Tenofovir alafenamide

Dosing

25 mg PO q24h. Take with food.

Safety and efficacy in pediatric pts <18y of age have not been established

Mild, Child-Pugh ADecompensated, Child-Pugh B or CNo dose adjustmentNot recommended

CrCl ≥15End-stage renal disease (ESRD) CrCl <15 not receiving chronic HDNo dose adjustmentNot recommended

General Information

Type B viral hepatitis, chronic, with compensated liver disease.

Black Box Warning: Severe acute exacerbations of hepatitis may occur in patients who have discontinued anti-hepatitis B therapy, including tenofovir alafenamide. Closely monitor hepatic function in these patients for several months following discontinuation and resume anti-HBV therapy if warranted.

Test for HIV-1 prior to initiation.

Test for serum creatinine, estimated creatinine clearance, urine glucose, and urine protein prior to or when initiating treatment and periodically during therapy as clinically necessary.

Monitor hepatic function for at least several months after discontinuation.

Test serum phosphorus in patients with chronic kidney disease prior to or when initiating treatment and periodically during therapy as clinically necessary.

Decrease in HBV DNA levels, HBV surface antigen loss and seroconversion, HBV antigen loss and seroconversion, and normalization of ALT may indicate efficacy.

Common

  • Abdominal pain

  • Backache

  • Headache

  • Cough

  • Fatigue

Severe

  • Lactic acidosis

  • Pancreatitis

  • Hepatomegaly (with steatosis)

  • Acute renal failure

  • Renal impairment

  • Fanconi syndrome

Contraindications:

  • Carbamazepine

  • St. John's wort

  • Phenytoin

  • Phenobarbital

  • Rifampin

Major drug-drug interactions:

  • BCRP substrates

  • Capmatinib

  • Lasmiditan

  • Anticonvulsants

  • Tipranavir

  • Selected antimycobacterials

Antimicrobial class: Antiretroviral agent, Nucleotide reverse transcriptase inhibitor

Average serum half life: 0.51 hour

Precautions:

  • Increased risk of HIV-1 resistance with coinfection; HIV antibody testing should be performed prior to use.

  • Use not recommended in patients with end stage renal disease (CrCl <15 mL/min).

  • Renal impairment has been reported with tenofovir prodrugs with an increased risk in patients receiving nephrotoxic agents (e.g. NSAID therapy); monitoring recommnended and discontinuation required.

  • Use not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment.

  • Suspend treatment if lactic acidosis or hepatotoxicity are suspected.

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