Prolia 60 mg solution for injection in pre-filled syringe
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Prolia 60mg solution for injection in pre-filled syringe
denosumab
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you must not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.
- Your doctor will provide you with a patient reminder card containing important safety information you should know before and during treatment with Prolia.
Contents of this leaflet
- What Prolia is and what it is used for
- What you need to know before using Prolia
- How to use Prolia
- Possible side effects
- How to store Prolia
- Contents of the pack and other information
1. What Prolia is and how it works and what it is used for
What Prolia is and how it works
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 strengthens bones and reduces the risk of fractures.
Bone is a living tissue that is constantly being renewed. Oestrogens help maintain bone health. After menopause, oestrogen levels decrease, which may cause bones to become thinner and more fragile. Over time, this can lead to a condition called osteoporosis. Osteoporosis can also occur in men due to various causes, including age and/or low levels of the male hormone testosterone. It can also occur in patients receiving glucocorticoid therapy. Many patients with osteoporosis do not have symptoms, yet they remain at risk of bone fractures, particularly in the spine, hip, and wrists.
Surgical procedures or medications that suppress the production of oestrogen or testosterone, used to treat patients with prostate or breast cancer, can also cause bone loss. As a result, bones become weaker and more prone to breaking.
What Prolia is used for
Prolia is used to treat:
- postmenopausal osteoporosis in women and osteoporosis in men who have an increased risk of fracture (broken bones), reducing the risk of hip, vertebral, and non-vertebral fractures.
- bone loss caused by reduced hormone levels (testosterone) due to surgery or medication treatment in men with prostate cancer.
- bone loss resulting from long-term glucocorticoid therapy in patients who have a high risk of fracture.
2. What you need to know before using Prolia
Do not use Prolia:
- if you have low levels of calcium in your blood (hypocalcemia).
- if you are allergic to denosumab or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Prolia.
While receiving Prolia treatment, you may develop a skin infection with symptoms such as a swollen and red area of skin, most commonly on the lower leg, which feels warm and tender to the touch (cellulitis), possibly accompanied by fever. Contact your doctor immediately if you experience any of these symptoms.
In addition, you must take calcium and vitamin D supplements during treatment with Prolia. Your doctor will discuss this with you.
While receiving Prolia, you may experience low levels of calcium in your blood. Contact your doctor immediately if you notice any of the following symptoms: muscle spasms, twitches or cramps, and/or numbness or tingling in the fingers, toes or around the mouth, and/or seizures, confusion or loss of consciousness.
Rarely, cases of very low blood calcium levels have been reported, requiring hospitalization and, in some cases, potentially life-threatening reactions. Therefore, before each dose is administered, and in patients predisposed to hypocalcemia, within two weeks after the first dose, your blood calcium levels will be checked (through a blood test).
Inform your doctor if you have or have had severe kidney problems, kidney failure, if you have required dialysis, or if you are taking medicines called glucocorticoids (such as prednisolone or dexamethasone), as these may increase your risk of low blood calcium levels if you do not take calcium supplements.
Problems in the mouth, teeth or jaw
In patients receiving Prolia for osteoporosis, a rare adverse effect called osteonecrosis of the jaw (ONJ) (damage to the jawbone) has been reported (may affect up to 1 in 1,000 people). 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 may also occur after stopping treatment. It is important to try to prevent ONJ, as it can be a painful condition that may be difficult to treat. To reduce the risk of developing ONJ, follow these precautions:
Before receiving treatment, inform your doctor or nurse (healthcare professional) if:
- you have any problems with your mouth or teeth, such as poor dental health, gum disease, or planned dental extraction.
- you do not receive regular dental check-ups or have not had a dental check-up for a long time.
- you are a smoker (as this may increase the risk of dental problems).
- you have previously been treated with a bisphosphonate (used to prevent or treat bone disorders).
- you are taking medicines called corticosteroids (such as prednisolone or dexamethasone).
- you have cancer.
Your doctor may ask you to have a dental examination before starting Prolia treatment.
During treatment with Prolia, you should maintain good oral hygiene and have routine dental check-ups. If you wear dentures, ensure they fit properly. If you are undergoing dental treatment or are scheduled for dental surgery (e.g., tooth extractions), inform your doctor about your dental treatment and inform your dentist that you are being treated with Prolia.
Contact your doctor and dentist immediately if you experience any problems in your mouth or teeth, such as loose teeth, pain or swelling, or non-healing or oozing sores, as these could be symptoms of ONJ.
Unusual femur fractures
Some people have developed unusual fractures in the femur while being treated with Prolia. Consult your doctor if you experience new or unusual pain in your hip, groin, or thigh.
Children and adolescents
Prolia should not be used in individuals under 18 years of age.
Using Prolia with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. It is especially important that you inform your doctor if you are being treated with another medicine containing denosumab.
You must not use Prolia together with another medicine containing denosumab.
Pregnancy and breastfeeding
Prolia has not been studied in pregnant women. It is important that you inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Prolia is not recommended during pregnancy. Women of childbearing potential should use effective contraception during treatment with Prolia and for at least 5 months after stopping treatment with Prolia.
If you become pregnant during treatment with Prolia or within 5 months after stopping treatment with Prolia, inform your doctor.
It is unknown whether Prolia is excreted in human breast milk. It is important that you inform your doctor if you are breastfeeding or plan to breastfeed. Your doctor will help you decide whether to discontinue breastfeeding or to stop using Prolia, taking into account the benefits of breastfeeding for the child and the benefits of Prolia for the mother.
If you are breastfeeding during treatment with Prolia, please inform your doctor.
Consult your doctor or pharmacist before using any medicine.
Driving and using machines
The effect of Prolia on the ability to drive and use machines is negligible or none.
Prolia contains sorbitol
This medicine contains 47 mg of sorbitol per ml of solution.
Prolia contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 60 mg dose; hence, it is essentially “sodium-free”.
3. How to use Prolia
The recommended dose is one 60 mg pre-filled syringe administered under the skin (subcutaneously) as a single injection every 6 months. The best places to administer the injection are the upper thighs and the abdomen. If a caregiver (attending person) is giving the injection, they may also administer it into the outer surface of the upper arm. Consult your doctor for the date of your next possible injection. Each Prolia package contains a reminder card that can be detached from the carton and used to keep a record of the date of your next injection.
In addition, you must take calcium and vitamin D supplements during treatment with Prolia. Your doctor will discuss this with you.
Your doctor may decide whether it is better for you or a caregiver to administer the Prolia injection. Your doctor or healthcare professional will show you or your caregiver how to use Prolia. If you would like instructions on how to inject Prolia, please read the last section of this leaflet.
Do not shake.
If you forget to use Prolia
If you miss a dose of Prolia, the injection should be given as soon as possible. After that, injections should be scheduled every 6 months from the date of the last injection.
If you stop using Prolia
To get the maximum benefit from your treatment and to reduce the risk of fractures, it is important to use Prolia for the entire period prescribed by your doctor. Do not stop treatment without first talking to your doctor.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Patients treated with Prolia may rarely develop skin infections (mainly cellulitis). Contact your doctor immediately if any of the following symptoms occur during treatment with Prolia: a swollen, red area of skin, usually on the lower leg, which is warm and tender to the touch and may be accompanied by fever.
Rarely, patients receiving Prolia may develop pain in the mouth and/or jaw, swelling or non-healing ulcers in the mouth or jaw, pus discharge, numbness or heaviness in the jaw, or loose teeth. These could be symptoms of bone damage in the jaw (osteonecrosis). Contact your doctor and dentist immediately if you experience such symptoms while being treated with Prolia or after stopping treatment.
Rarely, patients receiving Prolia may develop low levels of calcium in the blood (hypocalcemia); very low calcium levels in the blood may require hospitalization and could even be life-threatening. Symptoms include muscle spasms, contractions, or cramps, and/or numbness or tingling in the fingers, toes, or around the mouth and/or seizures, confusion, or loss of consciousness. If you experience any of these, contact your doctor immediately. Low calcium levels in the blood may also cause a change in heart rhythm called QT prolongation, which can be detected by performing an electrocardiogram (ECG).
Rarely, unusual femoral fractures may occur in patients receiving Prolia. Consult your doctor if you experience new or unusual pain in your hip, groin, or thigh, as this may be an early sign of a possible femoral fracture.
Rarely, allergic reactions may occur in patients receiving Prolia. Symptoms include swelling of the face, lips, tongue, throat, or other parts of the body; skin rash, itching, or hives; wheezing or difficulty breathing. Contact your doctor if you experience such symptoms while being treated with Prolia.
Very common adverse effects (may affect more than 1 in 10 people):
- bone, joint, and/or muscle pain, sometimes severe,
- pain in the arms or legs (limb pain).
Common adverse effects (may affect up to 1 in 10 people):
- painful urination, frequent urination, blood in the urine, urinary incontinence,
- upper respiratory tract infection,
- pain, tingling, or numbness radiating down the lower leg (sciatica),
- constipation,
- abdominal discomfort,
- skin rash,
- skin condition with itching, redness, and/or dryness (eczema),
- hair loss (alopecia).
Uncommon adverse effects (may affect up to 1 in 100 people):
- fever, vomiting, and abdominal pain or discomfort (diverticulitis),
- ear infection,
- skin rash or mouth ulcers (drug-induced lichenoid eruptions).
Very rare adverse effects (may affect up to 1 in 10,000 people):
- allergic reaction that may damage blood vessels, mainly in the skin (e.g., purple or brownish-red spots, hives, or skin ulcers) (hypersensitivity vasculitis).
Frequency not known (cannot be estimated from available data):
- contact your doctor if you have ear pain, ear discharge, and/or an ear infection. These could be symptoms of damage to the bones of the ear.
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Prolia
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 the carton after “CAD” or “EXP”. The expiry date refers to the last day of the stated month.
Store in a refrigerator (between 2 °C and 8 °C).
Do not freeze.
Keep the pre-filled syringe in the outer packaging to protect it from light.
Before injection, the pre-filled syringe may be removed from the refrigerator and allowed to reach room temperature (up to 25 °C) to make the injection more comfortable. Once the syringe has reached room temperature (up to 25 °C), it must be used within 30 days.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the container and other information
Composition of Prolia
- The active substance is denosumab. Each 1 ml pre-filled syringe contains 60 mg of denosumab (60 mg/ml).
- The other components are glacial acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 20, and water for injections.
Appearance of Prolia and contents of the container
Prolia is a clear, colorless to slightly yellow, injectable solution available in a pre-filled syringe ready for use.
Each pack contains one pre-filled syringe with a needle shield.
Each pack contains one pre-filled syringe.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Amgen Europe B.V.
Minervum 7061,
4817 ZK Breda,
The Netherlands
Marketing Authorization Holder
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
The Netherlands
Manufacturer
Amgen Technology (Ireland) Unlimited Company
Pottery Road
Dun Laoghaire
Co Dublin
Ireland
Manufacturer
Amgen NV
Telecomlaan 5-7
1831 Diegem
Belgium
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
Belgium/Belgium/Belgium s.a. Amgen n.v. Tel/Tel: +32 (0)2 7752711 | Lithuania Amgen Switzerland AG Vilnius Branch Tel: +370 5 219 7474 |
| Luxembourg/Luxembourg s.a. Amgen Belgium/Belgium Tel/Tel: +32 (0)2 7752711 |
Czech Republic Amgen s.r.o. Tel: +420 221 773 500 | Hungary Amgen Kft. Tel.: +36 1 35 44 700 |
Denmark Amgen branch of Amgen AB, Sweden Tlf: +45 39617500 | Malta Amgen S.r.l. Italy Tel: +39 02 6241121 |
Germany Amgen GmbH Tel.: +49 89 1490960 | Netherlands Amgen B.V. Tel: +31 (0)76 5732500 |
Estonia Amgen Switzerland AG Vilnius Branch Tel: +372 586 09553 | Norway Amgen AB Tlf: +47 23308000 |
Greece Amgen Hellas Pharmaceutical E.P.E. Tel: +30 210 3447000 | Austria Amgen GmbH Tel: +43 (0)1 50 217 |
Spain Amgen S.A. Tel: +34 93 600 18 60 | Poland Amgen Biotechnologia Sp. z o.o. Tel.: +48 22 581 3000 |
France Amgen S.A.S. Tél: +33 (0)9 69 363 363 | Portugal Amgen Biofarmacêutica, Lda. Tel: +351 21 4220606 |
Croatia Amgen d.o.o. Tel: +385 (0)1 562 57 20 | Romania Amgen România SRL Tel: +4021 527 3000 |
Ireland Amgen Ireland Limited Tel: +353 1 8527400 | Slovenia AMGEN zdravila d.o.o. Tel: +386 (0)1 585 1767 |
Iceland Vistor hf. Tel: +354 535 7000 | Slovakia Amgen Slovakia s.r.o. Tel: +421 2 321 114 49 |
Italy Amgen S.r.l. Tel: +39 02 6241121 | Finland/Suomi Amgen AB, branch in Finland/Amgen AB, filial i Finland Puh/Tel: +358 (0)9 54900500 |
Cyprus C.A Papaellinas Ltd Tel: +357 22741 741 | Sweden Amgen AB Tel: +46 (0)8 6951100 |
Latvia Amgen Switzerland AG Riga Branch Tel: +371 257 25888 | United Kingdom (Northern Ireland) Amgen Limited Tel: +44 (0)1223 420305 |
Date of the most recent review of this leaflet:
Other sources of information
Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/
Instructions for use: | |
Components guide | |
Before use | After use |
|
|
Important | |
Read this important information before using the Prolia pre-filled syringe with automatic needle shield:
If you have any doubts, contact your doctor or healthcare professional. | |
Step 1: Preparation | |
A | Remove the pre-filled syringe from the packaging inside the carton and gather the materials you will need for your injection: alcohol wipes, cotton or gauze, a plaster, and a sharps disposal container (not included). |
For a more comfortable injection, allow the pre-filled syringe to reach room temperature for about 30 minutes before the injection. Wash your hands thoroughly with soap and water. Place the new pre-filled syringe and other materials on a clean, well-lit surface.
|
B | Open the container by removing the cover. Grasp the pre-filled syringe by the safety shield to remove it from the container. |
| |
For safety reasons:
|
C | Inspect the medication and the prefilled syringe. |
| |
Do not use the prefilled syringe if:
| |
In any of these cases, contact your doctor or healthcare professional. |
Step 2: Prepare | |
A | Wash your hands thoroughly. Prepare and clean the injection site. |
You may inject the medication into:
| |
Clean the injection site with an alcohol swab. Allow the skin to dry.
Avoid injecting into areas with scars or stretch marks. | |
B | Carefully pull the gray needle cap straight off, holding the syringe away from your body. |
|
Do not inject into areas where the skin is tender, bruised, red, or has lumps.
C | Pinch the injection site to create a firm surface. |
| |
Step 3: Inject | |
A | Keep the skin pinched. INSERT the needle into the skin. |
| |
B | PRESS the plunger head with light, steady pressure until you feel or hear a "click". Push down completely until you hear the "click". |
|
It is important to keep the skin pinched while injecting.
It is important to press down completely until you hear the "click" to receive your full dose.C | STOP PRESSING the plunger rod. Then, REMOVE the syringe from the skin. |
After releasing the plunger rod, the safety shield of the pre-filled syringe will safely cover the needle.
| |
Step 4: Final | |
A | Dispose of the used pre-filled syringe and other materials in a sharps disposal container. |
Medicines should be disposed of in accordance with local regulations. Ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment. Keep the syringe and sharps container out of sight and reach of children.
|
B | Examine the injection site. |
If you see blood, press the injection site with a cotton ball or gauze. Do not rub the injection site. If needed, apply a bandage. |
Instructions for injecting Prolia prefilled syringe
This section contains information on how to use the Prolia prefilled syringe. It is important that you or your caregiver (the person assisting you) do not administer the injection until you have received instructions on how to do so from your doctor or healthcare professional. Always wash your hands before administering the injection. If you have any doubts about how to administer the injection, consult your doctor or healthcare professional.
Before you start
Read all instructions carefully before using the prefilled syringe.
DO NOT use the prefilled syringe if it is missing the needle cap.
How to use the Prolia prefilled syringe
Your doctor has prescribed a Prolia prefilled syringe to be injected into the tissue just beneath the skin (subcutaneously). You must inject the entire contents (1 mL) of the Prolia prefilled syringe once every 6 months, as directed by your doctor.
Materials:
To administer an injection, you will need:
- One new Prolia prefilled syringe;
- An alcohol swab or similar.
What to do before administering a subcutaneous injection of Prolia
- Remove the prefilled syringe from the refrigerator.
DO NOT handle the prefilled syringe by the plunger or the needle cap. This could damage the device.
- The prefilled syringe may be left outside the refrigerator to reach room temperature. This will make the injection less uncomfortable.
DO NOT warm the syringe in any other way, such as in a microwave or in hot water.
DO NOT leave the syringe exposed to direct sunlight.
-
DO NOT shake the prefilled syringe.
-
DO NOT remove the needle cap from the prefilled syringe until you are ready to administer the injection.
-
Check the expiry date on the label of the prefilled syringe (EXP).
DO NOT use it if the date has passed the last day of the month indicated.
-
Check the appearance of Prolia. It should be a clear, colorless to slightly yellowish solution. Do not inject if it contains particles or if it appears cloudy or discolored.
-
Find a clean, comfortable, and well-lit surface and place all necessary materials within reach.
-
Wash your hands thoroughly.
Where should the injection be administered? The best places to give the injection are the upper thighs and the abdomen. Your caregiver may also administer the injection into the outer area of the upper arms. |
|
How is the injection administered?
DO NOT touch the needle or press the plunger.
|
|
Remember: if you have any difficulties, do not hesitate to ask your doctor or healthcare professional for help and advice. How to dispose of used syringes
|
