Tenofovir AF

Known hypersensitivity reactions (eg, urticaria, angioedema, bronchoconstriction, anaphylaxis, or Stevens-Johnson syndrome)

Autoimmune hepatitis

Hepatic decompensation (Child-Pugh score >6 [class B and C]) in cirrhotic patients with or without HIV coinfection before treatment

Use in neonates and infants

Combination therapy with ribavirin is contraindicated in females who are pregnant and men whose female partners are pregnant

Lactic acidosis and severe hepatomegaly with steatosis, including fatalities, reported with nucleoside analogs, including tenofovir disoproxil fumarate in combination with other antiretrovirals; most were reported in women; obesity and prolonged nucleoside exposure may be risks factors 

Discontinuation of antihepatitis B drugs may result in severe acute exacerbations of hepatitis B (see Black Box Warnings); all patients should be tested for presence of chronic hepatitis B virus (HBV) before or when initiating therapy

Resumption of anti-hepatitis B therapy may be warranted, in patients with advanced liver disease or cirrhosis, since posttreatment exacerbation of hepatitis may lead to hepatic decompensation and liver failure

Due to risk of development of HIV-1 resistance, tenofovir AF alone is not recommended for treatment of HIV-1 infection; safety and efficacy have not been established in patients coinfected with HBV and HIV-1; perform HIV antibody testing on all HBV-infected patients before initiating therapy; if positive, use an appropriate antiretroviral combination regimen recommended for patients coinfected with HIV-1

Persistent or worsening bone pain, pain in extremities, fractures and/or muscular pain or weakness may be manifestations of proximal renal tubulopathy and should prompt an evaluation of renal function in patients at risk of renal dysfunction