Evenity 105 mg solution for injection in pre-filled pen

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

EVENITY 105 mg solution for injection in a pre-filled pen

romosozumab

Read the entire 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 give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are possible adverse reactions not listed in this leaflet. See section 4.
• You will be provided with a patient alert card containing important safety information you need to know before and during your treatment with EVENITY.

Contents of the 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 adverse 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 strengthen bones and reduce the risk of fracture.

What EVENITY is used for

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

Osteoporosis is a disease that causes bones to become fragile and brittle. Many patients with osteoporosis do not show any symptoms, but may 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 bind to specific proteins in the body. EVENITY binds to a protein called sclerostin. By binding to and blocking its activity, EVENITY:

• helps form new bone and
• slows down the loss of existing bone.

This makes bones stronger and reduces the risk of fracture.

2. What you need to 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 can tell you if your levels are too low;
• if you have a history of myocardial infarction or stroke.

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

Warnings and precautions

Talk to your doctor or pharmacist and discuss your medical history before starting treatment with EVENITY.

Myocardial infarction and stroke

Myocardial infarction and stroke have been reported in people receiving EVENITY.

Seek immediate medical attention if 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 your risk of cardiovascular problems before allowing you to start 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, 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 doctor if you notice:

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

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

Severe allergic reactions

People using EVENITY may experience severe allergic reactions.

Seek immediate medical attention if you experience:

• swelling of the face, mouth, throat, hands, feet, ankles, or lower legs (angioedema), or hives;
• an acute skin rash showing multiple round red/pink 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 1,000 people), a side effect called osteonecrosis of the jaw (ONJ, bone damage in the jaw) has been reported in patients receiving EVENITY. 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 ONJ, you should take certain 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 if you are scheduled for a tooth 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 have a dental examination before starting treatment with EVENITY.

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

Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth, such as:

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

Atypical femoral fractures

In rare cases, atypical femoral fractures (caused by minor or no trauma) have occurred in people who have used EVENITY. These types of fractures were often preceded by warning signs such as pain in the femur or groin for several weeks before the fracture occurred. It is unknown whether 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

The use of 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 expected to be used only for the treatment of postmenopausal women.

EVENITY must not be used in women of childbearing potential, during pregnancy, or while breastfeeding. It is unknown whether EVENITY can harm the fetus or breastfed infant. Contact your doctor if you have any questions.

Driving and using machines

The influence of EVENITY on the ability to drive or use machines is expected to be none or negligible.

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 any 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 supervised by specialized physicians experienced in the treatment of osteoporosis. Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor.

Only a person with appropriate training should administer the injection.

How much to use

• The recommended dose of EVENITY is 210 mg.
• Since a single pre-filled pen contains 105 mg of the active substance 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 at a different injection site.
• This should be done once a month for 12 months.

How to use

• EVENITY must be injected under the skin (subcutaneous injection).
• EVENITY should be injected into the stomach (abdominal) area or the thigh. The outer part of the upper arm may also be used as an injection site, but only if another person administers the injection.
• If the same general area is to be used for the second injection, a different injection site within that area must be selected.
• EVENITY must not be injected into areas where the skin is painful, bruised, red, or hardened.

It is important that you read the Instructions for use for information on how to use the EVENITY pre-filled pen.

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

If you use more EVENITY than you should

If you have used more EVENITY than you should by mistake, you must 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 should 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 this with your doctor. Your doctor will advise you on how long you should receive treatment with EVENITY.

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

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

4. Possible adverse effects

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

Seek immediate medical attention if you experience any of the following possible symptoms of myocardial infarction or stroke (uncommon: may affect up to 1 in 100 people):

• 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 attention if you experience the following symptoms of 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 presenting as multiple round red/pink spots with a blister or crust in the center (erythema multiforme);
• difficulty swallowing or breathing.

Inform your doctor if you notice symptoms of low calcium levels in the blood (hypocalcemia) (uncommon: may affect up to 1 in 100 people), as listed below:

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

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

Other adverse effects may include:

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

• Common cold;
• Joint pain.

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

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

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

• Hives (urticaria);
• Cataracts.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 the carton after “EXP/CAD”. The expiry date refers to the last day of the month indicated.

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

Once the carton containing the pre-filled pens has been removed from the refrigerator for use, it must not be returned to the refrigerator, but may be kept at room temperature (up to 25 °C) for 30 days. If not used within this period, the product must be discarded.

Keep the pre-filled pen in its outer packaging to protect it from light.

Visually inspect the solution. Do not use the solution if it has changed colour, is 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 and packaging no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of EVENITY

• 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 components are calcium acetate, glacial acetic acid, sodium hydroxide (for pH adjustment), sucrose, polysorbate 20, and water for injections. See section 2 “EVENITY contains sodium”.

Appearance of the product and contents of the pack

EVENITY is an injectable solution, clear to opalescent, colourless to slightly yellow, supplied in a single-use, disposable pre-filled pen. The syringe inside the pen is made of plastic and has a stainless steel needle.

Pack containing 2 pre-filled pens.

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

Only certain 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

You can request further information about this medicinal product by contacting the local representative of the Marketing Authorisation Holder.

Belgium/Belgium/Belgium UCB Pharma SA/NV Tel/Tel: + 32 / (0)2 559 92 00	Lithuania UCB Pharma Oy Finland Tel: + 358 9 2514 4221
	Luxembourg/Luxembourg UCB Pharma SA/NV Tél/Tel: + 32 / (0)2 559 92 00
Czech Republic UCB s.r.o. Tel: + 420 221 773 411	Hungary UCB Magyarország Kft. Tel.: + 36-(1) 391 0060
Denmark UCB Nordic A/S Tlf: + 45 / 32 46 24 00	Malta Pharmasud Ltd. Tel: + 356 / 21 37 64 36
Germany UCB Pharma GmbH Tel: + 49 /(0) 2173 48 4848	Netherlands UCB Pharma B.V. Tel.: + 31 / (0)76-573 11 40
Estonia UCB Pharma Oy Finland Tel: + 358 9 2514 4221	Norway UCB Nordic A/S Tlf: + 45 / 32 46 24 00
Greece UCB Α.Ε. Tel: + 30 / 2109974000	Austria UCB Pharma GmbH Tel: + 43-(0)1 291 80 00
Spain UCB Pharma, S.A. Tel: + 34 / 91 570 34 44	Poland UCB Pharma Sp. z o.o. Tel: + 48 22 696 99 20
France UCB Pharma S.A. Tél: + 33 / (0)1 47 29 44 35	Portugal UCB Pharma (Pharmaceutical Products), Lda Tel: + 351 / 21 302 5300
Croatia Medis Adria d.o.o. Tel: +385 (0) 1 230 34 46	Romania UCB Pharma Romania S.R.L. Tel: + 40 21 300 29 04
Ireland UCB (Pharma) Ireland Ltd. Tel: + 353 / (0)1-46 37 395	Slovenia Medis, d.o.o. Tel: + 386 1 589 69 00
Iceland Vistor hf. Tel: + 354 535 7000	Slovakia UCB s.r.o., organizational unit Tel: + 421 (0) 2 5920 2020
Italy UCB Pharma S.p.A. Tel: + 39 / 02 300 791	Finland/Sweden UCB Pharma Oy Finland Puh/Tel: + 358 9 2514 4221
Cyprus Lifepharma (Z.A.M.) Ltd Tel: + 357 22 34 74 40	Sweden UCB Nordic A/S Tel: + 46 / (0) 40 29 49 00
Latvia UCB Pharma Oy Finland Tel: + 358 9 2514 4221 (Finland)

Date of the most recent review of this leaflet: MM/YYYY

Other sources of information

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

Turn over to see the instructions for use

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INSTRUCTIONS FOR USING EVENITY INJECTION WITH A PRE-FILLED PEN

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

The instructions below 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 important to ensure that the injection is administered only by a person who has received appropriate training.

• The pre-filled pen is also referred to as the "medicine".

Guide to parts: pre-filled pen

Read this before injecting the medicine. Your doctor has prescribed a monthly dose of 210 mg: To receive the full dose, two pre-filled pens containing 105 mg each must be injected, one immediately after the other.

Step 1: Prepare

A

• Remove the box containing the two pre-filled pens from the refrigerator.

• The pre-filled pens should 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 gather all the materials needed for the injection (as listed in Step B).

• Wash your hands thoroughly.

• Lift the pre-filled pens straight up and out of the box. Do not remove the white caps from the pens yet.

• Do not shake the pre-filled pens.

• Check the medication through the viewing window. The medication should be a solution ranging from clear to opalescent, colorless to slightly yellow.

• Do not use the pre-filled pen if the solution has changed color, is cloudy, or contains flakes or particles.

• Air bubbles may be visible. It is harmless to inject a solution containing air bubbles subcutaneously (under the skin).

• Do not use the pre-filled pen if:

• It has been dropped;

• The white cap is missing or not securely attached;

• The seal is missing, broken, or if any part appears cracked or damaged.

In these 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 pieces of cotton or gauze; two adhesive bandages; one container for special waste.

C Prepare and clean the skin where you are going to inject the medication. You may choose from:

the thighs; the stomach area (abdomen), except within the 5 cm area around the navel; or the outer part of the arm (if someone else is giving you the injection).

• The second injection should be administered at a different site from the first injection. If you wish to use the same injection area, make sure it is not the exact same injection point.

• Do not administer the injection in areas where the skin is painful, bruised, red, hardened, scarred, or has stretch marks, or where there are lesions or thick, red, scaly patches.

• Clean the injection site with an alcohol wipe. Allow the skin to dry before injecting.

• Do not touch this area again before the injection.

Step 2: Prepare yourself

D	Remove the white stopper directly before injection. Once the stopper has been removed, the injection should be administered within 5 minutes. There is no need to rush: 5 minutes is sufficient time to give the injection.

• Do not twist or bend the white cap.
• Dispose of the white cap in the container for special waste. Do not reinsert the white cap into the pre-filled pen.
• Although out of sight, the needle tip is now exposed. Do not attempt to touch the needle, as this could activate the pre-filled pen. It is normal to see a drop of liquid at the needle tip (within the yellow safety shield).

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

Stretch

• Stretch the skin firmly by moving the thumb and fingers in opposite directions to create an area approximately 5 cm wide.

O

Pinch

• Pinch the skin firmly between the thumb and fingers to create an area approximately 5 cm wide.

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

Step 3: Administer the injection

F

Important: Do not push down the pre-filled pen until you are ready to administer the injection. You must keep the skin stretched or pinched firmly. With your other hand, place the yellow safety cap of the pre-filled pen onto the area of skin you previously cleaned (the “injection site”) at a 90° angle.

G	The pre-filled pen must be pressed firmly against the skin until the yellow safety shield stops moving. When you hear or feel a click, the injection will begin.

H	Continue pressing on the skin. The injection may take about 15 seconds. When the injection is complete, the viewing window will turn completely yellow, and you may hear or feel a second click.

• You may now remove the pre-filled pen by carefully pulling it straight away from the skin.
• Important: When you remove the pre-filled pen, if the viewing window has not turned completely yellow or if it appears that medicine is still being injected, this indicates that the full dose has not been delivered. You must inform your healthcare professional as soon as possible.
• After removing the pen from the skin, the needle will be automatically covered. Do not attempt to touch the needle.

Step 4: Disposal

I	Dispose of the used pre-filled pen and the white cap into a special container immediately after use.
	Do not throw (dispose of) the pre-filled pen into household waste. Do not reuse the pre-filled pen. Important: Always keep the special waste container out of sight and reach of children.

Step 5: Examine the injection site

J	If there is blood, use a piece of cotton or gauze and apply gentle pressure over the injection site for a few seconds. Do not rub the injection site. You may cover the injection site with a bandage, if necessary.

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

K	Repeat all steps starting from step C with the second pre-filled pen to inject the full dose. The second injection must be administered at a different site from the first injection. If you wish to use the same injection site, ensure it is not exactly at the same injection point.