Conexxence 60 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
Conexxence 60 mg solution for injection in pre-filled syringe
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 these side effects.
Please read this entire leaflet carefully before you start using this medicine, as 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, since it may harm them.
- If you experience any side effects, talk to your doctor or pharmacist, 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 Conexxence.
Contents of this leaflet
- What Conexxence is and what it is used for
- What you need to know before using Conexxence
- How to use Conexxence
- Possible side effects
- How to store Conexxence
- Contents of the pack and other information
1. What Conexxence is and what it is used for
What Conexxence is and how it works
Conexxence contains denosumab, a protein (monoclonal antibody) that interferes with the action of another protein in order to treat bone loss and osteoporosis. Treatment with Conexxence strengthens bones and reduces the likelihood of fractures.
Bone is a living tissue that is continuously renewed. Oestrogens contribute to maintaining bone health. After menopause, oestrogen levels decrease, which may cause bones to become thinner and more fragile. Over time, this can lead to a condition called osteoporosis. Osteoporosis can also occur in men due to various causes, including age and/or low levels of the male hormone testosterone. It may also occur in patients receiving glucocorticoid treatment. Many patients with osteoporosis do not have symptoms, yet they remain at risk of bone fractures, particularly in the spine, hip, and wrists.
Surgical procedures or medications that suppress the production of oestrogen or testosterone, used to treat patients with prostate or breast cancer, can also cause bone loss. As a result, bones become weaker and more prone to breaking.
What Conexxence is used for
Conexxence is used to treat:
- postmenopausal osteoporosis in women and osteoporosis in men who have an increased risk of fracture (bone breakage), by reducing the risk of hip, vertebral, and non-vertebral fractures.
- bone loss caused by reduced hormone levels (testosterone) resulting from surgery or medical treatment in patients with prostate cancer.
- bone loss resulting from long-term glucocorticoid therapy in patients who have a high risk of fracture.
2. What you need to know before using Conexxence
Do not use Conexxence:
- if you have low levels of calcium in your blood (hypocalcemia).
- if you are allergic to denosumab or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before starting treatment with Conexxence.
While being treated with Conexxence, you may develop a skin infection with symptoms such as a swollen and red area of skin, most commonly on the lower leg, which feels warm and tender to the touch (cellulitis), and which may be accompanied by fever. Immediately inform your doctor if you experience any of these symptoms.
In addition, you must take calcium and vitamin D supplements during treatment with Conexxence. Your doctor will discuss this with you.
While receiving Conexxence, you may develop low levels of calcium in the blood. Immediately inform your doctor if you notice any of the following symptoms: muscle spasms, twitching or cramps, and/or numbness or tingling in the fingers, toes or around the mouth, and/or seizures, confusion or loss of consciousness.
Inform your doctor if you have or have had severe kidney problems, renal failure, if you have required dialysis, or if you are taking medicines called glucocorticoids (such as prednisolone or dexamethasone), as these may increase the risk of low calcium levels in the blood if you do not take calcium supplements.
Problems in the mouth, teeth or jaw
In patients receiving Conexxence for osteoporosis, a rare adverse effect called osteonecrosis of the jaw (ONJ) (damage to the jawbone) has been reported (may affect up to 1 in 1,000 people). The risk of ONJ increases in patients treated for a long time (may affect up to 1 in 200 people if treated for 10 years). ONJ may also occur after stopping treatment. It is important to try to prevent ONJ from developing, as it can be a painful condition that may be difficult to treat. To reduce the risk of developing ONJ, follow these precautions:
Before starting treatment, inform your doctor or nurse (healthcare professional) if:
- you have any problems with your mouth or teeth, such as poor dental health, gum disease, or planned dental extraction.
- you do not receive regular dental check-ups or have not had a dental examination for a long time.
- you are a smoker (as this may increase the risk of dental problems).
- you have previously been treated with a bisphosphonate (used to prevent or treat bone disorders).
- you are taking medicines called corticosteroids (such as prednisolone or dexamethasone).
- you have cancer.
Your doctor may ask you to have a dental examination before starting treatment with Conexxence.
During treatment, you should maintain good oral hygiene and have routine 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 Conexxence.
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 oozing sores, as these could be symptoms of ONJ.
Unusual femur fractures
Some people have developed unusual fractures in the femur while being treated with Conexxence. Consult your doctor if you experience new or unusual pain in the hip, groin, or thigh.
Children and adolescents
Conexxence should not be used in individuals under 18 years of age.
Other medicines and Conexxence
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. It is especially important that you inform your doctor if you are being treated with another medicine containing denosumab.
You must not use Conexxence together with another medicine containing denosumab.
Pregnancy and breastfeeding
Conexxence 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. Conexxence is not recommended during pregnancy. Women of childbearing potential should use effective contraception during treatment with Conexxence and for at least 5 months after stopping treatment with Conexxence.
If you become pregnant during treatment with Conexxence or within 5 months after stopping treatment with Conexxence, inform your doctor.
It is unknown whether Conexxence 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 discontinue using Conexxence, taking into account the benefits of breastfeeding for the child and the benefits of Conexxence for the mother.
If you are breastfeeding during treatment with Conexxence, please inform your doctor.
Talk to your doctor or pharmacist before using any medicine.
Driving and using machines
The influence of Conexxence on the ability to drive and use machines is negligible or none.
Conexxence contains sorbitol
This medicine contains 47 mg of sorbitol per ml of solution.
Conexxence contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 60 mg dose; hence, it is essentially “sodium-free”.
Conexxence contains polysorbate 20
This medicine contains 0.1 mg of polysorbate 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 Conexxence
The recommended dose is one pre-filled syringe of 60 mg administered under the skin (subcutaneous route) as a single injection every 6 months. The best sites for the injection are the upper thigh and the abdomen. If the injection is given by a caregiver (a person providing care), the injection may also be administered into the outer side of the upper arm. Please consult your doctor about the date of your next possible injection.
In addition, you must take calcium and vitamin D supplements during treatment with Conexxence. Your doctor will discuss this with you.
Your doctor may decide whether it is best for you or your caregiver to administer the Conexxence injection. Your doctor or healthcare professional will show you or your caregiver how to use Conexxence. If you would like instructions on how to inject Conexxence, please read the last section of this leaflet.
Do not shake.
If you forget to use Conexxence
If you miss a dose of Conexxence, the injection should be given as soon as possible. After that, injections should be scheduled every 6 months starting from the date of the last injection.
If you stop using Conexxence
To get the maximum benefit from your treatment and to reduce the risk of fractures, it is important to use Conexxence for the entire period prescribed by your doctor. Do not stop treatment without speaking to your doctor first.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Patients treated with Conexxence may occasionally develop skin infections (mainly cellulitis). Contact your doctor immediately if any of the following symptoms occur during treatment with Conexxence: swollen and red area of skin, usually on the lower leg, which feels warm and tender to the touch and may be accompanied by fever.
Rarely, patients receiving Conexxence may develop pain in the mouth and/or jaw, swelling or non-healing ulcers in the mouth or jaw, pus discharge, numbness or a feeling of heaviness in the jaw, or loose teeth. These could be symptoms of bone damage in the jaw (osteonecrosis). Contact your doctor and dentist immediately if you experience such symptoms while being treated with Conexxence or after stopping treatment.
Rarely, patients receiving Conexxence may develop low levels of calcium in the blood (hypocalcemia). Symptoms include muscle spasms, contractions, or cramps, and/or numbness or tingling in the fingers, toes, or around the mouth, and/or seizures, confusion, or loss of consciousness. If you experience any of these, contact your doctor immediately. Low calcium levels in the blood may also cause a change in heart rhythm known as QT prolongation, which can be detected by performing an electrocardiogram (ECG).
Rarely, unusual femur fractures may occur in patients receiving Conexxence. Consult your doctor if you experience new or unusual pain in the hip, groin, or thigh, as this may be an early sign of a possible femur fracture.
Rarely, allergic reactions may occur in patients receiving Conexxence. Symptoms include swelling of the face, lips, tongue, throat, or other parts of the body; skin rash, itching, or hives; wheezing or difficulty breathing. Contact your doctor if you experience such symptoms while being treated with Conexxence.
Very common adverse effects (may affect more than 1 in 10 people):
- bone, joint, and/or muscle pain, which may sometimes be severe,
- pain in the legs or arms (limb pain).
Common adverse effects (may affect up to 1 in 10 people):
- painful urination, frequent urination, blood in the urine, urinary incontinence,
- upper respiratory tract infection,
- pain, tingling, or numbness radiating down the lower leg (sciatica),
- constipation,
- abdominal discomfort,
- skin rash,
- skin condition with itching, redness, and/or dryness (eczema),
- hair loss (alopecia).
Uncommon adverse effects (may affect up to 1 in 100 people):
- fever, vomiting, and abdominal pain or discomfort (diverticulitis),
- ear infection,
- skin rash or mouth ulcers (drug-induced lichenoid eruptions).
Very rare adverse effects (may affect up to 1 in 10,000 people):
- allergic reaction that may damage blood vessels, mainly in the skin
(e.g. purple or reddish-brown spots, hives, or skin ulcers) (hypersensitivity vasculitis).
Frequency not known (cannot be estimated from available data):
- consult your doctor if you have ear pain, ear discharge, and/or 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 or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Conexxence
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton 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 container in the outer packaging to protect it from light.
Prior to 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 less uncomfortable. Once the 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 their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Conexxence
- The active substance is denosumab. Each 1 ml pre-filled syringe contains 60 mg of denosumab (60 mg/ml).
- The other components are acetic acid, sodium acetate trihydrate, sorbitol (E420), polysorbate 20 (E432) and water for injections.
Appearance of Conexxence and contents of the pack
Conexxence is a clear, colourless to slightly yellowish injectable solution available in a ready-to-use pre-filled syringe.
Each pack contains one pre-filled syringe with a needle protector.
Marketing Authorization Holder
Fresenius Kabi Deutschland GmbH
Else-Kroener-Strasse 1,
61352 Bad Homburg von der Hoehe,
Germany
Manufacturer responsible
Fresenius Kabi Austria GmbH
Hafnerstrasse 36
8055 Graz
Austria
For more information about this medicine, please contact the local representative of the Marketing Authorization Holder:
Belgium/Belgium/Belgium Fresenius Kabi nv/sa Tel/Tel: +32 3 880 73 00 | Lithuania UAB Fresenius Kabi Baltics Tel: +370 5 252 3213 |
| Luxembourg/Luxembourg Fresenius Kabi nv/sa Tel/Tel: +32 3 880 73 00 |
Czech Republic Fresenius Kabi s.r.o. Tel: +420 225 270 111 | Hungary Fresenius Kabi Hungary Kft. Tel: +36 1 250 8371 |
Denmark Fresenius Kabi branch of Fresenius Kabi AB Sweden Tlf.: +45 33181600 | Malta Fresenius Kabi Deutschland GmbH Tel: +49 0800 788 7070 |
Germany Fresenius Kabi Deutschland GmbH Tel: +49 0800 788 7070 | Netherlands Fresenius Kabi Nederland bv Tel: +32 3 880 73 00 |
Estonia Fresenius Kabi Deutschland GmbH Tel: +49 0800 788 7070 | Norway Fresenius Kabi Norge AS Tlf: +47 22 58 80 00 |
Greece FRESENIUS KABI HELLAS MONOPROSOPI EPE Tel: +30 210 6542909 | Austria Fresenius Kabi Deutschland GmbH Tel: +49 0800 788 7070 |
Spain Laboratorios Rubió, S.A. Tel: +34 93 772 25 09 | Poland Fresenius Kabi Polska Sp. z o.o. Tel: +48 22 345 67 89 |
France Fresenius Kabi France Tél: +33 1 41 14 26 00 | Portugal Fresenius Kabi Pharma Portugal, Lda, Tel: +351 21 424 1280 |
Croatia Fresenius Kabi d.o.o. Tel: +385 1 2333 242 | Romania FRESENIUS KABI ROMANIA SRL Tel: +40 (0)268 40 62 60 |
Ireland Fresenius Kabi Ireland Tel: +353 (0) 1841 3030 | Slovenia Fresenius Kabi Deutschland GmbH Tel: +49 0800 788 7070 |
Iceland Vistor Simi: +354 535 7000 | Slovakia Fresenius Kabi s.r.o., organizational unit Tel: +421 232 101 621 |
Italy Fresenius Kabi Italia S.r.l Tel: +39 0456649311 | Finland Fresenius Kabi AB - branch in Finland, branch in Finland Puh/Tel: +358 9 428 1550 |
Cyprus Innopro Healthcare Ltd Tel: +357 22483000 | Sweden Fresenius Kabi AB Tfn: +46 18 64 40 00 |
Latvia Fresenius Kabi Deutschland GmbH Tel: +49 0800 788 7070 |
Date of the most recent review of this leaflet
Other sources of information
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 Conexxence pre-filled syringe 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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Conexxence 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 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 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 Conexxence pre-filled syringe
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Store Conexxence in a refrigerator between 2°C and 8°C in the original packaging. Do not freeze.
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Before injection, allow Conexxence to reach room temperature up to 25°C while still in the original packaging. This may take between 15 and 30 minutes. Do not heat Conexxence in any other way.
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Once Conexxence has been removed from the refrigerator, it must be used within 30 days. If not used within 30 days, Bomyntra must be discarded.
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Do not use Conexxence after the expiry date stated on the label.
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Conexxence must be protected from direct light and heat.
If you have any doubts, contact your doctor or healthcare professional.
Step 1: Prepare materials
1.1 Gather materials
On a clean, well-lit work surface, collect the materials needed for your injection (see Figure A):
- alcohol wipes
- cotton wool or gauze
- adhesive plaster
- 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.
1.3 Wash your hands
Wash your hands with soap and water and dry them with a clean towel (see Figure D).
1.4 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 upwards and out of the tray (see Figure E).
Do not hold it by the plunger.
Do not hold it by the needle cap.
1.5 Examine the pre-filled syringe and the medicine
Inspect the pre-filled syringe to ensure:
- The name on the label is Conexxance (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 Conexxance.
- 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 yellow 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 at the following sites (see Figure H):
- the upper thighs
- the abdomen, except for an area 5 cm around the navel
- the outer side of the upper arm (only if someone else administers the injection)
Do not inject the medicine 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 dry naturally.
Do not blow on or touch the injection site after cleaning.
2.3 Remove the needle cap
Carefully pull the needle cap straight 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 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 reattach the needle cap to 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 cannot be pushed further 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 withdraw from the skin at the same angle as insertion. The transparent needle shield will safely cover the needle (see Figure O).
Do not replace the needle cap on used pre-filled syringes.
3.5 Treat the injection site
If there is blood or liquid at the injection site, gently press the area with cotton wool or gauze (see Figure P).
Apply an adhesive plaster if needed.
Do not rub the injection site.
Step 4: Dispose of your pre-filled syringe
4.1 Dispose
Immediately after use, dispose of your used pre-filled syringe and the needle cap in a sharps disposal container (see Figure Q).
Medicines should 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.