Description

1. Product Overview: Renofix 100 is a tablet formulation of Roxadustat INN 100 mg, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor used for the treatment of anemia in patients with chronic kidney disease (CKD).
2. Composition: Active Ingredient: Roxadustat INN 100 mg | Dosage Form: Tablet
3. Pharmacological Class: HIF-PH (Hypoxia-Inducible Factor Prolyl Hydroxylase) Inhibitor
4. Mechanism of Action: Roxadustat stabilizes hypoxia-inducible factors (HIF), leading to increased endogenous erythropoietin production, enhanced iron metabolism, and stimulation of red blood cell production.
5. Indications: Anemia associated with chronic kidney disease (CKD) in both dialysis and non-dialysis patients
6. Dosage & Administration: As prescribed by physician | Oral use | Typically administered three times weekly | Dose individualized based on hemoglobin levels
7. Clinical Benefits: Increases hemoglobin levels | Reduces need for injectable erythropoiesis-stimulating agents | Improves iron utilization | Oral administration for patient convenience
8. Contraindications: Hypersensitivity to Roxadustat or any component
9. Precautions: Monitor hemoglobin levels regularly | Risk of hypertension and thrombotic events | Use under medical supervision
10. Drug Interactions: May interact with phosphate binders and iron supplements; spacing of administration may be required
11. Special Populations: Pregnancy: Use only if clearly needed | Lactation: Consult physician | Pediatric use not established | Dose adjustment may be required in hepatic impairment
12. Adverse Effects: Hypertension | Nausea | Diarrhea | Headache | Thromboembolic events
13. Storage Conditions: Store below 30°C | Protect from light and moisture | Keep out of reach of children
14. Packaging: Tablet in blister pack
15. Manufacturer: Everest Pharmaceutical Ltd.