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Tenofovir AF

    Brands

    DEA Class; Rx

    Common Brand Names; Vemlidy

    • Hepatitis B, NRTIs

    Hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor
    Used to treat chronic HBV infection in patients 12 years and older with compensated liver disease; guidelines recommend use with other antiretroviral agents to treat HIV
    Black Box Warning for acute HBV exacerbations upon treatment discontinuation

    Indicated for treatment of chronic hepatitis B virus (HBV) infection in patients aged ≥12 years with compensated liver disease

    For the treatment of chronic hepatitis B infection.
    For the treatment of human immunodeficiency virus (HIV) infection in combination with other anti-retroviral agents.

    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

    • Headache (9-12%)
    • Bone mineral density decline (5-11%)
    • Abdominal pain (7-9%)
    • ALT >5 x ULN (8%)
    • Cough (8%)
    • Fatigue (6%)
    • Nausea (6%)
    • LDL-cholesterol fasted >190 mg/dL (6%)
    • Back pain (6%)
    • Glycosuria ≥3+ (5%)
    • Nausea (5%)
    • Arthralgia (5%)
    • Diarrhea (5%)
    • Dyspepsia (5%)
    • AST >5 x ULN (3%)
    • Creatine kinase ≥10 x ULN (3%)
    • Serum amylase >2 x ULN (3%)

    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

    Unknown if distributed in human breast milk

    Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

    Adults

    25 mg/day PO.

    Geriatric

    25 mg/day PO.

    Adolescents

    25 mg/day PO.

    Children

    12 years: 25 mg/day PO.
    1 to 11 years: Safety and efficacy not established.

    Infants

    Safety and efficacy not established.

    Neonates

    Safety and efficacy not established.

    Tenofovir alafenamide

    tablet

    • 25mg