Jubbonti 60 mg solution for injection in pre-filled syringe

Patient Information Leaflet

Introduction

Patient Information Leaflet

Jubbonti 60mg solution for injection in pre-filled syringe

denosumab

This medicine is subject to additional monitoring, which will allow quicker detection of new safety information. You can help by reporting any side effects you may experience. Section 4, towards the end, includes information on how to report side effects.

Read this 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 and must not be given to other people, even if they have the same symptoms as you, since it could 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 treatment with Jubbonti.

Leaflet Contents

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

1. What Jubbonti is and what it is used for

What Jubbonti is and how it works

Jubbonti contains denosumab, a protein (monoclonal antibody) that interferes with the action of another protein, aimed at treating bone loss and osteoporosis. Treatment with Jubbonti strengthens bones and reduces the likelihood of fractures.

Bone is a living tissue that is continuously renewed. Estrogens contribute to maintaining bone health. After menopause, estrogen levels decrease, which may cause bones to become thinner and more fragile. Over time, this can lead to a disease called osteoporosis. Osteoporosis can also occur in men due to various causes, including age and/or low levels of the male hormone testosterone. It may also occur in patients receiving glucocorticoid therapy. 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 estrogen or testosterone production, 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 Jubbonti is used for

Jubbonti is used to treat:

• Postmenopausal osteoporosis in women and men who have an increased risk of fracture (bone breakage), reducing the risk of hip, vertebral, and non-vertebral fractures.
• Bone loss caused by reduced hormone levels (testosterone) resulting from surgery or drug treatment in patients with prostate cancer.
• Bone loss resulting from long-term glucocorticoid therapy in patients who have a high risk of fracture.

2. What you need to know before using Jubbonti

Do not use Jubbonti:

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

Warnings and precautions

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

While being treated with Jubbonti, 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. Inform your doctor immediately if you experience any of these symptoms.

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

While receiving Jubbonti, you may develop low levels of calcium in the blood. Inform 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 instances, potentially life-threatening reactions. Therefore, before each dose is administered, and in patients predisposed to hypocalcemia, blood calcium levels will be checked (through 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 the risk of low blood calcium levels if calcium supplements are not taken.

Problems in the 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 may be a painful condition that can be difficult to treat. To reduce the risk of developing ONJ, follow these precautions:

Before receiving 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 a 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 Jubbonti.

While being treated with Jubbonti, 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 Jubbonti.

Contact your doctor and dentist immediately if you experience any problems in your mouth or teeth such as loose teeth, pain or swelling, or non-healing or oozing 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. Consult your doctor if you experience new or unusual pain in your hip, groin or thigh.

Children and adolescents

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

Other medicines and Jubbonti

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 Jubbonti together with another medicine containing denosumab.

Pregnancy and breastfeeding

Denosumab 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. Jubbonti is not recommended during pregnancy. Women of childbearing potential should use effective contraceptive methods during treatment with Jubbonti and for at least 5 months after stopping treatment with Jubbonti.

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

It is unknown whether denosumab is excreted in human 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 stop using Jubbonti, taking into account the benefits of breastfeeding for the child and the benefits of Jubbonti for the mother.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

Jubbonti contains sorbitol

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

Jubbonti contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per ml of solution; this is essentially “sodium-free”.

3. How to use Jubbonti

Follow exactly the instructions for administering this medicine as given by your doctor. If you are unsure, ask your doctor or pharmacist.

The recommended dose is one pre-filled syringe of 60 mg administered under the skin (subcutaneous route) as a single injection every 6 months. The best places to administer the injection are the upper thighs and the abdomen. If the injection is given by a caregiver (a person who cares for you), the injection may also be administered into the outer side of the upper arm. Consult your doctor for the date of your next possible injection. Each Jubbonti pack contains a calendar card with a sticker that can be used to keep a record of the date of your next injection.

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

Your doctor may decide whether it is better for you or a caregiver to administer the Jubbonti injection. Your doctor or healthcare professional will show you or your caregiver how to use Jubbonti.

If you would like instructions on how to inject Jubbonti, please read section 7 “Instructions for use” at the end of this leaflet.

Do not shake.

If you forget to use Jubbonti

If you miss a dose of Jubbonti, 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 using Jubbonti

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

Rarely, patients receiving denosumab may develop pain in the mouth and/or jaw, swelling or non-healing sores in the mouth or jaw, discharge, numbness or heaviness sensation in the jaw, or loose teeth. These could be symptoms of bone damage in the jaw (osteonecrosis). Contact your doctor and dentist immediately if you experience such symptoms while on treatment with Jubbonti or after stopping treatment.

Rarely, patients receiving Jubbonti 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 an electrocardiogram (ECG).

Rarely, unusual femoral fractures may occur in patients receiving Jubbonti. 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 femoral fracture.

Rarely, allergic reactions may occur in patients receiving denosumab. 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 on treatment with Jubbonti.

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

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

Common adverse 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 adverse 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 adverse 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 dark red spots, hives, or skin ulcers) (hypersensitivity vasculitis).

Frequency not known (cannot be estimated from 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 bones of the ear.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Jubbonti

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 “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. Detailed information can be found in section 7 “Instructions for use” at the end of this leaflet.

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. Contents of the pack and other information

Composition of Jubbonti

• The active substance is denosumab. Each 1 ml pre-filled syringe with safety guard contains 60 mg of denosumab (60 mg/ml).
• The other components are glacial acetic acid, sorbitol (E420), polysorbate 20, sodium hydroxide, hydrochloric acid, and water for injections.

Appearance of Jubbonti and contents of the pack

Jubbonti is a clear to slightly opalescent, colourless to slightly yellow or slightly brownish injectable solution. Jubbonti is available in a ready-to-use, transparent, type I glass pre-filled syringe with a 29 G stainless steel needle and safety guard, a rubber needle cap (thermoplastic elastomer), a rubber plunger stopper (bromobutyl rubber), and a plastic syringe rod.

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

Marketing Authorization Holder

Sandoz GmbH

Biochemiestr. 10

6250 Kundl

Austria

Manufacturer

Novartis Pharmaceutical Manufacturing GmbH

Biochemiestr. 10

6336 Langkampfen

Austria

You can request further information about this medicinal product by contacting 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.europa.eu.

1. Instructions for use

These “Instructions for use” contain information on how to inject Jubbonti.

If your doctor decides that you or your caregiver may administer Jubbonti injections at home, ensure that your doctor or nurse shows you or your caregiver how to prepare and give the injection with the Jubbonti pre-filled syringe before using it for the first time.

Make sure to read and understand these Instructions for use before administering the injection with the Jubbonti pre-filled syringe. If you have any doubts, speak with your doctor.