Bilprevda 120 mg solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Bilprevda 120 mg solution for injection

denosumab

This medicine is subject to additional monitoring, which will allow faster detection of new information on its safety. You can help by reporting any side effects you may experience. Information on how to report side effects is included 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, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.
• Your doctor will provide you with a patient alert card containing important safety information that you should know before and during treatment with Bilprevda.

Leaflet contents

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

1. What Bilprevda is and what it is used for

Bilprevda contains denosumab, a protein (monoclonal antibody) that inhibits bone destruction occurring when cancer spreads to the bones (bone metastases) or in giant cell tumor of bone.

Bilprevda is used in adults with advanced cancer to prevent serious complications caused by bone metastases (e.g., fractures, spinal cord compression, or the need for radiotherapy or surgery).

Bilprevda is also used for the treatment of giant cell tumor of bone that cannot be treated with surgery, or when surgery is not the best option, in adults and adolescents whose bones have stopped growing.

2. What you need to know before using Bilprevda

Do not use Bilprevda

• if you are allergic to denosumab or to any of the other components of this medicine (listed in section 6).

Your healthcare professional will not administer Bilprevda if you have untreated very low levels of calcium in your blood.

Your healthcare professional will not administer Bilprevda if you have unhealed wounds from dental or oral surgery.

Warnings and precautions

Talk to your doctor before starting treatment with Bilprevda.

Calcium and vitamin D supplements

You must take calcium and vitamin D supplements during treatment with Bilprevda unless your blood calcium levels are high. Your doctor will explain this to you. If your blood calcium level is low, your doctor may decide to prescribe calcium supplements before starting treatment with Bilprevda.

Low calcium levels in the blood

Contact your doctor immediately if you experience muscle spasms, twitching, or cramps and/or numbness or tingling in your fingers, toes, or around the mouth and/or seizures, confusion, or loss of consciousness during treatment with Bilprevda. Your blood calcium level may be low.

Kidney problems

Inform your doctor if you have or have had severe kidney problems, kidney failure, or if you have required dialysis, as this may increase the risk of low calcium levels in the blood, especially if you do not take calcium supplements.

Problems with mouth, teeth, and jaw

A side effect called osteonecrosis of the jaw (damage to the jawbone) has been frequently reported (may affect up to 1 in 10 people) in patients receiving injectable denosumab for cancer-related conditions. 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, you should take the following precautions:

• Before receiving treatment, inform your doctor or nurse (healthcare professional) if you have any problems with your mouth or teeth. Your doctor should delay the start of your treatment if you have unhealed wounds in your mouth due to dental procedures or oral surgery. Your doctor will recommend a dental examination before starting treatment with Bilprevda.
• While being treated, you should maintain good oral hygiene and have regular dental check-ups. If you wear dentures, ensure they fit properly.
• If you are undergoing dental treatment or will have dental surgery (e.g., tooth extractions), inform your doctor about your dental treatment and inform your dentist that you are being treated with Bilprevda.
• 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 draining sores, as these could be signs of osteonecrosis of the jaw.

Patients undergoing chemotherapy and/or radiotherapy, taking steroids or anti-angiogenic medications (used to treat cancer), who have had dental surgery, who do not have regular dental check-ups, who have gum disease, or who smoke may have a higher risk of developing osteonecrosis of the jaw.

Unusual fractures of the thigh bone

Some people have developed unusual fractures of the thigh bone during treatment with denosumab. Contact your doctor if you experience new or unusual pain in your hip, groin, or thigh.

High calcium levels in the blood after stopping treatment with Bilprevda

Some patients with giant cell tumor of bone have developed high calcium levels in the blood weeks or months after stopping treatment. Your doctor will monitor for signs and symptoms of high calcium levels after stopping treatment with Bilprevda.

Children and adolescents

Bilprevda is not recommended for children and adolescents under 18 years of age except for adolescents with giant cell tumor of bone whose bones have stopped growing. The use of denosumab has not been studied in children and adolescents with other types of cancer that have spread to the bones.

Other medicines and Bilprevda

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. It is very important that you inform your doctor if you are being treated with

• another medicine containing denosumab
• a bisphosphonate

You should not take Bilprevda together with other medicines containing denosumab or bisphosphonates.

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. Bilprevda is not recommended during pregnancy. Women of childbearing potential must use effective contraception during treatment with Bilprevda and for at least 5 months after stopping treatment with Bilprevda.

If you become pregnant during treatment with Bilprevda or within 5 months after stopping treatment with Bilprevda, please 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 you should stop breastfeeding or stop taking Bilprevda, taking into account the benefit of breastfeeding for the child and the benefit of Bilprevda for the mother.

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

Consult your doctor or pharmacist before taking any other medicine.

Driving and using machines

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

Bilprevda contains sorbitol and polysorbate 20

This medicine contains 78.2 mg of sorbitol and 0.17 mg of polysorbate 20 in each vial. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

Bilprevda contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 120 mg dose; this is essentially "sodium-free".

3. How to use Bilprevda

Bilprevda must be administered under the supervision of a healthcare professional.

The recommended dose of Bilprevda is 120 mg given once every 4 weeks as a single subcutaneous injection (under the skin). Bilprevda will be injected into the thigh, abdomen, or upper arm. If you are being treated for giant cell bone tumor, you will receive an additional dose 1 and 2 weeks after the first dose.

Do not shake.

You should also take calcium and vitamin D supplements during treatment with Bilprevda unless you have high levels of calcium in your blood. Your doctor will explain this to you.

If you have any further questions about the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

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

Tell your doctor immediately if you develop any of the following symptoms during treatment with Bilprevda (may affect more than 1 in 10 people):

• muscle spasms, tics, cramps, numbness or tingling in the fingers and toes or around the mouth, and/or seizures, confusion or loss of consciousness. These symptoms may be signs that your blood calcium levels are low. Low blood calcium levels may also cause a change in heart rhythm called QT prolongation, which is detected by an electrocardiogram (ECG).

Tell your doctor and dentist immediately if you develop any of the following symptoms during treatment with Bilprevda or after stopping treatment (may affect up to 1 in 10 people):

• persistent pain in the mouth and/or jaw, swelling and/or non-healing ulcers in the mouth or jaw, pus discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth, which may be signs of bone damage in the jaw (osteonecrosis).

Very common adverse effects (may affect more than 1 in 10 people):

• bone, joint and/or muscle pain, sometimes severe,
• breathing difficulties,
• diarrhoea.

Common adverse effects (may affect up to 1 in 10 people):

• low blood phosphate levels (hypophosphataemia),
• dental extraction,
• excessive sweating,
• in patients with advanced cancer: development of another type of cancer.

Uncommon adverse effects (may affect up to 1 in 100 people):

• high blood calcium levels (hypercalcaemia) after stopping treatment in patients with giant cell bone tumour,
• new or unusual pain in the hip, groin or thigh (this may be an early sign of a possible fracture of the thigh bone),
• skin rash or mouth ulcers (drug-induced lichenoid eruptions).

Rare adverse effects (may affect up to 1 in 1,000 people):

• allergic reactions (e.g. wheezing or breathing difficulties; swelling of the face, lips, tongue, throat or other body parts; skin rash, itching or hives). Allergic reactions may rarely be severe.

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 ear bones.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bilprevda

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and label after "EXP". The expiry date refers to the last day of the month indicated.

Store in a refrigerator (between 2 °C and 8 °C).

Do not freeze.

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

Before injection, the vial may be removed from the refrigerator and allowed to reach room temperature (up to 25 °C) to make the injection less uncomfortable. Once the vial has reached room temperature (up to 25 °C), do not return it to the refrigerator; it must be used within 30 days.

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 will help protect the environment.

6. Contents of the container and other information

Composition of Bilprevda

• The active substance is denosumab. Each vial contains 120 mg of denosumab in 1.7 ml of solution (equivalent to 70 mg/ml).
• The other components are glacial acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 20 (E432), and water for injections.

Appearance of the medicinal product and contents of the container

Bilprevda is an injectable solution.

Bilprevda is a solution that is transparent to slightly opalescent, colorless to slightly yellowish. It may contain residual amounts of particles that are transparent to white.

Each pack contains one single-use vial.

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

More information about 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.

This information is intended for healthcare professionals only:

• The Bilprevda solution should be inspected visually before administration. The solution may contain residual amounts of translucent to white protein particles. Do not inject the solution if it is cloudy or discolored.
• Do not shake.
• To minimize injection site discomfort, allow the vial to reach room temperature (up to 25 °C) before injection, and administer the injection slowly.
• The entire contents of the vial must be injected.
• A 27 G needle is recommended for the administration of denosumab.
• Do not reinsert the needle into the vial.

Disposal of unused medicine and of all materials that have come into contact with it must be carried out in accordance with local regulations.