Roxadustat – an EPO-like tablet for anaemia in CKD patients

Roxadustat – an EPO-like tablet for anaemia in CKD patients

Roxadustat is an EPO-stimulating tablet for kidney-related anaemia

A hormone (erythropoietin, EPO) is normally made by the kidneys. EPO’s function is to stimulate the bone marrow to make red blood cells.

Roxadustat (brand name Evrenzo) is from a newer class of medication for treating renal (kidney-related) anaemia – and works by stimulating the body to produce its own natural erythropoietin.

Unlike traditional injections, this is an oral treatment that changes how your body senses and uses oxygen and iron.

What is Roxadustat?

• An Oral Alternative: It is a ‘HIF-PH inhibitor’, the first of its kind to be used as a pill rather than an injection for anaemia.
• Small Molecule Therapy: It is a synthetic compound designed to mimic the body’s natural response to low oxygen levels (like being at a high altitude).
• ESA Alternative: It provides a different option for patients who may not want or cannot use traditional Erythropoiesis-Stimulating Agents (ESAs) like darbepoetin alfa.

How It Works

• Mimics Low Oxygen: It blocks an enzyme called prolyl hydroxylase. This ‘tricks’ the body into thinking oxygen levels are low.
• HIF Stabilisation: This process stabilises Hypoxia-Inducible Factor (HIF), a protein that triggers the body to produce its own natural erythropoietin.
• Improved Iron Use: Unlike older treatments, roxadustat helps the body better absorb iron from the gut and move stored iron into the bloodstream to help build new red blood cells.

Who is Roxadustat used for?

• Chronic Kidney Disease (CKD): It is primarily used to treat symptomatic aanemia in adult patients with CKD.
• Dialysis and Non-Dialysis: It is approved in many regions (such as Europe and Japan) for patients regardless of whether they are currently on dialysis.

Dose

• Dose: Initially 70mg 3 times a week, adjusted according to response; usual maintenance 20–400mg 3 times a week.
• It is often given to patients with chronic kidney disease (CKD) when they become anaemic with a haemoglobin (Hb) < 100 g/L – and other causes of anaemia have been excluded. The target Hb is 110-120 g/L (i.e. not normal).
• Oral Pill: It is taken as a tablet by mouth, which many patients find more convenient than needles.
• Schedule: It is typically taken three times a week, and usually not on consecutive days (for example: Monday, Wednesday, Friday).

Note. Timing with Other Meds: It is important to separate roxadustat from ‘phosphate binders’ or supplements containing calcium, magnesium, or aluminum by at least two hours, as these can stop the drug from being absorbed.

Side-effects

Common side-effects

• Hypertension (high blood pressure).
• Nausea or diarrhoea.
• Peripheral oedema (swelling in the ankles or legs).

Less common (but more serious) side-effects

• Thrombosis: Increased risk of blood clots, including pulmonary embolism (PE).
• Haemodialysis patients with a fistula (AVF) or graft (AVG): AVF or AVG may clot
• Seizures: A known risk with many anaemia medications.
• Sepsis: Some studies have noted a potential increase in serious infections.

Monitoring

Your doctor needs to monitor:

• Haemoglobin Levels: You will need regular blood tests to ensure your Hb (red blood cell count) stays within the target range.
• Blood Pressure Check: Because it can raise blood pressure, you should monitor your readings at home or at the clinic.
• Liver Function: With blood tests.
• Iron Stores: While roxadustat helps use iron better, your doctor will still monitor your ferritin levels to ensure you have the ‘raw materials’ needed to make blood.

Comparison Table: Darbepoetin (traditional ESA) vs. Roxadustat

Other Resources

UK Clinical Guidelines

• BNF (British National Formulary): Roxadustat The primary UK reference for dosage, interactions (such as the 2-hour separation from phosphate binders), and specific prescribing cautions.

• NICE Technology Appraisal (TA807) The official UK clinical guideline that recommends roxadustat as an option for treating symptomatic anaemia in adults with stage 3 to 5 chronic kidney disease.

US Clinical Guidelines

• KDIGO 2026 Clinical Practice Guideline for Anemia in CKD The global standard (heavily used in the US) for managing kidney-related anaemia, which includes the most recent clinical frameworks for using HIF-PH inhibitors like roxadustat.

• FDA Briefing Document: Roxadustat The official US regulatory review and data summary (PDF) regarding the efficacy and safety profile of roxadustat, specifically detailing cardiovascular safety data.