Junod 60 mg solution for injection in pre-filled syringe
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Junod 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. Information on how to report side effects is provided at the end of section 4.
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 or pharmacist.
- 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. 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 treatment with Junod.
Contents of this leaflet
- What Junod is and what it is used for
- What you need to know before using Junod
- How to use Junod
- Possible side effects
- How to store Junod
- Contents of the pack and other information
1. What Junod is and what it is used for
What Junod is and how it works
Junod contains denosumab, a protein (monoclonal antibody) that interferes with the action of another protein in order to treat bone loss and osteoporosis. Treatment with Junod strengthens bones and reduces the risk of fractures.
Bone is living tissue that is constantly being renewed. Oestrogens help maintain bone health.
In women, 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 therapy.
Many patients with osteoporosis do not have symptoms, yet they still have an increased 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 Junod is used for
Junod 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) due to surgery or drug 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 Junod
Do not use Junod
- if you have low levels of calcium in your blood (hypocalcemia).
- if you are allergic to denosumab or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Junod.
During treatment with denosumab, you may develop a skin infection with symptoms such as a swollen, red area on the skin, most commonly on the lower leg, which feels warm and tender to the touch (cellulitis), and which may be accompanied by fever. Inform your doctor immediately if you experience any of these symptoms.
In addition, you must take calcium and vitamin D supplements during treatment with Junod. Your doctor will discuss this with you.
Your blood calcium level may decrease during treatment with denosumab. Inform your doctor immediately 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.
Rarely, cases of very low blood calcium levels have been reported, requiring hospitalization and, in some cases, potentially life-threatening reactions. Therefore, before each dose is administered, and in patients at risk of hypocalcemia, your blood calcium levels will be checked (via a blood test) within two weeks after the initial dose.
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 your risk of low blood calcium levels if you do not take calcium supplements.
Problems in the mouth, teeth, or jaw
In patients receiving denosumab 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 can 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 receiving 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 extractions.
- 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 Junod.
While being treated, 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 Junod.
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 denosumab. Consult your doctor if you experience new or unusual pain in your hip, groin, or thigh.
Children and adolescents
Junod should not be used in individuals under 18 years of age.
Other medicines and Junod
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 should not use Junod together with another medicine containing denosumab.
Inform your doctor if you are taking medicines called glucocorticoids (such as prednisolone or dexamethasone); see also the section “Warnings and precautions”.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Denosumab has not been studied in pregnant women. Use of Junod during pregnancy is not recommended. Women of childbearing potential should use effective contraception during treatment with Junod and for at least 5 months after stopping treatment with Junod.
If you become pregnant during treatment with Junod or within 5 months after stopping treatment with Junod, 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 to stop using Junod, taking into account the benefits of breastfeeding for the child and the benefits of Junod for you.
Driving and using machines
The influence of Junod on the ability to drive and use machines is negligible or none.
Junod contains sorbitol, polysorbate 20, and sodium
This medicine contains 46 mg of sorbitol in each ml of solution.
This medicine contains 0.1 mg of polysorbate 20 in each ml of solution. Polysorbates may cause allergic reactions. Inform your doctor if you or your child have any known allergies.
This medicine contains less than 1 mmol of sodium (23 mg) per ml; essentially “sodium-free”.
3. How to use Junod
Follow exactly the administration instructions for this medicine as indicated by your physician. If in doubt, consult your doctor or pharmacist again.
The recommended dose is one 60 mg prefilled syringe administered under the skin (subcutaneous route) as a single injection every 6 months.
The best sites for the injection are the upper thighs and the abdomen. If a caregiver (attending person) administers the injection, it may also be given into the outer area of the upper arm.
Consult your physician for the date of your next possible injection.
Each Junod package contains a reminder card that can be detached from the carton and used to keep a record of the date of your next injection.
In addition, you must take calcium and vitamin D supplements during treatment with Junod. Your doctor will discuss this with you.
Your doctor may decide whether it is better for you or a caregiver to administer the Junod injection. Your doctor or healthcare professional will show you or your caregiver how to use Junod. If you would like instructions on how to inject Junod, please read the last section of this leaflet.
Do not shake.
If you forget to use Junod
If you miss a dose of Junod, the injection should be administered as soon as possible. Afterwards, injections should be scheduled every 6 months starting from the date of the last injection.
If you stop using Junod
To obtain the maximum benefit from your treatment and reduce the risk of fractures, it is important that you use Junod for the entire period prescribed by your doctor. Do not interrupt treatment without first speaking to your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Patients treated with denosumab may rarely develop skin infections (mainly cellulitis) (may affect up to 1 in 100 people). Contact your doctor immediately if any of the following symptoms occur during treatment with Junod: a swollen and red area of skin, usually on the lower leg, which is warm and tender to the touch, and which may be accompanied by fever.
Rarely (may affect up to 1 in 1,000 people), patients receiving denosumab may develop pain in the mouth and/or jaw, swelling or non-healing ulcers in the mouth or jaw, discharge, numbness or 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 Junod or after stopping treatment.
Rarely (may affect up to 1 in 1,000 people), patients receiving denosumab may develop low levels of calcium in the blood (hypocalcaemia); very low calcium levels may require hospitalization and could even be life-threatening. 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 an electrocardiogram (ECG).
Rarely (may affect up to 1 in 1,000 people), unusual femoral fractures may occur in patients receiving denosumab. 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 (may affect up to 1 in 1,000 people), allergic reactions may occur in patients receiving denosumab. 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 Junod.
Very common adverse effects (may affect more than 1 in 10 people):
- bone, joint, and/or muscle pain, sometimes severe,
- pain in legs or arms (limb pain).
Common adverse effects (may affect up to 1 in 10 people):
- painful urination, frequent urination, blood in 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).
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 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 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 Junod
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 the carton, following "EXP". The expiry date refers to the last day of the month indicated.
Do not use this medicine if you notice particles in the solution, or if it is cloudy or discoloured.
Store in a refrigerator (between 2 °C and 8 °C). Do not freeze.
Keep the pre-filled syringe in its outer packaging to protect it from light.
After removal from the refrigerator, Junod may be stored at room temperature (up to 25 °C) for a maximum of 30 days in the original container and outer packaging to protect it from light. 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 medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Junod
- The active substance is denosumab. Each mL of pre-filled syringe contains 60 mg of denosumab.
- The other components are glacial acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 20 (E432), and water for injections.
Appearance of the product and contents of the container
Junod is a clear, colourless to slightly yellowish injectable solution supplied in a ready-to-use pre-filled syringe.
One mL of Junod is presented in a single glass pre-filled syringe (Type I glass) with a FluroTec® plunger stopper, fitted with a needle (27 G × 12.7 mm), and a rigid needle shield (rigid elastomer + polypropylene housing).
The pack contains one pre-filled syringe with a safety needle shield.
Marketing Authorisation Holder
Gedeon Richter Plc.
Gyömroi út 19-21.
1103 Budapest Hungary
Manufacturer
Gedeon Richter Plc.
Gyömroi út 19-21.
1103 Budapest Hungary
Chemical Works of Gedeon Richter Plc.
(Gedeon Richter Plc.)
Richter Gedeon utca 20. Debrecen
4031
Hungary
Date of the most recent revision of this leaflet:
Other sources of information
Detailed information on this product is also available by scanning the QR code included below or on the outer packaging with your mobile phone. The same information is also available at the following URL: www.junodinfo.com
QR code must be included
Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu , and on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.
INSTRUCTIONS FOR USE
Guide to parts
Important
Before using the pre-filled syringe Junod with automatic needle safety shield, read all of this important information thoroughly to the end. Follow the instructions carefully when using the syringe.
- It is important that you do not attempt to self-administer the injection unless you have been trained by your doctor or healthcare professional.
- Junod is administered as an injection that passes through the skin tissue (subcutaneous injection).
- Do not remove the grey needle cap from the pre-filled syringe until you are ready to inject.
- Do not use the pre-filled syringe if it has fallen onto a hard surface. Use a new pre-filled syringe and contact your doctor or healthcare professional.
- Do not attempt to activate the pre-filled syringe before injection.
- Do not attempt to remove the safety shield from the pre-filled syringe.
Contact your doctor or healthcare professional if you have any questions.
Step 1: Preparation
- Open the pack containing the pre-filled syringe and gather the materials needed for your injection: alcohol wipes, cotton ball or gauze, a plaster, and a sharps disposal container (not included).
For a more comfortable injection, allow the pre-filled syringe to reach room temperature for approximately 15–30 minutes before injecting. Wash your hands thoroughly with soap and water.
On a clean, well-lit work surface, place the new pre-filled syringe and other materials.
- Do not attempt to heat the pre-filled syringe using a heat source such as hot water or 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.
- Grasp the safety shield of the syringe to remove it from the pack.
For safety reasons:
- Do not grasp the plunger.
- Do not grasp the grey needle cap.
- Examine the medicine and the pre-filled syringe.
Do not use the pre-filled syringe if:
- The solution is cloudy or contains particles. It should be a clear, colourless to slightly yellowish solution.
- Any part appears cracked or broken.
- The grey needle cap is missing or not properly attached.
- The expiry date printed on the label has passed the last day of the month indicated.
In all cases, consult your doctor or healthcare professional.
Step 2: Prepare
- Wash your hands carefully. Prepare and clean the injection site.
You may use:
- Upper thigh.
- Abdomen, except for an area within 5 cm around the navel.
- Outer area of the upper arm (only if someone else administers the injection).
Clean the injection site with an alcohol wipe. Allow the skin to dry.
- Do not touch the injection site before injecting.
- Do not inject into areas where the skin is tender, bruised, red, or hardened.
Avoid injecting into areas with scars or stretch marks.
- Carefully pull the grey needle cap straight off and away from your body.
- Pinch the injection site to create a firm surface.
It is important to keep the skin pinched during injection.
Step 3: Inject
- Hold the skin pinch. INSERT the needle at an angle of 45 to 90 degrees into the skin.
- Do not touch the cleaned area of the skin.
- Push the plunger with slow, steady pressure until you feel or hear a “click”. Push down completely until you hear the “click”.
Note: It is important to push down until you hear the “click” to ensure the full dose is delivered.
- Release your thumb. Then withdraw the syringe from the skin.
After releasing the plunger, the safety shield on the pre-filled syringe will automatically and securely cover the injection needle.
Do not re-cap the used pre-filled syringe with the grey needle cap.
Step 4: Finish
- Dispose of the used pre-filled syringe and other materials in a sharps disposal container.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.
Keep the syringe and the sharps disposal container out of the sight and reach of children.
- Do not reuse the pre-filled syringe.
- Do not recycle pre-filled syringes or throw them in the household trash.
- Examine the injection site.
If there is bleeding, press a cotton ball or gauze pad against the injection site. Do not rub the injection site. Apply a plaster if necessary.