Bomyntra 120 mg solution for injection in pre-filled syringe
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Bomyntra 120 mg solution for injection in pre-filled syringe
denosumab
This medicinal product is subject to additional monitoring, which will allow for faster identification of new safety information. You can help by reporting any adverse reactions you may experience. Section 4 at the end of this leaflet includes information on how to report adverse reactions.
Read this entire 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 adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions 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 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 tumor of bone.
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 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 Bomyntra
Do not use Bomyntra
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if you are allergic to denosumab or any of the other ingredients 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 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 calcium levels in blood
Contact your doctor immediately if you experience muscle spasms, twitches or cramps and/or numbness or tingling in the fingers, toes or around the 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 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 starting 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 receiving treatment, 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 problems with your mouth or teeth, such as loose teeth, pain or swelling, or non-healing or draining sores, as these could be signs of osteonecrosis of the jaw.
Patients receiving chemotherapy and/or radiotherapy, taking steroids or anti-angiogenic medicines (used to treat cancer), who have undergone 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 Bomyntra. Contact your doctor if you experience new or unusual pain in your hip, groin or thigh.
High levels of calcium in blood after stopping Bomyntra
Some patients with giant cell tumor of bone have developed high levels of calcium in blood weeks or months after stopping treatment. Your doctor will monitor for 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 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 to inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Bomyntra is not recommended during pregnancy. 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 to inform your doctor if you are breastfeeding or plan to breastfeed. Your doctor will help you decide whether to stop 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 negligible or none.
Bomyntra contains sorbitol
This medicine contains 78 mg of sorbitol in each pre-filled syringe.
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 polisorbate 20
This medicine contains 0.17 mg of polisorbate 20 in each pre-filled syringe, equivalent to 0.1 mg/ml. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.
3. How to use Bomyntra
For instructions on how to inject Bomyntra, please read the last section of this leaflet.
The recommended dose of Bomyntra is 120 mg administered once every 4 weeks as a single subcutaneous (under the skin) injection. You may administer the injection using the Bomyntra pre-filled syringe into the thigh or abdomen (except within 5 cm of the navel). The first self-injection with the Bomyntra pre-filled syringe should be supervised by a healthcare professional. If someone else administers the injection for you, Bomyntra may be injected into the thigh, abdomen, or outer upper arm. You or your caregiver must receive training in injection techniques from a healthcare professional. 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 Bomyntra 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 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 called 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 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, 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),
- tooth 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 tumour of bone,
- new or unusual pain in the hip, groin or thigh (this may be an early sign of a possible femur bone fracture),
- 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). In rare cases, allergic reactions could be severe.
Frequency not known (cannot be estimated from available data):
- consult your doctor if you have ear pain, ear discharge and/or an ear infection. These could be symptoms of damage to the ear bones.
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 detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage instructions for 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 "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 pre-filled syringe in the outer packaging to protect it from light.
Before injection, the pre-filled syringe may be removed from the refrigerator and allowed to reach room temperature (up to 25 °C) to make the injection more comfortable. Once the pre-filled syringe has reached room temperature (up to 25 °C), 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 any unused medicines and packaging. This helps protect the environment.
6. Contents of the pack and other information
Composition of Bomyntra
- The active substance is denosumab. Each pre-filled syringe 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.
Appearance of the product and contents of the pack
Bomyntra is an injectable solution.
Bomyntra is a transparent, colourless to slightly yellowish solution, free from visible particles.
Each pack contains one, three, or four single-use pre-filled syringes.
Only certain pack sizes may be marketed.
Marketing Authorization 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 review of this leaflet
Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/
- Instructions for use
Guide to the components:
Read this important information before using the pre-filled syringe of Bomyntra with automatic needle shield:
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It is important that you do not attempt to administer the injection yourself unless you have been trained by your doctor or healthcare professional.
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Bomyntra is administered as an injection into the tissue just beneath the skin (subcutaneous injection).
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Do not remove the grey needle cap from the pre-filled syringe until you are ready for the injection.
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Do not use the pre-filled syringe if the outer packaging is damaged or the seal is broken.
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Do not use the pre-filled syringe if it has been dropped onto a hard surface. Use a new pre-filled syringe and contact your doctor or healthcare professional.
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Do not attempt to press the plunger rod of the pre-filled syringe before the injection.
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Do not shake the pre-filled syringe.
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Important: Keep the pre-filled syringe out of the sight and reach of children.
Storage of the pre-filled syringe Bomyntra
- Store Bomyntra in the refrigerator at 2°C to 8°C in the original packaging. Do not freeze.
- Before injection, allow Bomyntra to reach room temperature up to 25°C while remaining in the original packaging. This may take between 15 and 30 minutes. Do not heat Bomyntra by any other method.
- Once Bomyntra has been removed from the refrigerator, it must be used within 30 days. If not used within 30 days, Bomyntra must be discarded.
- Do not use Bomyntra after the expiry date stated on the label.
- Protect Bomyntra from light and direct heat.
If you have any doubts, contact your doctor or healthcare professional.
Step 1: Prepare the materials
- Gather the materials
On a clean, well-lit work surface, collect the materials needed for your injection (see Figure A):
- Alcohol wipes
- Cotton wool or gauze
- An adhesive bandage
- Sharps disposal container (see Step 4: Dispose of your pre-filled syringe)
1.2 Wait 15 to 30 minutes until the pre-filled syringe reaches room temperature
Remove the pack from the refrigerator (see Figure B) and place it on a flat surface.
Leave the pack at room temperature for 15 to 30 minutes (see Figure C).
Do not attempt to heat the pre-filled syringe using a heat source such as hot water or a microwave.
Do not leave the pre-filled syringe exposed to direct sunlight.
Do not shake the pre-filled syringe.
Keep the pre-filled syringe out of the sight and reach of children.
- Wash your hands
Wash your hands with soap and water and dry them with a clean towel (see Figure D).
- Remove the pre-filled syringe from the tray
Place two fingers, one on each side, in the center of the transparent needle shield. Pull the pre-filled syringe upward and out of the tray (see Figure E).
Do not hold it by the plunger.
Do not hold it by the needle cap.
- Examine the pre-filled syringe and the medicine
Inspect the pre-filled syringe to ensure:
- The name on the label is Bomyntra (see Figure F).
- The expiry date on the label has not passed.
- The pre-filled syringe is not cracked or broken.
Check the liquid for particles or discoloration (see Figure G).
Do not use the pre-filled syringe if:
- The name on the label is not Bomyntra.
- The expiry date on the label has passed.
- Any component is cracked or broken.
- The needle cap is missing or loose.
- The medicine is cloudy or contains particles. It should be a clear, colourless to slightly yellowish solution.
In all these cases, use a new pre-filled syringe and contact your doctor or healthcare professional.
Step 2: Prepare for injection
2.1. Choose an injection site
You may inject the medicine into (see Figure H):
- the upper thighs
- the abdomen, except within a 5 cm radius around the navel
- the outer side of the upper arm (only if someone else administers the injection)
Do not inject into areas where the skin is tender, bruised, red, or hardened.
Avoid injecting into areas with scars or stretch marks.
2.2. Clean the injection site
Clean the injection site with an alcohol-impregnated swab (see Figure I).
Allow the skin to air dry.
Do not blow on or touch the injection site after cleaning.
2.3. Remove the needle cap
Carefully pull the needle cap straight off and away from your body (see Figure J). Some force may be required to remove the needle cap.
Do not remove the needle cap from the pre-filled syringe until you are ready for the injection.
Do not hold the pre-filled syringe by the plunger rod.
Do not twist or bend the needle cap.
Dispose of the needle cap in your sharps disposal container (see Step 4: Dispose of your pre-filled syringe).
Do not re-cap the pre-filled syringe.
Do not touch the needle or allow it to touch any surface after removing the needle cap.
Step 3: Inject the medicine
3.1. Pinch the skin
Pinch the injection site to create a firm surface (see Figure K).
Note: It is important to keep the skin pinched during injection.
3.2. Insert the needle
Quickly insert the needle directly into the pinched skin at an angle of 45 to 90 degrees (see Figure L).
Do not inject into muscle or blood vessels.
3.3. Inject
Push the plunger slowly and steadily (see Figure M) until it can no longer be pushed and all the liquid has been injected under the skin (subcutaneously) (see Figure N). You may hear or feel a "click".
Do not lift the pre-filled syringe from the skin.
3.4. Stop pressing the plunger
Slowly stop pressing the plunger and allow the needle to be withdrawn from the skin at the same angle as insertion. The transparent needle shield will safely cover the needle (see Figure O).
Do not recap used pre-filled syringes.
3.5. Treat the injection site
If there is blood or fluid at the injection site, gently press the area with cotton wool or gauze (see Figure P).
Apply an adhesive bandage if needed.
Do not rub the injection site.
Step 4: Dispose of your pre-filled syringe
4.1. Disposal
Immediately after use, dispose of your used pre-filled syringe and the needle cap in a sharps disposal container (see Figure Q).
Medicines must be disposed of in accordance with local regulations. Ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.
Do not reuse the pre-filled syringe.
Do not throw (dispose of) used syringes into your household waste.
Do not reuse your sharps disposal container.
Keep Bomyntra pre-filled syringes, the sharps disposal container, and all medicines out of the sight and reach of children.