Erenzo 100mg 3pcs Tablet

✔️ Roxadustat is a HIF prolyl hydroxylase inhibitor (HIF-PHI) with anti-anemic properties:

• Prevents HIF degradation under normal oxygen conditions, leading to enhanced transcriptional activity of HIF-related genes.
• Increases erythropoiesis through endogenous EPO production and improved iron metabolism.
• Reduces hepcidin, increasing iron availability and hemoglobin levels.
• Enhances intestinal iron absorption, promotes iron transport, and releases stored iron.
• Maintains plasma EPO levels within or near the physiological range.
• Reduces cholesterol levels regardless of concurrent lipid-lowering agents.

✔️ Common Side Effects:

• Hypertension
• Vascular access thrombosis
• Diarrhea
• Peripheral edema
• Hyperkalemia
• Nausea

✔️ Dosage & Administration

General Guidelines:

• Administer orally, three times per week (not on consecutive days).
• Target hemoglobin (Hb) levels: 10–12 g/dL.

Initial Dosing:

Patients not on EPO-stimulating agents:

• Adults weighing <100 kg: 70 mg thrice weekly.
• Adults weighing ≥100 kg: 100 mg thrice weekly.

Patients switching from EPO-stimulating agents:

• Start with 70–100 mg thrice weekly, adjusted as needed.

Dose Adjustments:

• Increase or decrease dose based on hemoglobin monitoring (e.g., avoid rapid Hb increases >2.0 g/dL in 4 weeks).
• Follow the available dose sequence: 20 mg → 40 mg → 50 mg → 70 mg → 100 mg → 150 mg → 200 mg → 250 mg → 300 mg → 400 mg (for dialysis patients).

• Children: Not indicated.
• Severe liver dysfunction: Not recommended.

Missed Dose:

• If >24 hours remain until the next dose: Take immediately.
• If <24 hours remain: Skip the missed dose and continue with the next scheduled dose.

Administration:

• Take with or without food.

✔️ Overdose

Symptoms: Elevated heart rate and Hb concentration.
Management: Reduce or discontinue dose as necessary. Roxadustat is not removed by dialysis.

✔️ Drug Interactions

With phosphate binders and multivalent cation products (except lanthanum carbonate):

• Risk: Decreased drug absorption.
• Recommendation: Take Erenzo 1 hour after such products.

With gemfibrozil or probenecid:

• Risk: Increased Erenzo exposure (AUC and Cmax).
• Recommendation: Adjust Erenzo dose based on Hb monitoring.

With OATP1B1 or BCRP substrates (e.g., simvastatin, rosuvastatin, atorvastatin):

• Risk: Increased AUC and Cmax.
• Recommendation: Adjust Erenzo dose based on Hb monitoring.

✔️ Pregnancy & Lactation

• Pregnancy: Contraindicated during pregnancy or in women planning pregnancy.
• Lactation: Contraindicated during breastfeeding.

✔️ Precautions & Warnings

• Use with caution in patients with thrombotic vascular events (TVEs), such as a history of obesity or prior TVEs.
• Use cautiously in patients with a history of seizures.

✔️ Do not use in patients with

• Serious infections.
• Severe liver dysfunction.
• Pregnant women.

✔️ Storage Conditions

• Store below 30°C, protected from light and moisture.
• Keep out of reach of children.