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TENOFOVIR ALAFENAMIDE ORAL TABLET

Clinical Criteria Summary

Exclusion Criteria

  • Patient prescribed combination product containing tenofovir disoproxil fumarate or tenofovir alafenamide fumarate for HBV and/or HIV infection
  • Inclusion Criteria (Must meet at least one)
  • Patient with calculated CrCl or eGFR of 15-59 mL/min or has end stage renal disease (ESRD) and is receiving dialysis
  • Patient prescribed concomitant nephrotoxic medications (eg: ACE-inhibitors, calcineurin inhibitors, certain chemotherapy agents, diuretics, etc.)
  • Patient at risk of fracture or with evidence of bone mineral destruction (including, but not limited to: active treatment for osteoporosis or osteopenia, history of stress fracture, oral glucocorticoid use within past 3 months at a prednisolone dose ≥7.5 mg daily, currently smoking, etc.)

Dosage and Administration

  • One 25 mg tablet orally once daily taken with food

Dosing Considerations

  • No dose adjustment is needed for patients with a CrCl 15-59 mL/min OR CrCl <15mL/min AND receiving hemodialysis
  • Not recommended in patients with ESRD (CrCl < 15 mL/min who are NOT receiving dialysis)

Source Documents