105 mg injection, solution in a prefilled pen
romosozumab
1. What EVENITY is and what it is used for
What EVENITY is
EVENITY contains the active substance romosozumab, a medicine that helps to strengthen the skeleton and reduces the risk of bone fractures.
What EVENITY is used for
EVENITY is used to treat severe osteoporosis ( osteoporosis ) in postmenopausal women and that has a high risk of breaking bones ( fractures ).
Osteoporosis is a disease that causes your skeleton to become thin and brittle. Many patients with osteoporosis have no symptoms but may still have an increased risk of fractures.
How EVENITY works
EVENITY is a monoclonal antibody. A monoclonal antibody is a type of protein designed to recognize and attach to specific proteins in your body. EVENITY binds to a protein called sclerostin. By binding to and blocking the activity of sclerostin, EVENITY does the following:
- helps to form new bone tissue
- slows the loss of existing bone tissue.
This makes the skeleton stronger and the risk of bone fractures is reduced.
2. What you need to know before using EVENITY
Do not use EVENITY
- if you are allergic to romosozumab or any of the other ingredients of this medicine (listed in section 6).
- if you have low levels of calcium in your blood (hypocalcemia). Your doctor will tell you if your levels are too low.
- if you have previously had a heart attack or stroke.
Do not use EVENITY if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using EVENITY.
Warnings and cautions
Talk to your doctor or pharmacist and discuss your previous illnesses before using EVENITY.
Myocardial infarction and stroke
Myocardial infarction and stroke have been reported in people receiving EVENITY.
Seek medical attention immediately if you experience:
- chest pain, shortness of breath,
- headache, loss of sensation or weakness in the face, arms, or legs, speech difficulties, vision changes, balance problems.
Your doctor will carefully evaluate the risk of cardiovascular problems before allowing you to start treatment with EVENITY. Tell your doctor if you know you have an increased risk of cardiovascular problems, such as an established cardiovascular disease, high blood pressure, high blood fat levels, diabetes, smoking, or kidney problems.
Low levels of calcium in the blood
EVENITY can cause low calcium levels in the blood.
Tell your doctor if you notice:
- spasms, twitches, or cramps in the muscles
- loss of sensation or tingling in the fingers, toes, or around the mouth.
Your doctor may prescribe calcium and vitamin D to help prevent low blood calcium levels before you start treatment and while you are taking EVENITY. Take calcium and vitamin D according to your doctor’s instructions.
Tell your doctor if you have or have ever had severe kidney problems, kidney failure, or need dialysis as this may increase the risk of low blood calcium if you do not take calcium supplements.
Severe allergic reactions
Severe allergic reactions may affect people using EVENITY.
Seek medical attention immediately if you experience :
- swelling of the face, mouth, neck, hands, feet, ankles, lower legs ( angioedema ), or hives.
- acute skin rash that appears as several round red/pink dots with blisters or scabs in the middle (erythema multiforme)
- difficulty swallowing or breathing.
Problems with the mouth, teeth, or jaw
A side effect called osteonecrosis of the jaw (skeletal injury of the jaw) has been reported in rare cases (may affect up to 1 in 1,000 people) in patients receiving EVENITY. Osteonecrosis of the jaw can also occur after the end of treatment. It is important to prevent the development of osteonecrosis of the jaw as it is a painful condition that can be difficult to treat. To reduce the risk of developing osteonecrosis of the jaw, there are some preventative measures you can take.
Before taking EVENITY, tell your doctor or nurse if you:
- have problems with the mouth or teeth, such as poor oral health, gum disease, or have to undergo scheduled tooth extraction
- do not visit a dentist regularly or if it has been a long time since the last dental examination
- are smokers (this may increase the risk of dental problems)
- previously treated with bisphosphonates (used to treat or prevent skeletal diseases such as osteoporosis).
- taking medicines called corticosteroids (such as prednisolone or dexamethasone)
- have cancer.
Your doctor may ask you to undergo a dental examination before starting treatment with EVENITY.
While you are being treated, you should take good care of your oral hygiene and go for regular dental check-ups. If you have false teeth, make sure that they are properly seated. If you are undergoing dental treatment or are about to undergo dental surgery (for example, extraction of teeth), you should inform your doctor about your dental treatment and tell your dentist that you are being treated with EVENITY.
Contact your doctor and dentist immediately if you have problems with your mouth or teeth, such as:
- loose teeth
- pain or swelling
- sores in the mouth that do not heal
- suppuration.
Unusual femoral fractures
People who have used EVENITY have in rare cases developed unusual fractures of the femur caused by limited or no bodily injury. This type of fracture is often preceded by warning signs with pain in the thigh or groin several weeks before a fracture occurs. It is unknown whether EVENITY caused these unusual fractures. Tell your doctor or pharmacist if you experience new or unusual pain in your hip, groin, or thigh.
Children and young people
The use of romosozumab in children and adolescents has not been studied and is not approved for use in children and adolescents (under 18 years of age).
OTHER MEDICINES AND EVENITY
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
EVENITY is only for the treatment of postmenopausal women.
EVENITY should not be used by women of childbearing potential, or during pregnancy or lactation. It is not known if EVENITY can harm fetuses or breastfed infants.
Contact a doctor if you have any questions.
Driving and using machines
EVENITY is expected to have no or negligible effect on the ability to drive and use machines.
EVENITY contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’.
3. How to use EVENITY
EVENITY will be deployed and supervised by specialists experienced in the treatment of osteoporosis. Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.
Injection one should only be given by a person with appropriate training.
How much to use
- The recommended dose of EVENITY is 210 mg.
- As one pre-filled pen contains 105 mg of the active substance romosozumab in 1.17 ml solution (90 mg/ml), 2 pre-filled pens must be used for each dose. The second injection must be given immediately after the first but at a different injection site.
- Do this once a month for 12 months.
User instructions
- EVENITY must be injected under the skin ( subcutaneous injection ).
- EVENITY should be injected into the abdominal area (abdomen) or thigh. The outside of the upper arm can also be used as an injection site but only if someone else gives you an injection.
- If you plan to use the same injection site for the second injection, a different injection site should be used.
- EVENITY should not be injected into areas where the skin is tender, bruised, red, or hard.
You must read the instruction manual for detailed information on how EVENITY pre-filled pen should be used.
Talk to your doctor or pharmacist if you have any further questions on the use of this medicine.
If you use more EVENITY than you should
If you use too much EVENITY by mistake, contact your doctor or pharmacist.
If you forget to use or could not take EVENITY at the usual time
If you miss a dose of EVENITY, contact your doctor as soon as possible to plan when to take another dose. Thereafter, the next dose should not be given earlier than one month after the last dose.
If you stop taking EVENITY
If you are considering stopping EVENITY treatment, discuss this with your doctor. Your doctor will advise you on how long you should be treated with EVENITY.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Talk to your doctor about switching to another treatment for osteoporosis after stopping treatment with EVENITY.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Seek immediate medical attention if you experience any of the following possible symptoms of a heart attack or stroke (uncommon: may affect up to 1 in 100 people):
- chest pain, shortness of breath
- headache, numbness or weakness of the face, arms, or legs, speech difficulties, visual disturbances, balance difficulties
Seek immediate medical attention if you experience the following symptoms of a severe allergic reaction (rare: may affect up to 1 in 1,000 people):
- swelling of the face, mouth, neck, hands, feet, ankles, or lower legs ( angioedema ) or hives
- acute skin rash that appears as several round red/pink dots with blisters or scabs in the middle (erythema multiforme)
- difficulty swallowing or breathing.
Tell your doctor if you notice any of the following symptoms of low blood calcium (hypocalcemia) (uncommon: may affect up to 1 in 100 people):
- spasms, twitches, or cramps in the muscles
- loss of sensation or tingling in the fingers, toes, or around the mouth.
See also section 2 “What you need to know before using Evenity”.
Other side effects may include:
Very common side effects are (may affect more than 1 in 10 people):
- Cold
- Joint pain
Common side effects are (may affect up to 1 in 10 people):
- Rash, dermatitis
- Headache
- Sinusitis ( sinusitis )
- Neck pain
- Muscle spasms
- Redness or pain around the place where the injection a given
Less common side effects are (may affect up to 1 in 100 people):
- Hives ( urticaria )
- Cataract
5. How to store EVENITY
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.
Once the carton with the pre-filled pens has been removed from the refrigerator for use, they must not be put back in the refrigerator but can be stored at room temperature (up to 25 ° C) for up to 30 days. If the product is not used within this period, it should be discarded.
Keep the pre-filled pen in the outer carton. Sensitive to light.
Check the solution visually. Do not use it if the solution is discolored, cloudy, or contains flakes or particles.
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.
6. Contents of the packaging and other information
Content declaration
- The active substance is romosozumab. Each pre-filled pen contains 105 mg romosozumab in 1.17 ml solution (90 mg / ml).
- The other ingredients are calcium acetate, concentrated acetic acid, sodium hydroxide (for pH adjustment), sucrose, polysorbate, and water for injections. See section 2 “EVENITY contains sodium”
What the medicine looks like and the contents of the pack
EVENITY is a clear to opalescent, colorless to pale yellow injection solution provided in a pre-filled pen disposable. The syringe inside the pen is made of plastic and has a stainless steel needle.
Pack of 2 pre-filled pens.
Multi-pack containing 6 (3 packs of 2) pre-filled pens.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
UCB Pharma SA
Research Avenue 60
B-1070 Brussels, Belgium
Manufacturer
Amgen Europe BV
Minervum 7061
4817 ZK Breda, Netherlands