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The product code(s) for this leaflet is: PLGB 13832/0042.
Prolia
Prolia 60 mg solution for injection in pre-filled syringe
denosumab
1. What Prolia is and what it is used for
2. What you need to know before you use Prolia
3. How to use Prolia
4. Possible side effects
5. How to store Prolia
6. Contents of the pack and other information
Prolia contains denosumab, a protein (monoclonal antibody) that interferes with the action of another protein, in order to treat bone loss and osteoporosis. Treatment with Prolia 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.
Prolia is used to treat:
Talk to your doctor or pharmacist before using Prolia.
Whilst being treated with Prolia 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 Prolia. Your doctor will discuss this with you.
You may have low levels of calcium in your blood while receiving Prolia. 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.
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 Prolia 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:
Your doctor may ask you to undergo a dental examination before you start treatment with Prolia.
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 Prolia.
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 Prolia. Contact your doctor if you experience new or unusual pain in your hip, groin, or thigh.
Prolia 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 Prolia together with another medicine containing denosumab.
Prolia 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. Prolia is not recommended for use if you are pregnant. Women of child-bearing potential should use effective methods of contraception while being treated with Prolia and for at least 5 months after stopping treatment with Prolia.
If you become pregnant during treatment with Prolia or less than 5 months after stopping treatment with Prolia, please inform your doctor.
It is not known whether Prolia 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 Prolia, considering the benefit of breast-feeding to the baby and the benefit of Prolia to the mother.
If you are breast-feeding during Prolia treatment, please inform your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Prolia 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’.
The recommended dose is one pre-filled syringe of 60 mg administered once every 6 months, as a single injection under the skin (subcutaneous). The best places to inject are the top of your thighs and the abdomen. Your carer can also use the outer area of your upper arm. Please consult your doctor on the date for a potential next injection. Each pack of Prolia contains a reminder card, that can be removed from the carton and used to keep a record of the next injection date.
You should also take calcium and vitamin D supplements while being on treatment with Prolia. Your doctor will discuss this with you.
Your doctor may decide that it is best for you or a carer to inject Prolia. Your doctor or healthcare provider will show you or your carer how to use Prolia. For instructions on how to inject Prolia, please read the section at the end of this leaflet.
Do not shake.
If a dose of Prolia 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 Prolia for as long as your doctor prescribes it for you. Do not stop your treatment without contacting your doctor.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Uncommonly, patients receiving Prolia may develop skin infections (predominantly cellulitis). Please tell your doctor immediately if you develop any of these symptoms while being on treatment with Prolia: swollen, red area of skin, most commonly in the lower leg, that feels hot and tender, and possibly with symptoms of fever.
Rarely, patients receiving Prolia may develop pain in the mouth and/or jaw, swelling or non-healing of sores in the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth. These could be signs of bone damage in the jaw (osteonecrosis). Tell your doctor and dentist immediately if you experience such symptoms while being treated with Prolia or after stopping treatment.
Rarely, patients receiving Prolia may have low calcium levels in the blood (hypocalcaemia). Symptoms include 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. If any of these apply to you, tell your doctor immediately. Low calcium in the blood may also lead to a change in heart rhythm called QT prolongation which is seen by electrocardiogram (ECG).
Rarely unusual fractures of the thigh bone may occur in patients receiving Prolia. Contact your doctor if you experience new or unusual pain in your hip, groin or thigh as this may be an early indication of a possible fracture of the thigh bone.
Rarely, allergic reactions may occur in patients receiving Prolia. Symptoms include swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin, wheezing or difficulty breathing. Please tell your doctor if you develop any of these symptoms while being treated with Prolia.
Very common side effects (may affect more than 1 in 10 people):
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Very rare side effects (may affect up to 1 in 10,000 people):
Not known (frequency cannot be estimated from the available data):
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
or search for MHRA Yellow Card in the Google Play or Apple App Store
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 container in the outer carton in order to protect from light.
Your pre-filled syringe may be left outside the refrigerator to reach room temperature (up to 25°C) before injection. This will make the injection more comfortable. Once your syringe has been left to reach room temperature (up to 25°C), it must be used within 30 days.
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 to protect the environment.
Prolia is a clear, colourless to slightly yellow solution for injection provided in a ready to use pre-filled syringe.
Each pack contains one pre-filled syringe with a needle guard.
Each pack contains one pre-filled syringe.
Not all pack sizes may be marketed.
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
This leaflet was last revised in May 2022.
Important
Before you use a Prolia pre-filled syringe with automatic needle guard, read this important information:
Call your doctor or healthcare provider if you have any questions.
Step 1: Prepare
A Remove the pre-filled syringe tray from the package and gather the supplies needed for your injection: alcohol wipes, a cotton ball or gauze pad, a plaster and a sharps disposal container (not included).
For a more comfortable injection, leave the pre-filled syringe at room temperature for about 30 minutes before injecting. Wash your hands thoroughly with soap and water.
On a clean, well-lit work surface, place the new pre-filled syringe and the other supplies.
B Open the tray, peeling away the cover. Grab the pre-filled syringe safety guard to remove the pre-filled syringe from the tray.
For safety reasons:
C Inspect the medicine and pre-filled syringe.
In all cases, call your doctor or healthcare provider.
Step 2: Get ready
A Wash your hands thoroughly. Prepare and clean your injection site.
You can use:
Clean the injection site with an alcohol wipe. Let your skin dry.
B Carefully pull the grey needle cap straight out and away from your body.
C Pinch your injection site to create a firm surface.
It is important to keep the skin pinched when injecting.
Step 3: Inject
A Hold the pinch. INSERT the needle into skin.
B PUSH the plunger with slow and constant pressure until you feel or hear a “snap”. Push all the way down through the snap.
It is important to push down through the “snap” to deliver your full dose.
C RELEASE your thumb. Then LIFT the syringe off skin.
After releasing the plunger, the pre-filled syringe safety guard will safely cover the injection needle.
Step 4: Finish
A Discard the used pre-filled syringe and other supplies in a sharps disposal container.
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.
Keep the syringe and sharps disposal container out of sight and reach of children.
B Examine the injection site.
If there is blood, press a cotton ball or gauze pad on your injection site. Do not rub the injection site. Apply a plaster if needed.
This section contains information on how to use the Prolia pre-filled syringe. It is important that you or your carer do not give the injection unless training from your doctor or healthcare provider has been received. Always wash your hands before every injection. If you have questions about how to inject, please ask your doctor or healthcare provider for assistance.
Read all instructions thoroughly before using the pre-filled syringe.
DO NOT use the pre-filled syringe if the needle cover has been removed.
Your doctor has prescribed a Prolia pre-filled syringe for injection into the tissue just under the skin (subcutaneous). You must inject the entire content (1 mL) of the Prolia pre-filled syringe and it should be injected once every 6 months as instructed by your doctor.
To give an injection, you will need:
1. A new Prolia pre-filled syringe
2. Alcohol wipes or similar.
1. Remove the pre-filled syringe from the refrigerator.
DO NOT pick up the pre-filled syringe by the plunger or needle cover. This could damage the device.
2. The pre-filled syringe may be left outside the refrigerator to reach room temperature. This will make the injection more comfortable.
DO NOT warm it in any other way, for example, in a microwave or in hot water.
DO NOT leave the syringe exposed to direct sunlight.
3. DO NOT shake the pre-filled syringe.
4. DO NOT remove the needle cover from the pre-filled syringe until you are ready to inject.
5. Check the expiry date on the pre-filled syringe label (EXP).
DO NOT use it if the date has passed the last day of the month shown.
6. Check the appearance of Prolia. It must be a clear, colourless to slightly yellow solution. The solution should not be injected if it contains particles or if it is discoloured or cloudy.
7. Find a comfortable, well-lit, clean surface and put all the equipment within reach.
8. Wash your hands thoroughly.
The best places to inject are the top of your thighs and the abdomen.
Your carer can also use the outer area of your upper arms.
1. Disinfect the skin by using an alcohol wipe.
2. To avoid bending the needle, gently pull the cover from the needle straight off without twisting, as shown in pictures 1 and 2.
DO NOT touch the needle or push the plunger.
3. You may notice a small air bubble in the pre-filled syringe. You do not have to remove the air bubble before injecting. Injecting the solution with the air bubble is harmless.
4. Pinch (without squeezing) the skin between your thumb and forefinger. Put the needle fully into the
skin as shown by your doctor or healthcare provider.
5. Push the plunger with a slow constant pressure, always keeping the skin pinched. Push the plunger all the way down as far as it will go to inject all the solution.
6. Remove the needle and let go of the skin.
7. If you notice a spot of blood you may gently dab it away with a cotton ball or tissue. Do not rub the injection site. If needed, you may cover the injection site with a plaster.
8. Only use each pre-filled syringe for one injection. DO NOT use any Prolia that is left in the syringe.
Remember: if you have any problems, please ask your doctor or healthcare provider for help and advice.