Renustat 50mg Tablet 1 Strip

✔️ Pharmacology

• Roxadustat works by inhibiting the enzyme HIF-PH, which prevents the degradation of HIF (Hypoxia-Inducible Factor). This promotes HIF activity, leading to the increased production of erythropoietin (EPO) and the enhancement of erythropoiesis (production of red blood cells).
• The inhibition of HIF-PH also reduces hepcidin expression, improving iron absorption, iron transport, and hemoglobin levels.
• Roxadustat has been shown to induce coordinated erythropoiesis and significantly improve hemoglobin levels in CKD patients, both dialysis-dependent and non-dialysis-dependent. It does not require intravenous iron supplementation.

✔️ Side Effects:

• Common Side Effects:
  • Hypertension (high blood pressure)
  • Vascular access thrombosis
  • Diarrhea
  • Peripheral edema (swelling)
  • Hyperkalemia (high potassium levels)
  • Nausea

✔️

• Take Roxadustat three times per week, on non-consecutive days.
• Starting Dose: For adults not on erythropoiesis-stimulating agents, the usual starting dose is 50 mg three times per week. For patients weighing less than 100 kg, start with 70 mg, and for those weighing 100 kg or more, start with 100 mg.
• For patients switching from erythropoiesis-stimulating agents, the starting dose is usually 70 or 100 mg three times per week.
• Children: Not indicated for children.
• Liver Dysfunction: Not recommended for use in patients with severe hepatic impairment.

✔️ Missed Dose:

• If more than 24 hours have passed, take the missed dose immediately. If less than 24 hours remain until the next dose, skip the missed dose and continue with the regular schedule

✔️ Administration Method:

 Take Roxadustat orally, with or without food.

✔️ Dose Adjustment:

Adjust the dose based on hemoglobin levels, following the recommended sequence. Doses should be adjusted to maintain hemoglobin levels between 10 to 12 g/dL. Avoid rapid increases (>2.0 g/dL) in hemoglobin within 4 weeks to minimize risks.

✔️ Overdose Effects:

• Symptoms of overdose may include an increased heart rate and an unnecessary increase in hemoglobin levels.
• Treatment: Dose reduction or interruption may be necessary. Roxadustat is not removed by dialysis.

✔️ Drug Interactions:

• Phosphate Binders & Multivalent Cations: These may decrease the absorption of Renustat. It's recommended to take Renustat at least 1 hour after these medications.
• Gemfibrozil & Probenecid: These can increase Renustat levels, requiring dose adjustments based on hemoglobin monitoring.
• Statins (Simvastatin, Rosuvastatin, Atorvastatin): Co-administration may increase Renustat levels, necessitating dose adjustments.

✔️ Pregnancy & Lactation:

• Pregnancy: Roxadustat is contraindicated during pregnancy.
• Lactation: It should not be used during breastfeeding.

✔️ Precautions & Warnings:

• Renustat should be used cautiously in patients with a history of thrombotic vascular events (TVEs) or seizures.
• Liver disorders and severe infections are contraindications for using this drug.
• It should not be initiated in pregnant women.

✔️ Storage:

• Store in a cool (below 30°C), dry place, away from light and moisture.
• Keep out of reach of children.