Bildyos

Package leaflet: Information for the patient

Bildyos 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 other people, 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, inform 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 Bildyos.

Contents of this leaflet

1. What Bildyos is and what it is used for
2. What you need to know before using Bildyos
3. How to use Bildyos
4. Possible side effects
5. How to store Bildyos
6. Contents of the pack and other information

1. What Bildyos is and what it is used for

What Bildyos is and how it works
Bildyos contains denosumab, a protein (monoclonal antibody) that interferes with the action of another protein, for the treatment of bone loss and osteoporosis. Treatment with Bildyos 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 cause bones to become 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, particularly 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 which type of treatment is Bildyos used?
Bildyos is used for the treatment of:

• osteoporosis in postmenopausal women 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 resulting from reduced hormone levels (testosterone) due to surgery or pharmacological 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 Bildyos

Do not use Bildyos

• if you have low levels of calcium in your blood (hypocalcemia).
• if you are allergic to denosumab or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Bildyos.
While being treated with Bildyos, 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), possibly accompanied by fever. Inform your doctor immediately if you experience any of these symptoms.
While being treated with Bildyos, you must also take calcium and vitamin D supplements. Your doctor will discuss this with you.
During treatment with Bildyos, you may develop 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 the fingers, toes or around the mouth, and/or seizures, confusion or loss of consciousness.
In rare cases, severe hypocalcemia has been reported, leading to hospitalization and even life-threatening reactions. Therefore, your blood calcium levels will be monitored (through blood tests) 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 undergoing 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 rare side effect called osteonecrosis of the jaw (serious deterioration of the jawbone tissue) has been reported (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 time (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 starting treatment, inform your doctor or nurse (healthcare provider) if you:

• have any problems with your mouth or teeth, 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 Bildyos.
During treatment, it is important to maintain good oral hygiene and to 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 the dental procedure and inform your dentist that you are being treated with Bildyos.
Contact your doctor and dentist immediately if you notice any new problems with your mouth or teeth, such as loose teeth, pain or swelling, or if mouth sores do not heal or there is discharge, as these may be signs of a side effect called osteonecrosis of the jaw.

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
Bildyos must not be used in children and adolescents under 18 years of age.

Other medicines and Bildyos
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 Bildyos together with other medicines containing denosumab.

Pregnancy and breastfeeding
Denosumab 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 are planning to become pregnant. The use of Bildyos is not recommended during pregnancy. Women of childbearing potential must use effective contraception while taking Bildyos and for at least 5 months after stopping treatment with Bildyos.
If you become pregnant during treatment with Bildyos or within 5 months after stopping treatment with Bildyos, 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 discontinue breastfeeding or the use of Bildyos, taking into account the benefit of breastfeeding for the child and the benefit of taking Bildyos for the mother.
If you breastfeed while being treated with Bildyos, inform your doctor.
Ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
Bildyos has no effect or has a negligible effect on the ability to drive and use machines.

Bildyos contains sorbitol and polysorbate 20
This medicine contains 47 mg of sorbitol and 0.1 mg of polysorbate 20 per mL of solution.
Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

Bildyos contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 60 mg, i.e., essentially “sodium-free”.

3. How to use Bildyos

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 you have a caregiver administering the injection, the outer area of the upper arm may also be used. Consult your doctor regarding the timing of your next possible injection. Each package of Bildyos contains a reminder card that can be removed from the box and used to keep track of the date of your next injection.
During treatment with Bildyos, 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 your caregiver to administer the Bildyos injection. Your doctor or nursing staff will show you or your caregiver how to administer Bildyos. For instructions on how to inject Bildyos, see the section at the end of this leaflet.
Do not shake.
If you forget to take Bildyos
If you have forgotten a dose of Bildyos, the injection should be given as soon as possible.
Afterwards, injections should be given every 6 months from the date of the last injection.
If you stop treatment with Bildyos
To obtain the maximum benefit from treatment in reducing the risk of fractures, it is important to take Bildyos for the entire duration prescribed by your doctor. Do not stop treatment without consulting your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Infections of the skin (especially cellulitis) may occur uncommonly in patients treated with Bildyos. Contact your doctor immediately if you experience any of the following symptoms while taking Bildyos: appearance of redness and swelling of the skin, most commonly in the lower leg, associated with warmth, pain, and possibly fever.
Rarely, patients treated with Bildyos may develop 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 could be signs of severe deterioration of the jawbone (osteonecrosis). Contact your doctor and dentist immediately if you experience any of these symptoms during or after stopping treatment with Bildyos.
Rarely, patients treated with Bildyos may develop low levels of calcium in the blood (hypocalcemia); severely low calcium levels can lead to hospitalization and may even 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 you experience any of these symptoms. 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, atypical femoral fractures may occur in patients treated with Bildyos. 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, allergic reactions may occur in patients treated with Bildyos. Symptoms include swelling of the face, lips, tongue, throat, or other body parts; skin rash, itching, hives, wheezing, or difficulty breathing. Contact your doctor if you experience any of these symptoms during treatment with Bildyos.

Very common side effects (may occur in more than 1 in 10 people):

• bone, joint, and/or muscle pain, sometimes severe,
• pain in arms or legs (limb pain).

Common side effects (may occur in up to 1 in 10 people):

• frequent and painful urination, 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 occur in up to 1 in 100 people):

• fever, vomiting, abdominal pain or abdominal disorders (diverticulitis),
• ear infections,
• skin rash or mouth ulcers (drug-induced lichenoid eruptions).

Very rare side effects (may occur in 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 an ear infection. These could be signs of damage to the ear bone.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bildyos

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and on the carton after
Exp. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Keep the container in the outer packaging to protect the medicine from light.
The pre-filled syringe may be removed from the refrigerator and allowed to reach room temperature (up to 25 °C) before injection. This will make the injection more comfortable.
Once the syringe has reached room temperature (up to 25 °C), it must be used within 30 days.
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 Bildyos contains

• 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, glacial, sodium hydroxide, sorbitol (E420), polysorbate 20 (E432), and water for injections.

Description of the appearance of Bildyos and contents of the pack
Bildyos is a ready-to-use injectable solution, from clear to slightly opalescent, colourless to slightly yellow, contained in a pre-filled syringe. It may contain traces of transparent to white particles.
Each pack contains one pre-filled syringe with a needle safety guard.

Marketing Authorisation Holder
SciencePharma Sp. z o.o.
Chełmska 30/34
00-725 Warsaw
Poland

Manufacturer
Cilatus Manufacturing Services Limited
Pembroke House, 28-32 Pembroke Street Upper
Dublin 2,
D02 EK84,
Ireland

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
SciencePharma Sp. z o.o. SciencePharma Sp. z o.o.
Chełmska 30/34, 00-725 Warsaw Chełmska 30/34, 00-725 Warsaw
Poland Poland
[email protected] [email protected]

България Luxembourg/Luxemburg
SciencePharma Sp. z o.o. SciencePharma Sp. z o.o.
Chełmska 30/34, 00-725 Warsaw Chełmska 30/34, 00-725 Warsaw
Poland Poland
[email protected] [email protected]

Česká republika Magyarország
SciencePharma Sp. z o.o. SciencePharma Sp. z o.o.
Chełmska 30/34, 00-725 Warsaw Chełmska 30/34, 00-725 Warsaw
Poland Poland
[email protected] [email protected]

Danmark Malta
SciencePharma Sp. z o.o. SciencePharma Sp. z o.o.
Chełmska 30/34, 00-725 Warsaw Chełmska 30/34, 00-725 Warsaw
Poland Poland
[email protected] [email protected]

Deutschland Nederland
Organon Healthcare GmbH SciencePharma Sp. z o.o.
Tel: 0800 3384 726 (+49 (0) 89 2040022 10) Chełmska 30/34, 00-725 Warsaw
[email protected] Poland
[email protected]

Eesti Norge
SciencePharma Sp. z o.o. SciencePharma Sp. z o.o.
Chełmska 30/34, 00-725 Warsaw Chełmska 30/34, 00-725 Warsaw
Poland Poland
[email protected] [email protected]

Ελλάδα Österreich
SciencePharma Sp. z o.o. SciencePharma Sp. z o.o.
Chełmska 30/34, 00-725 Warsaw Chełmska 30/34, 00-725 Warsaw
Poland Poland
[email protected] [email protected]

España Polska
Organon Salud, S.L. SciencePharma Sp. z o.o.
Tel: +34 91 591 12 79 Chełmska 30/34, 00-725 Warsaw
[email protected] Poland
[email protected]

France Portugal
Organon France SciencePharma Sp. z o.o.
Tél: +33 (0) 1 57 77 32 00 Chełmska 30/34, 00-725 Warsaw
Poland
[email protected]

Hrvatska România
SciencePharma Sp. z o.o. SciencePharma Sp. z o.o.
Chełmska 30/34, 00-725 Warsaw Chełmska 30/34, 00-725 Warsaw
Poland Poland
[email protected] [email protected]

Ireland Slovenija
SciencePharma Sp. z o.o. SciencePharma Sp. z o.o.
Chełmska 30/34, 00-725 Warsaw Chełmska 30/34, 00-725 Warsaw
Poland Poland
[email protected] [email protected]

Ísland Slovenská republika
SciencePharma Sp. z o.o. SciencePharma Sp. z o.o.
Chełmska 30/34, 00-725 Warsaw Chełmska 30/34, 00-725 Warsaw
Poland Poland
[email protected] [email protected]

Italia Suomi/Finland
Organon Italia S.r.l. SciencePharma Sp. z o.o.
Tel: +39 06 90259059 Chełmska 30/34, 00-725 Warsaw
[email protected] Poland
[email protected]

Κύπρος Sverige
SciencePharma Sp. z o.o. SciencePharma Sp. z o.o.
Chełmska 30/34, 00-725 Warsaw Chełmska 30/34, 00-725 Warsaw
Poland Poland
[email protected] [email protected]

Latvija
SciencePharma Sp. z o.o.
Chełmska 30/34, 00-725 Warsaw
Poland
[email protected]

Further sources of information
More detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu/.

Instructions for use:

Important
Before using a pre-filled Bildyos syringe with automatic needle protection, read
these important instructions:
It is important that you do not attempt to administer the injection yourself unless you have
received proper training from your doctor or a healthcare professional.
Bildyos is administered as an injection into the tissue just beneath the skin (subcutaneous injection).
 Do not remove the black needle cap from the pre-filled syringe until you are ready to inject.
 Do not use the pre-filled syringe if it has been dropped on 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 the injection.
 Do not attempt to remove the transparent safety shield from the pre-filled syringe.
Contact your doctor or healthcare professional for any questions.

Package leaflet: information for the user

Bildyos 60 mg solution for injection

denosumab
This medicinal product is subject to additional monitoring. This will allow for 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 all of this leaflet carefully before using this medicine, as 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 they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Your doctor will give you a patient reminder card containing important safety information that you need to know before and during treatment with Bildyos.

Contents of this leaflet

1. What Bildyos is and what it is used for
2. What you need to know before using Bildyos
3. How to use Bildyos
4. Possible side effects
5. How to store Bildyos
6. Contents of the pack and other information

1. What Bildyos is and what it is used for

What Bildyos is and how it works
Bildyos contains denosumab, a protein (monoclonal antibody) that interferes with the action of another protein, used for the treatment of bone loss and osteoporosis. Treatment with Bildyos makes bones stronger and less prone to fractures.
Bone is a living tissue that is constantly being renewed. Estrogens help maintain healthy bones. After menopause, the reduction in estrogen levels can make bones thin and fragile, which may lead to the development of a condition called osteoporosis. Osteoporosis can also occur in men for various reasons, including aging 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 estrogen 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 Bildyos used?
Bildyos is used for the treatment of:

• osteoporosis in postmenopausal women 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 resulting from reduced hormone levels (testosterone) due to surgery or pharmacological 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 Bildyos

Do not use Bildyos

• 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 Bildyos.
While being treated with Bildyos, 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 Bildyos, you must also take calcium and vitamin D supplements. Your doctor will discuss this with you.
While being treated with Bildyos, 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 the fingers, toes or around the 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 blood tests) 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 the mouth, teeth or jaw
A side effect called osteonecrosis of the jaw (a serious deterioration of the jawbone tissue) 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 starting treatment, inform your doctor or nurse (healthcare professional) if you:

• have any problems with your mouth or teeth, 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 Bildyos.
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 Bildyos.
Contact your doctor and dentist immediately if you notice any new problems with your mouth or teeth, such as loose teeth, pain or swelling, or failure of mouth sores to heal, or if you have discharge, as these may be signs of a side effect called osteonecrosis of the jaw.

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
Bildyos must not be used in children and adolescents under 18 years of age.

Other medicines and Bildyos
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 Bildyos together with other medicines containing denosumab.

Pregnancy and breastfeeding
Denosumab has not been studied in pregnant women. It is important that you inform your doctor if you are pregnant, think you might be pregnant, or are planning a pregnancy. The use of Bildyos is not recommended during pregnancy. Women of childbearing potential must use effective contraceptive methods while taking Bildyos and for at least 5 months after stopping treatment with Bildyos.
If you become pregnant during treatment with Bildyos or within 5 months after stopping treatment with Bildyos, 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 discontinue breastfeeding or the use of Bildyos, taking into account the benefits of breastfeeding for the child and the benefits of taking Bildyos for the mother.
If you are breastfeeding during treatment with Bildyos, inform your doctor.
Ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
Bildyos has no effect or has a negligible effect on the ability to drive and use machines.

Bildyos contains sorbitol and polysorbate 20
This medicine contains 47 mg of sorbitol and 0.1 mg of polysorbate 20 per mL of solution. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

Bildyos contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially 'sodium-free'.

3. How to use Bildyos

The recommended dose is one 60 mg vial administered once every 6 months, as a single
subcutaneous injection (under the skin). Bildyos is injected into the thigh, abdomen, or upper arm.
Please consult your doctor regarding the timing of your next possible injection.
During treatment with Bildyos, you must also take calcium and vitamin D supplements. Your doctor will discuss this with you.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.
Do not shake.
If you forget to use Bildyos
If you have missed a dose of Bildyos, the injection should be given as soon as possible.
Afterwards, injections should be administered every 6 months from the date of the last injection.
If you stop using Bildyos
To achieve the maximum benefit from treatment in reducing the risk of fractures, it is important to use Bildyos for the entire duration prescribed by your doctor. Do not stop treatment without consulting your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Uncommonly, patients treated with Bildyos may develop skin infections (especially cellulitis). Contact your doctor immediately if any of the following symptoms occur while you are taking Bildyos: skin redness and swelling, most commonly in the lower leg, accompanied by warmth, pain, and possibly fever.
Rarely, patients treated with Bildyos may experience pain in the mouth and/or jaw, swelling or non-healing lesions in the mouth or jaw, discharge, numbness or a sensation of heaviness in the jaw, or loose teeth. These could be signs of a serious deterioration of the jawbone (osteonecrosis). Contact your doctor and dentist immediately if you experience any of these symptoms during or after treatment with Bildyos.
Rarely, patients treated with Bildyos may have low levels of calcium in the blood (hypocalcemia). Severe hypocalcemia can lead to hospitalization and may 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. Contact your doctor immediately if any of these symptoms occur. Low calcium levels in the blood may also lead to changes in heart rhythm known as QT interval prolongation, which can be detected by electrocardiogram (ECG).
Rarely, atypical femoral fractures may occur in patients treated with Bildyos. Contact your doctor if you develop new or unusual pain in the hip, groin, or thigh, as this could be an early sign of a possible femoral fracture.
Rarely, allergic reactions may occur in patients treated with Bildyos. Symptoms include swelling of the face, lips, tongue, throat, or other body parts; skin rash, itching, hives, wheezing, or difficulty breathing. Contact your doctor if you experience any of these symptoms during treatment with Bildyos.

Very common side effects (may occur in more than 1 in 10 people):

• bone, joint, and/or muscle pain, sometimes severe,
• pain in the arms or legs (limb pain).

Common side effects (may occur in up to 1 in 10 people):

• frequent and painful urination, blood in the 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 occur in up to 1 in 100 people):

• fever, vomiting, and abdominal pain or abdominal disorders (diverticulitis),
• ear infections,
• skin rash or mouth ulcers (drug-induced lichenoid eruptions).

Very rare side effects (may occur in up to 1 in 10,000 people):

• allergic reaction that may damage blood vessels, mainly at the skin level (e.g. purple or reddish-brown spots, hives, or skin ulcers) (hypersensitivity vasculitis).

Not known (frequency cannot be estimated from the available data):

• contact your doctor if you experience ear pain, ear discharge, and/or an ear infection. These could be signs of damage to the ear bone.

Reporting of side effects
If you experience any side effect, 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 Bildyos

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and on the carton after
Exp. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Keep the vial in the outer packaging to protect the medicine from light.
The vial may be removed from the refrigerator and allowed to reach room temperature (up to 25 °C) before injection. This will make the injection more comfortable. Once the vial has reached room temperature (up to 25 °C), it must be used within 30 days.
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 Bildyos contains

• The active substance is denosumab. Each 1 mL vial contains 60 mg of denosumab (60 mg/mL).
• The other components are glacial acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 20 (E432) and water for injections.

Description of the appearance of Bildyos and contents of the pack
Bildyos is an injectable solution (injection).
Bildyos is a solution that is clear to slightly opalescent, colourless to slightly yellow. It may
contain traces of transparent to white particles.
Each pack contains one single-use vial.

Marketing Authorisation Holder
SciencePharma Sp. z o.o.
Chełmska 30/34
00-725 Warsaw
Poland

Manufacturer
Cilatus Manufacturing Services Limited
Pembroke House, 28-32 Pembroke Street Upper
Dublin 2,
D02 EK84,
Ireland

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
SciencePharma Sp. z o.o. SciencePharma Sp. z o.o.
Chełmska 30/34, 00-725 Warsaw Chełmska 30/34, 00-725 Warsaw
Poland Poland
[email protected] [email protected]

България Luxembourg/Luxemburg
SciencePharma Sp. z o.o. SciencePharma Sp. z o.o.
Chełmska 30/34, 00-725 Warsaw Chełmska 30/34, 00-725 Warsaw
Poland Poland
[email protected] [email protected]

Česká republika Magyarország
SciencePharma Sp. z o.o. SciencePharma Sp. z o.o.
Chełmska 30/34, 00-725 Warsaw Chełmska 30/34, 00-725 Warsaw
Poland Poland
[email protected] [email protected]

Danmark Malta
SciencePharma Sp. z o.o. SciencePharma Sp. z o.o.
Chełmska 30/34, 00-725 Warsaw Chełmska 30/34, 00-725 Warsaw
Poland Poland
[email protected] [email protected]

Deutschland Nederland
Organon Healthcare GmbH SciencePharma Sp. z o.o.
Tel: 0800 3384 726 (+49 (0) 89 2040022 10) Chełmska 30/34, 00-725 Warsaw
[email protected] Poland
[email protected]

Eesti Norge
SciencePharma Sp. z o.o. SciencePharma Sp. z o.o.
Chełmska 30/34, 00-725 Warsaw Chełmska 30/34, 00-725 Warsaw
Poland Poland
[email protected] [email protected]

Ελλάδα Österreich
SciencePharma Sp. z o.o. SciencePharma Sp. z o.o.
Chełmska 30/34, 00-725 Warsaw Chełmska 30/34, 00-725 Warsaw
Poland Poland
[email protected] [email protected]

España Polska
Organon Salud, S.L. SciencePharma Sp. z o.o.
Tel: +34 91 591 12 79 Chełmska 30/34, 00-725 Warsaw
[email protected] Poland
[email protected]

France Portugal
Organon France SciencePharma Sp. z o.o.
Tél: +33 (0) 1 57 77 32 00 Chełmska 30/34, 00-725 Warsaw
Poland
[email protected]

Hrvatska România
SciencePharma Sp. z o.o. SciencePharma Sp. z o.o.
Chełmska 30/34, 00-725 Warsaw Chełmska 30/34, 00-725 Warsaw
Poland Poland
[email protected] [email protected]

Ireland Slovenija
SciencePharma Sp. z o.o. SciencePharma Sp. z o.o.
Chełmska 30/34, 00-725 Warsaw Chełmska 30/34, 00-725 Warsaw
Poland Poland
[email protected] [email protected]

Ísland Slovenská republika
SciencePharma Sp. z o.o. SciencePharma Sp. z o.o.
Chełmska 30/34, 00-725 Warsaw Chełmska 30/34, 00-725 Warsaw
Poland Poland
[email protected] [email protected]

Italia Suomi/Finland
Organon Italia S.r.l. SciencePharma Sp. z o.o.
Tel: +39 06 90259059 Chełmska 30/34, 00-725 Warsaw
[email protected] Poland
[email protected]

Κύπρος Sverige
SciencePharma Sp. z o.o. SciencePharma Sp. z o.o.
Chełmska 30/34, 00-725 Warsaw Chełmska 30/34, 00-725 Warsaw
Poland Poland
[email protected] [email protected]

Latvija
SciencePharma Sp. z o.o.
Chełmska 30/34, 00-725 Warsaw
Poland
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu/ .

The following information is intended exclusively for healthcare professionals:

• Before administration, the Bildyos solution should be inspected visually. The solution may contain traces of protein particles ranging from translucent to white. Do not inject the solution if it is cloudy or discolored.
• Do not shake.
• To minimize discomfort at the injection site, allow the vial to reach room temperature (up to 25 °C) before injection, and inject the medication slowly.
• The entire contents of the vial must be injected.
• For denosumab administration, use of a 27-gauge needle is recommended.
• The vial must not be reused.

Any unused medicine and waste materials derived from this medicine must be disposed of in accordance with
local regulations.