Nexataf 25 mg (Tablet)

Indications

• Treatment of chronic hepatitis B virus infection in adults with compensated liver disease

Pharmacology

• Tenofovir alafenamide is a phosphonamidate prodrug of tenofovir

Dosage & Administration

• Recommended dosage is 25 mg once daily with food

Testing Prior to Initiation of Tenofovir alafenamide

• Patients should be tested for HIV-1 infection

Dosage in Patients with Renal Impairment

• No dosage adjustment is required in patients with estimated creatinine clearance greater than or equal to 15 ml per minute

Dosage in Patients with Hepatic Impairment

• No dosage adjustment is required in patients with mild hepatic impairment (Child-Pugh A)

Pediatric Use

• Safety and effectiveness in pediatric patients less than 18 years of age have not been established

Geriatric Use

• No clinically significant differences in safety or efficacy observed between elderly subjects and adult subjects

Interaction

• Nexataf is a substrate of P-glycoprotein (P-gp) and BCRP

Drugs Affecting Renal Function

• Coadministration with drugs that reduce renal function may increase concentrations of tenofovir

Side Effects

• Headache
• Stomach pain
• Tiredness
• Cough
• Nausea
• Back pain

Pregnancy

• Prevalence of birth defects in live births was 4.2% and 3.0% following first and second/third trimester exposure to TAF-containing regimens

Lactation

• Effects on the breastfed infant should be considered along with the mother’s clinical need

Severe Acute Exacerbation of Hepatitis B after Discontinuation of Treatment

• Discontinuation may result in severe acute exacerbations of hepatitis B

Risk of Development of HIV-1 Resistance in Patients Coinfected with HBV and HIV-1

• Due to the risk of development of HIV-1 resistance, Nexataf alone is not recommended for the treatment of HIV-1 infection

New Onset or Worsening Renal Impairment

• Postmarketing cases of renal impairment have been reported with TAF-containing products

Lactic Acidosis/Severe Hepatomegaly with Steatosis

• Lactic acidosis and severe hepatomegaly with steatosis including fatal cases have been reported with the use of nucleoside analogs

Overdose Effects

• Treatment of overdosage consists of general supportive measures

Therapeutic Class

• Hepatic viral infections (Hepatitis B)

Storage Conditions

• Store below 30°C
• Protect from light
• Keep out of children’s reach

Related Brands

• Alfavir 25 mg (Tablet) - incepta-pharmaceuticals-ltd