Bilprevda

Package leaflet: Information for the patient

Bilprevda 120 mg solution for injection

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 all of this leaflet carefully before you start 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. 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 Bilprevda.

Contents of this leaflet

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 acts to reduce bone destruction caused by the spread of cancer to the bone (bone metastases) or by giant cell tumour of the bone.
Bilprevda is used in adults with advanced cancer to prevent serious complications caused by bone metastases (e.g. fracture, pressure on the spinal cord, or the need for radiotherapy or surgery).
Bilprevda is also used to treat giant cell tumour of the bone that cannot be treated surgically or when surgery is not the best option, in adults and adolescents whose bones have stopped growing.

2. What you must know before using Bilprevda

Do not use Bilprevda

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

The healthcare provider will not administer Bilprevda to you if you have very low levels of calcium in the blood that have not been treated.
The healthcare provider will not administer Bilprevda to you if you have unhealed wounds from dental or oral surgery.

Warnings and precautions
Talk to your doctor before using Bilprevda.

Calcium and vitamin D supplementation
You must take calcium and vitamin D supplements while being treated with Bilprevda, except when your blood calcium levels are high. Your doctor will discuss this with you. If your blood calcium level is low, your doctor may decide to give you calcium supplements before starting treatment with Bilprevda.

Low levels of calcium in the blood
Tell your doctor immediately if, during treatment with Bilprevda, you experience 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. You may have low levels of calcium in the blood.

Kidney problems
Tell your doctor if you currently have or have ever had severe kidney problems, kidney failure, or if you have undergone dialysis, as these conditions may increase the risk of low blood calcium levels, especially if you are not taking calcium supplements.

Problems with mouth, teeth or jaw
An adverse effect called osteonecrosis of the jaw (damage to the jaw bone) has been commonly reported (may occur in up to 1 in 10 people) in patients who have received denosumab injections for tumour-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 is 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, tell your doctor/nurse (healthcare provider) if you have any mouth or dental problems. Your doctor should delay starting treatment if you have unhealed wounds in your mouth following dental procedures or oral surgery. Your doctor may ask you to have a dental examination before starting treatment with Bilprevda.
• During treatment, you must maintain good oral hygiene and have regular dental check-ups. If you wear dentures, make sure they fit properly.
• If you are currently undergoing dental treatment or are planning to have dental surgery (e.g. tooth extractions), inform your doctor about the dental treatment and inform your dentist that you are being treated with Bilprevda.
• 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 discharge, as these may be signs of osteonecrosis of the jaw.

Patients who are receiving chemotherapy and/or radiotherapy, who are taking steroids or anti-angiogenic medicines (used to treat cancer), who undergo dental surgery, who do not receive routine dental care, who have gum problems, or who smoke may have a higher risk of developing osteonecrosis of the jaw.

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

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

Children and adolescents
Bilprevda is not recommended for children and adolescents under 18 years of age, except for adolescents with giant cell tumour of the bone whose bones have stopped growing. The use of denosumab in children and adolescents with other tumours that have invaded the bone has not been studied.

Other medicines and Bilprevda
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription. In particular, it is important that you tell your doctor if you are taking:

• another medicine containing denosumab
• a bisphosphonate

You must 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, suspect you may be pregnant, or are planning a pregnancy. The use of Bilprevda is not recommended during pregnancy. Women of childbearing potential must use effective contraception while taking 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 not known whether denosumab is excreted in human milk. It is important that you inform your doctor if you are breastfeeding or planning to breastfeed. Your doctor will then help you decide whether to discontinue breastfeeding or discontinue 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.

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

Driving and using machines
Bilprevda has no or negligible influence on the ability to drive and use machines.

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

Bilprevda contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 120 mg dose, i.e. 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. Bilprevda will be injected into the thigh, abdomen, or upper arm. If you are being treated for giant cell tumor of bone, you will receive additional doses 1 week and 2 weeks after the first dose.
Do not shake.
During treatment with Bilprevda, you must also take calcium and vitamin D supplements unless you have excess calcium in your blood. Your doctor will discuss this with you.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if, during treatment with Bilprevda, you notice any of the following symptoms (may affect more than 1 in 10 people):

• muscle spasms, contractions, cramps, numbness or tingling in the fingers of the hands and feet or around the mouth and/or seizures, confusion or loss of consciousness. These signs could indicate low levels of calcium in the blood. Low calcium levels may also lead to a change in heart rhythm called QT prolongation, which is seen on an electrocardiogram (ECG).

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

• persistent pain in the mouth and/or jaw/mandible, and/or swelling or failure of healing of sores in the mouth or in the jaw/mandible, presence of discharge, numbness or a feeling of heaviness in the jaw/mandible, or loosening of a tooth, as these signs could indicate a serious deterioration of the jaw/mandible bone tissue (osteonecrosis).

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

• bone, joint and/or muscle pain, sometimes severe,
• shortness of breath (dyspnea),
• diarrhoea.

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

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

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

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

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

• allergic reactions (e.g. wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; skin rash, itching or hives). In rare cases, allergic reactions can be severe.

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 get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bilprevda

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.
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 not be returned to the refrigerator and 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 Bilprevda contains

• The active substance is denosumab. Each vial contains 120 mg 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.

Description of the appearance of Bilprevda and contents of the pack
Bilprevda is an injectable solution (injectable).
Bilprevda is a solution ranging from clear to slightly opalescent, from colourless to slightly yellow. It may contain traces of particles from transparent to white.
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 about 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 Bilprevda 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 shows any discoloration.
• 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 slowly.
• The entire contents of the vial must be administered.
• A 27-gauge steel needle is recommended for denosumab administration.
• The vial must not be reused.

Any unused medicinal product and waste material derived from this medicine must be disposed of in accordance with
local applicable regulations.