OSENVELT 120 mg Injectable Solution

Зміст інструкції

1. Osenvelt 120 mg injectable solution
   1. What is Osenvelt and what is it used for?
   2. What you need to know before you use Osenvelt
   3. How to use Osenvelt
   4. Possible side effects
   5. How to store Osenvelt
   6. Contents of the pack and other information

Osenvelt 120 mg injectable solution

denosumab
Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before using this medicine as 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 could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
• Your doctor will give you 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 is Osenvelt and what is it used for?

Osenvelt contains denosumab, a protein (monoclonal antibody) that works by decreasing the
destruction of bone caused by the spread of cancer to the bone (bone metastases) or for giant cell bone
tumour.
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 to receive radiotherapy or
surgery).
Osenvelt is also used in the treatment of giant cell bone tumour, which cannot be
treated surgically or where surgery is not the best option, in adults and adolescents whose bones have
stopped growing.

2. What you need to know before you use Osenvelt

Do not use Osenvelt

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

The healthcare professional will not give you Osenvelt if you have a very low level of calcium
in your blood that has not been treated.

The healthcare professional will not give you Osenvelt if you have unhealed wounds from dental or oral
surgery.

Warnings and precautions
Talk to your doctor before using Osenvelt.
Calcium and vitamin D supplementation
You must take calcium and vitamin D supplements while you are 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 blood calcium levels
Tell your doctor immediately if you experience spasms, twitching
or muscle cramps, and/or numbness or tingling in your fingers and toes or around
your mouth, and/or seizures, confusion or loss of consciousness while being treated with Osenvelt. You may have low levels of calcium
in your blood.
Kidney problems
Tell your doctor if you suffer from or have ever suffered from severe kidney problems, kidney failure or if you have
been on dialysis, as these conditions may increase the risk of having low levels of
calcium in your blood, especially if you are not taking calcium supplements.
Problems with the mouth, teeth or jaw/mandible
An undesirable effect called osteonecrosis of the jaw/mandible (severe degeneration of the
bone tissue of the jaw/mandible) has been reported commonly (may occur in up to
1 in 10 people) in patients who received denosumab injections for conditions related to
cancer. Osteonecrosis of the jaw/mandible can also occur after stopping the
treatment.
It is important to try to prevent the development of osteonecrosis of the jaw/mandible as it is
a painful condition that can be difficult to treat. In order to reduce the risk of developing
osteonecrosis of the jaw/mandible you must take some precautions:

• Before receiving treatment, tell your doctor/nurse (healthcare professional) if you have any problems with your mouth or teeth. 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 check-up before starting treatment with Osenvelt.
• During treatment, you must maintain good oral hygiene and have regular dental check-ups. If you wear dentures, you must make sure they fit properly.
• If you are undergoing dental treatment or are planning to have dental surgery (e.g. tooth extractions), tell your doctor about the dental treatment and tell your dentist that you are being treated with Osenvelt.
• Contact your doctor and dentist immediately if you notice the appearance of problems with your mouth or teeth, such as loose teeth, pain or swelling, or failure of mouth sores to heal or the presence of discharge, as these could be signs of osteonecrosis of the jaw/mandible.

Patients who are undergoing chemotherapy and/or radiotherapy, who are taking steroids or
anti-angiogenic medicines (used for the treatment of cancer), who are undergoing dental
surgery, who are not receiving routine dental care, who suffer from gum problems or who are
smokers may have a higher risk of developing osteonecrosis of the jaw/mandible.
Unusual fractures of the thigh bone (femur)
Some people have developed unusual fractures of the femur during treatment with denosumab.
Contact your doctor if you experience new or unusual hip, groin, or thigh pain.
High blood calcium levels after stopping treatment with denosumab
Some patients with giant cell bone tumor have developed high blood calcium levels
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 bone tumor whose bones have stopped growing. The use of
Osenvelt in children and adolescents with other tumors that have invaded the bones has not been studied.

Other medicines and Osenvelt
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 to tell your doctor if you are taking

• another medicine containing denosumab
• a bisphosphonate

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

Pregnancy and breastfeeding
Osenvelt has not been studied in pregnant women. It is important that you tell your doctor if you are
pregnant, suspect you may be pregnant or are planning to become pregnant. The use of Osenvelt is not
recommended if you are pregnant. Women of childbearing potential must use effective
contraceptive methods while taking Osenvelt and for at least 5 months after stopping treatment with
Osenvelt.
If you become pregnant during treatment with Osenvelt or less than 5 months after stopping the
treatment with Osenvelt, please inform your doctor.
It is not known whether Osenvelt is excreted in breast milk. It is important that you tell your doctor if you are
breastfeeding or are planning to breastfeed. Your doctor will then help you decide whether to
stop breastfeeding or stop taking Osenvelt, considering the benefit of breastfeeding for the baby and the benefit of taking Osenvelt for the mother.
If you are breastfeeding during treatment with Osenvelt, please inform your doctor.
Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Osenvelt does not affect or has a negligible effect on the ability to drive and operate 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, which is
essentially ‘sodium-free’.

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

3. How to use Osenvelt

Osenvelt must be administered under the responsibility of a healthcare professional.
The recommended dose of Osenvelt is 120 mg administered once every 4 weeks, as a single
injection under the skin (subcutaneous). Osenvelt 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 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 an excess of calcium in your blood. Your doctor will discuss this with you.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.

Tell your doctor immediatelyif you experience any of these symptoms while being treated with Osenvelt (they may affect more than 1 in 10 people):

• spasms, contractions, muscle 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 may indicate low levels of calcium in the blood. Low levels of calcium in the blood can also lead to a change in heart rhythm called prolongation of the QT interval, which is seen on an electrocardiogram (ECG).

Tell your doctor and dentist immediatelyif you experience any of these symptoms during or after treatment with Osenvelt (may occur in up to 1 in 10 people):

• persistent pain in the mouth and/or jaw/mandible, and/or swelling or failure to heal sores in the mouth or jaw/mandible, presence of discharge, numbness or a feeling of heaviness in the jaw/mandible, or loosening of a tooth, as these signs may indicate severe degeneration of the jaw 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),
• diarrhea.

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 cancer: development of another form of cancer.

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 tumor,
• 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 that may occur on the skin or sores in the mouth (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; rash, itching or hives on the skin). In rare cases, allergic reactions can be severe.

Not known(frequency cannot be estimated from available data):

• tell your doctor if you experience ear pain, ear discharge, and/or an ear infection. These may be signs of damage to the ear bone.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through 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 which is stated on the label after EXP and on the
pack after Scad. 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 left out of the refrigerator in order 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 in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Osenvelt contains

• The active substance is denosumab. Each vial contains 120 mg in 1.7 mL of solution (corresponding to 70 mg/mL).
• The other ingredients 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 solution, from colourless to pale yellow.
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, contact the local representative of the Marketing Authorisation Holder

België/Belgique/Belgien
Celltrion Healthcare Belgium BVBA
Tél/Tel: + 32 1528 7418
[email protected]

Lietuva
EGIS PHARMACEUTICALS PLC representation
Tel: +370 5 231 4658

България
EGIS Bulgaria EOOD
Тел.: + 359 2 987 6040

Luxembourg/Luxemburg
Celltrion Healthcare Belgium BVBA
Tél/Tel: + 32 1528 7418
[email protected]

Česká republika
EGIS Praha, spol. s r.o
Tel: + 420 227 129 111

Magyarország
Egis Gyógyszergyár Zrt.
Tel.: + 36 1 803 5555

Danmark
Celltrion Healthcare Denmark ApS
Tlf.: +45 3535 2989
[email protected]

Malta
Mint Health Ltd
Tel: +356 2093 9800

Deutschland
Celltrion Healthcare Deutschland GmbH
Tel: +49 (0)30 346494150
[email protected]

Nederland
Celltrion Healthcare Netherlands B.V.
Tel: + 31 20 888 7300
[email protected]

Norge
Celltrion Healthcare Norway AS
[email protected]

Ελλάδα
ΒΙΑΝΕΞ Α.Ε.
Τηλ: +30 210 8009111 - 120

Eesti
Celltrion Healthcare Hungary Kft.
[email protected]

Österreich
Astro-Pharma GmbH
Tel: +43 1 97 99 860

España
CELLTRION FARMACEUTICA (ESPAÑA)
S.L.
Tel: +34 919 94 23 90

Polska
EGIS Polska Sp. z o.o.
Tel.: + 48 22 417 9200

France
Celltrion Healthcare France SAS
Tél.: +33 (0)1 71 25 27 00

Portugal
CELLTRION PORTUGAL, UNIPESSOAL
LDA
Tel: +351 21 936 8542

Hrvatska
Oktal Pharma d.o.o.
Tel: +385 1 6595 777

România
Egis Pharmaceuticals PLC Romania
Tel: + 40 21 412 0017

Ireland
Celltrion Healthcare Ireland Limited
Tel: +353 1 223 4026
[email protected]

Slovenija
OPH Oktal Pharma d.o.o.
Tel.: +386 1 519 29 22

Ísland
Celltrion Healthcare Hungary Kft.
[email protected]

Slovenská republika
EGIS SLOVAKIA spol. s r.o
Tel: +421 2 3240 9422

Italia
Celltrion Healthcare Italy S.R.L.
Tel: +39 0247927040
[email protected]

Suomi/Finland
Celltrion Healthcare Finland Oy.
Puh/Tel: +358 29 170 7755
[email protected]

Κύπρος
C.A. Papaellinas Ltd
Τηλ: +357 22741741

Sverige
Celltrion Healthcare Hungary Kft.
[email protected]

Latvija
EGIS Pharmaceuticals PLC representation
in Latvia
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 .

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The following information is intended for healthcare professionals only:

• Before administration, the Osenvelt solution must be visually inspected. Do not inject the solution if it contains visible particles or is cloudy or if there is a change in colour.
• Do not shake.
• To avoid 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 injected.
• A 27-gauge steel needle is recommended for the administration of denosumab.
• The vial must not be reused.

Unused medicinal product and waste materials derived from such medicinal product must be disposed of in accordance with current local regulations.