Concise Prescribing Info
Tenofovir disoproxil fumarate
In combination w/ other antiretroviral agents for treatment of HIV-1 infection in adults & ped patients ≥12 yr. Treatment of chronic hepatitis B virus (HBV) in adults.
Dosage/Direction for Use
Adult 1 tab once daily. Ped patient (≥12 yr & ≥35 kg) HIV-1 1 tab once daily.
May be taken with or without food: Take at the same time each day.
Special Precautions
Reports of severe acute exacerbations of HBV after discontinuation of anti-HBV treatment. Closely monitor hepatic function w/ both clinical & laboratory follow-up for at least several mth in HBV-infected patients who discontinue anti-hepatitis B therapy. New onset or worsening renal impairment. Assess serum creatinine, estimated CrCl, urine glucose & urine protein in all patients prior to treatment initiation & during therapy; in patients w/ chronic kidney disease, also assess serum P. Should only be used in HIV-1 & HBV coinfected patients as part of an appropriate antiretroviral combination regimen. Reports of immune reconstitution syndrome; bone loss & mineralization defects; lactic acidosis/severe hepatomegaly w/ steatosis. Adjust dosing interval & closely monitor renal function in patients w/ CrCl <50 mL/min. Pregnancy & lactation. Elderly.
Adverse Reactions
HIV: Rash, diarrhea, headache, pain, depression, asthenia, nausea. HBV: Abdominal pain, diarrhea, headache, dizziness, fatigue, nasopharyngitis, back pain, skin rash; nausea, insomnia, pruritus, vomiting, pyrexia.
Drug Interactions
Co-administration of Viread w/ drugs that are eliminated by active tubular secretion may increase conc of tenofovir &/or the co-administered drug [eg, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (eg, gentamicin), & high-dose or multiple NSAIDs]. In chronic hepatitis B treatment, do not administer w/ adefovir dipivoxil. Increased conc of didanosine. Increased tenofovir conc w/ drugs that decrease renal function; lopinavir/ritonavir, atazanavir/ritonavir, darunavir/ritonavir; sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir, ledipasvir/sofosbuvir.
MIMS Class
ATC Classification
J05AF07 - tenofovir disoproxil ; Belongs to the class of nucleoside and nucleotide reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
Viread film-coated tab 300 mg
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