This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: PLGB 00166/0427, PLGB 00166/0428, PLGB 00166/0429, PLGB 00166/0430, PLGB 00166/0431.
Evrenzo (roxadustat) film-coated tablets (Great Britain)
Evrenzo 20 mg film-coated tablets
Evrenzo 50 mg film-coated tablets
Evrenzo 70 mg film-coated tablets
Evrenzo 100 mg film-coated tablets
Evrenzo 150 mg film-coated tablets
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
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
Evrenzo is a medicine that increases the number of red blood cells and haemoglobin level in your blood. It contains the active substance roxadustat.
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.
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.
Talk to your doctor, or pharmacist before taking Evrenzo:
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:
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.
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.
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:
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.
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.
This medicine may affect your ability to drive or use machines. Seizures can occur as a side effect (see section 4).
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.
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).
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 tablets or a higher dose than you should, contact your doctor straight away.
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.
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people)
Not known (frequency cannot be estimated from the available data)
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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.
Evrenzo 20 mg:
Evrenzo 50 mg:
Evrenzo 70 mg:
Evrenzo 100 mg:
Evrenzo 150 mg:
The other ingredients are:
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.
Each pack contains 12 x 1 film-coated tablets in PVC/aluminium perforated unit dose blisters.
This leaflet was last revised in 12/2022