Bomyntra 120 mg solution for injection in vial
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Bomyntra 120 mg solution for injection in vial
denosumab
This medicinal product is subject to additional monitoring, which will allow rapid identification of new safety information. You can help by reporting any side effects you may experience. The end of section 4 includes information on how to report side effects.
Read 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 must not be given to other people, even if they have the same symptoms as you, because it could 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 reminder card containing important safety information you should know before and during your treatment with Bomyntra.
Contents of this leaflet
- What Bomyntra is and what it is used for
- What you need to know before using Bomyntra
- How to use Bomyntra
- Possible side effects
- How to store Bomyntra
- Contents of the pack and other information
1. What Bomyntra is and what it is used for
Bomyntra 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.
Bomyntra 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).
Bomyntra is also used for the treatment of giant cell bone tumor 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 Bomyntra
Do not use Bomyntra
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if you are allergic to denosumab or to any of the other components of this medicine (listed in section 6).
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if you have untreated low levels of calcium in your blood.
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if you have unhealed wounds resulting from dental or oral surgery.
Warnings and precautions
Talk to your doctor before starting treatment with Bomyntra.
Calcium and vitamin D supplements
You must take calcium and vitamin D supplements during treatment with Bomyntra 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 Bomyntra.
Low blood calcium levels
Contact your doctor immediately if you experience muscle spasms, twitches 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 Bomyntra. Your blood calcium level may be low.
Kidney problems
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 jaw bone) has been reported in patients receiving injectable Bomyntra for cancer-related conditions. Osteonecrosis of the jaw can 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 Bomyntra.
- 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 Bomyntra.
- Contact your doctor and dentist immediately if you experience any mouth or dental problems, such as loose teeth, pain or swelling, non-healing or oozing sores, as these could be signs of osteonecrosis of the jaw.
Patients receiving chemotherapy and/or radiotherapy, taking steroids or anti-angiogenic drugs (used to treat cancer), undergoing dental surgery, not having regular dental check-ups, having 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 Bomyntra. Contact your doctor if you experience new or unusual pain in your hip, groin or thigh.
High levels of calcium in the blood after stopping Bomyntra treatment
Some patients with giant cell tumor of the bone have developed high levels of calcium in the blood weeks or months after stopping treatment. Your doctor will monitor signs and symptoms of high calcium levels after stopping treatment with Bomyntra.
Children and adolescents
Bomyntra is not recommended for children and adolescents under 18 years of age, except for adolescents with giant cell tumor of the bone whose bones have stopped growing. The use of Bomyntra has not been studied in children and adolescents with other types of cancer that have spread to the bones.
Other medicines and Bomyntra
Inform your doctor or pharmacist if you are taking, have recently taken or might need to take any other medicines, including those 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 Bomyntra together with other medicines containing denosumab or bisphosphonates.
Pregnancy and breastfeeding
Bomyntra 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. The use of Bomyntra during pregnancy is not recommended. Women of childbearing potential must use effective contraception during treatment with Bomyntra and for at least 5 months after stopping treatment with Bomyntra.
If you become pregnant during treatment with Bomyntra or within 5 months after stopping treatment with Bomyntra, please inform your doctor.
It is unknown whether Bomyntra 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 to stop taking Bomyntra, taking into account the benefits of breastfeeding for the child and the benefits of Bomyntra for the mother.
If you are breastfeeding during treatment with Bomyntra, please inform your doctor. Consult your doctor or pharmacist before taking any other medicine.
Driving and using machines
The influence of Bomyntra on the ability to drive and use machines is none or negligible.
Bomyntra contains sorbitol
This medicine contains 78 mg of sorbitol per vial.
Bomyntra contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 120 mg dose; this is essentially “sodium-free”.
Bomyntra contains polysorbate 20
This medicine contains 0.17 mg of polysorbate 20 per vial, equivalent to 0.10 mg/ml. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.
3. How to use Bomyntra
Bomyntra must be administered under the supervision of a healthcare professional.
The recommended dose of Bomyntra is 120 mg given once every 4 weeks as a single subcutaneous (under the skin) injection. Bomyntra will be injected into the thigh, abdomen, or upper arm. If you are being treated for giant cell bone tumor, 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 Bomyntra unless you have high levels of calcium in your blood. Your doctor will explain this to you.
If you have any further questions about how to use 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 experience any of the following symptoms during treatment with Bomyntra:
- muscle spasms, tics, cramps, numbness or tingling in the fingers and 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 can be detected by an electrocardiogram (ECG).
Tell your doctor and dentist immediately if you experience any of the following symptoms during treatment with Bomyntra or after stopping treatment:
- 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. These 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 (hypophosphatemia),
- 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 (hypercalcemia) after stopping treatment in patients with giant cell bone tumour,
- new or unusual pain in the hip, groin, or thigh (which 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 (e.g. wheezing or breathing difficulties; swelling of the face, lips, tongue, throat, or other body parts; skin rash, itching, or hives). Allergic reactions may rarely be severe.
Frequency not known (cannot be estimated from available data):
- consult your doctor if you have ear pain, discharge from the ear, and/or an 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 can 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 Bomyntra
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". 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 the outer packaging 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 must be used within 30 days.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Bomyntra
- 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 acetic acid, sodium acetate trihydrate, sorbitol (E420), polysorbate 20 (E432), and water for injections.
Nature of the product and pack contents
Bomyntra is an injectable solution.
Bomyntra is a clear, colourless to slightly yellowish solution, free from visible particles.
Each pack contains one, three, or four single-use vials.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder
Fresenius Kabi Deutschland GmbH
Else-Kroener-Strasse 1
61352 Bad Homburg von der Hoehe
Germany
Manufacturer
Fresenius Kabi Austria GmbH
Hafnerstrasse 36
8055 Graz
Austria
Date of the most recent revision of this leaflet
Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.
This information is intended for healthcare professionals only:
- The Bomyntra solution should be inspected visually before administration. The solution must not contain visible particles. Do not inject the solution if it is cloudy or discoloured.
- Do not shake.
- To minimize 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.
Any unused medicine and materials that have come into contact with it should be disposed of in accordance with local regulations.