition that can be difficult to treat. To reduce the risk of developing osteonecrosis of the jaw, you should take some precautions:

• Before treatment, tell your doctor or nurse (healthcare professional) if you have any problems with your mouth or teeth. Your doctor should delay the start of your treatment if you have open wounds in your mouth due to dental or oral surgery. Your doctor will recommend a dental examination before starting treatment with Jubereq.
• While being treated, you should maintain good oral hygiene and receive regular dental check-ups. If you wear dental prostheses, you should ensure they fit properly.
• If you are undergoing dental treatment or will undergo dental surgery (e.g., tooth extractions), inform your doctor about your dental treatment and inform your dentist that you are being treated with Jubereq.
• Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth, such as loose teeth, pain, or swelling, ulcers that do not heal, or discharge, as these could be signs of osteonecrosis of the jaw.

Patients undergoing chemotherapy and/or radiation therapy, taking steroids or anti-angiogenic medications (used to treat cancer), undergoing dental surgery, not receiving regular dental check-ups, having gum disease, or being smokers may have a higher risk of developing osteonecrosis of the jaw.

Unusual fractures of the thigh bone

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

High blood calcium levels after stopping Jubereq treatment

Some patients with giant cell tumors of bone have developed high blood calcium levels weeks or months after stopping treatment. Your doctor will monitor you for signs and symptoms of high blood calcium levels after stopping Jubereq treatment.

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 has not been studied in children and adolescents with other types of cancer that have spread to the bones.

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. It is very important that you inform your doctor if you are being treated with

• another medicine that contains denosumab
• a bisphosphonate

You should not take Jubereq with other medicines that contain denosumab or bisphosphonates.

Pregnancy and breastfeeding

Jubereq has not been tested in pregnant women. It is essential that you inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Jubereq should not be used during pregnancy. Women of childbearing age should use effective contraceptive methods during treatment with Jubereq and for at least 5 months after stopping treatment with Jubereq.

If you become pregnant during treatment with Jubereq or less than 5 months after stopping treatment with Jubereq, please inform your doctor.

It is not known if Jubereq is excreted in breast milk. It is essential that you inform your doctor if you are breastfeeding or plan to breastfeed. Your doctor will help you decide whether to stop breastfeeding or stop taking Jubereq, considering the benefits of breastfeeding for the child and the benefits of Jubereq for the mother.

If you are breastfeeding during treatment with Jubereq, please inform your doctor.

Consult your doctor or pharmacist before taking any other 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 in each 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. Inform your doctor if you have known allergies.

Jubereq contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 120 mg; this is essentially "sodium-free".

3. How to use Jubereq

Jubereq should be administered under the supervision of a healthcare professional.

The recommended dose of Jubereq is 120 mg administered once every 4 weeks in a single injection under the skin (subcutaneously). 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 1 and 2 weeks after the first dose.

Do not shake.

You should also take calcium and vitamin D supplements during treatment with Jubereq unless you have high levels of calcium in your blood. Your doctor will explain this to you.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediatelyif you get any of these symptoms during treatment with Jubereq (may affect more than 1 in 10 people):

• muscle spasms, twitching, or cramps, and/or numbness or tingling in your fingers and toes or around your mouth, and/or seizures, confusion, or loss of consciousness. These symptoms may be a sign of low blood calcium levels. Low blood calcium levels can also cause a change in heart rhythm called QT prolongation, which is seen on an electrocardiogram (ECG).

Tell your doctor and dentist immediatelyif you get any of these symptoms during treatment with Jubereq or after stopping treatment (may affect up to 1 in 10 people):

• persistent pain in the mouth and/or jaw, swelling, and/or ulcers that do not heal in the mouth or jaw, discharge, numbness, or heaviness in the jaw or loosening of a tooth may be signs of bone damage in the jaw (osteonecrosis).

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

• bone, joint, and/or muscle pain that can be severe,
• breathing difficulties,
• diarrhea.

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

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

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

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

Rare side effects(may affect 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 can be severe.

Frequency not known(cannot be estimated from the available data):

• consult your doctor if you experience ear pain, discharge from the ear, and/or ear infection. These could be symptoms of damage to the bones of the ear.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 carton and on the label after "EXP". The expiry date refers to the last day of the month shown.

Store in a refrigerator (2°C - 8°C).

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

Before injection, the vial may be left at room temperature (up to 25°C) for a maximum of 30 days. Once the vial has reached room temperature (up to 25°C), it should not be put back in the refrigerator; it must be used within 30 days.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Jubereq contains

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

Appearance and packaging

Jubereq is a solution for injection (injectable).

Jubereq is a clear to slightly yellowish 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

You can request more information about this medicine from 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

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.

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This information is intended only for healthcare professionals:

• The Jubereq solution should be inspected visually before administration. The solution may contain residual amounts of protein particles that are translucent to white. Do not inject the solution if it is cloudy or has changed color.
• Do not shake.
• To avoid discomfort at the injection site, before injecting, let the vial reach room temperature (up to 25°C) and inject slowly.
• The entire contents of the vial should be injected.
• For the administration of denosumab, it is recommended to use a 27 G needle.
• Do not reinsert the needle into the vial.

Disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.