BOMYNTRA 120 mg Injectable Solution in Vial

2. What you need to know before you use Bomyntra

Do not use Bomyntra

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

• if you have very low levels of calcium in your blood that have not been treated.

• if you have open wounds in your jaw due to dental or oral surgery.

Warnings and precautions

Consult your doctor before starting treatment with Bomyntra.

Calcium and vitamin D supplements

You should take calcium and vitamin D supplements during treatment with Bomyntra unless you have high levels of calcium in your blood. Your doctor will explain this to you. If your blood calcium levels are low, your doctor may decide to prescribe calcium supplements before starting treatment with Bomyntra.

Low blood calcium levels

Contact your doctor immediately if you experience muscle spasms, twitches, or cramps, and/or numbness or tingling in your fingers and toes or around your mouth, and/or seizures, confusion, or loss of consciousness during treatment with Bomyntra. You may have low blood calcium levels.

Kidney problems

Tell your doctor if you have or have had severe kidney problems, kidney failure, or if you have needed dialysis, as this may increase the risk of low blood calcium levels, especially if you do not take calcium supplements.

Problems with your mouth, teeth, and jaw

A side effect called jaw bone damage (osteonecrosis of the jaw) has been reported in patients receiving injectable Bomyntra for cancer-related conditions. Osteonecrosis of the jaw can also occur after stopping treatment.

It is essential to try to prevent the development of osteonecrosis of the jaw, as it can be a painful condition that can be difficult to treat. To reduce the risk of developing osteonecrosis of the jaw, you should take some precautions:

• Before treatment, tell 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 open wounds in your mouth due to dental or oral surgery. Your doctor will recommend a dental examination before starting treatment with Bomyntra.
• While being treated, you should maintain good oral hygiene and receive regular dental check-ups. If you wear dental prostheses, you should ensure they fit properly.
• If you are undergoing dental treatment or are going to have dental surgery (e.g., tooth extractions), inform your doctor about your dental treatment and inform your dentist that you are being treated with Bomyntra.
• Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth, such as loose teeth, pain, or swelling, ulcers that do not heal, or discharge, as these could be signs of osteonecrosis of the jaw.

Patient undergoing chemotherapy and/or radiotherapy, taking steroids or anti-angiogenic medications (used to treat cancer), undergoing dental surgery, not receiving regular dental check-ups, having gum disease, or being a smoker may have a higher 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 Bomyntra. Contact your doctor if you experience recent or unusual pain in the hip, groin, or thigh.

High blood calcium levels after stopping treatment with Bomyntra

Some patients with giant cell tumors of bone have developed high blood calcium levels weeks or months after stopping treatment. Your doctor will monitor you for signs and symptoms of high blood calcium levels after stopping treatment with Bomyntra.

Children and adolescents

Bomyntra 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 Bomyntra has not been studied in children and adolescents with other types of cancer that have spread to the bones.

Other medicines and Bomyntra

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes those bought without a prescription. It is very important that you tell your doctor if you are being treated with

• another medicine that contains denosumab
• a bisphosphonate

You should not take Bomyntra with other medicines that contain denosumab or bisphosphonates.

Pregnancy and breastfeeding

Bomyntra has not been tested in pregnant women. It is essential that you tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Bomyntra should not be used during pregnancy. Women of childbearing age should use effective contraceptive methods during treatment with Bomyntra and for at least 5 months after stopping treatment with Bomyntra.

If you become pregnant during treatment with Bomyntra or less than 5 months after stopping treatment with Bomyntra, please tell your doctor.

It is not known if Bomyntra is excreted in breast milk. It is essential that you tell your doctor if you are breastfeeding or plan to breastfeed. Your doctor will help you decide whether to stop breastfeeding or stop taking Bomyntra, considering the benefit of breastfeeding for the child and the benefit of Bomyntra for the mother.

If you are breastfeeding during treatment with Bomyntra, please tell your doctor. Consult your doctor or pharmacist before taking any other medicine.

Driving and using machines

Bomyntra has no or negligible influence on the ability to drive and use machines.

Bomyntra contains sorbitol

This medicine contains 78 mg of sorbitol in each vial.

Bomyntra contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 120 mg dose; this is essentially "sodium-free".

Bomyntra contains polysorbate 20

This medicine contains 0.17 mg of polysorbate 20 in each vial, equivalent to 0.10 mg/ml. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

3. How to use Bomyntra

Bomyntra should be administered under the responsibility of a healthcare professional.

The recommended dose of Bomyntra is 120 mg administered once every 4 weeks in a single injection under the skin (subcutaneously). Bomyntra will be injected into the thigh, abdomen, or upper arm. If you are being treated for giant cell tumor of bone, you will receive an additional dose 1 and 2 weeks after the first dose.

Do not shake.

You should also take calcium and vitamin D supplements during treatment with Bomyntra unless you have high levels of calcium in your blood. Your doctor will explain this to you.

If you have any further questions on 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 gets them.

Tell your doctor immediatelyif you experience any of these symptoms during treatment with Bomyntra:

• muscle spasms, twitches, or cramps, and/or numbness or tingling in your fingers and toes or around your mouth, and/or seizures, confusion, or loss of consciousness. These symptoms may be a sign that your blood calcium levels are low. Low blood calcium levels can also cause a change in heart rhythm called QT prolongation, which can be seen on an electrocardiogram (ECG).

Tell your doctor and dentist immediatelyif you experience any of these symptoms during treatment with Bomyntra or after stopping treatment:

• persistent pain in your mouth and/or jaw, swelling, and/or ulcers that do not heal in your mouth or jaw, discharge, numbness, or a feeling of heaviness in the jaw or loosening of a tooth may be signs of jaw bone damage (osteonecrosis).

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

• bone, joint, and/or muscle pain that can be severe,
• breathing difficulties,
• diarrhea.

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

• low levels of phosphate in the blood (hypophosphatemia),
• tooth 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 levels of calcium in the blood (hypercalcemia) after stopping treatment in patients with giant cell tumor of bone,
• recent 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 difficulty breathing; swelling of the face, lips, tongue, throat, or other parts of the body; skin rash, itching, or hives). In rare cases, allergic reactions can be severe.

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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 Bomyntra

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 carton and label after "EXP". The expiry date refers to the last day of the month shown.

Store in a refrigerator (2°C - 8°C).

Do not freeze.

Keep the vial in the outer packaging to protect it from light.

Before injection, the vial may be left outside the refrigerator to reach room temperature (up to 25°C). This will make the injection less painful. Once the vial has reached room temperature (up to 25°C), it must be used within 30 days.

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

6. Contents of the pack and other information

What Bomyntra contains

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

Appearance and packaging

Bomyntra is a solution for injection.

Bomyntra is a clear, colorless to slightly yellowish solution without visible particles.

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

Not all pack sizes may be marketed.

Marketing authorization holder

Fresenius Kabi Deutschland GmbH

Else-Kroener-Strasse 1

61352 Bad Homburg von der Hoehe

Germany

Manufacturer

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

8055 Graz

Austria

Date of last revision of this leaflet

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

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This information is intended only for healthcare professionals:

• The Bomyntra solution should be inspected visually before administration. The solution should not contain visible particles. Do not inject the solution if it is cloudy or discolored.
• Do not shake.
• To avoid discomfort at the injection site, let the vial reach room temperature (up to 25°C) before injecting and inject slowly.
• The entire contents of the vial should be injected.
• For the administration of denosumab, it is recommended to use a 27 G needle.
• Do not reinsert the needle into the vial.

Disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.