Patient Information Leaflet

Evrenzo20mg Film-Coated Tablets

Evrenzo50mg Film-Coated Tablets

Evrenzo70mg Film-Coated Tablets

Evrenzo100mg Film-Coated Tablets

Evrenzo150mg Film-Coated Tablets

roxadustat

This medicine is subject to additional monitoring. This will help speed up the detection of any new safety information. You can help by reporting any side effects you get. The final part of section 4 includes information on how to report these side effects.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. This includes very rare side effects. Check with your doctor or pharmacist before taking any other medicines.

1.What Evrenzo is and what it is used for

2.What you need to know before you start taking Evrenzo

3.How to take Evrenzo

4.Possible side effects

5.Storage of Evrenzo

6.Contents of the pack and other information

What is Evrenzo

Evrenzo is a medication that increases the number of red blood cells and the level of hemoglobin in the blood. The active ingredient it contains is roxadustat.

How is Evrenzo used

Evrenzo is used for the treatment of symptomatic anemia that occurs in adult patients with chronic kidney disease. Anemia occurs when you have very few red blood cells and your hemoglobin level is too low. As a result, it is possible that your body does not receive enough oxygen. Anemia can cause symptoms such as fatigue, weakness, or shortness of breath.

How Evrenzo works

Roxadustat, the active ingredient in Evrenzo, increases the level of HIF, a substance in the body that increases the production of red blood cells when oxygen levels are low. By increasing the level of HIF, this medication increases the production of red blood cells and hemoglobin (the protein that transports oxygen in red blood cells). This improves oxygen supply to all parts of the body and may reduce anemia symptoms.

Do not take Evrenzo

• If you are allergic to peanuts or soy, do not use this medication. Evrenzo contains soy lecithin.
• If you are allergic to roxadustat or any of the other components of this medication (listed in section6).
• If you are more than 6months pregnant (it is also recommended to avoid this medication in the early stages of pregnancy; see the section on pregnancy).
• If you are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Evrenzo:

• If you have epilepsy or have ever experienced seizures or convulsions.
• If you present signs or symptoms of an infection, such as fever, sweating or chills, sore throat, runny nose, shortness of breath, feeling weak or dizzy, confusion, cough, vomiting, diarrhea or stomach pain, burning sensation while urinating, redness or pain of the skin or body lesions.
• If you have a liver disorder.

Chronic kidney disease and anemia may increase the risk of cardiovascular events and death. It is essential to treat your anemia. Your doctor will monitor your hemoglobin and determine your treatment plan, as the treatment for anemia and switching between anemia treatments may also have a negative impact on your cardiovascular health.

Consult your doctor or pharmacist immediately:

• If you experience blood clots:

1. In the veins of your legs (deep vein thrombosis or DVT), whose signs may include pain or swelling of the legs and cramps or a sensation of heat in the affected leg.
2. In your lungs (pulmonary embolism or PE), whose signs may include sudden shortness of breath, chest pain (usually more intense when breathing), feeling anxious, dizziness, fainting, rapid heartbeat, or cough (sometimes with blood).
3. In your vascular access for hemodialysis (vascular access thrombosis or VAT) that stops the functioning of the vascular access; the signs of this may include swelling, redness, hardening or thickening of the skin around the access, exudation at the access site, or absence of the sensation of vibration ("tingling") over the access area.

• If you experience a seizure or possible warning signs of a seizure, such as headache, irritability, fear, confusion, or unusual sensations.
• If you present signs or symptoms of an infection, such as fever, sweating or chills, sore throat, runny nose, shortness of breath,sensación de debilidad or dizziness, confusion, cough, vomiting, diarrhea or stomach pain, burning sensation while urinating, redness or pain of the skin or body lesions.
• If you present signs and symptoms of a stroke (cerebrovascular accident), which include sudden weakness or numbness of the face, arm, or leg, especially on one side of the body, sudden confusion, problems speaking or understanding, sudden problems seeing with one or both eyes, severe headache, loss of consciousness or fainting, seizures, loss of coordination, loss of balance.

The misuse of the medication may cause an increase in blood cells and, as a consequence, thicken the blood. This may cause potentially fatal heart or blood vessel problems.

Children and adolescents

Do not administer Evrenzo to children and adolescents under18years of age, as there is not enough information available about its use in this age group.

Other medications and Evrenzo

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to takeany other medication. Evrenzo may affect how these medications work or these medications may affect how Evrenzo works.

Particularly, inform your doctor or pharmacist if you have taken or are taking any of the following medications:

• Medications to reduce phosphate levels in the blood (called phosphate binders) orothermedications or supplements containing calcium, iron, magnesium, or aluminum (called multivalent cations), such as sevelamer carbonate or calcium acetate. You must take Evrenzo at least 1hour after taking these medications or supplements. Otherwise, your body will not absorb roxadustat properly.
• A medication for the treatment of gout called probenecid.
• Medications used to reduce cholesterol, such as simvastatin, atorvastatin, or rosuvastatin (also called "statins") or gemfibrozil.
• Other medications used to treat anemia, such as erythropoiesis-stimulating agents (ESAs).

If you normally take any of these medications, your doctor may change your treatment and prescribe another one that you will take during the time you are taking Evrenzo.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor.

Evrenzo may cause harm to your baby. Evrenzo is not recommended during the first 6months of pregnancy and should not be taken during the last 3months of pregnancy.Women taking Evrenzo and who may become pregnant should use an effective contraceptive method during treatment with Evrenzo and, at least, during the week after the last dose of Evrenzo. If you use a hormonal contraceptive method, you should also use a barrier method, such as a condom or diaphragm.

If you are being treated with Evrenzo, do not breastfeed your child. It is unknown whether Evrenzo passes into breast milk; if so, it may cause harm to your baby.

Driving and operating machinery

This medication may affect your ability to drive and operate machinery. You may experience a seizure; this is one of the possible side effects (see section4).

Evrenzo contains lactose, soy lecithin, and aluminum lake red Allura AC

Evrenzo contains sugar (lactose), traces of peanuts and soy (soy lecithin), and an azo dye (aluminum lake red Allura AC). If your doctor has told you that you have an intolerance to certain sugars or are allergic to peanuts, soy, or azo dyes, consult with them before taking this medication.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will indicate the dose of Evrenzo that you should take.

Additionally, your doctor will measure your hemoglobin levels periodically and, if necessary, will increase or decrease the dose.

Evrenzo is taken orally in the form of tablets.

Evrenzo intake

• Take your Evrenzo dose three times a week, unless your doctor has indicated otherwise.
• Never take Evrenzo on consecutive days.
• Take Evrenzo on the same three days of each 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 taking medications to reduce blood phosphate levels (called phosphate binders) or other medications or supplements containing calcium, iron, magnesium, or aluminum (called multivalent cations).

Dosing regimen

Three times a week dosing regimen

Evrenzo is presented in a blister pack containing medication for 4 weeks (12 tablets) distributed in 4 rows. Each row contains medication for 1 week (3 tablets). Make sure to take the tablets from the same row each week.

Your dose may range from 20 mg three times a week to a maximum of 400 mg three times a week.

Different dosing frequencies

In exceptional cases (based on your hemoglobin levels), your doctor may decide to reduce your Evrenzo dose to 20 mg twice or once a week. In this case, your doctor will indicate on which day or days of the week you should take the dose.

If the required dose is more than 1 tablet

Most of the time, you will have 1 blister pack per month. If your dose requires more than 1 blister pack, you should take one tablet from each blister pack on the day you have a scheduled dose. Your doctor will indicate how many tablets you should take and when to take them.

Your doctor will monitor your hemoglobin level and may temporarily interrupt treatment if your hemoglobin level becomes too high. Do not restart 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 than you should or a dose higher than you should, contact your doctor immediately.

If you forget to take Evrenzo

• Never take a double dose to compensate for missed doses.
• If more than 24 hours (1 day) have passed since the next scheduled dose, take the missed dose as soon as possible and the next dose on the scheduled day.
• If less than 24 hours (1 day) have passed since the next scheduled dose: ignore the missed dose and take the next dose on the scheduled day.

If you interrupt Evrenzo treatment

Do not stop taking this medication unless your doctor has told you to.

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

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

Some possible side effects can be serious. Contact your doctor immediately if you experience any of the following:

• Deep vein thrombosis (blood clot in the veins of the legs) (may affect up to1in every10people).
• Pulmonary embolism (blood clot in the lungs) (may affect up to1in every100people).
• Blood clot in the dialysis access(vascular access thrombosis or VAT) that causes the vascular accessto become obstructed or stop functioning if you are using a fistula or graft for dialysis access (may affect more than1in every10people).
• Seizure and warning signs of seizures (convulsions or attacks) (may affect up to1in every10people).
• Sepsis, a severe and, in rare cases, potentially fatal infection (may affect up to1in every10people).
• Widespread skin redness and peeling, which may cause itching or pain (exfoliative dermatitis) (the frequencycannot be estimated from the available data).

Other possible side effects

Very common (may affect more than1in every10people)

• Increased potassium levels
• High blood pressure (hypertension)
• Sensation of illness (nausea)
• Diarrhea
• Swelling due to fluid retention in the extremities (peripheral edema)

Common (may affect up to1in every10people)

• Difficulty sleeping (insomnia)
• Headache
• Vomiting
• Constipation

Uncommon (may affect up to1in every100people)

• Increased bilirubin levels in the blood

Frequency not known (cannot be estimated from the available data)

• Decreased thyroid function
• Elevated copper levels in the blood

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 reporting system included in theAppendixV.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed ofthrough drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Evrenzo Composition

Evrenzo 20 mg:

• The active ingredient is roxadustat. Each tablet contains 20 mg of roxadustat.

Evrenzo 50 mg:

• The active ingredient is roxadustat. Each tablet contains50mg of roxadustat.

Evrenzo 70 mg:

• The active ingredient is roxadustat. Each tablet contains70mg of roxadustat.

Evrenzo 100 mg:

• The active ingredient is roxadustat. Each tablet contains100mg of roxadustat.

Evrenzo 150 mg:

• The active ingredient is roxadustat. Each tablet contains150mg of roxadustat.

The other components are:

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

• Coating: polyvinyl alcohol (E1203), talc (E553b), macrogol (E1521), red iron oxide (E129), titanium dioxide (E171), soy lecithin (E322).

Appearance of the product and contents of the package

Evrenzo20mg are oval-shaped, red-coated tablets with the number "20" embossed on one side.

Evrenzo50mg are oval-shaped, red-coated tablets with the number "50" embossed on one side.

Evrenzo70mg are round, red-coated tablets with the number "70" embossed on one side.

Evrenzo100mg are oval-shaped, red-coated tablets with the number "100" embossed on one side.

Evrenzo150mg are almond-shaped, red-coated tablets with the number "150" embossed on one side.

Evrenzo is available in packages containing 12×1tablet and 36×1tablet in PVC/aluminum blisters with pre-scored doses.

Only some package sizes may be marketed.

Marketing Authorization Holder

Astellas Pharma Europe B.V.

Sylviusweg62

2333BELeiden

Netherlands

Responsible for manufacturing

Delpharm Meppel B.V.

Hogemaat 2

7942 JG Meppel

Netherlands

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last revision date of this leaflet:MM/AAAA

Other sources of information

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