Roxatat 20 mg (Tablet)

Unit Price: ৳ 200.00 (1 x 3: ৳ 600.00)
Strip Price: ৳ 600.00

Medicine Details

Category Details
Generic Roxadustat
Company Healthcare pharmaceuticals ltd
Also available as
Roxatat 50 mg tablet Roxatat 100 mg tablet

Title

  • Roxadustat Tablet

Categories

  • Medicine
  • Anemia Treatment
  • Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor
  • Oral Medication
  • Erythropoiesis-Stimulating Agent

Description

Roxadustat is an orally administered medicine indicated for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease (CKD). It is a first-in-class HIF-PH inhibitor that promotes erythropoiesis through increasing endogenous production of erythropoietin, improving iron regulation, and overcoming the EPO-suppressive effects of inflammation on hemoglobin synthesis and red blood cell production by downregulating hepcidin.

Pharmacology

Roxadustat is an orally bioavailable, HIF-PHI, with potential anti-anemic activity. It binds to and inhibits HIF-PH, preventing HIF breakdown and promoting HIF activity. Increased HIF activity leads to an increase in endogenous erythropoietin production, enhancing erythropoiesis. It also reduces hepcidin expression, improves iron availability, and boosts hemoglobin levels. HIF regulates the expression of genes required for erythropoiesis and iron metabolism.

Dosage and Administration

  • Dosage:
    • Orally three times per week, not on consecutive days
  • Individualized Dose:
    • To achieve and maintain target Hb levels of 10 to 12 g/dL
  • Starting Dose:
    • Patients without erythropoiesis-stimulating agent treatment:
      • 50 mg three times weekly for adults
      • 70 mg three times weekly for patients weighing less than 100 kg
      • 100 mg three times weekly for patients weighing 100 kg and over
    • Patients switching from erythropoiesis-stimulating agents:
      • 70 or 100 mg three times weekly for adults
  • Dose Adjustment:
    • Increase or decrease according to the dose adjustment table and stepwise dose adjustment sequence

Interaction

  • Potential Interactions:
    • Phosphate binders and multivalent cation-containing products:
      • Roxadustat should be taken at least 1 hour after administration
    • Gemfibrozil or probenecid:
      • Adjust the dose following Hb monitoring
    • OATP1B1 or BCRP Substrates (such as simvastatin, rosuvastatin & atorvastatin):
      • Adjust the dose following Hb monitoring

Side Effects

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

Pregnancy and Lactation

Contraindicated during pregnancy and breastfeeding

Precautions and Warnings

  • Potential thrombotic vascular events in patients with risk factors
  • Caution in patients with a history of seizures
  • Do not administer if serious signs of infection or liver disorder are present
  • Avoid in pregnant women

Use in Special Populations

  • Children: Not indicated for use in children
  • Liver Dysfunction Patients: Not recommended for use in patients with severe hepatic impairment

Overdose Effects

  • Symptoms: Increased heart rate transient, likely increase in hemoglobin concentration
  • Treatment: Appropriate measures of dose reduction or interruption, as Roxadustat is not removed by dialysis

Therapeutic Class

Drugs for Haemolytic Hypoplastic & Renal Anemia

Storage Conditions

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

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