Oroxat 70

✔️ 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.