Osenvelt

Package leaflet: Information for the patient

Osenvelt 120 mg injectable solution

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 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 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, talk to your doctor, pharmacist, or nurse. See section 4.
• Your doctor will provide you with a patient reminder card containing important safety information that you need to know before and during treatment with Osenvelt.

Contents of this leaflet

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

1. What Osenvelt is and what it is used for

Osenvelt contains denosumab, a protein (monoclonal antibody) that works by reducing bone destruction caused by the spread of tumour to the bone (bone metastases) or by giant cell tumour of the bone.
Osenvelt is used in adults with advanced cancer to prevent serious complications caused by bone metastases (e.g. fracture, pressure on the spinal cord, or need for radiotherapy or surgery).
Osenvelt is also used to treat giant cell tumour of the bone that cannot be treated surgically or where surgery is not the best option, in adults and in adolescents whose bones have stopped growing.

2. What you need to know before using Osenvelt

Do not use Osenvelt

• 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 Osenvelt to you if you have severely low levels of calcium in your blood that have not been treated.
The healthcare provider will not administer Osenvelt if you have untreated dental or oral surgical wounds.

Warnings and precautions

Talk to your doctor before using Osenvelt.

Calcium and vitamin D supplementation
You must take calcium and vitamin D supplements while being treated with Osenvelt, unless 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 Osenvelt.

Low calcium levels in the blood
Tell your doctor immediately if, during treatment with Osenvelt, you experience muscle spasms, twitching, or cramps, and/or numbness or tingling in your fingers, toes, or around your mouth, and/or seizures, confusion, or loss of consciousness. These may be signs of low calcium levels in your blood.

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

Problems with mouth, teeth, or jaw
A side effect called osteonecrosis of the jaw has been commonly reported (may occur in up to 1 in 10 people) in patients receiving denosumab injections 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 is a painful condition that can be difficult to treat. To reduce the risk of developing osteonecrosis of the jaw, you should take the following precautions:

• Before starting treatment, inform your doctor/nurse (healthcare provider) if you have any mouth or dental problems. Your doctor should delay the start of 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 Osenvelt.
• During treatment, you must maintain good oral hygiene and have regular dental check-ups. If you wear dentures, ensure they fit properly.
• If you are currently undergoing dental treatment or are scheduled to have dental surgery (e.g., tooth extraction), inform your doctor about the dental procedure and inform your dentist that you are being treated with Osenvelt.
• Contact your doctor and dentist immediately if you notice any new mouth or dental problems, such as loose teeth, pain or swelling, or failure of mouth sores to heal, or presence of discharge, as these could be signs of osteonecrosis of the jaw.

Patients who are receiving chemotherapy and/or radiotherapy, those taking steroids or anti-angiogenic medicines (used to treat cancer), those undergoing dental surgery, those not receiving routine dental care, those with gum disease, or smokers 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 calcium levels in the blood after stopping denosumab treatment
Some patients with giant cell tumor of bone have developed high calcium levels in the blood weeks to months after stopping treatment. Your doctor will monitor you for signs and symptoms of high calcium levels after you stop taking Osenvelt.

Children and adolescents
Osenvelt 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 Osenvelt in children and adolescents with other cancers that have spread to bone has not been studied.

Other medicines and Osenvelt
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. In particular, it is important to inform your doctor if you are taking:

• another medicine containing denosumab
• a bisphosphonate

You must not take Osenvelt together with other medicines containing denosumab or bisphosphonates.

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

If you become pregnant during treatment with Osenvelt or within 5 months after stopping treatment with Osenvelt, please inform your doctor.

It is not known whether Osenvelt is excreted in human 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 stop taking Osenvelt, taking into account the benefits of breastfeeding for the child and the benefits of Osenvelt for the mother.

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

Talk to your doctor or pharmacist before taking this medicine.

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

Osenvelt contains sorbitol (E420)
This medicine contains 79.9 mg of sorbitol per vial.

Osenvelt contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 120 mg dose, i.e., essentially 'sodium-free'.

Osenvelt contains polysorbate 20 (E432)
This medicine contains 0.17 mg of polysorbate 20 per vial, equivalent to 0.1 mg/mL.
Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Osenvelt

Osenvelt must be administered under the supervision of a healthcare professional.
The recommended dose of Osenvelt is 120 mg given once every 4 weeks, as a single
subcutaneous injection (under the skin). Osenvelt will be injected into the thigh, abdomen, or upper arm. If you are being treated for giant cell bone tumour, you will receive additional doses 1 week and 2 weeks after the first dose.
Do not shake.
During treatment with Osenvelt, 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 everyone gets them.
Contact your doctor immediately if, during treatment with Osenvelt, 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 interval prolongation, which is seen on an electrocardiogram (ECG).

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

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

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

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

Common side effects (may occur in 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 form of tumour.

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

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

Rare side effects (may occur in 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; rash, itching or hives on the skin). In rare cases, allergic reactions may 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 experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via 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 Osenvelt

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
packaging 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) prior to 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 medicines 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 Osenvelt 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 acetic acid, sodium acetate trihydrate, sorbitol (E420), polysorbate 20 (E432) and water for injections.

Description of the appearance of Osenvelt and contents of the pack
Osenvelt is an injectable solution (injectable).
Osenvelt is a clear, colourless to pale yellow solution.
Each pack contains one, three or four single-use vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Celltrion Healthcare Hungary Kft.
062 Budapest
Váci út 1-3. WestEnd Office Building B tower
Hungary

Manufacturer
Nuvisan France S.A.R.L
2400 Route des Colles,
Biot, 06410
France

Manufacturer
Midas Pharma GmbH
Rheinstrasse 49, West,
Ingelheim Am Rhein,
Rhineland-Palatinate, 55218
Germany

Manufacturer
Kymos S.L.
Ronda de Can Fatjó, 7B
Parc Tecnològic del Vallès,
Cerdanyola del Vallès,
Barcelona, 08290
Spain

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

België/Belgique/Belgien Lietuva
Celltrion Healthcare Belgium BVBA EGIS PHARMACEUTICALS PLC atstovybė
Tél/Tel: + 32 1528 7418 Tel: +370 5 231 4658
[email protected]

България Luxembourg/Luxemburg
EGIS Bulgaria EOOD Celltrion Healthcare Belgium BVBA
Tel.: + 359 2 987 6040 Tél/Tel: + 32 1528 7418
[email protected]

Česká republika Magyarország
EGIS Praha, spol. s r.o Egis Gyógyszergyár Zrt.
Tel: + 420 227 129 111 Tel.: + 36 1 803 5555

Danmark Malta
Celltrion Healthcare Denmark ApS Mint Health Ltd
Tlf.: +45 3535 2989 Tel: +356 2093 9800
[email protected]

Deutschland Nederland
Celltrion Healthcare Deutschland GmbH Celltrion Healthcare Netherlands B.V.
Tel: +49 (0)30 346494150 Tel: + 31 20 888 7300
[email protected] [email protected]

Eesti Norge
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Norway AS
[email protected] [email protected]

Ελλάδα Österreich
ΒΙΑΝΕΞ Α.Ε. Astro-Pharma GmbH
Τηλ: +30 210 8009111 - 120 Tel: +43 1 97 99 860

España Polska
CELLTRION FARMACEUTICA (ESPAÑA) EGIS Polska Sp. z o.o.
S.L. Tel.: + 48 22 417 9200
Tel: +34 919 94 23 90

France Portugal
Celltrion Healthcare France SAS CELLTRION PORTUGAL, UNIPESSOAL
Tél.: +33 (0)1 71 25 27 00 LDA
Tel: +351 21 936 8542

Hrvatska România
Oktal Pharma d.o.o. Egis Pharmaceuticals PLC Romania
Tel: +385 1 6595 777 Tel: + 40 21 412 0017

Ireland Slovenija
Celltrion Healthcare Ireland Limited OPH Oktal Pharma d.o.o.
Tel: +353 1 223 4026 Tel.: +386 1 519 29 22
[email protected]

Ísland Slovenská republika
Celltrion Healthcare Hungary Kft. EGIS SLOVAKIA spol. s r.o
[email protected] Tel: +421 2 3240 9422

Italia Suomi/Finland
Celltrion Healthcare Italy S.R.L. Celltrion Healthcare Finland Oy.
Tel: +39 0247927040 Puh/Tel: +358 29 170 7755
[email protected] [email protected]

Κύπρος Sverige
C.A. Papaellinas Ltd Celltrion Healthcare Hungary Kft.
Τηλ: +357 22741741 [email protected]

Latvija
EGIS Pharmaceuticals PLC pārstāvniecība Latvijā
Tel: +371 67613859

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:

• Prior to administration, the Osenvelt solution should be inspected visually. Do not inject the solution if visible particles are present, if it is cloudy, or if there is 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 medicine and waste material derived from this medicine must be disposed of in accordance with
local applicable regulations.