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Viral infections
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Generic Name and Formulations:

Tenofovir disoproxil fumarate 40mg per 1g pwd.

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Indications for VIREAD ORAL POWDER:

HIV-1 infection. Chronic hepatitis B virus (HBV) in adults.


May use tabs or oral pwd (if unable to swallow). Mix oral pwd with 2–4oz of soft food not requiring chewing (eg, applesauce, baby food, yogurt). HIV or HBV: ≥12yrs (≥35kg): 300mg once daily. Renal impairment: CrCl 30–49mL/min: 300mg every 48hrs; CrCl 10–29mL/min: 300mg every 72–96hrs; hemodialysis: 300mg every 7 days or after a total of 12hrs of dialysis; CrCl <10mL/min: not recommended.


Mix oral pwd with 2–4oz of soft food not requiring chewing (eg, applesauce, baby food, yogurt). HIV: <2yrs: not established. ≥2yrs: 8mg/kg once daily; max 300mg/day. ≥17kg: may use tabs if able to swallow. 17–<22kg: 150mg once daily. 22–<28kg: 200mg once daily. 28–<35kg: 250mg once daily. ≥35kg: 300mg once daily. See full labeling for additional dosing based on body wt. HBV: <12yrs or <35kg: not established.


Risk of lactic acidosis and severe hepatomegaly with steatosis; suspend if occur. Calculate CrCl prior to initiating therapy. Monitor CrCl and serum phosphorus in patients at risk for renal impairment. Liver disease. Women, obesity, prolonged nucleoside exposure, other risk factors for hepatic dysfunction: increased risk of toxicity. Monitor hepatic function during and for several months after stopping anti-HBV treatment (discontinuing therapy may exacerbate HBV infection). HIV-1 and HBV coinfection: do HIV-1 antibody testing for HBV-infected patients, and test for presence of HBV in HIV-1 infected patients before starting therapy. History or risk of fractures, osteoporosis or bone loss: consider bone mineral density (BMD) assessment; Vit. D and calcium supplementation may be beneficial. Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended.


Avoid concomitant with other tenofovir disoproxil fumarate-containing products (eg, Atripla, Complera, Stribild, Truvada) or adefovir dipivoxil (eg, Hepsera). Avoid concomitant or recent use of nephrotoxic agents. Potentiates didanosine toxicity (reduce didanosine dose); discontinue if toxicity develops. Monitor drugs that reduce renal function or compete for renal tubular secretion (eg, cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir). Potentiated by lopinavir/ritonavir, atazanavir + ritonavir, darunavir + ritonavir, ledipasvir/sofosbuvir; monitor for toxicity. Concomitant atazanavir: must give with ritonavir. Caution with triple nucleoside-only regimens (high rate of early viral non-response); monitor and consider alternative therapy. See full labeling for dosing on concomitant didanosine or ritonavir.

See Also:


Pharmacological Class:

Nucleotide analogue (HIV-1 and HBV reverse transcriptase inhibitor).

Adverse Reactions:

Rash, diarrhea, headache, pain, depression, asthenia, nausea, insomnia, dizziness, pyrexia, abdominal pain, vomiting, pruritus, lab abnormalities; lactic acidosis, severe hepatomegaly with steatosis, fat redistribution, immune reconstitution syndrome, worsening renal impairment, decreased BMD, severe acute exacerbation of hepatitis, autoimmune disorders (eg, Graves' disease, polymyositis, Guillain-Barre).


Note: Register pregnant patients exposed to tenofovir DF by calling (800) 258-4263.



Generic Availability:


How Supplied:

Tabs—30; Oral pwd—60g (w. dosing scoop)