Evenity

Package leaflet: Information for the user

EVENITY 105 mg solution for injection in pre-filled pen

romosozumab
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• You will be given a patient alert card containing important safety information that you must know before and during treatment with EVENITY.

Contents of this leaflet

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

1. What EVENITY is and what it is used for

What EVENITY is
EVENITY contains the active substance romosozumab, a medicine that helps make bones stronger and reduces the risk of bone fractures.

What EVENITY is used for
EVENITY is used for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture.
Osteoporosis is a disease that causes bones to become thin and fragile. Many patients with osteoporosis do not have symptoms, but are at increased risk of fractures.

How EVENITY works
EVENITY is a monoclonal antibody, which is a type of protein designed to recognise specific proteins in the body and bind to them. EVENITY binds to a protein called sclerostin. By binding to sclerostin and blocking its activity, EVENITY:

• promotes the formation of new bone, and
• slows down the loss of existing bone.

This makes bones stronger and reduces the risk of fractures.

2. What you should know before using EVENITY

Do not use EVENITY

• if you are allergic to romosozumab or to 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 advise you whether your levels are too low;
• if you have previously had a heart attack or stroke.

Do not use EVENITY if any of the conditions described above apply to you. If you have any doubts, consult your doctor or pharmacist before using EVENITY.
Warnings and precautions
Talk to your doctor or pharmacist and report your medical history before using EVENITY.
Heart attack and stroke
Cases of heart attack and stroke have been reported in people taking EVENITY.
Contact your doctor immediately if you experience:

• chest pain, shortness of breath;
• headache, numbness or weakness in the face, arms, or legs, difficulty speaking, changes in vision, loss of balance.

Your doctor will carefully evaluate your risk of cardiovascular problems before starting treatment with EVENITY. Inform your doctor if you know you have an increased risk of cardiovascular problems such as established cardiovascular disease, high blood pressure, elevated blood lipid levels, diabetes, if you smoke, or have kidney disease.
Low calcium levels in the blood
EVENITY may cause a decrease in calcium levels in the blood.
Inform your doctor if you notice:

• muscle spasms, twitching, or cramps;
• numbness or tingling in the fingers of hands and feet or around the mouth.

Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels before starting treatment and while taking EVENITY. Take calcium and vitamin D as directed by your doctor.
Inform your doctor if you have or have previously had severe kidney problems, kidney failure, or if you have required dialysis, as this may increase your risk of low calcium levels if you do not take calcium supplements.
Severe allergic reactions
People using EVENITY may develop severe allergic reactions.
Contact your doctor immediately if you experience:

• swelling of the face, mouth, throat, hands, feet, ankles, lower legs (angioedema) or hives;
• an acute skin rash appearing as multiple red/rosy circular patches with central blisters or crusts (erythema multiforme);
• difficulty swallowing or breathing.

Problems affecting the mouth, teeth, or jaw
A side effect called osteonecrosis of the jaw (ONJ) (damage to the jawbone) has been reported rarely (may affect up to 1 in 1,000 people) in patients taking EVENITY. ONJ may also occur after stopping treatment. It is important to try to prevent ONJ from developing, as it may be a painful condition that could be difficult to treat. To reduce the risk of developing ONJ, there are certain precautions you must take.
Before starting EVENITY, inform your doctor or nurse if:

• you have problems with your mouth or teeth, such as poor dental hygiene, gum disease, or a planned dental extraction;
• you do not receive regular dental care or have not had a dental examination 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 treat or prevent bone disorders such as osteoporosis);
• you are currently taking medicines called corticosteroids (such as prednisolone or dexamethasone);
• you have cancer.

Your doctor may ask you to have a dental examination before starting treatment with EVENITY.
During treatment, you must maintain good oral hygiene and undergo regular dental check-ups.
If you wear dentures, ensure they fit properly. If you are receiving dental treatment or are scheduled to undergo dental surgery (e.g., tooth extraction), inform your doctor about the dental treatment and inform your dentist that you are being treated with EVENITY.
Contact your doctor and dentist immediately if you notice any problems with your mouth or teeth, including:

• loose teeth;
• pain or swelling;
• non-healing mouth ulcers;
• discharge.

Atypical femoral fractures
In rare cases, fractures of the femur (thigh bone) have occurred in people using EVENITY, caused by minor trauma or even without trauma. These types of fractures have often been preceded by warning signs such as thigh or groin pain for several weeks before the fracture.
It is not known whether EVENITY caused these atypical fractures. Inform your doctor or pharmacist if you experience new or unusual pain in your hip, groin, or thigh.
Children and adolescents
Romosozumab has not been studied in children and adolescents and is not approved for use in pediatric patients (age <18 years).
Other medicines and EVENITY
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
EVENITY is intended solely for the treatment of postmenopausal women.
EVENITY must not be used by women of childbearing potential, during pregnancy, or while breastfeeding. It is not known whether EVENITY may cause harm to the fetus or to breastfed infants.
Contact your doctor if you have any doubts.
Driving and using machines
EVENITY is expected to have negligible or no influence on the ability to drive vehicles or use machines.
EVENITY contains sodium and polysorbate 20
This medicine contains 0.070 mg of polysorbate 20 in each pre-filled pen. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially 'sodium-free'.

3. How to use EVENITY

Treatment with EVENITY will be initiated and monitored by specialist doctors experienced in the management of osteoporosis. Always use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.
The injection must be administered only by a properly trained person.

Dosage

• The recommended dose of EVENITY is 210 mg.
• Since a pre-filled pen contains 105 mg of the active substance romosozumab in 1.17 ml of solution (90 mg/ml), 2 pre-filled pens must be used for each dose. The second injection must be administered immediately after the first, but at a different injection site.
• Administration should be performed once a month for 12 months.

How to use it

• EVENITY must be injected under the skin (subcutaneous injection).
• EVENITY may be injected into the abdominal area or the thigh. The outer area of the upper arm may also be used as an injection site, but only if the injection is administered by another person.
• If you plan to administer the second injection in the same general area, a different injection site must be used.
• EVENITY must not be injected into areas where the skin is tender, bruised, red, or hard.

It is important that you read the instructions for use for detailed information on how to use the EVENITY pre-filled pen.
If you have further questions about the use of this medicine, consult your doctor or pharmacist.

If you use more EVENITY than you should
If, by mistake, you have used more EVENITY than prescribed, contact your doctor or pharmacist.

If you forget to use or cannot take EVENITY at the usual time
If you miss a dose of EVENITY, contact your doctor as soon as possible to reschedule the dose.
The next dose should then be administered no sooner than one month after the date of the last dose.

If you stop treatment with EVENITY
If you are considering stopping treatment with EVENITY, discuss this with your doctor. Your doctor will advise you on how long you should continue treatment with EVENITY.
If you have any doubts about using this medicine, consult your doctor or pharmacist.
Discuss with your doctor the need for switching to another osteoporosis treatment after completing therapy with EVENITY.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience any of the following possible symptoms of
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, difficulty speaking, vision changes, loss of balance.

Contact your doctor immediately 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, throat, hands, feet, ankles, lower legs (angioedema) or hives;
• acute skin rash appearing as multiple circular red/rose-colored spots with central blisters or crusts (erythema multiforme);
• difficulty swallowing or breathing.

Contact your doctor if you notice the following symptoms caused by low calcium levels in the blood
(hypocalcaemia) (uncommon: may affect up to 1 in 100 people):

• muscle spasms, stiffness or cramps;
• numbness or tingling in the fingers of hands and feet or around the mouth.

Also refer to section 2 “What you need to know before using EVENITY”.
Other side effects may include:
Very common side effects (may affect more than 1 in 10 people):

• Common cold;
• Joint pain.

Common side effects (may affect up to 1 in 10 people):

• Rash, skin inflammation;
• Headache;
• Sinus inflammation;
• Neck pain;
• Muscle spasms;
• Redness or pain around the injection site.

Uncommon side effects (may affect up to 1 in 100 people):

• Hives;
• Cataract.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

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 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.
Once removed from the refrigerator, the carton containing the pre-filled pens for use must not be returned to the refrigerator, but may be kept at room temperature (up to 25 °C) for a maximum of 30 days. If not used within this period, the product must be discarded.
Keep the pre-filled pen in its outer packaging to protect the medicine from light.
Visually inspect the solution. Do not use the solution if it has changed colour, is cloudy, or contains residues or particles.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What EVENITY contains

• The active substance is romosozumab. Each pre-filled pen contains 105 mg of romosozumab in 1.17 ml of solution (90 mg/ml).
• The other ingredients are calcium acetate, glacial acetic acid, sodium hydroxide (for pH adjustment), sucrose, polysorbate 20, and water for injections. See section 2 “EVENITY contains sodium”.

Description of the appearance of EVENITY and contents of the pack
EVENITY is an injectable solution, from colourless to slightly yellow, from clear to opalescent, supplied in a single-use disposable pre-filled pen. The syringe inside the pen is made of plastic with a stainless steel needle.
Pack containing 2 pre-filled pens.
Multiple pack containing 6 (3 packs of 2) pre-filled pens.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
UCB Pharma S.A.,
Allée de la Recherche 60,
B-1070 Brussels, Belgium

Manufacturer
Amgen Europe B.V.,
Minervum 7061,
4817 ZK Breda, The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Lietuva
UCB Pharma SA/NV UCB Pharma Oy Finland
Tél/Tel: + 32 / (0)2 559 92 00 Tel: + 358 9 2514 4221
България Luxembourg/Luxemburg
UCB Bulgaria EOOD UCB Pharma SA/NV
Teл.: + 359 (0) 2 962 30 49 Tél/Tel: + 32 / (0)2 559 92 00
Česká republika Magyarország
UCB s.r.o. UCB Magyarország Kft.
Tel: + 420 221 773 411 Tel: + 36-(1) 391 0060
Danmark Malta
UCB Nordic A/S Pharmasud Ltd.
Tlf: + 45 / 32 46 24 00 Tel: + 356 / 21 37 64 36
Deutschland Nederland
UCB Pharma GmbH UCB Pharma B.V.
Tel: + 49 /(0) 2173 48 4848 Tel: + 31 / (0)76-573 11 40
Eesti Norge
UCB Pharma Oy Finland UCB Nordic A/S
Tel: + 358 9 2514 4221 Tlf: + 47 / 67 16 5880
Ελλάδα Österreich
UCB Α.Ε. UCB Pharma GmbH
Τηλ: + 30 / 2109974000 Tel: + 43-(0)1 291 80 00
España Polska
UCB Pharma, S.A. UCB Pharma Sp. z o.o. / VEDIM Sp. z o.o.
Tel: + 34 / 91 570 34 44 Tel: + 48 22 696 99 20
France Portugal
UCB Pharma S.A. UCB Pharma (Produtos Farmacêuticos), Lda
Tél: + 33 / (0)1 47 29 44 35 Tel: + 351 / 21 302 5300
Hrvatska România
Medis Adria d.o.o. UCB Pharma Romania S.R.L.
Tel: +385 (0) 1 230 34 46 Tel: + 40 21 300 29 04
Ireland Slovenija
UCB (Pharma) Ireland Ltd. Medis, d.o.o.
Tel: + 353 / (0)1-46 37 395 Tel: + 386 1 589 69 00
Ísland Slovenská republika
Vistor hf. UCB s.r.o., organizačná zložka
Simi: + 354 535 7000 Tel: + 421 (0) 2 5920 2020
Italia Suomi/Finland
UCB Pharma S.p.A. UCB Pharma Oy Finland
Tel: + 39 / 02 300 791 Puh/Tel: + 358 9 2514 4221
Κύπρος Sverige
Lifepharma (Z.A.M.) Ltd UCB Nordic A/S
Τηλ: + 357 22 056300 Tel: + 46 / (0) 40 29 49 00
Latvija
UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Finland)

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu.
The Instructions for Use are printed on the reverse side.

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INSTRUCTIONS FOR USE FOR INJECTION OF EVENITY USING A PRE-FILLED PEN
Inject two pre-filled pens one immediately after the other to receive a complete dose

= 1 dose
The following instructions explain how to use the pre-filled pen to inject EVENITY.

• Read these instructions carefully and follow them step by step.
• If you have any questions or doubts about the injection procedure, contact your doctor or pharmacist.
• It is important to ensure that the injection is administered only by a properly trained person.
• The pre-filled pen may also be referred to as “the medicine”.

Guide to parts: pre-filled pen
Before use After use

Expiry date Expiry date
Yellow window
Yellow window (injection complete)
Medicine
Safety shield
White cap inserted
White cap
disengaged

STOP

Read the following before injecting the medicine.

Your doctor has prescribed a dose of 210 mg to be administered every month: to receive the complete dose, two pre-filled pens of 105 mg must be injected one immediately after the other.
Step 1: Preparation
A • Take the pack containing the two pre-filled pens out of the refrigerator.

• The pre-filled pens must remain outside the refrigerator to reach room temperature (up to 25 °C) for at least 30 minutes before injection (do not heat them in any other way). This will make the injection more comfortable.
• Open the box and prepare all materials needed for the injection (as listed in Step B).
• Wash your hands thoroughly.
• Remove the pre-filled pens from the pack by lifting them out; do not remove the white caps from the pre-filled pens yet.
• Do not shake the pre-filled pens.
• Inspect the medicine through the viewing window. The medicine should be a solution from clear to opalescent, from colourless to slightly yellow. – Do not use the pre-filled pens if the solution has changed colour, is cloudy, or contains residues or particles. – You may notice air bubbles. Injecting the solution containing air bubbles subcutaneously (under the skin) is not dangerous.
• Do not use the pre-filled pens if: – they have been dropped; – the white cap is missing or not properly closed; – the seal is missing or broken, or if there are any cracks or signs of damage at any point. In such cases, use a new pen and contact your doctor as soon as possible.

B On a clean, well-lit work surface, place:

• two pre-filled pens;

• two alcohol wipes;
• two cotton balls or gauzes;
• two adhesive bandages;
• a sharps disposal container.

C Prepare and clean the skin where the medicine will be injected. You may choose from the following injection sites:

• thighs;

• abdominal area (stomach), except for a 5 cm area around the navel;
• outer upper arm (if the injection is administered by another person).
• The second injection must be given at a different site than the one used for the first injection. If you wish to use the same injection site, ensure it is not exactly the same spot.
• Do not inject in areas where the skin is tender, injured, red, hard, scarred, or has stretch marks, or if there are thickened, red, or flaky skin lesions.
• Clean the injection site with an alcohol wipe. Allow the skin to dry before injection.

• Do not touch this area again before the injection.

Step 2: Preparation for injection
D • Remove the white cap just before injection.

• Once the cap is removed, the injection must be administered within 5 minutes. You do not need to rush. You have up to 5 minutes to perform the injection.

  

• Do not twist or bend the white cap.

• Dispose of the white cap in the sharps disposal container. Do not reattach the white cap to the pre-filled pen.

• Although not visible, the needle tip is now exposed. Do not touch the needle, as movement could activate the pre-filled pen. It is normal to see a drop of liquid at the tip of the needle (inside the yellow safety shield).

E Stretch or pinch the injection site to create a stable surface.
Stretch method

• Firmly stretch the skin by moving the thumb and other fingers in opposite directions to create an area approximately 5 cm long.

OR
Pinch method

• Firmly lift the skin between the thumb and other fingers to create an area approximately 5 cm long.

• Important: Keep the skin stretched or pinched during the injection.

Step 3: Injection
F • Important: Do not press down on the pre-filled pen until you are actually ready to inject.

• Keep the skin stretched or pinched. Using the other hand, place the yellow safety shield of the pre-filled pen onto the previously cleaned skin area (the “injection site”) at a 90° angle.

Yellow safety shield
G • Press the pre-filled pen firmly against the skin until the yellow safety shield stops moving. The injection will start when you hear or feel a click.
H • Continue pressing against the skin. The injection may last approximately 15 seconds.

• Once the injection is complete, the viewing window will turn completely yellow, and you may hear or feel a second click.

Press down

“click”

15 seconds “click”

The window turns completely yellow when the injection is complete.

• The pre-filled pen can now be gently removed by lifting it upward from the skin.
• Important: When removing the pre-filled pen, if the window has not turned completely yellow or if the medicine appears to still be injecting, this means the full dose has not been administered. Inform the healthcare provider as soon as possible.
• After removing the pre-filled pen from the skin, the needle will automatically cover. Do not attempt to touch the needle.

Step 4: Disposal
I • Immediately after use, dispose of the entire used pre-filled pen and the white cap in a sharps disposal container.

• Do not throw away (dispose of) the pre-filled pen in household waste.
• Do not reuse the pre-filled pen.
• Important: Always keep the sharps disposal container out of sight and reach of children.

Step 5: Examine the injection site
J If you notice bleeding, use a cotton ball or gauze and apply gentle pressure to the injection site for a few seconds. Do not rub the injection site. The injection site may be covered with a small adhesive bandage if needed.
Step 6: Repeat for the second injection to receive the complete dose
K Repeat all steps starting from Step C with the second pre-filled pen to administer the complete dose. The second injection must be given at a different site than the first injection. If you wish to use the same injection site, ensure it is not exactly the same spot.

Package leaflet: information for the user

EVENITY 105 mg solution for injection in pre-filled syringe

romosozumab
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• You will be given a patient alert card containing important safety information that you must know before and during treatment with EVENITY.

Contents of this leaflet

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

1. What EVENITY is and what it is used for

What EVENITY is
EVENITY contains the active substance romosozumab, a medicine that helps make bones stronger and reduces the risk of bone fractures.
What EVENITY is used for
EVENITY is used for the treatment of severe osteoporosis in postmenopausal women at high risk of bone fracture.
Osteoporosis is a disease that causes bones to become thin and weak. Many patients with osteoporosis do not have symptoms, but are at increased risk of fractures.
How EVENITY works
EVENITY is a monoclonal antibody, which is a type of protein designed to recognise specific proteins in the body and bind to them. EVENITY binds to a protein called sclerostin. By binding to sclerostin and blocking its activity, EVENITY:

• promotes the formation of new bone, and
• slows down the loss of existing bone. This makes bones stronger and reduces the risk of fractures.

2. What you should know before using EVENITY

Do not use EVENITY

• if you are allergic to romosozumab or to 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 advise 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 conditions described above apply to you. If you have any doubts, consult your doctor or pharmacist before using EVENITY.

Warnings and precautions

Talk to your doctor or pharmacist and report your medical history before using EVENITY.

Heart attack and stroke

Cases of heart attack and stroke have been reported in people taking EVENITY.

Contact your doctor immediately if you experience:

• chest pain, shortness of breath;
• headache, numbness or weakness in the face, arms, or legs, difficulty speaking, changes in vision, loss of balance.

Your doctor will carefully assess your risk of cardiovascular problems before starting treatment with EVENITY. Inform your doctor if you know you have an increased risk of cardiovascular problems, such as established cardiovascular disease, high blood pressure, elevated blood lipid levels, diabetes, if you smoke, or if you have kidney disease.

Low levels of calcium in the blood

EVENITY may cause a decrease in calcium levels in the blood.

Inform your doctor if you notice:

• muscle spasms, twitching, or cramps;
• numbness or tingling in the fingers, toes, or around the mouth.

Your doctor may prescribe calcium and vitamin D supplements to help prevent low calcium levels before and during treatment with EVENITY. Take calcium and vitamin D exactly as directed by your doctor. Inform your doctor if you have or have previously had severe kidney problems, kidney failure, or if you have required dialysis, as this may increase your risk of low calcium levels if you do not take calcium supplements.

Severe allergic reactions

People using EVENITY may develop severe allergic reactions. Contact your doctor immediately if you experience:

• swelling of the face, mouth, throat, hands, feet, ankles, lower legs (angioedema), or hives;
• acute skin rash appearing as multiple red or rosy circular spots with central blisters or crusts (erythema multiforme);
• difficulty swallowing or breathing.

Problems affecting the mouth, teeth, or jaw

A side effect called osteonecrosis of the jaw (ONJ) (damage to the jawbone) has been reported rarely (may affect up to 1 in 1,000 people) in patients taking EVENITY. ONJ may also occur after stopping treatment. It is important to try to prevent ONJ from developing, as it may be a painful condition that could be difficult to treat. To reduce the risk of developing ONJ, you should take certain precautions.

Before starting EVENITY, inform your doctor or nurse if:

• you have mouth or dental problems, such as poor dental hygiene, gum disease, or a planned tooth extraction;
• you do not have regular dental check-ups or have not visited a dentist for a long time;
• you smoke (as this may increase the risk of dental problems);
• you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders such as osteoporosis);
• you are currently taking medicines called corticosteroids (such as prednisolone or dexamethasone);
• you have cancer.

Your doctor may ask you to have a dental examination before starting treatment with EVENITY.

During treatment, you must maintain good oral hygiene and attend regular dental check-ups. If you wear dentures, ensure they fit properly. If you are undergoing dental treatment or need to have dental surgery (e.g., tooth extraction), inform your doctor about the dental procedure and inform your dentist that you are being treated with EVENITY.

Contact your doctor and dentist immediately if you notice any new problems with your mouth or teeth, including:

• loose teeth;
• pain or swelling;
• mouth sores that do not heal;
• discharge.

Atypical femoral fractures

In people who have used EVENITY, rare cases of femur fractures have occurred, caused by minor trauma or even in the absence of trauma. These types of fractures have often been preceded by warning signs such as thigh or groin pain for several weeks before the fracture. It is not known whether EVENITY caused these atypical fractures. Inform your doctor or pharmacist if you experience new or unusual pain in your hip, groin, or thigh.

Children and adolescents

Romosozumab has not been studied in children and adolescents and is not approved for use in pediatric patients (age <18 years).

Other medicines and EVENITY

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding

EVENITY is intended only for the treatment of postmenopausal women.

EVENITY must not be used by women of childbearing potential, during pregnancy, or while breastfeeding. It is not known whether EVENITY may cause harm to the fetus or to breastfed infants.

Contact your doctor if you have any concerns.

Driving and using machines

EVENITY is expected to have negligible or no influence on the ability to drive vehicles or operate machinery.

EVENITY contains sodium and polysorbate 20

This medicine contains 0.070 mg of polysorbate 20 in each pre-filled syringe. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially ‘sodium-free’.

3. How to use EVENITY

Treatment with EVENITY will be initiated and monitored by specialist physicians experienced in the management of osteoporosis. Always use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.
The injection must be administered only by a properly trained person.

Dosage

• The recommended dose of EVENITY is 210 mg.
• Since a single pre-filled syringe contains 105 mg of the active substance romosozumab, two pre-filled syringes must be used for each dose. The second injection must be administered immediately after the first, but at a different injection site.
• Administration should be performed once a month for 12 months.

How to use it

• EVENITY must be injected under the skin (subcutaneous injection).
• EVENITY may be injected in the abdominal area or thigh. The outer area of the upper arm may also be used as an injection site, but only if the injection is administered by another person.
• If the second injection is to be given in the same general area, a different injection site must be used.
• EVENITY must not be injected into areas where the skin is tender, bruised, red, or hard.

It is important that you read the Instructions for Use for detailed information on how to use the pre-filled syringe of EVENITY.
If you have further questions about the use of this medicine, consult your doctor or pharmacist.

If you use more EVENITY than you should
If you accidentally use more EVENITY than prescribed, contact your doctor or pharmacist immediately.

If you forget to use or cannot take EVENITY at the usual time
If you miss a dose of EVENITY, contact your doctor as soon as possible to reschedule the dose.
The next dose should then be administered no sooner than one month after the date of the last dose.

If you stop treatment with EVENITY
If you are considering stopping treatment with EVENITY, discuss this with your doctor. Your doctor will advise you on how long your treatment with EVENITY should last.
If you have any doubts about using this medicine, consult your doctor or pharmacist.
Discuss with your doctor the need to switch to another osteoporosis treatment after completing therapy with EVENITY.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

Contact your doctor immediately if you experience the following possible symptoms of 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, difficulty speaking, vision changes, loss of balance.

Contact your doctor immediately 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, throat, hands, feet, ankles or lower legs (angioedema) or hives;
• acute skin rash appearing as multiple red/rose-colored circular patches with blisters or central crusts (erythema multiforme);
• difficulty swallowing or breathing.

Contact your doctor if you notice the following symptoms caused by low calcium levels in the blood (hypocalcaemia) (uncommon: may affect up to 1 in 100 people):

• muscle spasms, cramps or twitching;
• numbness or tingling in the fingers, toes or around the mouth.

Also refer to section 2 “What you need to know before using EVENITY”.

Other side effects may include:

Very common side effects (may affect more than 1 in 10 people):

• Common cold;
• Joint pain.

Common side effects (may affect up to 1 in 10 people):

• Skin rash, skin inflammation;
• Headache;
• Sinus inflammation;
• Neck pain;
• Muscle spasms;
• Redness or pain around the injection site.

Uncommon side effects (may affect up to 1 in 100 people):

• Hives;
• Cataract.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

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 on the 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.
Once the carton containing the pre-filled syringes to be used has been removed from the refrigerator,
it must not be returned to the refrigerator, but may be kept at room temperature (up to 25 °C) for a maximum
of 30 days. If not used within this period, the product must be discarded.
Keep the pre-filled syringe in its outer packaging to protect the medicine from light.
Visually inspect the solution. Do not use the solution if it has changed colour, is cloudy, or contains
residues or particles.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What EVENITY contains

• The active substance is romosozumab. Each pre-filled syringe contains 105 mg of romosozumab in 1.17 ml of solution (90 mg/ml).
• The other ingredients are calcium acetate, glacial acetic acid, sodium hydroxide (for pH adjustment), sucrose, polysorbate 20, and water for injections. See section 2 “EVENITY contains sodium”.

Description of the appearance of EVENITY and contents of the pack
EVENITY is an injectable solution, from colourless to pale yellow, from clear to opalescent, supplied in a single-use disposable pre-filled syringe. The syringe is made of plastic and contains a stainless steel needle.
Pack of 2 pre-filled syringes.
Multiple pack containing 6 (3 packs of 2) pre-filled syringes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium

Manufacturer
Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Lietuva
UCB Pharma SA/NV UCB Pharma Oy Finland
Tél/Tel: + 32 / (0)2 559 92 00 Tel: + 358 9 2514 4221

България Luxembourg/Luxemburg
Ю СИ БИ България ЕООД UCB Pharma SA/NV
Teл.: + 359 (0) 2 962 30 49 Tél/Tel: + 32 / (0)2 559 92 00

Česká republika Magyarország
UCB s.r.o. UCB Magyarország Kft.
Tel.: + 420 221 773 411 Tel: + 36-(1) 391 0060

Danmark Malta
UCB Nordic A/S Pharmasud Ltd.
Tlf: + 45 / 32 46 24 00 Tel: + 356 / 21 37 64 36

Deutschland Nederland
UCB Pharma GmbH UCB Pharma B.V.
Tel: + 49 /(0) 2173 48 4848 Tel: + 31 / (0)76-573 11 40

Eesti Norge
UCB Pharma Oy Finland UCB Nordic A/S
Tel: + 358 9 2514 4221 Tlf: + 47 / 67 16 5880

Ελλάδα Österreich
UCB Α.Ε. UCB Pharma GmbH
Τηλ: + 30 / 2109974000 Tel: + 43-(0)1 291 80 00

España Polska
UCB Pharma, S.A. UCB Pharma Sp. z o.o. / VEDIM Sp. z o.o.
Tel: + 34 / 91 570 34 44 Tel: + 48 22 696 99 20

France Portugal
UCB Pharma S.A. UCB Pharma (Produtos Farmacêuticos), Lda
Tél: + 33 / (0)1 47 29 44 35 Tel: + 351 / 21 302 5300

Hrvatska România
Medis Adria d.o.o. UCB Pharma Romania S.R.L.
Tel: +385 (0) 1 230 34 46 Tel: + 40 21 300 29 04

Ireland Slovenija
UCB (Pharma) Ireland Ltd. Medis, d.o.o.
Tel: + 353 / (0)1-46 37 395 Tel: + 386 1 589 69 00

Ísland Slovenská republika
Vistor hf. UCB s.r.o., organizačná zložka
Simi: + 354 535 7000 Tel: + 421 (0) 2 5920 2020

Italia Suomi/Finland
UCB Pharma S.p.A. UCB Pharma Oy Finland
Tel: + 39 / 02 300 791 Puh/Tel: + 358 9 2514 4221

Κύπρος Sverige
Lifepharma (Z.A.M.) Ltd UCB Nordic A/S
Τηλ: + 357 22 056300 Tel: + 46 / (0) 40 29 49 00

Latvija
UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Finland)

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Instructions for use are printed on the reverse side.

INSTRUCTIONS FOR INJECTION OF EVENITY USING A PREFILLED SYRINGE

PREFILLED
Inject two prefilled syringes one immediately after the other to receive a complete dose

1 dose
The following instructions explain how to use the prefilled syringe to inject EVENITY.

• Read these instructions carefully and follow them step by step.
• If you have any questions or doubts about the injection procedure, contact your doctor or pharmacist.
• It is important to ensure that the injection is administered only by a properly trained person.
• The prefilled syringe may also be referred to as “the medicine”.

Guide to parts: prefilled syringe

Before use After use

STOP Read the following before injecting the medicine.

Your doctor has prescribed a dose of 210 mg to be administered every month: to receive the complete dose,
two prefilled syringes of 105 mg must be injected,
one immediately after the other.
Step 1: Preparation
A • Take the package containing the two prefilled syringes out of the refrigerator.

• The prefilled syringes must be left outside the refrigerator to reach room temperature (up to 25 °C) for at least 30 minutes before injection (do not heat them in any other way). This will make the injection more comfortable.
• Open the box and prepare all materials needed for the injection (as listed in Section B).
• Wash your hands thoroughly.
• Remove two prefilled syringes from the package as shown in the figure.
• Important: always hold the prefilled syringes by the barrel of the syringe.
• Use your thumb or finger to hold the edge of the support to keep it steady while removing the prefilled syringes.
• Grasp the barrel of the syringe to remove the prefilled syringes from the support.

• Do not touch the plunger rod or the grey needle cap.
• Do not remove the grey needle cap from the prefilled syringes yet.
• Do not remove the finger grip. It is part of the prefilled syringe.
• Do not shake the prefilled syringes.
• Check the medicine in the syringes. The medicine should be a solution ranging from clear to opalescent, from colourless to pale yellow. – Do not use the prefilled syringes if the solution has changed colour, is cloudy, or contains residues or particles. – You may notice air bubbles. Subcutaneous injection (under the skin) of a solution containing air bubbles is not dangerous.
• Do not use the prefilled syringes if: – they have been dropped; – the grey cap is missing or not properly closed; – the seal is missing or broken, or if there are any cracks or signs of damage at any point. In such cases, use a new syringe and contact your doctor as soon as possible.

B On a clean, well-lit work surface, place:

• two prefilled syringes;

• two alcohol wipes;
• two cotton balls or gauze pads;
• two adhesive bandages;
• a sharps disposal container.

C Prepare and clean the skin at the site where the medicine will be injected. You may choose from the following injection sites:

• thighs;
• abdominal area (abdomen), except for a 5 cm area around the navel;
• outer upper arm (if the injection is administered by another person).
• The second injection must be given at a different site from the one used for the first injection. If you wish to use the same injection site, make sure it is not exactly the same spot.
• Do not inject into areas where the skin is tender, injured, red, hard, scarred, or has stretch marks, or if there are thickened, red, or scaly patches or lesions.
• Clean the injection area with an alcohol wipe. Allow the skin to dry before injecting.

• Do not touch this area again before the injection.

Step 2: Preparation for injection
D • Remove the grey needle cap by pulling it away from yourself just before injection.
– Be careful not to touch the needle or allow the needle to touch any surface.

• Once the cap is removed, the injection must be administered within 5 minutes. There is no need to rush. You have up to 5 minutes to administer the injection. – It is normal to see a drop of liquid at the tip of the needle.

• Do not twist or bend the grey needle cap.
• Dispose of the grey needle cap in the sharps disposal container. Do not recap the grey needle cap onto the prefilled syringe.

E • Firmly pinch the skin between your thumb and fingers to create a skin fold approximately 5 cm long.

• Important: keep the skin pinched during the injection.

Step 3: Injection
F • Important: do not press the plunger until you are actually ready to inject.

• Keep the skin pinched with your fingers. Using your other hand, insert the needle of the prefilled syringe into the previously cleaned injection site at an angle of 45–90°.
• Do not place your finger on the plunger while inserting the needle.

G • Applying slow and steady pressure, push the plunger all the way down until it stops moving, indicating that the full dose has been delivered. The prefilled syringe must remain inserted in the skin while the dose is being administered.

H • After administration is complete, remove your thumb and gently withdraw the prefilled syringe from the skin at the same angle it was inserted.

• After removing the prefilled syringe from the skin, the barrel of the syringe should be empty.

• Important: if it appears that medicine remains in the barrel of the syringe, this means the full dose was not administered. The healthcare provider must be notified as soon as possible.

Step 4: Disposal
I • Immediately after use, dispose of the entire used prefilled syringe and the grey needle cap

into a sharps disposal container.

• Do not throw away (dispose of) the prefilled syringe in household waste.
• Do not reuse the prefilled syringe.
• Important: always keep the sharps disposal container out of sight and reach of children.

Step 5: Examine the injection site
J If you see blood, use a cotton ball or gauze pad and apply light pressure to the injection site for a few seconds. Do not rub the injection site. The injection site may be covered with a small adhesive bandage if needed.
Step 6: Repeat for the second injection to receive the complete dose
K Repeat all steps starting from point C using the second prefilled syringe to administer the complete dose. The second injection must be administered at a different site from the first injection. If you wish to use the same site, make sure it is not exactly the same spot.

1 dose