Bomyntra 120 mg solution for injection in pre-filled syringe – patient leaflet, side effects, dosage

1. What Bomyntra is and what it is used for

Bomyntra contains denosumab, a protein (monoclonal antibody) that works to slow down bone destruction caused by cancer spreading to the bone (bone metastasis) or by giant cell tumour of bone.

Bomyntra is used in adults with advanced cancer to prevent serious complications caused by bone metastasis (e.g. fracture, pressure on the spinal cord or the need to receive radiation therapy or surgery).

Bomyntra is also used to treat giant cell tumour of bone, which cannot be treated by surgery 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 Bomyntra

Do not use Bomyntra

• if you are allergic to denosumab or any of the other ingredients

  of this medicine (listed in section 6).

• Your healthcare professional will not administer Bomyntra to you

  if you have a very low level of calcium in your blood which has not been treated.

• Your healthcare professional will not administer Bomyntra to you

  if you have unhealed wounds from dental or oral surgery.

Warnings and precautions

Talk to your doctor before using Bomyntra.

Calcium and vitamin D supplementation

You should take calcium and vitamin D supplements while being treated with Bomyntra unless your blood calcium is high. Your doctor will discuss this with you. If the level of calcium in your blood is low, your doctor may decide to give you calcium supplements before you start treatment with Bomyntra.

Low calcium levels in the blood

Please tell your doctor immediately if you have spasms, twitches, or cramps in your muscles, and/or numbness or tingling in your fingers, toes or around your mouth and/or seizures, confusion or loss of consciousness while being treated with Bomyntra. You may have low levels of calcium in your blood.

Renal impairment

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

Problems with your mouth, teeth or jaw

A side effect called osteonecrosis of the jaw (bone damage in the jaw) has been reported commonly (may affect up to 1 in 10 people) in patients receiving Bomyntra injections for cancer-related

conditions. Osteonecrosis of the jaw can also occur after stopping treatment.

It is important to try to prevent osteonecrosis of the jaw developing as it may be a painful condition that can be difficult to treat. In order to reduce the risk of developing osteonecrosis of the jaw, there are some precautions you should take:

• 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 your treatment if you have unhealed wounds in your mouth from dental procedures or oral surgery. Your doctor may recommend a dental examination before you start treatment with Bomyntra.

• While being treated, you should maintain good oral hygiene

  and receive routine dental check-ups. If you wear dentures you

  should make sure these fit properly.

• If you are under dental treatment or will undergo dental surgery

  (e.g. tooth extractions), inform your doctor about your dental treatment and tell 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, non-healing of sores or discharge, as these could be signs of osteonecrosis of the jaw.

Patients undergoing chemotherapy and/or radiotherapy, taking steroids or anti-angiogenic medicines (used to treat cancer), undergoing dental surgery, who do not receive routine dental care, have gum disease or who are smokers, may have a higher risk of developing osteonecrosis of the jaw.

Unusual thigh bone fractures

Some people have developed unusual fractures in their thigh bone while being treated with Bomyntra. Contact your doctor if you experience new or unusual pain in your hip, groin, or thigh.

High calcium levels in the blood after stopping treatment with Bomyntra

Some patients with giant cell tumour of the bone have developed high calcium levels in the blood weeks to months after stopping treatment. Your doctor will monitor you for signs and symptoms of high levels of calcium, after you stop receiving Bomyntra.

Children and adolescents

Bomyntra 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 Bomyntra has not been studied in children and adolescents with other cancers that have spread to bone.

Other medicines and Bomyntra

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. It is especially important that you tell your doctor if you are being treated with:

• another medicine containing denosumab
• a bisphosphonate

You should not take Bomyntra together with other medicines containing denosumab or bisphosphonates.

Pregnancy and breast-feeding

Bomyntra has not been tested in pregnant women. It is important to tell your doctor if you are pregnant, think you may be pregnant, or plan to get pregnant. Bomyntra is not recommended for use if you are pregnant. Women of child-bearing potential should use effective methods of contraception while being treated 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 inform your doctor.

It is not known whether Bomyntra is excreted in breast milk. It is important to tell your doctor if you are breast-feeding or plan to do so. Your doctor will then help you decide whether to stop breast-feeding or whether to stop taking Bomyntra, considering the benefit of breast-feeding to the baby and the benefit of Bomyntra to the mother.

If you are nursing during treatment with Bomyntra, please inform your doctor. Ask your doctor or pharmacist for advice before taking any 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 sorbitol in each pre-filled syringe.

Bomyntra contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per 120 mg dose, that is to say essentially ‘sodium-free’.

Bomyntra contains polysorbate 20

This medicine contains 0.17 mg of polysorbate 20 in each pre-filled syringe which is equivalent to 0.1 mg/mL Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

3. How to use Bomyntra

For instructions on how to inject Bomyntra, please read the section at the end of this leaflet.

The recommended dose of Bomyntra is 120 mg administered once every 4 weeks, as a single injection under the skin (subcutaneous).

You can inject the Bomy belly (except 5 cm (2 inc self-administration with be supervised by a healt you the injection, Bomy or outer area of the upp trained in injection tech are being treated for gia additional dose 1 week a

Do not shake.

You should also take cal being treated with Bomy in the blood. Your docto

If you have any further

ntra pre-filled syringe in your thigh or hes) around your belly button). The first the Bomyntra pre-filled syringe should hcare professional. If someone else gives ntra can be injected into your thigh, belly, er arm. You or your caregiver should be niques by a healthcare professional. If you nt cell tumour of bone, you will receive an nd 2 weeks after the first dose.

cium and vitamin D supplements while ntra unless you have an excess of calcium r will discuss this with you.

questions on the use of this medicine, ask

your doctor, pharmacist

4. Possible side effect

Like all medicines, this m not everybody gets the

Please tell your doctor

symptoms while being t than 1 in 10 people):

• spasms, twitches, cra

  in your fingers, toes confusion or loss of c you have low calcium blood may also lead t prolongation, which i

Please tell your doctor

or nurse.

s

edicine can cause side effects, although m.

immediately if you develop any of these reated with Bomyntra (may affect more

mps in your muscles, numbness or tingling or around your mouth and/or seizures, onsciousness. These could be signs that levels in the blood. Low calcium in the

o a change in heart rhythm called QT s seen by electrocardiogram (ECG).

and dentist immediately if you experience

any of these symptoms stopping treatment (ma

• persistent pain in the

  healing of sores in th feeling of heaviness i signs of bone damag

Very common side effe

• bone, joint, and/or m
• shortness of breath,
• diarrhoea.

Common side effects (

• low phosphate levels
• removal of a tooth,
• excessive sweating,

• in patients with adva

  while being treated with Bomyntra or after y affect upto 1 in 10 people):

  mouth and/or jaw, and/or swelling or non-e mouth or jaw, discharge, numbness or n the jaw, or loosening of a tooth could be e in the jaw (osteonecrosis).

  cts (may affect more than 1 in 10 people): uscle pain which is sometimes severe,

  may affect up to 1 in 10 people):

  in the blood (hypophosphataemia),

  nced cancer: development of another form

  of cancer.

Uncommon side effect

• high calcium levels in

  treatment in patients

• new or unusual pain

  early indication of a

• rash that may occur

  drug eruptions).

Rare side effects (may

• allergic reactions (e.g

  of the face, lips, tong itching or hives on th be severe.

Not known (frequency c data):

s (may affect up to 1 in 100 people): the blood (hypercalcaemia) after stopping with giant cell tumour of the bone, in your hip, groin or thigh (this may be an possible fracture of the thigh bone), on the skin or sores in the mouth (lichenoid

affect up to 1 in 1 000 people):

. wheezing or difficulty breathing; swelling ue, throat or other parts of the body; rash, e skin). In rare cases allergic reactions may

annot be estimated from the available

• talk to your doctor if you have ear pain, discharge from the ear,

  and/or an ear infection. These could be signs of bone damage in the ear.

  Reporting of side effects

  If you get 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 via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store 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 label and carton 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 pre-filled syringe in the outer carton in

order to protect from light.

The pre-filled syringe may be left outside the ref

rigerator to reach room temperature (up to 25°C) before injection.

This will make the injection more comfortable. Once your pre-filled

syringe has been left to reach room temperature (up to 25°C), it m

ust be used within

30 days.

Do not throw away any medicines via wastewate

r or household waste. Ask your pharmacist how to throw away

medicines you no longer use. These measures will help to protect t

he environment.

6. Contents of the pack and other information

What Bomyntra contains

• The active substance is denosumab.

  Each pre-filled syringe contains 120 mg of denosumab 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.

What Bomyntra looks like and contents of the pack

Bomyntra is a solution for injection.

Bomyntra is a clear, colourless to slightly yellow solution free from visible particles.

Each pack contains one, three or four single use container.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Fresenius Kabi Limited

Cestrian Court

Eastgate Way, Manor Park

Runcorn, Cheshire, WA7 1NT United Kingdom

Manufacturer

Fresenius Kabi Austria GmbH Hafnerstrasse 36

8055 Graz

Austria

This leaflet was last revised in July 2026.

Solution for injection in pre-filled syringe

denosumab

Subcutaneous use.

120 mg

Bomyntra®

Solution for injection in pre-filled syringe denosumab

Subcutaneous use.

120 mg

Bomyntra®

1. 7. Instructions for use

Guide to parts:

Before you use a Bomyntra pre-filled syringe with automatic needle guard, read this important information:

• It is important that you do not try to give yourself the injection

unless you have received training from your doctor or healthcare provider.

• Bomyntra is given as an injection into the tissue just under the

  skin (subcutaneous injection).

• Do not remove the grey needle cap from the pre-filled syringe

  until you are ready to inject.

• Do not use the pre-filled syringe if the carton is damaged or the

  seal is broken.

• Do not use the pre-filled syringe if it has been dropped on a

  hard surface. Use a new pre-filled syringe and call your doctor or healthcare provider.

• Do not try to push the plunger rod of the pre-filled syringe

  before the injection.

• Do not shake the pre-filled syringe.

• Important: Keep the pre-filled syringe out of the sight and

  reach of children.

Storing Bomyntra pre-filled syringe

• Store Bomyntra in a refrigerator between 2 °C to 8 °C in the

  original carton. Do not freeze.

• Before giving the injection, Bomyntra may be allowed to reach

  room temperature up to 25 °C in the original container. This takes 15 to 30 minutes. Do not warm Bomyntra in any other way.

• After Bomyntra is removed from the refrigerator, it must be

  used within 30 days. If not used in 30 days, Bomyntra should be thrown away (discarded).

• Do not use Bomyntra after the expiration date printed on the

  label.

• Protect Bomyntra from direct light and heat.

Call your doctor or healthcare provider if you have any questions.

Prepare to inject Step 2

2.1 Choose an injection site

You can inject into (see Figure H):

• upper thighs
• belly, except for a 5 cm area around the belly button
• outer area of upper arm (if you are injecting into someone else) Do not inject into areas where the skin is tender, bruised, red, or hard.

e plunger rod.

in your sharps

way your pre-filled

e pre-filled syringe.

Inject medicine Step 3

3.1 Pinch the skin

Pinch your injection site to create a firm surface (see Figure K).

Note: It is important to keep the skin pinched when injecting.

3.2 Insert the needle

Quickly insert the needle straight

Do not lift the pre-filled syringe off the skin.

3.4 Release plunger

Slowly release the plunger and allow the needle to come out of the skin at the same angle it was inserted. The clear needle guard will safely cover the needle (see Figure O).

Do not put the needle cap back on the needle.

Throw away your pre-filled syringe Step 4

4.1 Dispose

Put your used pre-filled syringe and needle cap in a sharps disposal container right away after use (see

Figure Q).

Medicines should be disposed of in accordance with local requirements. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Do not reuse the pre-filled syringe.

Do not throw away (dispose of) used syringes in your household trash.

Do not recycle your used sharps disposal container.

Keep Bomyntra pre-filled syringes, sharps disposal container and all medicines out of the reach and sight of children. Prepare materials Step 1

1.1 Gather supplies

On a clean, well-lit work surface,

gather the supplies needed for your

injection (see Figure A):

• alcohol wipes
• cotton ball or gauze pad
• adhesive bandage

• sharps disposal container (see

  Step 4 Throw away your pre-filled syringe)

in direct sunligh

Do not shake t

Keep the pre-fi

children.

1.3 Wash your han

Wash your han

and water and

clean towel (se

1.4 Remove pre-fil

tray

Place two finge

in the middle of

guard. Pull the

straight up and

(see Figure E).

Do not grasp th

Do not grasp th

1.5 Inspect pre-fill

medicine

Check the pre-f

make sure that:

• The name o

Bomyntra (

• The expirati

has not pas

• The pre-fille

Check the liqui

any particles or

Figure G).

Do not use the

• The name o

Bomyntra.

• The expirati

has passed.

• Any part ap

• The needle cap is missing or not firmly attached.

• The medicine is cloudy or there are particles in it. It must be a clear, colourless to slightly yellow solution. In all cases, use a new pre-filled syringe and call your doctor or healthcare provider.

  M0FO0013/X0 UK

After Use

Clear needle guard

Plunger

Needle covered Needle guard

spring extended

Bomyntra® 120 mg

Solution for injection in pre-filled syringe denosumab

Subcutaneous use.

Figure A

Figure H

Figure J

Figure K

Figure N

Figure O

Figure Q