Stoboclo 60 mg/ml pre-filled syringe, Solution for injection

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 or pharmacist. 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 Stoboclo.

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

Stoboclo contains denosumab, a protein (monoclonal antibody) that interferes with the action of another protein, in order to treat bone loss and osteoporosis. Treatment with Stoboclo makes bone stronger and less likely to break.

Bone is a living tissue and is renewed all the time. Oestrogen helps keep bones healthy. After the menopause, oestrogen level drops which may cause bones to become thin and fragile. This can eventually lead to a condition called osteoporosis. Osteoporosis can also occur in men due to a number of causes including ageing and/or a low level of the male hormone, testosterone. It can also occur in patients receiving glucocorticoids. Many patients with osteoporosis have no symptoms, but they are still at risk of breaking bones, especially in the spine, hips and wrists.

Surgery or medicines that stop the production of oestrogen or testosterone used to treat patients with breast or prostate cancer can also lead to bone loss. The bones become weaker and break more easily.

Stoboclo is used to treat:

• osteoporosis in women after the menopause (postmenopausal) and men who have an increased risk of fracture (broken bones), reducing the risk of spinal, non-spinal and hip fractures.
• bone loss that results from a reduction in hormone (testosterone) level caused by surgery or treatment with medicines in patients with prostate cancer.
• bone loss that results from long-term treatment with glucocorticoids in patients who have an increased risk of fracture.

Pharmacotherapeutic group: Drugs for treatment of bone diseases – Other drugs affecting bone structure and mineralisation, ATC code: M05BX04

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

Talk to your doctor or pharmacist before using Stoboclo.

Whilst being treated with Stoboclo you may develop a skin infection with symptoms such as a swollen, red area of skin, most commonly in the lower leg, that feels hot and tender (cellulitis), and possibly with symptoms of fever. Please tell your doctor immediately if you develop any of these symptoms.

You should also take calcium and vitamin D supplements while being on treatment with Stoboclo. Your doctor will discuss this with you.

You may have low levels of calcium in your blood while receiving Stoboclo. Please tell your doctor immediately if you notice any of the following symptoms: spasms, twitches, or cramps in your muscle, and/or numbness or tingling in your fingers, toes or around your mouth, and/or seizures, confusion, or loss of consciousness.

Severe low blood calcium levels leading to hospitalisation and even life-threatening reactions have been reported in rare cases. Before each dose and in patients predisposed to hypocalcaemia within two weeks after initial dose, the calcium levels in your blood will therefore be checked (via blood test).

Tell your doctor if you have or have ever had severe kidney problems, kidney failure or have needed dialysis or are taking medicines called glucocorticoids (such as prednisolone or dexamethasone), which may increase your risk of getting low blood calcium if you do not take calcium supplements.

Problems with your mouth, teeth or jaw

A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported rarely (may affect up to 1 in 1,000 people) in patients receiving denosumab for osteoporosis. 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 can also occur after stopping treatment. It is important to try to prevent ONJ developing as it may be a painful condition that can be difficult to treat. In order to reduce the risk of developing ONJ, take the following precautions:

Before receiving treatment, tell your doctor or nurse (health care professional) if you:

• have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction.
• don’t receive routine dental care or have not had a dental check-up for a long time.
• are a smoker (as this may increase the risk of dental problems).
• have previously been treated with a bisphosphonate (used to treat or prevent bone disorders).
• are taking medicines called corticosteroids (such as prednisolone or dexamethasone).
• have cancer.

Your doctor may ask you to undergo a dental examination before you start treatment with Stoboclo.

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 Stoboclo.

Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, or non-healing of sores or discharge, as these could be signs of ONJ.

Unusual thigh bone fractures

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

Stoboclo should not be used in children and adolescents under 18 years of age.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It is especially important that you tell your doctor if you are being treated with another medicine containing denosumab.

You should not take Stoboclo together with another medicine containing denosumab.

Stoboclo 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. Stoboclo is not recommended for use if you are pregnant. Women of child-bearing potential should use effective methods of contraception while being treated with Stoboclo and for at least 5 months after stopping treatment with Stoboclo.

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

It is not known whether denosumab 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 Stoboclo, considering the benefit of breast-feeding to the baby and the benefit of Stoboclo to the mother.

If you are breast-feeding during Stoboclo treatment, please inform your doctor.

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

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

This medicine contains 47 mg sorbitol in each mL of solution.

This medicine contains less than 1 mmol sodium (23 mg) per 60 mg, that is to say essentially ‘sodium-free’.

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

If a dose of Stoboclo is missed, the injection should be administered as soon as possible. Thereafter, injections should be scheduled every 6 months from the date of the last injection.

To get the most benefit from your treatment in reducing the risk of fractures, it is important to use Stoboclo for as long as your doctor prescribes it for you. Do not stop your treatment without contacting your doctor.

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 the 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 1 mL pre-filled syringe contains 60 mg of denosumab (60 mg/mL).
• The other ingredients are acetic acid, sodium acetate trihydrate, sorbitol (E420), polysorbate 20 (E432) and water for injections.

Stoboclo is a clear, colourless to pale yellow solution for injection provided in a ready to use pre-filled syringe.

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

Manufacturer

Manufacturer

For any information about this medicine, please contact the Marketing Authorisation Holder:

• Stoboclo is given as an injection into the tissue just under the skin (subcutaneous injection).
• Do not open the sealed carton until you are ready to use the pre-filled syringe.
• Do not remove the needle cap from the pre-filled syringe until just before you give the injection.
• Do not attempt to activate the pre-filled syringe prior to injection.
• Do not attempt to remove the clear safety guard from the pre-filled syringe.
• Do not use the pre-filled syringe if it has been dropped on a hard surface. Use a new pre-filled syringe.
• Do not shake the pre-filled syringe. Strong shaking may damage the medicine.
• The pre-filled syringe cannot be re-used. Dispose of the used pre-filled syringe immediately after use in a sharps disposal container (see Step 15. Dispose of Stoboclo).

• Keep the pre-filled syringe out of the sight and reach of children. Contains small parts.
• Store the pre-filled syringe in a refrigerator between 2 °C and 8 ºC. Do not freeze.
• Once removed from the refrigerator, Stoboclo must not be exposed to temperatures above 25 °C. Stoboclo must be stored in its original carton and used within 30 days. If not used within the 1-month period, Stoboclo should be discarded.
• Store the pre-filled syringe sealed inside its carton to protect it from light.

1. Gather the supplies for the injection.

1a. Prepare a clean, flat surface, such as a table or counter top, in a well-lit area.

1b. Take the carton containing the pre-filled syringe out of the refrigerator.

1c. Make sure you have the following supplies (see Figure B):

• Carton containing pre-filled syringe

Not included in the carton:

• Alcohol swab
• Cotton ball or gauze
• Adhesive bandage
• Sharps disposal container

2. Check the expiration date on the carton (see Figure C).

• Do not use it if the expiration date has passed. If the expiration date has passed, return the entire carton to the pharmacy.
• The printed expiration date refers to the last day of the month.

3. Remove the pre-filled syringe from the carton.

3a. Open the carton. Gripping the syringe body, lift the pre-filled syringe from the carton (see Figure D).

• Do not hold by the head of the plunger rod, plunger rod, safety guard, wings, or needle cap.
• Do not pull back on the plunger rod at any time.

4. Inspect the pre-filled syringe.

4a. Look at the pre-filled syringe and make sure you have the correct medicine (Stoboclo).

4b. Look at the pre-filled syringe and make sure it is not cracked or damaged.

4c. Check the expiration date on the label of the pre-filled syringe (see Figure E).

• Do not use if the needle cap is missing or not securely attached.
• Do not use if the expiration date has passed.
• Do not shake the pre-filled syringe.

5. Inspect the medicine.

5a. Look at the medicine and confirm that the liquid is clear, colourless to pale yellow, and does not contain any visible particles or flakes in it (see Figure F).

• Do not use the pre-filled syringe if the liquid is discoloured, cloudy, or has any visible particles or flakes in it.
• You may see air bubbles in the liquid. This is normal.

6. Wait 30 minutes.

6a. Let the pre-filled syringe stand outside the box for 30 minutes at room temperature (20 °C to 25 °C) to allow it to warm up (see Figure G).

• Do not warm the pre-filled syringe using heat sources such as hot water or a microwave.
• If the syringe does not reach room temperature, this could cause the injection to feel uncomfortable.

7. Choose an appropriate injection site (see Figure H).

7a. You may inject into:

• the upper thighs.
• the abdomen, except for the 5 cm around the belly button (navel).
• the outer area of the upper arms (only if you are a caregiver or HCP).
• Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard, or if there are cracks in the skin.
• Do not inject through clothing.

7b. Choose a different injection site for each new injection at least 2.5 cm away from the area used for the last injection.

8. Wash your hands.

8a. Wash your hands with soap and water and dry them thoroughly (see Figure I).

9. Clean the injection site.

9a. Clean the injection site with an alcohol swab using a circular motion (see Figure J).

9b. Let the skin dry before injecting.

• Do not blow on or touch the injection site again before giving the injection.

10. Remove the cap.

10a. Hold the body of the pre-filled syringe in one hand between the thumb and index finger. With the other hand, carefully pull the needle cap straight off (see Figure K).

• Do not hold the plunger rod while removing the cap.
• You may notice a drop of liquid at the tip of needle.

This is normal.

10b. Dispose of the cap right away in a sharps disposal container (see Step 15 and Figure K).

• Do not use the pre-filled syringe if it is dropped without the needle cap in place. If this happens, use a new pre-filled syringe.
• Remove the needle cap only when you are ready to inject.
• Do not re-cap the pre-filled syringe.
• Do not touch the needle. Doing so may result in a needle stick injury.

11. Insert the pre-filled syringe into the injection site.

11a. Hold the body of the pre-filled syringe in one hand between the thumb and index finger.

11b. Use the other hand to gently pinch the cleaned skin between your thumb and index finger. Do not squeeze it tightly.

Note: It is important to keep the skin pinched when inserting the needle to make sure that you inject under the skin (into the fatty area) but not any deeper (into muscle).

11c. With a quick and “dart-like” motion, insert the needle completely into the fold of skin at a 45-degree angle (see Figure L).

• Do not pull back on the plunger rod at any time.

12. Give the injection.

12a. After the needle is inserted, release the pinched skin.

12b. Slowly push the plunger rod all the way down until the full dose of medicine gets injected, and the syringe is empty (see Figure M).

• Do not change the position of the pre-filled syringe after the injection has started.
• If the plunger rod is not fully pressed, the safety guard will not extend to cover the needle when it is removed.

13. Remove the pre-filled syringe from the injection site.

13a. After the pre-filled syringe is empty, as the needle is being taken out, slowly remove the needle by lifting your thumb from the plunger rod until the needle is completely covered by the safety guard (see Figure N).

• If the needle is not covered, proceed to carefully dispose of the syringe (see Step 15. Dispose of Stoboclo).
• Do not put the needle cap back on used pre-filled syringes.
• Do not reuse the pre-filled syringe.
• Do not rub the injection site.

14. Care for the injection site.

14a. If some bleeding occurs, treat the injection site by gently pressing, not rubbing, a cotton ball or gauze to the site and apply an adhesive bandage if needed.

15. Dispose of the pre-filled syringe.

15a. Put the used pre-filled syringe in a sharps disposal container right away after use (see Figure O).

15b. Do not throw away (dispose of) the pre-filled syringe in your household trash.

• Keep the syringe and sharps disposal container out of the sight and reach of children.
• If you do not have a sharps disposal container, you may use a household container that is closable and puncture resistant.
• For the safety and health of you and others, needles and used syringes must never be re-used. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.