ATRASENTAN TAB
Clinical Criteria Summary
Indication & Patient Population
- • Adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression
- • Generally requires a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g
- • Persistent proteinuria (≥1 g/day) despite being on a maximally tolerated dose of a RAS inhibitor and failure of other agents
- • Biopsy-proven IgA nephropathy with an estimated glomerular filtration rate (eGFR) ≥ 30 ml/min/1.73 m²
- • Excludes patients with secondary IgA nephropathy or a history of heart failure
Dosing & Administration
- • 0.75 mg taken orally once daily, with or without food
- • Administered as add-on therapy to maximally tolerated renin-angiotensin system (RAS) inhibition (ACE inhibitor or ARB)
- • Patients must be on a stable, maximum tolerated dose of an ACE inhibitor or ARB for at least 12 weeks prior to screening/initiation
Contraindications & Safety Requirements
- • Pregnancy is contraindicated; pregnancy must be excluded before starting treatment
- • Effective contraception required before, during, and for two weeks after treatment
- • Hypersensitivity to atrasentan or any component of the product
- • Monitor liver enzymes before and during treatment as clinically indicated due to hepatotoxicity risk
- • Monitor for fluid retention; consider diuretic use and interrupt atrasentan if clinically significant fluid retention occurs
- • Counsel men about potential adverse effects on spermatogenesis/fertility
Formulary & Use Restrictions
- • Indicated specifically for reduction of proteinuria in primary IgAN at risk of rapid progression (UPCR ≥ 1.5 g/g)
- • Considered as an adjunct prior to or as an alternative to immunosuppression in select high-risk cases
- • Not established whether atrasentan slows kidney function decline; continued approval contingent upon verification of clinical benefit in a confirmatory trial
- • Avoid concomitant use with strong or moderate CYP3A inducers or OATP1B1/1B3 inhibitors due to altered exposure and efficacy/safety risks