Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - evenity

Document Subject

Generated Narrative: MedicinalProductDefinition mp57cff102c4a138734d137a31aea3135d

identifier: http://ema.europa.eu/identifier/EU/1/19/1411/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: EVENITY 105 mg solution for injection in pre-filled pen

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-57cff102c4a138734d137a31aea3135d

identifier: http://ema.europa.eu/identifier/EU/1/19/1411/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - evenity

Attesters

What is in this leaflet

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

What EVENITY is EVENITY contains the active substance romosozumab, a medicine that helps to make the bones stronger, and reduce the risk of broken bones.

What EVENITY is used for EVENITY is used to treat severe osteoporosis in women after the menopause who are at high risk of broken bone (fracture).
Osteoporosis is a disease that causes your bones to become thin and fragile. Many patients with osteoporosis have no symptoms, but they may be at increased 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 attach to specific proteins in the body. EVENITY attaches to a protein called sclerostin. By attaching to and blocking the activity of sclerostin, EVENITY:

• helps to form new bone, and
• slows down the loss of existing bone. This makes the bones stronger, and lowers the risk of fractures.

Draft

Do not use EVENITY if

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

Do not use EVENITY if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before using EVENITY.

Warnings and precautions
Talk to your doctor or pharmacist and discuss your medical history before using EVENITY.

Heart attack and stroke Heart attack and stroke have been reported in people receiving EVENITY.
Seek medical attention straight away if you get:

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

Your doctor will carefully evaluate the risk of cardiovascular problems before he/she lets you start treatment with EVENITY. Tell your doctor if you know that you have an increased risk of cardiovascular problems such as established cardiovascular disease, high blood pressure, high blood fat levels, diabetes, smoking or kidney problems.

Low levels of calcium in the blood EVENITY may cause low levels of calcium in your blood.
Tell your doctor if you notice:

• spasms, twitches, or cramps in your muscles;
• numbness or tingling in your fingers, toes or around your mouth.

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

Serious allergic reactions Serious allergic reactions can happen to people who use EVENITY.
Seek medical attention straight away if you get:

• swelling of the face, mouth, throat, hands, feet, ankles, lower legs (angioedema), or hives;
• acute skin eruption showing multiple round, red/pink spots with a blistering or crusting centre (erythema multiforme);
• difficulty in swallowing or breathing.

Problems with your mouth, teeth or jaw A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported rarely (may affect up to 1 in 1,000 people) in patients receiving EVENITY. ONJ can also occur after stopping treatment. It is important to try to prevent ONJ developing, as it may be a painful condition that can be difficult to treat. In order to reduce the risk of developing ONJ, there are some precautions you should take.

Draft

Before receiving EVENITY, tell your doctor or nurse if you:

• have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction;
• do not receive routine dental care or have not had a dental check-up for a long time;
• are a smoker (as this may increase the risk of dental problems);
• have previously been treated with a bisphosphonate (used to treat or prevent bone disorders, such as osteoporosis);
• are taking medicines called corticosteroids (such as prednisolone or dexamethasone);
• have cancer.

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

While being treated, you should maintain good oral hygiene and receive routine dental check-ups. If you wear dentures, you should make sure these fit properly. If you are under dental treatment or will undergo dental surgery (e.g. tooth extractions), 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 get any problems with your mouth or teeth such as:

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

Unusual thigh bone fractures People who have used EVENITY rarely developed unusual fractures of the thigh bone caused by little or no trauma. These fracture types are often preceded by warning signs of thigh or groin pain for several weeks before the fracture occurs. It is not known whether EVENITY caused these unusual fractures. Tell your doctor or pharmacist if you get any new or unusual pains in your hip, groin or thigh.

Children and adolescents The use of romosozumab in children and adolescents has not been studied and it is not approved for use in paediatric patients (age <18 years).

Other medicines and EVENITY Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding
EVENITY is only intended to treat women after menopause.
EVENITY should not be used by women of child-bearing potential, or when pregnant or breast- feeding. It is not known whether EVENITY may harm an unborn or breast-fed child.
Contact your doctor if you have any questions.

Driving and using machines EVENITY is expected to have no effect or very little effect on the ability to drive and use machines.

EVENITY contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium- free .

Draft

EVENITY will be initiated and supervised by specialist physicians experienced in the management of osteoporosis. Always use this medicine exactly as you doctor has told you. Check with your doctor if you are not sure. The injection should only be given by a person who has been properly trained.

How much to use

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

How to use

• EVENITY has to be injected under the skin (sub-cutaneous injection).
• EVENITY should be injected in either the stomach area (abdomen) or thigh. The outer area of your upper arm can also be used as an injection site, but only if someone else is giving you the injection.
• If the same injection area is planned to be used for the second injection, a different injection spot should be used.
• EVENITY should 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.

Ask your doctor or pharmacist if you have any further questions on the use of the medicine.

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

If you forget to use or cannot take EVENITY at your usual time If you miss a dose of EVENITY, contact your doctor as soon as possible to schedule another dose. Thereafter, the next dose should be given not earlier than one month after the date of the last dose.

If you stop taking EVENITY If you are considering stopping EVENITY treatment, please 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 medicine, 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 everybody gets them.

Seek medical attention straight away if you get 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 in your face, arms, or legs, difficulty talking, changes in vision, loss of balance.

Draft

Seek medical attention straight away if you get the following symptoms of a serious 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 eruption showing multiple round, red/pink spots with a blistering or crusting centre (erythema multiforme);
• difficulty in swallowing or breathing.

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

• spasms, twitches, or cramps in your muscles;
• numbness or tingling in your fingers, toes or around your mouth.

See also section 2 What you need to know before you use 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, inflammation of the skin;
• Headache;
• Sinusitis;
• Neck pain;
• Muscle spasms;
• Redness or pain around the site where the injection was given.

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

• Hives (urticaria);
• Cataract.

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 expiry date refers to the last day of that month.

Store in a refrigerator (2 C - 8 C). Do not freeze. Once you take the carton containing the pre-filled pens out of the refrigerator for use, you should not put it back into the refrigerator but you can keep it at room temperature (up to 25 C) for up to 30 days. If not used within this period the product should be discarded.

Keep the pre-filled pen in the outer carton in order to protect from light.

Draft

Visually check the solution. Do not use it if the solution is discoloured, cloudy, or contains flakes or particles.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What EVENITY contains

• The active substance is romosozumab. Each pre-filled pen contains 105 mg of romosozumab in 1.17 ml of solution (90mg/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

What EVENITY looks like and contents of the pack EVENITY is a clear to opalescent, colourless to light yellow solution for injection provided in a single use disposable pre-filled pen. The syringe inside the pen is made of plastic with a stainless steel needle.

Pack size of 2 pre-filled pens. Multipack containing 6 (3 packs of 2) pre-filled pens.
Not all pack sizes may be marketed.

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

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

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Belgi /Belgique/Belgien UCB Pharma SA/NV
T l/Tel: + 32 / (0)2 559 92 Lietuva UCB Pharma Oy Finland
Tel: + 358 9 2514 4

Te .: + 359 (0) 2 962 30 Luxembourg/Luxemburg UCB Pharma SA/NV
T l/Tel: + 32 / (0)2 559 92 esk republika UCB s.r.o.
Tel: + 420 221 773 Magyarorsz g UCB Magyarorsz g Kft.
Tel.: + 36-(1) 391 0Danmark UCB Nordic A/S
Tlf: + 45 / 32 46 24 Malta Pharmasud Ltd.
Tel: + 356 / 21 37 64 Draft

Deutschland UCB Pharma GmbH
Tel: + 49 /(0) 2173 48 4Nederland UCB Pharma B.V.
Tel.: + 31 / (0)76-573 11 Eesti UCB Pharma Oy Finland
Tel: + 358 9 2514 4Norge UCB Nordic A/S
Tlf: + 47 / 67 16 5
UCB . .
: + 30 / 2109974 sterreich UCB Pharma GmbH
Tel: + 43-(0)1 291 80 Espa a UCB Pharma, S.A.
Tel: + 34 / 91 570 34 Polska UCB Pharma Sp. z o.o. / VEDIM Sp. z o.o. Tel: + 48 22 696 99 France UCB Pharma S.A.
T l: + 33 / (0)1 47 29 44 Portugal UCB Pharma (Produtos Farmac uticos), Lda
Tel: + 351 / 21 302 5Hrvatska Medis Adria d.o.o.
Tel: +385 (0) 1 230 34 Rom nia UCB Pharma Romania S.R.L.
Tel: + 40 21 300 29 Ireland UCB (Pharma) Ireland Ltd.
Tel: + 353 / (0)1-46 37 Slovenija Medis, d.o.o.
Tel: + 386 1 589 69 sland Vistor hf.
Simi: + 354 535 7Slovensk republika UCB s.r.o., organiza n zlo ka
Tel: + 421 (0) 2 5920 2Italia UCB Pharma S.p.A.
Tel: + 39 / 02 300 Suomi/Finland UCB Pharma Oy Finland
Puh/Tel: + 358 9 2514 4
Lifepharma (Z.A.M.) Ltd
: + 357 22 056Sverige UCB Nordic A/S
Tel: + 46 / (0) 40 29 49 Latvija UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Somija)

United Kingdom (Northern Ireland) UCB (Pharma) Ireland Ltd.
Tel : + 353 / (0)1-46 37 This leaflet was last revised in MM/YYYY.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: