Bomyntra 120 mg solution for injection in pre-filled syringe

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
• Your doctor will give you a patient reminder card, which contains important safety information you need to be aware of before and during your treatment with Bomyntra.

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

• 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.

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.

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.

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.

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.

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

This medicine contains 78 mg sorbitol in each pre-filled syringe.

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

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.

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.

• 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.

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.

• 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.

• 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.

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)

1.2. Wait 15 to 30 minutes for the pre-filled syringe to reach room temperature

Remove the carton from the refrigerator (see Figure B) and place it on a flat surface.

Let it warm at room temperature for 15 to 30 minutes (see Figure C)

Do not try to warm the pre-filled syringe by using a heat source such as hot water or microwave.

Do not leave the pre-filled syringe in direct sunlight.

Do not shake the pre-filled syringe

Keep the pre-filled syringe out of sight and reach of children.

1.3. Wash your hands

Wash your hands well with soap and water and dry them with a clean towel (see Figure D).

1.4. Remove pre-filled syringe from tray

Place two fingers on either side, in the middle of the clear needle guard. Pull the pre-filled syringe straight up and out of the tray (see Figure E).

Do not grasp the plunger.

Do not grasp the needle cap.

1.5. Inspect pre-filled syringe and medicine

Check the pre-filled syringe to make sure that:

• The name on the label says Bomyntra (see Figure F).
• The expiration date on the label has not passed.
• The pre-filled syringe is not cracked or broken.

Check the liquid to see if there are any particles or discoloration (see Figure G).

Do not use the pre-filled syringe if:

• The name on the label is not Bomyntra.
• The expiration date on the label has passed.
• Any part appears cracked or broken.
• 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.

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.

Avoid injecting into areas with scars or stretch marks

2.2. Clean the injection site

Clean the injection site with an alcohol wipe (see Figure I).

Let your skin air dry.

Do not blow on or touch the injection site after cleaning.

2.3. Remove needle cap

Carefully pull the needle cap straight off and away from your body (see Figure J). It may take some force to remove the needle cap.

Do not remove the needle cap from the pre-filled syringe until you are ready to inject.

Do not hold the pre-filled syringe by the plunger rod.

Do not twist or bend the needle cap.

Throw away (dispose of) the needle cap in your sharps disposal container (see Step 4 Throw away your pre-filled syringe).

Do not put the needle cap back onto the pre-filled syringe.

Do not touch the needle or let it touch any surface after removal of the needle cap.

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 into the pinched skin at a 45 to 90-degree angle (see Figure L).

Do not inject into muscle or blood vessel.

3.3. Inject

Push the plunger with slow and constant pressure (see Figure M) until you cannot press anymore and have injected all of the liquid under the skin (subcutaneously) (see Figure N). You may hear or feel a “click”.

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.

3.5. Treat injection site

If there is blood or liquid at the injection site, gently press a cotton ball or gauze on the skin (see Figure P).

You may use an adhesive bandage if needed.

Do not rub the injection site.

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.