Xbonzy

Package leaflet: Information for the patient

Xbonzy 120 mg solution for injection

denosumab
This medicinal product is subject to additional monitoring. This will allow 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, contact your doctor, pharmacist, or nurse. See section 4.
• You will be given a patient reminder card containing important safety information that you must know before and during treatment with Xbonzy.

Contents of this leaflet

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

1. What Xbonzy is and what it is used for

Xbonzy contains denosumab, a protein (monoclonal antibody) that works to reduce bone destruction caused by the spread of cancer to the bone (bone metastases) or by giant cell tumor of bone.
Xbonzy is used in adults with advanced cancer to prevent serious complications due to bone metastases (e.g., fracture, spinal cord compression, or the need for radiation therapy or surgery).
Xbonzy is also used to treat giant cell tumor of bone that 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 using Xbonzy

Do not use Xbonzy

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

Warnings and precautions
Talk to your doctor before using Xbonzy.

Calcium and vitamin D supplementation
You must take calcium and vitamin D supplements while being treated with Xbonzy, except in cases where 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 Xbonzy.

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

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

Problems with mouth, teeth or jaw
A side effect called osteonecrosis of the jaw (a serious deterioration of the jawbone) has been commonly reported (may occur in up to 1 in 10 people) in patients receiving Xbonzy 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 receiving 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 Xbonzy.
• During treatment, you must maintain good oral hygiene and have regular dental check-ups. If you wear dentures, ensure they are properly fitted.
• If you are currently undergoing dental treatment or are planning to have dental surgery (e.g., tooth extractions), inform your doctor about the dental procedure and inform your dentist that you are being treated with Xbonzy.
• Contact your doctor and dentist immediately if you notice any new problems with your mouth or teeth, such as loose teeth, pain or swelling, or failure of mouth sores to heal, or if you have discharge, as these could be signs of osteonecrosis of the jaw.

Patients who are receiving chemotherapy and/or radiotherapy, who are taking steroids or anti-angiogenic medicines (used to treat cancer), who undergo dental surgery, who do not receive routine dental care, who have gum problems, or who smoke may have an increased risk of developing osteonecrosis of the jaw.

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 pain in your hip, groin, or thigh.

High levels of calcium in the blood after stopping Xbonzy treatment
Some patients with giant cell tumour of the bone have developed high levels of calcium 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 Xbonzy.

Children and adolescents
Xbonzy is not recommended for children and adolescents under 18 years of age, except for adolescents with giant cell tumour of the bone whose bones have stopped growing. The use of denosumab in children and adolescents with other cancers that have spread to the bones has not been studied.

Other medicines and Xbonzy
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 that you inform your doctor if you are taking:

• another medicine containing denosumab
• a bisphosphonate

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

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

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

It is not known whether denosumab 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 discontinue Xbonzy, taking into account the benefits of breastfeeding for the child and the benefits of Xbonzy for the mother.

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

Ask your doctor or pharmacist for advice before taking this medicine.

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

3. How to use Xbonzy

Xbonzy must be administered under the supervision of a healthcare professional.
The recommended dose of Xbonzy is 120 mg given once every 4 weeks, as a single
subcutaneous (under the skin) injection. Xbonzy 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 Xbonzy, you must also take calcium and vitamin D supplements unless you have high levels of 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 experiences them.
Contact your doctor immediately if, during treatment with Xbonzy, 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 in the blood 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 treatment with Xbonzy or after stopping treatment with Xbonzy, you notice any of the following symptoms (may affect up to 1 in 10 people):

• persistent pain in the mouth and/or jaw, and/or swelling or failure of mouth sores to heal, or 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 (osteonecrosis).

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

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

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 type of tumour.

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 tumour of bone,
• new or unusual pain in the hip, groin or thigh (this could be an early sign of a possible femur fracture),
• rash which 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 body parts; skin rash, itching or hives). 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 through the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Xbonzy

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
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 any medicine 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 Xbonzy 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 L-histidine, L-histidine monohydrochloride monohydrate, sucrose, poloxamer 188 and water for injections.

Description of the appearance of Xbonzy and contents of the pack
Xbonzy is an injectable solution (injection).
Xbonzy is a clear, colourless to slightly yellow solution. It may contain traces of translucent to white protein particles.
Each pack contains one, three or four single-use vials.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Reddy Holding GmbH
Kobelweg 95
86156 Augsburg
Germany

Manufacturer
Alvotech hf
Sæmundargata 15-19
102 Reykjavik
Iceland

For further information about this medicine, please contact the local representative of the marketing authorization holder:

België/Belgique/Belgien Lietuva
betapharm Arzneimittel GmbH betapharm Arzneimittel GmbH
Tél/Tel: + 49 821 74881 0 Tel: + 49 821 74881 0
[email protected] [email protected]

България Luxembourg/Luxemburg
betapharm Arzneimittel GmbH betapharm Arzneimittel GmbH
Teл.: +49 821 74881 0 Tél/Tel: + 49 821 74881 0
[email protected] [email protected]

Česká republika Magyarország
betapharm Arzneimittel GmbH betapharm Arzneimittel GmbH
Tel: +49 821 74881 0 Tel.: + 49 821 74881 0
[email protected] [email protected]

Danmark Malta
betapharm Arzneimittel GmbH betapharm Arzneimittel GmbH
Tlf: + 49 821 74881 0 Tel: + 49 821 74881 0
[email protected] [email protected]

Deutschland Nederland
betapharm Arzneimittel GmbH betapharm Arzneimittel GmbH
Kobelweg 95 Tel: + 49 821 74881 0
86156 Augsburg [email protected]
Tel: + 49 821 74881 0

Eesti Norge
betapharm Arzneimittel GmbH betapharm Arzneimittel GmbH
Tel: + 49 821 74881 0 Tlf: + 49 821 74881 0
[email protected] [email protected]

Ελλάδα Österreich
betapharm Arzneimittel GmbH betapharm Arzneimittel GmbH
Τηλ: + 49 821 74881 0 Tel: + 49 821 74881 0
[email protected] [email protected]

España Polska
Reddy Pharma Iberia S.A.U. betapharm Arzneimittel GmbH
Avenida Josep Tarradellas nº 38 Tel.: + 49 821 74881 0
E-08029 Barcelona [email protected]
Tel: + 34 93 355 49 16
[email protected]

France Portugal
Reddy Pharma SAS betapharm Arzneimittel GmbH
9 avenue Edouard Belin Tel: + 49 821 74881 0
F-92500 Rueil-Malmaison [email protected]
Tél: + 33 1 85 78 17 34
[email protected]

Hrvatska România
betapharm Arzneimittel GmbH Dr. Reddy´s Laboratories Romania SRL
Tel: + 49 821 74881 0 Tel: + 4021 224 0032
[email protected] [email protected]

Ireland Slovenija
betapharm Arzneimittel GmbH betapharm Arzneimittel GmbH
Tel: + 49 821 74881 0 Tel: + 49 821 74881 0
[email protected] [email protected]

Ísland Slovenská republika
betapharm Arzneimittel GmbH betapharm Arzneimittel GmbH
Sími: + 49 821 74881 0 Tel: + 49 821 74881 0
[email protected] [email protected]

Italia Suomi/Finland
Dr. Reddy’s S.r.l. betapharm Arzneimittel GmbH
Piazza Santa Maria Beltrade, 1 Puh/Tel: + 49 821 74881 0
I-20123 Milano [email protected]
Tel: + 39(0)2 70106808
[email protected]

Κύπρος Sverige
betapharm Arzneimittel GmbH betapharm Arzneimittel GmbH
Τηλ: + 49 821 74881 0 Tel: + 49 821 74881 0
[email protected] [email protected]

Latvija
betapharm Arzneimittel GmbH
Tel: + 49 821 74881 0
[email protected]

More detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu/.

The following information is intended for healthcare professionals only:

• Prior to administration, the Xbonzy solution should be inspected visually. The solution may contain traces of proteinaceous particles ranging from translucent to white. Do not inject the solution if it is cloudy, discolored, or contains numerous particles or foreign particulate matter.
• 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 regulations.