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Roxadustat inhibits HIF prolyl hydroxylase enzymes (HIF-PH), preventing the degradation of hypoxia-inducible factor (HIF) transcription factors. This increases HIF activity, leading to:
- Enhanced production of EPO and EPO receptors.
- Improved iron absorption, transport, and utilization.
- Lowered hepcidin levels, increasing iron availability.
- Coordinated erythropoiesis with hemoglobin (Hb) levels maintained near physiologic ranges, even in inflammatory conditions.
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✅ Description:
Renesis 50 (Roxadustat) is the first-in-class orally administered hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). It promotes erythropoiesis by:
- Increasing endogenous erythropoietin (EPO) production.
- Improving iron regulation.
- Overcoming EPO-suppressive effects of inflammation on hemoglobin synthesis and red blood cell production.
- Downregulating hepcidin to enhance iron availability.
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✔️ Indications:
Renesis 50 is indicated for the treatment of symptomatic anemia in adult patients associated with chronic kidney disease (CKD).
✔️ Side Effects
- Hypertension
- Vascular access thrombosis
- Diarrhea
- Peripheral edema
- Hyperkalemia
- Nausea
✔️ Detailed Dosage Instructions for Roxadustat
Roxadustat should be taken three times per week, ensuring non-consecutive days, and the dose must be tailored to achieve and maintain hemoglobin (Hb) levels between 10–12 g/dL.
1. Initial Dosing
For Patients Not on Erythropoiesis-Stimulating Agent Treatment:
- Starting Dose for Adults:
- <100 kg body weight: 70 mg, three times per week.
- ≥100 kg body weight: 100 mg, three times per week.
For Patients Switching from Erythropoiesis-Stimulating Agents:
- Starting Dose for Adults: 70 mg or 100 mg three times per week.
2. Dose Adjustments
When to Adjust:
- Increase or decrease the dose based on the patient's Hb levels and condition.
- Maintain the adjusted dose for at least 4 weeks before further adjustments.
- Rapid Hb Increase (>2.0 g/dL within 4 weeks):
- Reduce the dose or suspend treatment immediately.
Stepwise Dose Adjustment Sequence:
Follow this progression for dose adjustments (up or down):
20 mg → 40 mg → 50 mg → 70 mg → 100 mg → 150 mg → 200 mg → 250 mg → 300 mg → 400 mg (for dialysis patients only).
✔️ Missed Dose Instructions
- If ≥24 hours remain until the next dose: Take the missed dose immediately.
- If <24 hours remain until the next dose: Skip the missed dose and continue as per schedule.
- Do not take two doses on the same day.
✔️ Pregnancy & Lactation
Do not administer to women that may be pregnant or pregnant. Roxadustat is contraindicated during breast-feeding.
✔️ Drug Interactions
Phosphate Binders or Multivalent Cation-Containing Products:
- Risk: Reduced absorption of Renesis 50.
- Recommendation: Take Renesis 50 at least 1 hour after these products.
Gemfibrozil or Probenecid:
- Risk: Increased Renesis 50 levels (AUC ↑ 2.3-fold, Cmax ↑ 1.4-fold).
- Recommendation: Adjust dosage based on Hb monitoring.
Statins (Simvastatin, Rosuvastatin, Atorvastatin):
- Risk: Increased AUC and Cmax.
- Recommendation: Adjust dosage accordingly.
✔️ Precautions & Warnings
- Seizures: Use with caution in patients with a history of seizures.
- Infections: Avoid administration in patients with serious infections.
- Liver Disorders: Do not administer to patients with liver disease or severe hepatic impairment.
- Pregnancy: Contraindicated in pregnant women.
- Breastfeeding: Contraindicated during lactation.
- Children: Not indicated for pediatric use.
✔️ Storage:
- Store below 30°C in a cool, dry place.
- Protect from light and moisture.
- Keep out of reach of children.
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lab tests, medicines, all possible side effects, drug interactions,
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