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Discontinuation of anti-HBV therapy (including 3TC, TDF-containing products) 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 use of hepatotoxic drugs; monitor for hepatotoxicity. Monitor LFTs prior to and during therapy; consider discontinuing if serum transaminases elevated to >5×ULN or, discontinue if accompanied by hepatitis or hepatic decompensation. Suspend therapy if lactic acidosis or pronounced hepatotoxicity (eg, hepatomegaly, steatosis) occurs. New onset or worsening renal impairment. Assess SCr, estimated CrCl, urine glucose, urine protein in all patients prior to initiation and during therapy. Promptly evaluate if serious psychiatric symptoms occur. History of pancreatitis; discontinue immediately if occurs. History of seizures. Perform lipid tests prior to and periodically during therapy. History of pathologic fracture or risk factors for osteoporosis or bone loss: consider monitoring bone mineral density (BMD); calcium/vitamin D supplement may be beneficial. Moderate or severe hepatic or renal impairment (CrCl<50mL/min) or ESRD requiring hemodialysis: not recommended. Elderly. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception (barrier and hormonal) during and for 12 weeks after discontinuing treatment. Potential risk of neural tube defects: perform pregnancy testing prior to initiation. Pregnancy (esp. 1^st trimester), nursing mothers: not recommended.