Xbryk 120 mg solution for injection
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Xbryk 120mg solution for injection
denosumab
?This medicinal product is subject to additional monitoring, which will allow quicker identification of new safety information. You can help by reporting any side effects you may experience. Section 4 at the end includes information on 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, as 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, and you should not give it to other people even if they have the same symptoms as you, because it may harm them.
- If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.
- Your doctor will provide you with a patient alert card containing important safety information that you should know before and during treatment with Xbryk.
Contents of the leaflet
- What Xbryk is and what it is used for
- What you need to know before using Xbryk
- How to use Xbryk
- Possible side effects
- How to store Xbryk
- Contents of the pack and other information
1. What Xbryk is and what it is used for
Xbryk contains denosumab, a protein (monoclonal antibody) that slows down bone destruction occurring when cancer spreads to the bones (bone metastases) or in giant cell bone tumor.
Xbryk 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 therapy or surgery).
Xbryk is also used for the treatment of 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 using Xbryk
Do not use Xbryk
- if you are allergic to denosumab or to any of the other components of this medicine (listed in section 6).
Your healthcare professional will not administer Xbryk if you have untreated low blood calcium levels.
Your healthcare professional will not administer Xbryk if you have unhealed wounds from dental or oral surgery.
Warnings and precautions
Talk to your doctor before starting to use Xbryk.
Calcium and vitamin D supplements
You must take calcium and vitamin D supplements during treatment with Xbryk unless your blood calcium levels are high. Your doctor will explain this to you. If your blood calcium level is low, your doctor may decide to prescribe calcium supplements before starting treatment with Xbryk.
Low blood calcium levels
Contact your doctor immediately if you experience muscle spasms, twitching, or cramps and/or numbness or tingling in your fingers, toes, or around your mouth and/or seizures, confusion, or loss of consciousness during treatment with Xbryk. Your blood calcium level may be low.
Kidney failure
Inform your doctor if you have or have had severe kidney problems, kidney failure, or if you have required dialysis, as this may increase the risk of low blood calcium levels, especially if you are not taking calcium supplements.
Problems with mouth, teeth, and jaw
A side effect called osteonecrosis of the jaw (damage to the jawbone) has been frequently reported (may affect up to 1 in 10 people) in patients receiving injectable Xbryk for cancer-related conditions. Osteonecrosis of the jaw may also occur after stopping treatment.
It is important to try to prevent the development of osteonecrosis of the jaw, as it may be a painful condition that can be difficult to treat. To reduce the risk of developing osteonecrosis of the jaw, you should take the following precautions:
- Before receiving treatment, inform 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 unhealed wounds in your mouth due to dental procedures or oral surgery. Your doctor will recommend a dental examination before starting treatment with Xbryk.
- While being treated, you should maintain good oral hygiene and have regular dental check-ups. If you wear dentures, make sure they fit properly.
- If you are undergoing dental treatment or are scheduled for dental surgery (e.g., tooth extractions), inform your doctor about your dental treatment and inform your dentist that you are being treated with Xbryk.
- Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth, such as loose teeth, pain or swelling, non-healing or draining sores, as these could be signs of osteonecrosis of the jaw.
Patients undergoing chemotherapy and/or radiotherapy, taking steroids or anti-angiogenic medicines (used to treat cancer), who have had dental surgery, who do not have regular dental check-ups, who have gum disease, or who smoke 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 denosumab. Contact your doctor if you experience new or unusual pain in your hip, groin, or thigh.
High blood calcium levels after stopping Xbryk treatment
Some patients with giant cell tumor of bone have developed high blood calcium levels weeks or months after stopping treatment. Your doctor will monitor for signs and symptoms of high calcium levels after stopping treatment with Xbryk.
Children and adolescents
Xbryk 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 denosumab has not been studied in children and adolescents with other types of cancer that have spread to the bones.
Other medicines and Xbryk
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to 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 containing denosumab
- a bisphosphonate
You should not take Xbryk together with other medicines containing denosumab or bisphosphonates.
Pregnancy and breastfeeding
Denosumab has not been studied in pregnant women. It is important that you inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Xbryk is not recommended during pregnancy. Women of childbearing potential should use effective contraception during treatment with Xbryk and for at least 5 months after stopping treatment with Xbryk.
If you become pregnant during treatment with Xbryk or within 5 months after stopping treatment with Xbryk, inform your doctor.
It is unknown whether denosumab is excreted in human breast milk. It is important that you inform your doctor if you are breastfeeding or plan to breastfeed. Your doctor will help you decide whether to discontinue breastfeeding or discontinue treatment, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.
If you are breastfeeding during treatment with Xbryk, please inform your doctor.
Talk to your doctor or pharmacist before using any other medicine.
Driving and using machines
The influence of Xbryk on the ability to drive and use machines is none or negligible.
Xbryk contains sorbitol (E420)
This medicine contains 74.8 mg of sorbitol (E420) in each vial.
Xbryk contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 120 mg; hence, it is essentially “sodium-free”.
3. How to use Xbryk
Xbryk must be administered under the supervision of a healthcare professional.
The recommended dose of Xbryk is 120 mg given once every 4 weeks as a single subcutaneous injection (under the skin). Xbryk will be injected into the thigh, abdomen, or upper arm. If you are being treated for giant cell tumor of bone, you will receive additional doses 1 and 2 weeks after the first dose.
Do not shake.
You should also take calcium and vitamin D supplements during treatment with Xbryk unless you have excess calcium in your blood. Your doctor will explain this to you.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Tell your doctor immediately if you develop any of the following symptoms during treatment with Xbryk (may affect more than 1 in 10 people):
- muscle spasms, twitching, cramps, numbness or tingling in the fingers, toes or around the mouth, and/or seizures, confusion or loss of consciousness. These symptoms may be signs that your blood calcium levels are low. Low blood calcium levels may also cause a change in heart rhythm known as QT prolongation, which is detected by an electrocardiogram (ECG).
Tell your doctor and dentist immediately if you develop any of the following symptoms during treatment with Xbryk or after stopping treatment (may affect up to 1 in 10 people):
- persistent pain in the mouth and/or jaw, swelling and/or non-healing ulcers in the mouth or jaw, pus discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth, which may be signs of bone damage in the jaw (osteonecrosis).
Very common adverse effects (may affect more than 1 in 10 people):
- bone, joint and/or muscle pain, which may sometimes be severe,
- breathing difficulties,
- diarrhoea.
Common adverse effects (may affect up to 1 in 10 people):
- low blood phosphate levels (hypophosphataemia),
- dental extraction,
- excessive sweating,
- in patients with advanced cancer: development of another type of cancer.
Uncommon adverse effects (may affect up to 1 in 100 people):
- high blood calcium levels (hypercalcaemia) after stopping treatment in patients with giant cell bone tumour,
- new or unusual pain in the hip, groin or thigh (this may be an early sign of a possible fracture of the thigh bone),
- skin rash or mouth ulcers (drug-induced lichenoid eruptions).
Rare adverse effects (may affect up to 1 in 1,000 people):
- allergic reactions (for example: wheezing or breathing difficulties; swelling of the face, lips, tongue, throat or other body parts; skin rash, itching or hives). In rare cases, allergic reactions could be severe.
Frequency not known (cannot be estimated from the available data):
- consult your doctor if you have ear pain, ear discharge, and/or ear infection. These could be symptoms of damage to the bones of the ear.
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system listed in Appendix V.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Xbryk
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label after CAD/EXP. The expiry date refers to the last day of the month indicated.
Store in a refrigerator (between 2 °C and 8 °C).
Do not freeze.
Keep the vial in its carton to protect it from light.
Before injection, the vial may be removed from the refrigerator and allowed to reach room temperature (up to 25 °C) to make the injection less uncomfortable.
Once the vial has reached room temperature (up to 25 °C), it may be stored at room temperature for a single period of up to 60 days, without exceeding the original expiry date. If not used within this 60-day period, Xbryk may be returned to the refrigerator and stored for up to 28 days for future use. Do not use the vial after the expiry date printed on the label.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Xbryk
- 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 components are histidine, monohydrate histidine hydrochloride, sorbitol (E 420), polysorbate 20, water for injections.
Appearance of the product and contents of the pack
Xbryk is an injectable solution (injectable).
Xbryk is a clear, colourless to slightly yellowish solution, which may contain residual amounts of translucent to white particles.
Each pack contains one or three single-use vials.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Samsung Bioepis NL B.V.
Olof Palmestraat 10
2616 LR Delft
The Netherlands
Date of the most recent review of this leaflet:
Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.
This information is intended for healthcare professionals only:
- Xbryk solution should be inspected visually before administration. The solution may contain residual amounts of translucent to white protein particles. Do not inject the solution if it is cloudy or discoloured.
- Do not shake.
- To minimise discomfort at the injection site, allow the vial to reach room temperature (up to 25 °C) before injection, and administer the injection slowly.
- The entire contents of the vial must be injected.
- A 27 G gauge needle is recommended for the administration of denosumab.
- Do not reinsert the needle into the vial.
Disposal of unused medicine and of all materials that have come into contact with it must be carried out in accordance with local regulations.