Bildyos 60 mg Solution for injection in pre-filled syringe

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• Your doctor will give you a patient reminder card, which contains important safety information you need to be aware of before and during your treatment with Bildyos.

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

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 makes bone stronger and less likely to break.

Bone is a living tissue and is renewed all the time. Oestrogen helps keep bones healthy. After the menopause, oestrogen level drops which may cause bones to become thin and fragile. This can eventually lead to a condition called osteoporosis. Osteoporosis can also occur in men due to a number of causes including ageing and/or a low level of the male hormone, testosterone. It can also occur in patients receiving glucocorticoids. Many patients with osteoporosis have no symptoms, but they are still at risk of breaking bones, especially in the spine, hips and wrists.

Surgery or medicines that stop the production of oestrogen or testosterone used to treat patients with breast or prostate cancer can also lead to bone loss. The bones become weaker and break more easily.

Bildyos is used to treat:

• osteoporosis in women after the menopause (postmenopausal) and men who have an increased risk of fracture (broken bones), reducing the risk of spinal, non-spinal, and hip fractures.
• bone loss that results from a reduction in hormone (testosterone) level caused by surgery or treatment with medicines in patients with prostate cancer.
• bone loss that results from long-term treatment with glucocorticoids in patients who have an increased risk of fracture.

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

Talk to your doctor or pharmacist before using Bildyos.

Whilst being treated with Bildyos you may develop a skin infection with symptoms such as a swollen, red area of skin, most commonly in the lower leg, that feels hot and tender (cellulitis), and possibly with symptoms of fever. Please tell your doctor immediately if you develop any of these symptoms.

You should also take calcium and vitamin D supplements while being on treatment with Bildyos. Your doctor will discuss this with you.

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

Severe low blood calcium levels leading to hospitalisation and even life-threatening reactions have been reported in rare cases. Before each dose and in patients predisposed to hypocalcaemia within two weeks after initial dose, the calcium levels in your blood will therefore be checked (via blood test).

Tell your doctor if you have or have ever had severe kidney problems, kidney failure or have needed dialysis or are taking medicines called glucocorticoids (such as prednisolone or dexamethasone), which may increase your risk of getting low blood calcium if you do not take calcium supplements.

Problems with your mouth, teeth or jaw

A side effect called osteonecrosis of the jaw (bone damage in the jaw) has been reported rarely (may affect up to 1 in 1,000 people) in patients receiving denosumab for osteoporosis. 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 can also occur after stopping treatment. It is important to try to prevent osteonecrosis of the jaw developing as it may be a painful condition that can be difficult to treat. In order to reduce the risk of developing osteonecrosis of the jaw, take the following precautions:

Before receiving treatment, tell your doctor or nurse (health care professional) if you:

• have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction.
• don’t receive routine 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 undergo a dental examination before you start treatment with Bildyos.

While being treated, you should maintain good oral hygiene and receive routine dental check-ups. If you wear dentures you should make sure these fit properly. If you are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell 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 of sores or discharge, as these could be signs of osteonecrosis of the jaw.

Unusual thigh bone fractures

Some people have developed unusual fractures in their thigh bone while being treated with denosumab. Contact your doctor if you experience new or unusual pain in your hip, groin, or thigh.

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

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It is especially important that you tell your doctor if you are being treated with another medicine containing denosumab.

You should not take Bildyos together with another medicine containing denosumab.

Denosumab has not been tested in pregnant women. It is important to tell your doctor if you are pregnant; think you may be pregnant; or plan to get pregnant. Bildyos is not recommended for use if you are pregnant. Women of child-bearing potential should use effective methods of contraception while being treated with Bildyos and for at least 5 months after stopping treatment with Bildyos.

If you become pregnant during treatment with Bildyos or less than 5 months after stopping treatment with Bildyos, please inform your doctor.

It is not known whether denosumab is excreted in breast milk. It is important to tell your doctor if you are breast-feeding or plan to do so. Your doctor will then help you decide whether to stop breast-feeding, or whether to stop taking Bildyos, considering the benefit of breast-feeding to the baby and the benefit of Bildyos to the mother.

If you are breast-feeding during Bildyos treatment, please inform your doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

Bildyos has no or negligible influence on the ability to drive and use machines.

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

This medicine contains less than 1 mmol sodium (23 mg) per 60 mg, that is to say essentially ‘sodium-free’.

If a dose of Bildyos is missed, the injection should be administered as soon as possible. Thereafter, injections should be scheduled every 6 months from the date of the last injection.

To get the most benefit from your treatment in reducing the risk of fractures, it is important to use Bildyos for as long as your doctor prescribes it for you. Do not stop your treatment without contacting your doctor.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

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

Bildyos is a clear to slightly opalescent, colourless to slightly yellow solution for injection provided in a ready to use pre-filled syringe. It may contain trace amounts of clear to white particles.

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

Before you use a Bildyos pre-filled syringe with automatic needle guard, read this important information:

• It is important that you do not try to give yourself the injection unless you have received training from your doctor or healthcare provider.
• Bildyos is given as an injection into the tissue just under 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 call your doctor or healthcare provider.
• Do not attempt to activate the pre-filled syringe prior to injection.
• Do not attempt to remove the clear pre-filled syringe safety guard from the pre-filled syringe.

Call your doctor or healthcare provider if you have any questions.

Step 1: Prepare

A Remove the pre-filled syringe tray from the package and gather the supplies needed for your injection: alcohol wipes, a cotton ball or gauze pad, a plaster and a sharps disposal container (not included).

For a more comfortable injection, leave the pre-filled syringe at room temperature for about 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 the other supplies.

• Do not try to warm the syringe by 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.

B Open the tray, peeling away the cover. Grab the pre-filled syringe safety guard to remove the pre-filled syringe from the tray.

For safety reasons:

• Do not grasp the plunger.
• Do not grasp the black needle cap.

C Inspect the medicine and pre-filled syringe.

• Do not use the pre-filled syringe if:
  • The medicine is cloudy or discoloured. It must be a clear to slightly opalescent, colourless to slightly yellow solution.
  • Any part appears cracked or broken.
  • The black needle cap is missing or not securely attached.
  • The expiry date printed on the label has passed the last day of the month shown.

In all cases, call your doctor or healthcare provider.

Step 2: Get ready

A Wash your hands thoroughly. Prepare and clean your injection site.

You can use:

• Upper part of your thigh.
• Belly, except for a 5 cm (2-inch) area right around your belly button.
• Outer area of upper arm (only if someone else is giving you the injection).

Clean the injection site with an alcohol wipe. Let your skin dry.

• Do not touch the injection site before injecting.

Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks.

B Carefully pull the black needle cap straight out and away from your body.

C Pinch your injection site to create a firm surface.

It is important to keep the skin pinched when injecting.

Step 3: Inject

A Hold the pinch. INSERT the needle into the skin at 45 to 90 degrees.

• Do not touch the cleaned area of the skin.

B PUSH the plunger with slow and constant pressure until you feel or hear a “snap”. Push all the way down through the snap.

It is important to push down through the “snap” to deliver your full dose.

C RELEASE your thumb. Then LIFT the syringe off skin.

After releasing the plunger, the pre-filled syringe safety guard will safely cover the injection needle.

• Do not put the black needle cap back on used pre-filled syringes.

Step 4: Finish

A Discard the used pre-filled syringe and other supplies in a sharps disposal container.

Medicines should be disposed of in accordance with local requirements. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Keep the syringe and sharps disposal container out of sight and reach of children.

• Do not reuse the pre-filled syringe.
• Do not recycle pre-filled syringes or throw them into household waste.

B Examine the injection site.

If there is blood, press a cotton ball or gauze pad on your injection site. Do not rub the injection site. Apply a plaster if needed.