60 mg Solution for injection ( solution for injection ) in a pre-filled syringe.
denosumab
What Prolia is and what it is used for
Prolia contains denosumab, a protein (a monoclonal antibody ) that inhibits the function of another protein to counteract the loss of bone mass and treat osteoporosis (osteoporosis). Treatment with Prolia strengthens the bone tissue and reduces the risk of bone fractures.
Bone is a living tissue that is constantly renewed. Estrogen helps keep the bone tissue healthy. After menopause, the levels of estrogen fall, which can lead to skeletal bones becoming thinner and thus fragile. This can lead to a condition called osteoporosis. Men can also suffer from osteoporosis, which can be caused by, among other things, aging and/or low levels of the male sex hormone testosterone. Patients treated with glucocorticoids (eg cortisone, prednisolone, or dexamethasone) may also be affected. Many patients with osteoporosis have no symptoms but still risk breaking bones, especially in the back, hips, and wrists.
Surgeries or medications used to stop the production of estrogen or testosterone in patients with breast or prostate cancer can also cause loss of bone mass. This leads to the legs becoming weaker and breaking more easily.
What Prolia is used for
Prolia is used to treat:
- osteoporosis in postmenopausal women (postmenopausal) and men with an increased risk of fractures (bone fractures), to reduce the risk of fractures of the spine, hips, and other bones.
- loss of bone mass due to decreased hormone content ( testosterone ) due to surgery or drug treatment in patients with prostate cancer.
- loss of bone mass due to long-term treatment with glucocorticoids (eg cortisone, prednisolone, or dexamethasone) in patients at increased risk of fractures.
What you need to know before using Prolia
Do not use Prolia
- if you have low blood calcium (hypocalcemia).
- if you are allergic to denosumab or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before using Prolia.
During treatment with Prolia, you may develop a skin infection with symptoms such as a swollen, red area of skin, usually on the lower leg, which feels hot or tender ( cellulite ), and possibly with fever symptoms. Tell your doctor immediately if you experience any of these symptoms.
You should also take calcium and vitamin D supplements during treatment with Prolia. Your doctor will talk to you about this.
You may have low blood calcium levels during treatment with Prolia. Tell your doctor immediately if you experience any of the following symptoms: muscle spasms, twitching or cramping and/or numbness or tingling in the fingers, toes, or around the mouth and/or seizures, confusion, or loss of consciousness.
Tell your doctor if you have or have had severe kidney problems, kidney failure, or need dialysis treatment, or if you are taking medicines called glucocorticoids (eg cortisone, prednisolone, or dexamethasone), which may increase your risk of low calcium levels. in the blood, if you do not take calcium supplements.
Problems with the mouth, teeth, or jaw
A side effect called osteonecrosis of the jaw (ONJ) (skeletal injuries of the jaw) has been reported in rare cases (may affect up to 1 in 1,000 users) 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 patients if they have been treated for 10 years). ONJ can also occur when treatment is completed. It is important to try to prevent ONJ from developing, as it can be a painful condition that is difficult to treat. To reduce the risk of developing ONJ, observe the following precautions:
Before treatment, tell 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 tooth extractions.
- do not go for regular dental check-ups or have not been to an examination at the dentist for a long time.
- are smokers (because it can increase the risk of dental problems).
- previously treated with a bisphosphonate (used to treat or prevent skeletal diseases).
- use drugs called corticosteroids (such as prednisolone or dexamethasone).
- have cancer.
Your doctor may ask you to undergo a dental examination before starting treatment with Prolia.
During the treatment, you should maintain good oral hygiene and go to regular dental visits. If you use a denture, make sure it fits snugly. If you are undergoing dental treatment or are about to undergo dental surgery (eg tooth extractions), tell your doctor about dental treatment and tell your dentist that you are being treated with Prolia.
Contact a doctor and dentist immediately if you have problems with your mouth or teeth, e.g. loose teeth, pain or swelling, or wounds that do not heal or secrete fluid, as this may be a sign of ONJ.
Unusual femoral fractures
Some patients have suffered unusual femoral fractures during treatment with Prolia. Contact a doctor if you experience new or unusual pain in the hip, groin, or thigh.
Children and young people
Prolia is not recommended for children and adolescents under 18 years of age. The use of Prolia in children and adolescents has not been studied.
Other medicines and Prolia
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. You must tell your doctor if you are being treated with any other medicine that contains denosumab.
You should not take Prolia with other medicines that contain denosumab.
Pregnancy, breastfeeding, and fertility
Prolia has not been tested in pregnant women. It is important that you tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby. It is not recommended that you use Prolia if you are pregnant. Women of childbearing potential should use an effective method of contraception when treated 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, tell your doctor.
It is not known whether Prolia is excreted in human milk. You must tell your doctor if you are breastfeeding or planning to do so. Your doctor will help you decide whether to stop breastfeeding or stop taking Prolia, taking into account your baby’s benefit from breastfeeding and your benefit from Prolia.
If you are breastfeeding during treatment with Prolia, tell your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Prolia has no or negligible effect on the ability to drive and use machines.
Prolia contains sorbitol
This medicine contains 47 mg sorbitol per ml solution.
Prolia contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per 60 mg, ie essentially ‘sodium-free’.
How to use Prolia
The recommended dose is a pre-filled syringe of 60 mg given once every 6 months, as a single injection under the skin ( subcutaneously ). The best injection sites are high up on the thighs and the abdomen. Your healthcare provider may also use the outside of your upper arms. Talk to your doctor about the date you should get a possible next injection. Each pack of Prolia contains a reminder card that can be removed from the carton and used to keep track of the next injection date.
You should also take calcium and vitamin D supplements during treatment with Prolia. Your doctor will talk to you about this.
Your doctor may decide that it is best for you or a healthcare provider to inject Prolia. Your doctor or healthcare professional will show you or your healthcare provider how to use Prolia. For instructions on how to inject Prolia, read the section at the end of this leaflet.
Do not shake.
If you forget to use Prolia
If you forget to take a dose of Prolia, inject one as soon as possible. Thereafter, your injection should be taken every 6 months from the date of the last injection.
If you stop using Prolia
To get the most out of your treatment for the reduced risk of fractures, you must use Prolia for as long as your doctor prescribes it. Do not stop treatment without consulting your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In less common cases, patients receiving Prolia may develop skin infections (mainly cellulite ). Tell your doctor immediately if you develop any of the following symptoms while you are being treated with Prolia: swollen, red areas of skin, usually on the lower legs, which feel warm and sore, possibly with symptoms of fever.
In rare cases, patients receiving Prolia may experience pain in the mouth and/or jaw, swelling or sores that do not heal in the mouth or jaw, sores that secrete fluid, numbness, or heaviness in the jaw, or tooth loss. This may be a sign of skeletal damage in the jaw ( osteonecrosis ). Tell your doctor and dentist immediately if you experience such symptoms while you are being treated with Prolia or when treatment is over.
In rare cases, patients receiving Prolia may have low blood calcium levels (hypocalcemia). Symptoms include spasms, twitching or cramps in the muscles, and/or numbness or tingling in the fingers, toes, or around the mouth, and/or seizures, confusion, or loss of consciousness. If you get any of these symptoms, contact your doctor immediately. Low calcium levels in the blood can also lead to a change in heart rate called prolonged QT interval, which is observed using electrocardiography ( ECG ).
In rare cases, unusual femoral fractures may occur in patients taking Prolia. Contact a doctor if you experience new or unusual pain in the hip, groin, or thigh, as this may be an early sign of a possible femoral fracture.
In rare cases, patients taking Prolia may experience allergic reactions. Symptoms include swelling of the face, lips, tongue, throat, or other parts of the body; skin rash, itching or hives, wheezing, or difficulty breathing. Tell your doctor if you develop any of these symptoms while you are being treated with Prolia.
Very common side effects ( may affect more than 1 user in 10):
- pain in the skeleton, joints, and/or muscles which is sometimes severe,
- pain in the arm or leg (pain in extremity ).
Common side effects ( may affect up to 1 in 10 people):
- painful bladder discharge, frequent bladder emptying, blood in the urine, inability to hold urine,
- upper respiratory tract infection,
- pain, tingling, or numbness that moves down the leg (sciatica),
- constipation,
- stomach upset,
- rash,
- itching, redness, and / or dry skin ( eczema ),
- hair loss ( alopecia ).
Uncommon side effects ( may affect up to 1 in 100 people):
- fever, vomiting and abdominal pain or upset stomach ( diverticulitis ),
- ear infection,
- rash that can occur on the skin or sores in the mouth (a lichenoid rash caused by drugs).
Very rare side effects ( may affect up to 1 in 10,000 people):
- allergic reactions that can damage blood vessels, mainly on the skin (eg purple or brownish-red spots, hives, or skin ulcers) (hypersensitivity vasculitis).
Has been reported (occurs in an unknown number of users):
- consult a doctor if you get sore ears if there is fluid leaking from the ear, and/or if you suffer from ear infections. This may be a sign of skeletal damage to the ear.
How to store 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 carton after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C).
Do not freeze.
Store the syringe in the outer carton. Sensitive to light.
You can leave the pre-filled syringe outside the refrigerator to reach room temperature (up to 25 ° C) before injecting it. This makes injection more comfortable. Once the syringe has been removed from the refrigerator and allowed to reach room temperature (up to 25 ° C), it must be used within 30 days.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the packaging and other information
Content declaration
- The active substance is denosumab. 1 ml of the solution for injection in the pre-filled syringe contains 60 mg denosumab (60 mg/ml).
- The other ingredients are acetic acid (glacial acetic acid), sodium hydroxide, sorbitol (E420), polysorbate 20, and water for injections.
What the medicine looks like and the contents of the pack
Prolia is a clear, colorless to pale yellow solution for injection that is delivered in ready-to-use, pre-filled syringes.
Each pack contains a pre-filled syringe with a needle guard.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Amgen Europe BV
Minervum 7061
4817 ZK Breda
Netherlands