Prospect: information for the user

EVENITY 105 mg injectable solution in pre-filled pen

romosozumab

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed to you alone, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any kind of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospect. See section 4.
• You will be provided with a patient alert card that contains important safety information that you need to know before and during your treatment with EVENITY.

What is EVENITY

EVENITY contains the active ingredient romosozumab, a medication that contributes to strengthening bones and reducing the risk of fracture.

How is EVENITY used

EVENITY is used for the treatment of severe osteoporosis in women after menopause who have a high risk of suffering a fracture.

Osteoporosis is a disease that makes bones become fragile and brittle. Many patients with osteoporosis do not show any symptoms, but they may have a higher risk of fractures.

How EVENITY works

EVENITY is a monoclonal antibody. A monoclonal antibody is a type of protein that has been designed to recognize and bind to specific proteins in the body. EVENITY binds to a protein called sclerostin. By binding to it and blocking its activity, EVENITY:

• contributes to forming new bone and
• slows down the loss of existing bone.

This makes bones stronger and reduces the risk of fracture.

Do not use EVENITY

• if you are allergic to romosozumab or any of the other ingredients in this medicine (listed in section 6);
• if you have low levels of calcium in your blood (hypocalcemia). Your doctor may tell you if your levels are too low;
• if you have a history of heart attack or stroke.

Do not use EVENITY if you are in any of the above circumstances. If you are unsure, consult your doctor or pharmacist before using EVENITY.

Warnings and precautions

Consult your doctor or pharmacist and discuss your medical history before starting to use EVENITY.

Heart attack and stroke

Heart attacks and strokes have been reported in people who receive EVENITY.

Seek medical attention immediatelyif you experience:

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

Your doctor will carefully evaluate the risk of cardiovascular problems before allowing you to start treatment with EVENITY. Inform your doctor if you know you have a high risk of cardiovascular problems such as established cardiovascular disease, high blood pressure, high levels of fat in the blood, diabetes, smoking, or kidney problems.

Low levels of calcium in the blood

EVENITY may cause low levels of calcium in the blood.

Inform your doctorif you notice:

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

Your doctor may prescribe calcium and vitamin D to help prevent low levels of calcium in the blood before you start treatment and while you are taking EVENITY. Take calcium and vitamin D as directed by your doctor. Inform your doctor if you have had severe kidney problems, kidney failure, or have needed dialysis, as this may increase your risk of having low calcium levels in the blood if you do not take calcium supplements.

Severe allergic reactions

People who use EVENITY may experience severe allergic reactions.

Seek medical attention immediatelyif you experience:

• swelling of the face, mouth, throat, hands, feet, ankles, or lower legs (angioedema), or hives;
• acute skin rash showing multiple red, round spots with a blister or crust in the center (erythema multiforme);
• difficulty swallowing or breathing.

Problems in the mouth, teeth, or jaw

In rare cases (may affect up to 1 in 1000 people), patients who receive EVENITY have experienced an adverse effect called osteonecrosis of the jaw (ONJ, bone damage in the jaw). ONJ may also occur after stopping treatment. It is essential to try to prevent ONJ, as it can be a painful condition that may be difficult to treat. To reduce the risk of ONJ, you should take some precautions.

Before receiving EVENITY, inform your doctor or nurse if:

• you have any problems with your mouth or teeth, such as poor dental health, gingivitis, or have a scheduled extraction;
• you do not receive regular dental care 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 received treatment with bisphosphonates (used to treat or prevent bone disorders such as osteoporosis);
• you are taking medications called corticosteroids (such as prednisolone or dexamethasone);
• you have cancer.

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

During treatment, you should maintain good oral hygiene and undergo regular dental check-ups. If you wear dentures, ensure they fit correctly. If you are receiving dental treatment or are about to undergo a dental procedure (such as a tooth extraction), inform your doctor of your dental treatment and inform your dentist that you are receiving treatment with EVENITY.

Immediately contact your doctor and dentist if you experience any problems in your mouth or teeth, such as:

• loose teeth;
• pain or swelling;
• ulcers in the mouth that do not heal;
• discharge.

Atypical femoral fractures

In rare cases, people who have used EVENITY have experienced atypical femoral fractures caused by a small or no trauma. These types of fractures often occurred after warning signs such as pain in the femur or groin for several weeks before the fracture occurred. It is unknown if EVENITY caused these unusual fractures. Inform your doctor or pharmacist if you experience any new or unusual pain in your hip, groin, or thigh.

Children and adolescents

EVENITY has not been studied in children and adolescents and is not approved for use in pediatric patients (age <18

Other medicines and EVENITY

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

Pregnancy and breastfeeding

EVENITY is expected to be used only for postmenopausal women.

Do not use EVENITY in women of childbearing age, during pregnancy, or while breastfeeding. It is unknown if EVENITY may harm the fetus or infant. Contact your doctor if you have any questions.

Driving and operating machinery

It is expected that the influence of EVENITY on the ability to drive or operate machinery will be negligible or insignificant.

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 any allergies.

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which is essentially sodium-free.

The treatment with EVENITY will be initiated and supervised by specialized doctors with experience in the treatment of osteoporosis. Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor.

Only one person with the necessary training should administer the injection.

How much to use

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

How to use

• EVENITY must be injected under the skin (subcutaneous injection).
• EVENITY should be injected in the abdominal area or thigh. The outer part of the arm can also be used as an injection site, but only if someone else administers the injection.
• If the same injection site is expected to be used for the second injection, a different point must be used.
• EVENITY should not be injected in areas where the skin is painful, bruised, red, or hardened.

It is essential that you read theInstructions for useto obtain information on how to use the EVENITY pre-filled pen.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

If you use more EVENITY than you should

If you have accidentally used more EVENITY than you should, contact your doctor or pharmacist.

If you forget or cannot use EVENITY at your usual time

If you miss a dose of EVENITY, contact your doctor as soon as possible to schedule another dose. From then on, the next dose must be administered at least one month after the date of the last dose.

If you interrupt treatment with EVENITY

If you are considering interrupting treatment with EVENITY, discuss it with your doctor. Your doctor will inform you for how long you should receive treatment with EVENITY.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Discuss with your doctor the need to switch to another osteoporosis treatment after the end of your treatment with EVENITY.

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

Seek immediate medical attentionif you experience any of the possible symptoms ofmyocardial infarctionorstroke(rare: may affect up to 1 in 100 people) as indicated below:

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

Seek immediate medical attentionif you experience the following symptoms ofsevere allergic reaction(rare: may affect up to 1 in 1,000 people) as indicated below:

• swelling of the face, mouth, throat, hands, feet, ankles, lower legs (angioedema), or hives;
• acute skin rash showing multiple red/pink rounded spots with a blister or crust in the center (erythema multiforme);
• difficulty swallowing or breathing.

Inform your doctorif you observe symptoms oflow calcium levels in the blood (hypocalcemia)(rare: may affect up to 1 in 100 people) as indicated below:

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

Also see section 2 “What you need to know before starting to use EVENITY”.

Other side effects may include:

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

• common cold;
• joint pain.

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

• exanthema, skin inflammation;
• headache;
• inflammation of the paranasal sinuses;
• neck pain;
• muscle spasms;
• redness or pain around the injection site.

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

• hives (urticaria);
• cataracts.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and on the box after “EXP/CAD”. The expiration date is the last day of the month indicated.

Store in the refrigerator (between 2 °C and 8 °C). Do not freeze.

Once you remove the preloaded pen from the refrigerator for use, do not put it back in the refrigerator, but you can keep it at room temperature (up to 25 °C) for 30 days. If not used within this period, the product must be discarded.

Keep the preloaded pen in the outer packaging to protect it from light.

Visually check the solution. Do not use the solution if it has changed color, is cloudy, or contains scales or particles.

Medicines should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of EVENITY

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

Appearance of the product and contents of the pack

EVENITY is a clear to opalescent, colorless to yellowish injectable solution presented in a single-use pre-filled pen. The syringe inside the pen is made of plastic and has a stainless steel needle.

Pack with 2 pre-filled pens.

Multiple pack with 6 (3 packs of 2) pre-filled pens.

Only some pack sizes may be marketed.

Marketing Authorization Holder

UCB Pharma S.A.,

Allée de la Recherche 60,

B-1070 Brussels, Belgium

Manufacturer

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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder.

Date of the last revision of this leaflet: MM/AAAA.

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency:https://www.ema.europa.eu.

Go back to the page to see the usage instructions

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INSTRUCTIONS FOR USE FOR THE INJECTION OF EVENITY USING A PRE-FILLED PEN

Inject two pre-filled pens, one immediately after the other, to administer a complete dose

The instructions that follow 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 are unsure about the injection procedure, contact a doctor or pharmacist.
• It is essential to ensure that only a person with the necessary training administers the injection.
• The pre-filled pen is also referred to as the “medicine”.

Guide to the parts: pre-filled pen

Step 1: Prepare

A

• Take the box containing the two pre-filled pens out of the refrigerator.
• Your pre-filled pens should be left at room temperature (up to 25 °C)for at least 30 minutesbefore injection (do not heat them in any other way). This will make the injection more comfortable.
• Open the box and collect all the materials you need for the injection (as listed in Step B)
• Wash your hands thoroughly.
• Lift the pre-filled pens straight up to remove them from the box. Do not remove the white protective caps yet.
• Do not shake the pre-filled pens.
• Check the medicine through the viewer. The medicine should be a clear to opalescent, colorless to yellowish solution.
• Do not use the pre-filled pen if the solution has changed color, is cloudy, or contains flakes or particles.
• It is possible to see air bubbles. The subcutaneous injection (under the skin) of a solution containing air bubbles is harmless.
• Do not use the pre-filled pen if:

• It has fallen;
• The white protective cap is not in place or is not securely attached;
• The seal is not in place or is broken or if any part appears cracked or broken.

In these cases, use a new pre-filled pen and contact your doctor as soon as possible.

BOn a clean and well-lit work surface, place:

CPrepare and clean the skin where you will inject the medicine. You can choose between:

• The second injection must be administered in a different location from the first injection. If you want to use the same injection site, make sure it is not exactly the same spot.

• Do not administer the injection in areas where the skin is painful, has bruises, is red, hardened, has scars or stretch marks, or shows lesions or thick, red, or scaly patches.

• Clean the area where you will inject with an alcohol wipe. Let the skin dry before injecting.

• Do not touch this area before injecting.

Step 2: Prepare

• Do not twist or double the white protective cap.
• Dispose of the white protective cap in the special waste container. Do not put the cap back on the pre-filled pen.
• Although it is hidden from view, the needle tip is now exposed. Do not touch the needle, as this could activate the pre-filled pen. It is normal to see a drop of liquid at the needle tip (inside the yellow safety guard).

EStretch or press the injection site to create a firm surface.

Stretch

• Stretch the skin well by moving your thumb and fingers in opposite directions, to create a 5 cm wide area.

O

Press

• Press the skin firmly between your thumb and fingers to create a roughly 5 cm wide area

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

Step 3: Administer the injection

• You can now remove the pre-filled pen by pulling it straight out and away from the skin.
• Important:If the viewer does not turn completely yellow or if it appears that the medicine is still being injected, this indicates that the complete dose has not been administered. Inform your healthcare professional as soon as possible.
• After removing the pre-filled pen from the skin, the needle will be automatically covered. Do not touch the needle.

Step 4: Dispose

Step 5: Examine the injection site

Step 6: Repeat the process to administer the second injection and receive the complete dose