Osenvelt 120 mg solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Osenvelt 120 mg injection solution

denosumab

This medicinal product is subject to additional monitoring, which will allow rapid identification of new safety information. You can help by reporting any adverse reactions you may experience. Section 4 at the end of this leaflet includes information on how to report adverse reactions.

Read this entire 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 could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
• Your doctor will provide you with a patient reminder card containing important safety information you should 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 inhibits bone destruction occurring when cancer spreads to the bones (bone metastases) or in giant cell tumor of bone.

Osenvelt 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).

Osenvelt 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 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).

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

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

Warnings and precautions

Talk to your doctor before starting treatment with Osenvelt.

Calcium and vitamin D supplements

You must take calcium and vitamin D supplements during treatment with Osenvelt 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 Osenvelt.

Low blood calcium levels

Contact your doctor immediately if 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 during treatment with Osenvelt. Your blood calcium level may be low.

Renal impairment

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

Problems with the mouth, teeth, and jaw

A side effect called osteonecrosis of the jaw (damage to the jaw bone) 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 starting 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 Osenvelt.
• While receiving treatment, 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 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 Osenvelt.
• Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth, such as loose teeth, pain or swelling, non-healing or pus-discharging sores, as these could be signs of osteonecrosis of the jaw.

Patients undergoing chemotherapy and/or radiotherapy, taking steroids or anti-angiogenic medicines (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 an increased 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 levels of calcium in the blood after stopping denosumab treatment

Some patients with giant cell tumor of bone have developed high levels of calcium 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 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 has not been studied in children and adolescents with other types of cancer that have spread to the bones.

Other medicines and Osenvelt

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines 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 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, think you may be pregnant, or plan to become pregnant. Osenvelt is not recommended during pregnancy. Women of childbearing potential must use effective contraception during treatment with 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 unknown whether Osenvelt 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 discontinue 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 any other medicine.

Driving and using machines

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

Osenvelt contains sorbitol (E420)

This medicine contains 79.9 mg of sorbitol per vial.

Osenvelt contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 120 mg dose; hence, it is 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 any 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 tumor of bone, you will receive additional doses 1 and 2 weeks after the first dose.

Do not shake.

You should also take calcium and vitamin D supplements during treatment with Osenvelt unless you have excess 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 side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

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

• muscle spasms, tics, cramps, numbness or tingling in the fingers, 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 may also cause a change in heart rhythm called QT prolongation, which can be seen on an electrocardiogram (ECG).

Tell your doctor and dentist immediately if you experience any of the following symptoms during treatment with Osenvelt 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 loose teeth, which may be signs of bone damage in the jaw (osteonecrosis).

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

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

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

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

Rare side 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). In rare cases, allergic reactions could be severe.

Frequency not known (cannot be estimated from available data):

• consult your doctor if you have ear pain, discharge from the ear, and/or ear infection. These could be symptoms of bone damage in the ear.

Reporting of side effects

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

5. Storage of Osenvelt

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 “CAD” or “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 30 °C) to make the injection less uncomfortable. Once the vial has reached room temperature (up to 30 °C), it may be stored at room temperature for a single period of up to 63 days, without exceeding the original expiry date. If necessary, during this 63-day period, the vial may be returned to the refrigerator once and stored there until the original expiry date.

Dispose of the vial if it has not been used within the single 63-day period at room temperature or by the original expiry date, whichever comes first.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines and packaging no longer required. This will help protect the environment.

6. Contents of the container and other information

Composition of Osenvelt

• 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 acetic acid, sodium acetate trihydrate, sorbitol (E420), polysorbate 20 (E432), and water for injections.

Appearance of the product and contents of the container

Osenvelt is an injectable solution.

Osenvelt is a clear, colourless to pale yellow solution.

Each pack contains one, three, or four single-use vials.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Celltrion Healthcare Hungary Kft.

1062 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

More information about this medicinal product is available upon request to the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

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

This information is intended for healthcare professionals only:

• Osenvelt solution must be visually inspected before administration. Do not inject the solution if it contains visible particles or if it is cloudy or discolored.
• Do not shake.
• To minimize discomfort at the injection site, allow the vial to reach room temperature (up to 30 °C) before injection, and administer the injection slowly.
• The entire contents of the vial must be injected.
• For denosumab administration, it is recommended to use a 27 G gauge needle.
• 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.