Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - evrenzo

Document Subject

Generated Narrative: MedicinalProductDefinition mp83e919009d254ffa32b4c1748bcfba15

identifier: http://ema.europa.eu/identifier/EU/1/21/1574/001 – 005

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Evrenzo 20 mg film-coated tablets

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-83e919009d254ffa32b4c1748bcfba15

identifier: http://ema.europa.eu/identifier/EU/1/21/1574/001 – 005

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - evrenzo

Attesters

What is in this leaflet

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

What Evrenzo is Evrenzo is a medicine that increases the number of red blood cells and haemoglobin level in your blood. It contains the active substance roxadustat.

What Evrenzo is used for Evrenzo is used to treat adults with symptomatic anaemia that occurs in patients with chronic kidney disease. Anaemia is when you have too few red blood cells and your haemoglobin level is too low. As a result, your body might not receive enough oxygen. Anaemia can cause symptoms such as tiredness, weakness, or shortness of breath.

How Evrenzo works Roxadustat, the active substance in Evrenzo, works by increasing the level of HIF, a substance in the body which increases the production of red blood cells when oxygen levels are low. By raising HIF levels, the medicine increases the production of red blood cells and raises the levels of haemoglobin (the oxygen-carrying protein in red blood cells). This improves the oxygen supply to your body and may reduce your symptoms of anaemia.

Do not take Evrenzo

• if you are allergic to peanut or soya, do not use this medicine. Evrenzo contains soya lecithin.
• if you are allergic to roxadustat or any of the other ingredients of this medicine (listed in section 6).
• if you are more than 6 months pregnant (it is also better to avoid this medicine in early pregnancy - see pregnancy section).
• if you are breast-feeding.

Warnings and precautions Talk to your doctor, or pharmacist before taking Evrenzo:

• if you have epilepsy or have ever had convulsions or fits.
• if you have signs and symptoms of an infection, which may include fever, sweating or chills, sore throat, runny nose, shortness of breath, feeling weak, confusion, cough, vomiting, diarrhoea or stomach pain, feeling of burning when you pass urine, red or painful skin or sores on your body.
• if you have a liver disorder.

Chronic kidney disease and anaemia may increase the risk of cardiovascular events and death. Managing your anaemia is important. Your doctor will monitor your haemoglobin and also consider your treatment regimen as anaemia treatment and switching between anaemia treatments may also have a negative impact on your cardiovascular health.

Talk to your doctor, or pharmacist straight away:

• if you get blood clots:

1. in the veins of your legs (deep vein thrombosis or DVT), signs of which can include pain and/or swelling in the legs, cramping or a feeling of warmth in the affected leg;
2. in the lungs (pulmonary embolism or PE), signs of which can include sudden shortness of breath, chest pain (usually worse with breathing), feeling of anxiety, dizziness, light- headedness, or fainting; heart racing, coughing (sometimes with blood);
3. in your haemodialysis access (vascular access thrombosis or VAT) that stop the vascular access from working; signs of this can include swelling, redness, hardening or thickening of the skin around your access, oozing at the access site, not feeling a vibration ( thrill ) over the access area;

• if you have a seizure (convulsion or fit) or possible warning signs that a seizure may occur, such as headache, irritability, fear, confusion or unusual feelings;
• if you have signs and symptoms of an infection, which include fever, sweating or chills, sore throat, runny nose, shortness of breath, feeling weak or faint, confusion, cough, vomiting, diarrhoea, or stomach pain, burning when you pass urine, red or painful skin or sores on your body.

Misuse can lead to an increase in blood cells and consequently thicken the blood. This can cause life- threatening problems with the heart or blood vessels.

Children and adolescents Do not give Evrenzo to children and adolescents aged under 18 years because there is not enough information about its use in this age group.

Other medicines and Evrenzo Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Evrenzo may affect the way these medicines work, or these medicines may affect how Evrenzo works.

In particular, tell your doctor or pharmacist if you have, or are taking any of the following medicines:

• medicines to reduce phosphate levels in your blood (called phosphate binders) or other medicines or supplements that contain calcium, iron, magnesium or aluminium (called multivalent cations), such as sevelamer carbonate or calcium acetate. You must take Evrenzo at least 1 hour after these medicines or supplements. Otherwise roxadustat will not be properly absorbed by your body.
• a medicine to treat gout called probenecid.
• medicines used to lower cholesterol, such as simvastatin, atorvastatin, or rosuvastatin (also called statins ), or gemfibrozil.
• other medicines used to treat anaemia such as erythropoiesis-stimulating agents (ESAs).

If you normally take any of these medicines, your doctor might change it and prescribe a different medicine for you during your treatment with Evrenzo.

Pregnancy, breast-feeding and fertility If you are pregnant, think you may be pregnant or are planning to have a baby, contact your doctor. Evrenzo may harm your unborn baby. Evrenzo is not recommended in the first 6 months of pregnancy and must not be taken in the last 3 months of pregnancy. Women taking Evrenzo who are able to become pregnant should use an effective method of contraception during treatment with Evrenzo and for at least one week after the last dose of Evrenzo. If you use a hormonal contraceptive, you must also use a barrier method, such as a condom, or a diaphragm.

Do not breastfeed if you are on treatment with Evrenzo. It is not known if Evrenzo passes into your breast milk and could harm your baby.

Driving and using machines This medicine may affect your ability to drive or use machines. Seizures can occur as a side effect (see section 4).

Evrenzo contains lactose, soya lecithin and Allura Red AC aluminium lake Evrenzo contains sugar (lactose), traces of peanut and soya (soya lecithin), and an azo colouring agent (Allura Red AC aluminium lake). If you have been told by your doctor that you have an intolerance to some sugars or are allergic to peanut, soya or azo colouring agents, contact your doctor before taking this medicine.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will tell you what dose of Evrenzo to take.

Your doctor will check your haemoglobin levels regularly and increase or lower your dose based on your haemoglobin levels.

Evrenzo is taken by mouth as tablets.

Taking Evrenzo

• Take your Evrenzo dose three times per week unless your doctor told you otherwise
• Never take Evrenzo on consecutive days
• Take Evrenzo on the same three days every week
• Evrenzo can be taken with food or between meals
• Swallow the tablets whole
• Do not chew, break or crush the tablets

Take Evrenzo at least 1 hour after you have taken medicines that reduce phosphate levels in your blood (called phosphate binders) or other medicines or supplements that contain calcium, iron, magnesium or aluminium (called multivalent cations).

Dosing Schedule 3 times a week dosing schedule Evrenzo comes in a blister pack containing medicine for 4 weeks (12 tablets), divided into 4 rows. Each row contains 1 week of medicine (3 tablets). Make sure you take tablets from the same row for each week.

Your dose ranges from 20 mg three times per week up to a maximum 400 mg three times per week.

Different dosing frequencies In exceptional cases (based upon your haemoglobin levels), your doctor may decide to lower your Evrenzo dose to 20 mg two times or one time per week. In this case your doctor will explain which days week you need to take your dose.

More than 1 tablet needed to make up a dose In most cases you will have 1 blister package per month. If your dose requires more than 1 blister package, you will need to take a tablet from each blister per dosing day. Your doctor will explain when and how many tablets to take.

Your doctor will monitor your haemoglobin level and may temporarily stop your treatment if your haemoglobin level becomes too high. Do not restart your treatment until your doctor tells you to. Your doctor will tell you what dose of Evrenzo to take and when to start taking it again.

If you take more Evrenzo than you should If you take more tablets or a higher dose than you should, contact your doctor straight away.

If you forget to take Evrenzo

• Never take a double dose to make up for a forgotten dose.
• If more than 24 hours (1 day) remains before your next scheduled dose, take the missed dose as soon as possible and take the next dose on the next scheduled day.
• If less than 24 hours (1 day) remains before your next scheduled dose: skip the missed dose and take the next dose on the next scheduled day.

If you stop taking Evrenzo Do not stop taking this medicine unless your doctor tells you to do so.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some possible side effects may be serious. Contact your doctor straight away if you get any of the following:

• blood clot in the veins of your legs (deep vein thrombosis or DVT) (may affect up to 1 in people).
• blood clot in the lungs (pulmonary embolism) (may affect up to 1 in 100 people).
• blood clot in your haemodialysis access (vascular access thrombosis or VAT) that causes the vascular access to close up or stop working if you are using a fistula or graft for dialysis access (may affect more than 1 in 10 people).
• seizures and warning signs of seizures (convulsions or fits) (may affect up to 1 in 10 people).
• sepsis, a serious or in rare cases, life-threatening infection (may affect up to 1 in 10 people).
• redness and shedding of skin over a larger area of the body, which may be itchy or painful (exfoliative dermatitis) (frequency cannot be estimated from the available data).

Other possible side effects

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

• increased amount of potassium
• high blood pressure (hypertension)
• feeling sick (nausea)
• diarrhoea
• swelling due to fluid retention in the extremities (peripheral oedema)

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

• difficulty in sleeping (insomnia)
• headache
• vomiting
• constipation

Uncommon (may affect up to 1 in 100 people)

• increased amount of bilirubin in your blood

Not known (frequency cannot be estimated from the available data)

• thyroid function decreased

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 carton and blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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 Evrenzo contains Evrenzo 20 mg:

• The active substance is roxadustat. Each tablet contains 20 mg roxadustat.

Evrenzo 50 mg:

• The active substance is roxadustat. Each tablet contains 50 mg roxadustat.

Evrenzo 70 mg:

• The active substance is roxadustat. Each tablet contains 70 mg roxadustat.

Evrenzo 100 mg:

• The active substance is roxadustat. Each tablet contains 100 mg roxadustat.

Evrenzo 150 mg:

• The active substance is roxadustat. Each tablet contains 150 mg roxadustat. The other ingredients are:

• tablet core: lactose monohydrate, microcrystalline cellulose (E460), croscarmellose sodium (E468), povidone (E1201), magnesium stearate (E470b).

• film-coating: polyvinyl alcohol (E1203), talc (E553b), macrogol (E1521), Allura Red Aluminium Lake AC (E129), titanium dioxide (E171), lecithin (soya) (E322).

What Evrenzo looks like and contents of the pack Evrenzo 20 mg are red, oval, film-coated tablets, debossed with 20 on one side. Evrenzo 50 mg are red, oval, film-coated tablets, debossed with 50 on one side. Evrenzo 70 mg are red, round, film-coated tablets, debossed with 70 on one side. Evrenzo 100 mg are red, oval, film-coated tablets, debossed with 100 on one side. Evrenzo 150 mg are red, almond-shaped, film-coated tablets, debossed with 150 on one side.

Evrenzo is available in PVC/aluminium perforated unit dose blisters in packs containing 12 x 1 film-coated tablets and 36 x 1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Astellas Pharma Europe B.V. Sylviusweg 2333 BE Leiden The Netherlands

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

Belgi /Belgique/Belgien Astellas Pharma B.V. Branch T l/Tel: +32 (0)2 5580Lietuva Astellas Pharma d.o.o. Tel.: +370 37 408

Te .: +359 2 862 53 Luxembourg/Luxemburg Astellas Pharma B.V. Branch Belgique/Belgien T l/Tel: +32 (0)2 5580 esk republika Astellas Pharma s.r.o. Tel: +420 221 401 Magyarorsz g Astellas Pharma Kft. Tel.: +36 1 577 8Danmark Astellas Pharma a/s Tlf: +45 43 430Malta Astellas Pharmaceuticals AEBE Tel: +30 210 8189Deutschland Astellas Pharma GmbH Tel.: +49 (0)89 454Nederland Astellas Pharma B.V. Tel: +31 (0)71 5455Eesti Astellas Pharma d.o.o. Tel: +372 6 056 Norge Astellas Pharma Tlf: +47 66 76 46
Astellas Pharmaceuticals AEBE : +30 210 8189 sterreich Astellas Pharma Ges.m.b.H. Tel.: +43 (0)1 8772Espa a Astellas Pharma S.A. Tel: +34 91 4952Polska Astellas Pharma Sp.z.o.o. Tel.: +48 225451 France Astellas Pharma S.A.S. T l: +33 (0)1 55917Portugal Astellas Farma, Lda. Tel: +351 21 4401Hrvatska Astellas d.o.o Tel: +385 1670 0Rom nia S.C.Astellas Pharma SRL Tel: +40 (0)21 361 04 95/96/Ireland Astellas Pharma Co. Ltd. Tel: +353 (0)1 4671Slovenija Astellas Pharma d.o.o Tel: +386 14011 sland Vistor hf S mi: +354 535 7Slovensk republika Astellas Pharma s.r.o. Tel: +421 2 4444 2Italia Astellas Pharma S.p.A. Tel: +39 (0)2 921Suomi/Finland Astellas Pharma Puh/Tel: +358 (0)9 85606

Astellas Pharmaceuticals AEBE : +30 210 8189Sverige Astellas Pharma AB Tel: +46 (0)40-650 15 Latvija Astellas Pharma d.o.o. Tel: +371 67 619United Kingdom (Northern Ireland) Astellas Pharma Co., Limited Tel: +353 (0)1 4671Free call from Northern Ireland: 0800783 5This 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: