Odefsey

Discontinuation of emtricitabine and/or tenofovir disoproxil may be associated with severe acute exacerbations of hepatitis B. Closely monitor patients co-infected with HBV and HIV for several months after stopping treatment; if appropriate, anti-HBV therapy may be warranted (esp. in advanced liver disease or cirrhosis). Underlying hepatitis B or C, or marked elevations in liver-associated tests; monitor for hepatotoxicity. Consider monitoring LFTs in those without pre-existing hepatic dysfunction or other risks. Assess SCr, estimated CrCl, urine glucose, urine protein in all patients, and serum phosphorus (in chronic kidney disease) prior to or when initiating, and during therapy. Discontinue if significant renal dysfunction or Fanconi syndrome occurs. Suspend therapy if lactic acidosis or hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Prolongation of QTc interval with higher doses. Promptly evaluate if severe depressive symptoms occur. Discontinue immediately if severe skin or hypersensitivity reactions develop. ESRD (CrCl <15mL/min) receiving chronic hemodialysis: more monitoring and on hemodialysis days, give dose after session. Severe hepatic impairment: not studied. Pregnancy. Nursing mothers: not recommended.