Stoboclo 60 mg solution for injection in pre-filled syringe

Patient Information Leaflet

Introduction

Patient Information Leaflet

Stoboclo 60 mg solution for injection in pre-filled syringe

denosumab

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

Read this entire leaflet carefully before you start using this medicine, as 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 or pharmacist.
• This medicine has been prescribed for you only; do not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects 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 your treatment with Stoboclo.

Leaflet Contents

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

1. What Stoboclo is and what it is used for

What Stoboclo is and how it works

Stoboclo contains denosumab, a protein (monoclonal antibody) that interferes with the action of another protein, aiming to treat bone loss and osteoporosis. Treatment with Stoboclo strengthens bones and reduces the risk of fractures.

Bone is living tissue that is constantly being renewed. Oestrogens help maintain bone health. After menopause, oestrogen levels decrease, which may cause bones to become thinner and more fragile. Over time, this can lead to a condition called osteoporosis. Osteoporosis can also occur in men due to various causes, including age and/or low levels of the male hormone testosterone. It can also occur in patients receiving glucocorticoid treatment. Many patients with osteoporosis do not have symptoms, yet they still have an increased risk of bone fractures, particularly in the spine, hip, and wrists.

Surgical procedures or medications that suppress the production of oestrogen or testosterone, used to treat patients with prostate or breast cancer, can also cause bone loss. As a result, bones become weaker and more prone to breaking.

What Stoboclo is used for

Stoboclo is used to treat:

• postmenopausal osteoporosis in women and osteoporosis in men who have an increased risk of fracture, by reducing the risk of hip, vertebral, and non-vertebral fractures.
• bone loss caused by reduced hormone levels (testosterone) due to surgical intervention or medication in patients with prostate cancer.
• bone loss resulting from long-term glucocorticoid therapy in patients at high risk of fracture.

2. What you need to know before using Stoboclo

Do not use Stoboclo:

• if you have low levels of calcium in your blood (hypocalcemia).
• if you are allergic to denosumab or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Stoboclo.

While being treated with Stoboclo, you may develop a skin infection with symptoms such as a swollen and red area of skin, most commonly on the lower leg, which feels warm and tender to the touch (cellulitis), and which may be accompanied by fever. Contact your doctor immediately if you experience any of these symptoms.

In addition, you must take calcium and vitamin D supplements during treatment with Stoboclo. Your doctor will discuss this with you.

While receiving Stoboclo, you may develop low levels of calcium in the blood. Contact your doctor immediately if you notice any of the following symptoms: muscle spasms, contractions or cramps, and/or numbness or tingling in the fingers, toes, or around the mouth, and/or seizures, confusion, or loss of consciousness.

In rare cases, very low levels of calcium in the blood have been reported, requiring hospitalization and, in some cases, potentially life-threatening reactions. Therefore, before each dose is administered, and in patients at risk of hypocalcemia, your blood calcium levels will be checked (via a blood test) within two weeks after the initial dose.

Inform your doctor if you have or have had severe kidney problems, renal failure, if you have required dialysis, or if you are taking medicines called glucocorticoids (such as prednisolone or dexamethasone), as these may increase your risk of low blood calcium levels if calcium supplements are not taken.

Problems with mouth, teeth, or jaw

In patients receiving denosumab for osteoporosis, a rare adverse effect called osteonecrosis of the jaw (ONJ) (damage to the jaw bone) has been reported (may affect up to 1 in 1,000 people). The risk of ONJ increases in patients treated for a long time (may affect up to 1 in 200 people if treated for 10 years). ONJ may also occur after stopping treatment. It is important to try to prevent ONJ from developing, as it can be a painful condition that may be difficult to treat. To reduce the risk of developing ONJ, follow these precautions:

Before starting treatment, inform your doctor or nurse (healthcare professional) if:

• you have any problems with your mouth or teeth, such as poor dental health, gum disease, or planned dental extraction.
• you do not receive regular dental check-ups or have not had a dental check-up for a long time.
• you are a smoker (as this may increase the risk of dental problems).
• you have previously been treated with a bisphosphonate (used to prevent or treat bone disorders).
• you are taking medicines called corticosteroids (such as prednisolone or dexamethasone).
• you have cancer.

Your doctor may ask you to have a dental examination before starting treatment with Stoboclo.

While being treated with Stoboclo, you should maintain good oral hygiene and have routine 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 Stoboclo.

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 symptoms of ONJ.

Unusual femur fractures

Some people have developed unusual fractures in the femur while being treated with denosumab. Talk to your doctor if you experience new or unusual pain in your hip, groin, or thigh.

Children and adolescents

Stoboclo should not be used in individuals under 18 years of age.

Using Stoboclo with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. It is especially important that you inform your doctor if you are being treated with another medicine containing denosumab.

You must not use Stoboclo together with another medicine containing denosumab.

Pregnancy and breastfeeding

Stoboclo has not been studied in pregnant women. It is important to inform your doctor if you are pregnant, think you might be pregnant, or plan to become pregnant. Stoboclo is not recommended during pregnancy. Women of childbearing potential should use effective contraception during treatment with Stoboclo and for at least 5 months after stopping treatment with Stoboclo.

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

It is unknown whether denosumab is excreted in human breast milk. It is important to inform your doctor if you are breastfeeding or plan to breastfeed. Your doctor will help you decide whether to discontinue breastfeeding or to stop using Stoboclo, taking into account the benefits of breastfeeding for the child and the benefits of Stoboclo for the mother.

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Stoboclo contains sorbitol (E420)

This medicine contains 47 mg of sorbitol per ml of solution.

Stoboclo contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 60 mg; therefore, it is essentially “sodium-free”.

Stoboclo contains polysorbate 20 (E432)

This medicine contains 0.1 mg of polysorbate 20 in each syringe, equivalent to 0.1 mg/ml.

Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How to use Stoboclo

The recommended dose is one pre-filled syringe of 60 mg administered subcutaneously as a single injection once every 6 months. The best sites for the injection are the upper thighs and the abdomen. If the injection is administered by a caregiver, it may also be given in the outer side of the upper arm. Consult your doctor for the date of your next possible injection. Each Stoboclo package contains a reminder card included in the carton, which is used to keep a record of the date of your next injection.

Additionally, you must take calcium and vitamin D supplements during treatment with Stoboclo. Your doctor will discuss this with you.

Your doctor may decide whether it is better for you or a caregiver to administer the Stoboclo injection. Your doctor or healthcare professional will show you or your caregiver how to use Stoboclo. If you would like instructions on how to inject Stoboclo, read the last section of this leaflet.

Do not shake.

If you forget to use Stoboclo

If you miss a dose of Stoboclo, the injection should be administered as soon as possible. After that, injections should be scheduled every 6 months from the date of the last injection.

If you stop treatment with Stoboclo

To get the maximum benefit from your treatment and to reduce the risk of fractures, it is important that you use Stoboclo for the entire period prescribed by your doctor. Do not stop treatment without first talking to your doctor.

4. Possible side effects

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

Patients treated with Stoboclo may occasionally develop skin infections (mainly cellulitis). Contact your doctor immediately if any of the following symptoms occur during treatment with Stoboclo: a swollen and red area of skin, usually on the lower leg, which is warm and tender to the touch and may be accompanied by fever.

Rarely, patients receiving Stoboclo may develop mouth and/or jaw pain, swelling or non-healing ulcers in the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth. These could be symptoms of bone damage in the jaw (osteonecrosis). Contact your doctor and dentist immediately if you experience such symptoms while being treated with Stoboclo or after stopping treatment.

Rarely, patients receiving Stoboclo may develop low levels of calcium in the blood (hypocalcemia); very low calcium levels may require hospitalization and could even be life-threatening. Symptoms include muscle spasms, contractions or cramps, and/or numbness or tingling in the fingers, toes, or around the mouth, and/or seizures, confusion, or loss of consciousness. If you experience any of these, contact your doctor immediately. Low calcium levels in the blood may also cause a change in heart rhythm known as QT prolongation, which can be detected by performing an electrocardiogram (ECG).

Rarely, unusual femur fractures may occur in patients receiving Stoboclo. Consult your doctor if you experience new or unusual pain in the hip, groin, or thigh, as this may be an early sign of a possible femur fracture.

Rarely, allergic reactions may occur in patients receiving Stoboclo. Symptoms include swelling of the face, lips, tongue, throat, or other body parts; skin rash, itching, or hives; wheezing or difficulty breathing. Contact your doctor if you experience such symptoms while being treated with Stoboclo.

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

• bone, joint and/or muscle pain, sometimes severe,
• pain in arms or legs (limb pain).

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

• painful urination, frequent urination, blood in the urine, urinary incontinence,
• upper respiratory tract infection,
• pain, tingling, or numbness radiating down the lower leg (sciatica),
• constipation,
• abdominal discomfort,
• skin rash,
• skin condition with itching, redness and/or dryness (eczema),
• hair loss (alopecia).

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

• fever, vomiting, and abdominal pain or discomfort (diverticulitis),
• ear infection,
• skin rash or mouth ulcers (drug-induced lichenoid eruptions).

Rare side effects (may affect up to 1 in 10,000 people):

• allergic reaction that may damage blood vessels, mainly in the skin (e.g. purple or brownish-red spots, hives, or skin ulcers) (hypersensitivity vasculitis).

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

• contact your doctor if you have ear pain, discharge from the ear, and/or an ear infection. These could be symptoms of damage to the ear bones.

Reporting of side effects

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

5. Storage of Stoboclo

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

Do not use this medicine after the expiry date stated on the label and the carton 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 pre-filled syringe in the outer packaging to protect it from light.

Before injection, the pre-filled syringe may be removed from the refrigerator and allowed to reach room temperature (up to 25 °C) to make the injection less uncomfortable. Once the syringe has reached room temperature (up to 25 °C), it must be used within 30 days.

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

6. Package contents and other information

Composition of Stoboclo

• The active substance is denosumab. Each 1 ml pre-filled syringe contains 60 mg of denosumab (60 mg/mL).
• The other components are acetic acid, sodium acetate trihydrate, sorbitol (E420), polysorbate 20 (E432), and water for injections.

Appearance of Stoboclo and contents of the pack

Stoboclo is a clear, colourless to pale yellow injectable solution available in a ready-to-use pre-filled syringe.

Each pack contains one pre-filled syringe with a safety guard.

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,

06410 Biot,

France

Manufacturer

Midas Pharma GmbH

Rheinstrasse 49, West,

55218 Ingelheim Am Rhein,

Rhineland-Palatinate,

Germany

Manufacturer

Kymos S.L.

Ronda de Can Fatjó, 7B

Parc Tecnològic del Vallès,

Cerdanyola del Vallès,

08290 Barcelona,

Spain

For further information on this medicinal product, please contact 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 website of the European Medicines Agency: https://www.ema.europa.eu.

Instructions for use:

Read and follow the instructions for use provided with the Stoboclo pre-filled syringe before starting to use it and each time you receive a new supply. It may contain new information. Stoboclo may be administered by healthcare professionals, caregivers, or self-administered by patients if they have been properly trained. Consult your doctor if you have any questions about how to give yourself an injection.