Discontinue BIKTARVY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Do not initiate BIKTARVY in patients with estimated creatinine clearance (CrCl) <30 mL/min except in virologically suppressed adults <15 mL/min who are receiving chronic hemodialysis. New onset or worsening renal impairment: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)-containing products.Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.Consider the potential for drug interactions prior to and during BIKTARVY therapy and monitor for adverse reactions. Drug interactions: See Contraindications and Drug Interactions sections.Coadministration: Do not use BIKTARVY with dofetilide or rifampin.If appropriate, anti-hepatitis B therapy may be warranted.
Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue BIKTARVY.
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