VIREAD

What it is

VIREAD contains tenofovir disoproxil fumarate . VIREAD film-coated tablets contain 300 mg tenofovir disoproxil fumarate . Tenofovir disoproxil fumarate is a salt of an oral prodrug of tenofovir, a nucleoside monophosphate (nucleotide) analogue and obligate chain terminator with activity against HIV reverse transcriptase and HBV polymerase .

Approved indications

— Treatment of HIV-infected adults and paediatric patients 12 years of age and older in combination with other antiretroviral agents . — Treatment of chronic hepatitis B in adults . — Treatment of chronic hepatitis B in paediatric patients 12 years of age and older with compensated liver disease and with evidence of immune active disease, that is active viral replication, persistently elevated serum ALT levels or evidence of active inflammation .

Dosing overview

The recommended dose for adults is 300 mg (one tablet) once daily taken orally . To optimise the absorption of tenofovir, VIREAD should be taken with food . For paediatric patients 12 years of age and older who weigh ≥35 kg, the recommended dose is 300 mg (one tablet) once daily taken orally . Dosing interval adjustment is required in all patients with creatinine clearance <50 mL/min (calculated using the Cockcroft Gault equation) . There were no substantial alterations in tenofovir pharmacokinetics in patients with hepatic impairment compared with unimpaired patients, and no change in VIREAD dosing is required in patients with hepatic impairment .

Key safety warnings

Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphataemia), has been reported in association with the use of VIREAD . It is recommended that creatinine clearance is calculated in all patients prior to initiating therapy and, as clinically appropriate, during VIREAD therapy, and patients at risk for, or with a history of, renal dysfunction should be routinely monitored for changes in serum creatinine and phosphorus . Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of antiretroviral nucleoside analogues alone or in combination, including tenofovir disoproxil fumarate, in the treatment of HIV infection . Treatment with VIREAD should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or hepatotoxicity . Discontinuation of anti-HBV therapy, including VIREAD may be associated with severe acute exacerbations of hepatitis, and patients infected with HBV who discontinue VIREAD should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment . Bone toxicities including a reduction in bone mineral density (BMD) have been observed in studies in three animal species, although clinically relevant bone abnormalities have not been seen in long term clinical studies in adults (>3 years) .

Contraindications

Known hypersensitivity to tenofovir, tenofovir disoproxil fumarate, or to any of the excipients in the film-coated tablets . VIREAD must not be administered to children less than 12 years of age until further data become available . VIREAD should not be administered concurrently with fixed dose combination tablets containing tenofovir disoproxil fumarate, tenofovir alafenamide or adefovir dipivoxil .

PBS listing

Information regarding PBS listing is not available in the provided source documents.

Regulatory history

VIREAD was first listed on the ARTG on 2002-08-13 .