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Oroxat is indicated for the treatment of symptomatic anemia in adult patients associated with chronic kidney disease (CKD).
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✅ Description:
Oroxat (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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✔️ Mechanism of Action
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.
✔️ Benefits: Oroxat 70
- Reduces cholesterol levels.
- Enhances transferrin and releases stored iron.
✔️ Dosage & Administration of Oroxat 70
- General Dosing: Taken orally three times per week, not on consecutive days.
- Target Hemoglobin (Hb): 10–12 g/dL.
For Patients Not on Erythropoiesis-Stimulating Agents:
- Adults:
- Weighing <100 kg: 70 mg three times weekly.
- Weighing ≥100 kg: 100 mg three times weekly.
For Patients Switching from Erythropoiesis-Stimulating Agents:
- Adults: Starting dose: 70–100 mg three times weekly, adjusted as needed.
Dose Adjustments:
- Increase or decrease the dose based on Hb levels.
- Maintain adjusted doses for at least 4 weeks.
- Suspend treatment if Hb rises >2 g/dL within 4 weeks.
- Dose options range from 20 mg to 400 mg for CKD patients on dialysis.
✔️ Missed Dose: Oroxat 70
- If ≥24 hours remain before the next dose, take the missed dose immediately.
- If <24 hours remain, skip the missed dose.
- Do not take two doses in one day.
✔️ Administration: Oroxat 70
Can be taken with or without food.
✔️ Common Adverse Reactions
- Hypertension
- Vascular access thrombosis
- Diarrhea
- Peripheral edema
- Hyperkalemia
- Nausea
✔️ Interaction
Phosphate Binders or Multivalent Cation-Containing Products:
- Risk: Reduced absorption of Oroxat.
- Recommendation: Take Oroxat at least 1 hour after these products.
Gemfibrozil or Probenecid:
- Risk: Increased Oroxat 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.
✔️ Overdose:
- Symptoms include transient tachycardia and excessive Hb increase. Treatment involves dose reduction or treatment interruption.
✔️ 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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