Junod
Italy
Table of Contents
Patient Information Leaflet
Junod 60 mg solution for injection in pre-filled syringe
denosumab
This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine because it contains important information for you.
- Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
- Your doctor will give you a patient reminder card containing important safety information that you must 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
- Package contents 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, for the treatment of bone loss and osteoporosis. Treatment with Junod makes bones stronger and less prone to fractures.
Bone is a living tissue that is constantly being renewed. Oestrogens help maintain healthy bones. After menopause, the reduction in oestrogen levels can make bones thin and fragile, which may lead to the development of a condition called osteoporosis. Osteoporosis can also occur in men due to various causes, including ageing and/or low levels of the male hormone testosterone. It can also occur in patients receiving glucocorticoids. Many patients with osteoporosis do not have symptoms, but are still at risk of bone fractures, especially in the spine, hip, and wrists.
Surgical procedures or medications that suppress the production of oestrogen or testosterone, used in the treatment of patients with breast or prostate cancer, can also cause bone loss. As a result, bones become more fragile and more likely to fracture.
For what type of treatment is Junod used
Junod is used for the treatment of:
- osteoporosis in postmenopausal women (postmenopausal osteoporosis) and in men who have an increased risk of fractures (broken bones), to reduce the risk of vertebral, non-vertebral, and hip fractures.
- bone loss in men caused by reduced hormone levels (testosterone) due to surgery or drug therapy in patients with prostate cancer.
- bone loss due to long-term treatment with glucocorticoids in patients at increased 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 using Junod.
While being treated with denosumab, you may develop a skin infection with symptoms such as
swelling, redness, most commonly in the lower leg, with a feeling of warmth and pain (cellulitis), and
possibly fever. Inform your doctor immediately if you experience any of these symptoms.
While being treated with Junod, you must also take calcium and vitamin D supplements. Your doctor
will discuss this with you.
While being treated with denosumab, you may have low levels of calcium in your blood. Inform your
doctor immediately if you notice any of the following symptoms: 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.
In rare cases, severe low levels of calcium in the blood have been reported, leading to hospitalization
and even life-threatening reactions. Therefore, your blood calcium levels will be monitored (through a
blood test) before each dose and, in patients at risk of developing hypocalcemia, within two weeks after
the initial dose.
Inform your doctor if you have or have ever had severe kidney problems, impaired kidney function, if
you are on 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 with mouth, teeth or jaw
A side effect called osteonecrosis of the jaw (a serious deterioration of the jawbone) has been reported
rarely (may occur in up to 1 in 1,000 patients) in patients receiving denosumab for osteoporosis. The
risk of osteonecrosis of the jaw increases in patients treated for a long period (may occur in up to 1 in
200 patients if treated for 10 years). 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 is a painful condition
that may be difficult to treat. To reduce the risk of developing osteonecrosis of the jaw, take the
following precautions:
Before receiving treatment, inform your doctor or nurse (healthcare provider) if you:
- have any mouth or dental problems, such as poor dental hygiene, gum disorders, or if you are scheduled for a tooth extraction;
- do not regularly receive dental care or have not had a dental check-up for a long time;
- are a smoker (as this may increase the risk of dental problems);
- have previously been treated with a bisphosphonate (used to treat or prevent bone disorders);
- are taking medicines called corticosteroids (such as prednisolone or dexamethasone);
- have cancer.
Your doctor may ask you to have a dental examination (by a dentist) before starting treatment with
Junod.
During treatment, it is necessary to maintain good oral hygiene and to have regular dental check-ups. If
you wear dentures, ensure they are properly fitted. If you are undergoing dental treatment or are
scheduled for dental surgery (e.g., tooth extractions), inform your doctor about the dental treatment and
inform your dentist that you are being treated with Junod.
Contact your doctor and dentist immediately if you notice any problems with your mouth or teeth, such
as loose teeth, pain or swelling, or failure of mouth sores to heal, or presence of discharge, as these may
be signs of a side effect called osteonecrosis of the jaw (ONJ).
Atypical femoral fractures
Some people have developed atypical fractures of the femur during treatment with denosumab.
Contact your doctor if you experience new or unusual pain in your hip, groin, or thigh.
Children and adolescents
Junod must not be used in children and adolescents under 18 years of age.
Other medicines and Junod
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
It is particularly important that you inform your doctor if you are taking other medicines containing
denosumab. You must not take Junod together with other medicines containing denosumab.
Inform your doctor if you are taking medicines called glucocorticoids (such as prednisolone or
dexamethasone); see also section “Warnings and precautions”.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
Denosumab has not been studied in pregnant women. The use of Junod is not recommended during
pregnancy. Women of childbearing potential must use effective contraceptive methods while taking
Junod and for at least 5 months after stopping treatment with Junod.
If you become pregnant during treatment with Junod or within less than 5 months after stopping
treatment with Junod, please inform your doctor.
It is not known whether denosumab passes into breast milk. It is important that you inform your doctor
if you are breastfeeding or planning to breastfeed. Your doctor will help you decide whether to stop
breastfeeding or to stop taking Junod, considering the benefit of breastfeeding for the child and the
benefit of taking Junod for the mother.
Driving and using machines
Junod does not affect or has negligible effect on the ability to drive or use machines.
Junod contains sorbitol, polysorbate 20 and sodium
This medicine contains 46 mg of sorbitol per mL of solution.
This medicine contains 0.1 mg of polysorbate 20 per mL of solution. Polysorbates may cause allergic
reactions. Inform your doctor if you or your child have known allergies.
This medicine contains less than 1 mmol of sodium (23 mg) per mL, i.e., essentially ‘sodium-free’.
3. How to use Junod
Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one pre-filled syringe containing 60 mg administered once every 6 months as a single subcutaneous injection (under the skin). The most suitable injection sites are the upper thighs and the abdomen. If an assistant is giving you the injection, the outer upper arm may also be used. Consult your doctor regarding the timing of your next possible injection. Each Junod package contains a reminder card that can be removed from the box and used to record the date of your next injection.
During treatment with Junod, you must also take calcium and vitamin D supplements. Your doctor will discuss this with you.
Your doctor will decide whether it is better for you or for your assistant to administer the Junod injection. Your doctor or nursing staff will show you or your assistant how to use Junod. For instructions on how to inject Junod, see the section at the end of this leaflet.
Do not shake.
If you forget to use Junod
If you have forgotten a dose of Junod, the injection should be given as soon as possible. After that, injections should be given every 6 months from the date of the last injection.
If you stop using Junod
To achieve the maximum benefit from treatment in reducing the risk of fractures, it is important to use Junod for the entire duration prescribed by your doctor. Do not stop treatment without consulting your doctor.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Uncommonly (may affect up to 1 in 100 people), patients treated with denosumab may develop skin infections (especially cellulitis). Contact your doctor immediately if you experience any of the following symptoms while taking Junod: skin redness and swelling, most commonly in the lower leg, accompanied by warmth, pain, and possibly fever.
Rarely (may affect up to 1 in 1,000 people), patients treated with denosumab may experience pain in the mouth and/or jaw, swelling or non-healing lesions in the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loose teeth. These may be signs of a serious bone disorder of the jaw (osteonecrosis). Contact your doctor and dentist immediately if you experience any of these symptoms during or after treatment with Junod.
Rarely (may affect up to 1 in 1,000 people), patients treated with denosumab may develop low levels of calcium in the blood (hypocalcaemia). Severe hypocalcaemia may require hospitalisation and can be life-threatening. Symptoms include 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. Contact your doctor immediately if any of these symptoms occur. Low calcium levels may also lead to changes in heart rhythm known as QT interval prolongation, which can be detected by an electrocardiogram (ECG).
Rarely (may affect up to 1 in 1,000 people), atypical fractures of the femur may occur in patients treated with denosumab. Contact your doctor if you develop new or unusual pain in the hip, groin or thigh, as this may be an early sign of a possible femoral fracture.
Rarely (may affect up to 1 in 1,000 people), allergic reactions may occur in patients treated with denosumab. Symptoms include swelling of the face, lips, tongue, throat or other body parts; rash, itching, hives, wheezing or difficulty breathing. Inform your doctor if you experience any of these symptoms during treatment with Junod.
Very common side effects (may affect more than 1 in 10 people):
- bone, joint and/or muscle pain, sometimes severe,
- pain in arms or legs (extremity pain).
Common side effects (may affect up to 1 in 10 people):
- frequent and painful need to urinate, blood in urine, urinary incontinence,
- upper respiratory tract infections,
- pain, tingling or numbness radiating to the lower limbs (sciatica),
- constipation,
- abdominal discomfort,
- skin rash,
- itching, redness and/or dryness of the skin (eczema),
- hair loss (alopecia).
Uncommon side effects (may affect up to 1 in 100 people):
- fever, vomiting, abdominal pain or abdominal discomfort (diverticulitis),
- ear infections,
- rash or mouth ulcers (drug-induced lichenoid eruptions).
Very rare side effects (may affect up to 1 in 10,000 people):
- allergic reaction that may damage blood vessels, mainly affecting the skin (e.g. purple or red-brown spots, hives or skin ulcers) (hypersensitivity vasculitis).
Not known (frequency cannot be estimated from the available data):
- inform your doctor if you experience ear pain, ear discharge, and/or ear infection. These may be signs of damage to the ear bone.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store 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 after Exp. and on the
carton after Exp. The expiry date refers to the last day of that month.
Do not use this medicine if you notice that the solution contains particles, is cloudy or discoloured.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Keep the pre-filled syringe in the outer packaging to protect the medicine 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 packaging and outer packaging to protect the
medicine from light. It must be used within this 30-day period.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Junod contains
- The active substance is denosumab. Each 1 mL 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.
Description of the appearance of Junod and package contents
Junod is a clear, colourless to slightly yellow, injectable solution in a ready-to-use pre-filled syringe.
1 mL of Junod is supplied in a single-use pre-filled glass syringe (Type I glass) with FluroTec plunger stopper, needle with safety shield (27 G × ½ IN), and rigid needle protection (elastomer + rigid polypropylene shell).
Each package contains one pre-filled syringe with needle guard.
Marketing Authorization Holder
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Hungary
Manufacturers
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Hungary
Chemical Works of Gedeon Richter Plc.
(Gedeon Richter Plc.)
Richter Gedeon utca 20.
Debrecen
Hungary
Other sources of information
Detailed information on this product is also available by scanning with a smartphone the QR code included below or on the outer packaging. The same information is also available at the following website: www.junodinfo.com
[QR code to be included]
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/
INSTRUCTIONS FOR USE
Guide to parts
Before use After use
Used plunger
Plunger
Syringe label
Used syringe barrel
Finger rest base
Syringe label
Used needle
Syringe barrel
Needle safety shield
Safety spring of the
used needle
Safety spring of the
needle
Grey needle cap
Grey needle cap
removed
inserted
Important
Before using a Junod pre-filled syringe with automatic needle safety protection, read
these important instructions. Follow the syringe use instructions carefully.
o It is important that you do not attempt to administer the injection unless you have received
adequate instructions from your doctor or healthcare professional.
o Junod is administered as an injection into the tissue just beneath the skin (subcutaneous
injection).
o Do not remove the grey needle cap from the pre-filled syringe until you are ready to inject.
o Do not use the pre-filled syringe if it has fallen on a hard surface. Use a new pre-filled
syringe and contact your doctor or healthcare professional.
o Do not attempt to activate the pre-filled syringe before injection.
o Do not attempt to remove the transparent safety shield from the pre-filled syringe.
Contact your doctor or healthcare professional for any questions.
Step 1: Preparation
A. Open the box containing the pre-filled syringe and prepare the materials needed for injection:
alcohol swabs, cotton ball or gauze, adhesive bandage, and a sharps disposal container (not included).
For a more comfortable injection, allow the pre-filled syringe to reach room temperature for about
15–30 minutes before injection. Wash your hands thoroughly with soap and water.
Place the new pre-filled syringe and other necessary materials on a clean, well-lit work surface.
o Do not attempt to warm the syringe using a heat source such as hot water or microwave.
o Do not expose the pre-filled syringe to direct sunlight.
o Do not shake the pre-filled syringe.
Keep the pre-filled syringe out of sight and reach of children.
B. Hold the syringe safety shield to remove the pre-filled syringe from its packaging.
Hold here
For safety reasons:
o Do not hold the plunger.
o Do not hold the grey needle cap.
C. Check the medicine and the pre-filled syringe.
Medicine
Do not use the pre-filled syringe if:
o The medicine is cloudy or contains particles. It should be a clear, colourless to slightly yellow solution.
o Any parts appear cracked or broken.
o The grey needle cap is missing or not securely attached.
o The expiration date printed on the label has passed the last day of the month indicated.
In all cases, contact your doctor or healthcare professional.
Step 2: Preparation
A. Wash your hands thoroughly. Prepare and clean the injection site.
Upper arm
Abdomen
Upper thigh
You may use:
o The upper thigh.
o The abdomen, except for a 5-centimetre area immediately around the navel.
o The outer upper arm (only if someone else is administering the injection).
Clean the injection site with an alcohol swab. Allow the skin to dry.
o Do not touch the injection site before injecting.
o Do not inject into areas where the skin is tender, bruised, red, or hardened. Avoid injecting into areas with scars or stretch marks.
B. Carefully remove the grey needle cap by pulling it straight outward and away from the body.
C. Lift the skin at the injection site to create a stable surface.
It is important to keep the skin lifted during injection.
Step 3: Injection
A. Keep the skin lifted. Insert the needle into the skin at an angle between 45° and 90°.
o Do not touch the cleaned area of skin.
B. Push the plunger with slow, steady pressure until you feel or hear a “click”. Push all the way until the click occurs.
Note: It is important to push fully until the “click” to ensure the full dose is injected.
C. Release your thumb. Then withdraw the syringe from the skin.
After releasing the plunger, the safety shield of the pre-filled syringe will automatically cover the injection needle securely.
Do not replace the grey needle cap onto used pre-filled syringes.
Step 4: Completion
A. Dispose of the used pre-filled syringe and other materials in a sharps disposal container.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. These measures will help protect the environment.
Keep the syringe and the sharps disposal container out of sight and reach of children.
o Do not reuse the pre-filled syringe.
o Do not recycle pre-filled syringes or dispose of them in household waste.
B. Examine the injection site.
If you see blood, press a cotton ball or gauze pad against the injection site. Do not rub the injection site. Apply an adhesive bandage if needed.