Bildyos 60 mg solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bildyos 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 adverse 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; do not pass it on to others, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.
• Your doctor will provide you with a patient alert card containing important safety information you should 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 in order to treat bone loss and osteoporosis. Treatment with Bildyos strengthens bones and reduces the risk of fractures.

Bone is living tissue that is constantly being 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 can also occur in patients receiving glucocorticoid treatment. 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 stop 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 Bildyos is used for

Bildyos is used to treat:

• postmenopausal osteoporosis in women and osteoporosis in men who have an increased risk of fracture (broken bones), by reducing the risk of hip, spine, and non-spine fractures.
• bone loss caused by reduced hormone levels (testosterone) due to 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 Bildyos

Do not use Bildyos:

• if you have low levels of calcium in your blood (hypocalcaemia).
• 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 Bildyos.

While being treated with Bildyos, 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. Inform your doctor immediately if you experience any of these symptoms.

In addition, you must take calcium and vitamin D supplements during treatment with Bildyos. Your doctor will discuss this with you.

While receiving Bildyos, you may develop low levels of calcium in the blood. Inform your doctor immediately if you notice any of the following symptoms: muscle spasms, twitches or cramps, and/or numbness or tingling in the fingers, toes or around the mouth, and/or seizures, confusion or loss of consciousness.

In rare cases, very low levels of calcium in the blood have been reported, requiring hospitalisation and, in some cases, potentially life-threatening reactions. Therefore, before each dose is administered, and within two weeks after the first dose in patients predisposed to hypocalcaemia, your blood calcium levels will be checked (through a blood test).

Inform your doctor if you have or have had severe kidney problems, kidney 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 (damage to the jaw bone) has been reported (may affect up to 1 in 1,000 people). The risk of osteonecrosis of the jaw increases in patients treated for a long time (may affect up to 1 in 200 people 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 can be a painful condition that may be difficult to treat. To reduce the risk of developing osteonecrosis of the jaw, 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 extraction.
• you do not receive regular dental check-ups or it has been a long time since your last dental check-up.
• 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 Bildyos.

During treatment, you should maintain good oral hygiene and undergo 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 Bildyos.

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 osteonecrosis of the jaw.

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

Bildyos should not be used in individuals under 18 years of age.

Using Bildyos with other medicines

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 Bildyos together with another medicine 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 plan to become pregnant. Use of Bildyos during pregnancy is not recommended. Women of childbearing potential should use effective contraceptive methods during treatment with 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, 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 Bildyos, taking into account the benefits of breastfeeding for the child and the benefits of Bildyos for the mother.

If you are breastfeeding during treatment with Bildyos, please inform your doctor.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

The influence of Bildyos on the ability to drive and use machines is negligible or none.

Bildyos contains sorbitol and polysorbate 20

This medicine contains 47 mg of sorbitol and 0.1 mg of polysorbate 20 in each ml of solution. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

Bildyos contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 60 mg; hence, it is essentially “sodium-free”.

3. How to use Bildyos

The recommended dose is one pre-filled syringe containing 60 mg administered under the skin (subcutaneous route) as a single injection every 6 months. The best places to administer the injection are the upper thighs and the abdomen. If a caregiver (a person providing care) is giving the injection, they may also administer it into the outer area of the upper arm. Consult your doctor for the date of your next possible injection. Each package of Bildyos contains a reminder card that can be removed from the package 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 Bildyos. Your doctor will discuss this with you.

Your doctor will decide whether it is preferable for you or a caregiver to administer the Bildyos injection. Your doctor or healthcare professional will show you or your caregiver how to use Bildyos. If you would like instructions on how to inject Bildyos, please read the last section of this leaflet.

Do not shake.

If you forget to use Bildyos

If you miss a dose of Bildyos, the injection should be administered as soon as possible. After that, injections should be scheduled every 6 months starting from the date of the last injection.

If you stop treatment with Bildyos

To get the maximum benefit from your treatment and to reduce the risk of fractures, it is important to use Bildyos for the entire period prescribed by your doctor. Do not stop treatment without first speaking to your doctor.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Patients treated with Bildyos may occasionally develop skin infections (mainly cellulitis). Inform your doctor immediately if any of the following symptoms occur during treatment with Bildyos: a swollen, red area on the skin, usually on the lower leg, which is warm and tender to the touch and may be accompanied by fever.

Rarely, patients receiving Bildyos may develop pain in the mouth and/or jaw, swelling or non-healing ulcers in the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth. These could be symptoms of bone damage in the jaw (osteonecrosis). Inform your doctor and your dentist immediately if you experience such symptoms while being treated with Bildyos or after stopping treatment.

Rarely, patients receiving Bildyos may develop low levels of calcium in the blood (hypocalcemia); 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, inform 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 femoral fractures may occur in patients receiving Bildyos. 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 femoral fracture.

Rarely, allergic reactions may occur in patients receiving Bildyos. Symptoms include swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin; wheezing or difficulty breathing. Inform your doctor if you experience such symptoms while being treated with Bildyos.

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 arms or legs (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).

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 Bildyos

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 the refrigerator (between 2 ºC and 8 ºC).

Do not freeze.

Keep the container in the outer packaging to protect it from light.

Before injection, the pre-filled syringe may be removed from the refrigerator and allowed to reach room temperature (up to 25 ºC) to make the injection less uncomfortable. Once the syringe has reached room temperature (up to 25 ºC), 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 Bildyos

• The active substance is denosumab. Each 1 ml pre-filled syringe 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.

Appearance of the product and contents of the container

Bildyos is an injectable solution, ranging from clear to slightly opalescent, colorless to slightly yellow, supplied in a pre-filled syringe ready for use. It may contain residual amounts of particles ranging from transparent to white.

Each pack contains one pre-filled syringe with a needle safety guard.

Marketing Authorization Holder

SciencePharma Sp. z o.o.

Chelmska 30/34

00-725 Warsaw

Poland

Manufacturer

Cilatus Manufacturing Services Limited

Pembroke House, 28-32 Pembroke Street Upper

Dublin 2,

D02 EK84,

Ireland

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.