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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.
Relevant Products / প্রাসঙ্গিক পণ্য
✔️ 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.
Disclaimer:
ePharma sole intention is to ensure that its consumers get proper
information as musch as possible. Although we do not guarantee the
accuracy and the completeness of the information that provided and
here information is for informational purposes only.
The information contained herein should NOT be used as a substitute
for the advice of a qualified physician. This may not cover
everything about particular health conditions,
lab tests, medicines, all possible side effects, drug interactions,
warnings, alerts, etc. Please consult your healthcare professional
and discuss all your queries related to any disease or medicine. We
intend to support, not replace, the doctor-patient relationship.
