JUBEREQ 120 mg Инъекционный Раствор

Содержание инструкции

1. Jubereq 120 mg injectable solution
   1. What is Jubereq and what is it used for
   2. What you need to know before using Jubereq Do not use Jubereq
   3. How to use Jubereq
   4. Possible side effects
   5. How to store Jubereq
   6. Package contents and other information What Jubereq contains

Jubereq 120 mg injectable solution

denosumab
Medicinal product subject to additional monitoring. This will allow the rapid identification of new
safety information. You can contribute by reporting any adverse effects experienced
during the use of this medicinal product. See the end of section 4 for information on how
to report adverse effects.

Read this leaflet carefully before using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, 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 need to 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 you use 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 is Jubereq and what is it used for

Jubereq contains denosumab, a protein (monoclonal antibody) that works by decreasing the
destruction of bone caused by the spread of cancer to the bone (bone metastases) or for giant cell bone
tumour.
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 to receive radiotherapy or
surgery).
Jubereq is also used in the treatment of giant cell bone tumour, which 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 any of the other ingredients of this medicine (listed in section 6).

The healthcare professional will not administer Jubereq to you if you have a very low level of calcium
in your blood that has not been treated.
The healthcare professional will not administer Jubereq to you if you have unhealed wounds from dental
or oral surgery.

Warnings and precautions
Talk to your doctor before using Jubereq.
Calcium and vitamin D supplement
You must take calcium and vitamin D supplements while you are being treated with Jubereq, unless 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 blood calcium levels
Tell your doctor immediately if you experience spasms, twitching or
muscle cramps, and/or numbness or tingling in your fingers and toes or around the
mouth and/or seizures, confusion or loss of consciousness while being treated with Jubereq. You may
have low calcium levels in your
blood.
Kidney problems
Tell your doctor if you suffer from or have ever suffered from severe kidney problems, kidney failure or if
you have been undergoing dialysis as these conditions may increase the risk of having low levels of
calcium in your blood, especially if you are not taking calcium supplements.
Problems with the mouth, teeth or jaw/mandible
An undesirable effect called osteonecrosis of the jaw/mandible (severe degeneration of the
bone tissue of the jaw/mandible) has been reported commonly (may occur in up to
1 in 10 people) in patients who received Jubereq injections for conditions related to cancer.
Osteonecrosis of the jaw/mandible can also occur after stopping treatment.
It is important to try to prevent the development of osteonecrosis of the jaw/mandible as it is a
painful condition that can be difficult to treat. In order to reduce the risk of developing
osteonecrosis of the jaw/mandible you should take some precautions:

• Before receiving treatment, tell your doctor/nurse (healthcare professional) if you have any mouth or tooth problems. Your doctor should delay the start of treatment if you have unhealed wounds in your mouth following dental or oral surgery procedures. Your doctor may ask you to have a dental examination before starting treatment with Jubereq.
• During treatment, you must maintain good oral hygiene and undergo periodic dental check-ups. If you wear dentures, you must ensure that they fit properly.
• If you are undergoing dental treatment or plan to undergo dental surgery (e.g. tooth extractions), tell your doctor about the dental treatment and tell your dentist that you are being treated with Jubereq.
• Contact your doctor and dentist immediately if you notice the appearance of problems with your mouth or teeth, such as loosening of teeth, pain or swelling, or failure of mouth sores to heal or the presence of discharge, as these could be signs of osteonecrosis of the jaw/mandible.

Patients who are undergoing chemotherapy and/or radiotherapy, who are taking steroids or
anti-angiogenic medicines (used for cancer treatment), who are undergoing dental
surgery, who are not receiving routine dental care, who suffer from gum problems or who are
smokers may have a higher risk of developing osteonecrosis of the jaw/mandible.
Unusual fractures of the thigh bone (femur)
Some people have developed unusual fractures of the femur while being treated with Jubereq.
Contact your doctor if you experience new or unusual hip, groin or thigh pain.
High blood calcium levels after stopping treatment with Jubereq
Some patients with giant cell bone tumor have developed high blood calcium levels
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 the age of 18 years except for
adolescents with giant cell bone tumor 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 tell 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 tell your doctor if you are
pregnant, suspect you may be pregnant or are planning to become pregnant. The use of Jubereq is not
recommended if you are pregnant. Women of childbearing potential must use effective
contraceptive methods while taking 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 whether Jubereq is excreted in breast milk. It is important that you tell your doctor if you
are breastfeeding or are planning to breastfeed. Your doctor will then help you decide whether to
stop breastfeeding or taking Jubereq, considering the benefit of breastfeeding for the baby and the benefit 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 does not affect or has a negligible effect on the ability to drive and operate 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
can cause allergic reactions. If you have any known allergies, tell 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 responsibility of a healthcare professional.
The recommended dose of Jubereq is 120 mg administered once every 4 weeks, as a single
injection under the skin (subcutaneous). Jubereq will be injected into the thigh, abdomen, or upper
arm. If you are being treated for giant cell bone tumor, you will receive an additional dose
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 an excess of calcium in your blood. Your doctor will discuss this with you.
If you have any doubts about the use of this medicine, 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 experience any of these symptoms during treatment with Jubereq (they may affect more than 1 in 10 people):

• spasms, contractions, muscle cramps, numbness or tingling in the fingers and toes or around the mouth and/or convulsions, confusion or loss of consciousness. These signs may indicate low levels of calcium in the blood. Low levels of calcium in the blood can also lead to a change in heart rhythm called QT prolongation, which is seen on an electrocardiogram (ECG). -

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

• persistent pain in the mouth and/or jaw/maxilla, and/or swelling or failure of sores in the mouth or jaw/maxilla to heal, presence of discharge, numbness or feeling of heaviness in the jaw/maxilla, or loosening of a tooth as these signs may indicate severe degeneration of the jaw bone tissue (osteonecrosis). -

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

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

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

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

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

• high levels of calcium in the blood (hypercalcemia) after stopping treatment in patients with giant cell bone tumour, -
• new or unusual pain in the hip, groin or thigh (this could be an early sign of a possible fracture of the thigh bone), -
• rash that may occur on the skin or sores in the mouth (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; rash, itching or hives on the skin). In rare cases, allergic reactions can be severe. -

Not known(frequency cannot be estimated from available data):
tell 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 effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system listed 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
pack after Scad. 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 left out of the refrigerator in order 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 must be used within 30 days.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information What Jubereq contains

• The active ingredient is denosumab. Each vial contains 120 mg in 1.7 mL of solution (corresponding to 70 mg/mL).
• The other ingredients 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 Jubereq and package contents
Jubereq is an injectable solution (injectable).
Jubereq is a clear solution, from colourless to light yellow.
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 on this medicinal product, 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
for medicines, https://www.ema.europa.eu/.

The following information is intended exclusively for healthcare professionals:

• Before administration, the Jubereq solution must be visually inspected. The solution may contain trace amounts of proteinaceous particles from translucent to white. Do not inject the solution if it is cloudy or has a colour change.
• Do not shake.
• To avoid discomfort at the injection site, allow the vial to reach room temperature (up to 25°C) before injection and inject slowly.
• The entire contents of the vial must be injected.
• A 27 gauge steel needle is recommended for the administration of denosumab.
• The vial must not be reused.

Unused medicine or waste material from this medicine must be disposed of in accordance with
current local regulations.