Renustat 70 mg Tablet

Oral HIF prolyl-hydroxylase inhibitor for:

• Anaemia due to chronic kidney disease (CKD), in adults on dialysis or not on dialysis (specialist use)

Given three times weekly (not on consecutive days), with or without food — specialist-directed:

• Starting dose by body weight, for patients not previously on ESA: e.g. 70 mg three times weekly (45 to under 70 kg), 100 mg (70–160 kg); different rules when switching from erythropoietin.
• Adjusted every 4 weeks according to haemoglobin (target usually 10–12 g/dL); do not raise haemoglobin by more than 2 g/dL in 4 weeks.
• Swallow tablets whole.
• Take at least 1 hour after phosphate binders or iron/calcium/magnesium products.

• Allergy to roxadustat or peanut/soya (some tablets contain soya lecithin)
• Third trimester of pregnancy and breastfeeding
• Uncontrolled high blood pressure (relative)

Very common: high blood pressure, high potassium, swelling, diarrhoea, nausea.

Common: vascular access clotting (dialysis fistula/graft), headache, insomnia, dizziness, vomiting, constipation, raised liver enzymes.

Serious: blood clots (DVT, pulmonary embolism, stroke, heart attack), seizures, sepsis, hypothyroidism (central).

• Monitor haemoglobin every 2–4 weeks and blood pressure regularly.
• Check iron status and give iron if needed.
• History of seizures or clotting: caution.
• Liver impairment: dose reduction.

Contraindicated in the third trimester and during breastfeeding; avoid during pregnancy, use effective contraception.

• Phosphate binders (sevelamer, calcium acetate), iron, calcium, magnesium, zinc, antacids — reduce absorption; take roxadustat at least 1 hour after
• Statins (simvastatin, rosuvastatin, atorvastatin — levels rise; consider dose limits)
• Gemfibrozil, probenecid (raise roxadustat levels)

Possible rapid rise in haemoglobin, high blood pressure; supportive care and monitoring.

Store below 30°C.