VEMLIDY DOSING INFORMATION

A 25-MG ONCE-DAILY ORAL TABLET, TAKEN WITH FOOD1

VEMLIDY® (tenofovir alafenamide) tablet, 25-mg. See Full Prescribing & Safety Info, including BOXED WARNING.
VEMLIDY® Diameter: 7.9 mm
(Pill image shown is not actual size.)

No dosage adjustment in patients with1:

  • Mild, moderate, or severe renal impairment (estimated CrCl ≥15 mL/min)
  • End stage renal disease (ESRD; eCrCl <15 mL/min) who are receiving chronic hemodialysis
    • On days of hemodialysis, administer VEMLIDY after completion of hemodialysis treatment
  • Mild hepatic impairment (Child-Pugh A)

VEMLIDY is not recommended in patients with ESRD who are not receiving chronic hemodialysis or in patients with decompensated (Child-Pugh B or C) hepatic impairment.1


DOSE ADJUSTMENT IN ADULT CHRONIC HEPATITIS B PATIENTS WITH RENAL IMPAIRMENT (WITH PREFERRED/FIRST-LINE ORAL ANTIVIRAL THERAPIES)1-4

eCrCl ≥50
mL/min
eCrCl 30-49
mL/min
eCrCl 10-29
mL/min*
ESRD on chronic
hemodialysis
VEMLIDY 25 mg No dose adjustment required
Tenofovir disoproxil
fumarate 300 mga,b
None Every 48 hours Every 72 to 96 hours Every 7 days or after a total of approximately 12 hours of dialysis
Entecavir 0.5 mga,b None 0.25 mg once daily or
0.5 mg every 48 hours
0.15 mg once daily or
0.5 mg every 72 hours
0.05 mg once daily or
0.5 mg every 7 days
Entecavir 1 mg (lamivudine-refractory or decompensated liver disease)a,b None 0.5 mg once daily or
1 mg every 48 hours
0.3 mg once daily or
1 mg every 72 hours
0.1 mg once daily or
1 mg every 7 days

*VEMLIDY is not recommended in patients with ESRD (eCrCl >15 mL/min) who are not receiving chronic hemodialysis.

aGeneric tenofovir disoproxil fumarate and generic entecavir are therapeutically equivalent to the respective brand name drug. These generic drug products are designated Therapeutic Equivalence Code AB, which the FDA considers therapeutically equivalent to other pharmaceutically equivalent products. Please refer to the appropriate manufacturers of generic tenofovir disoproxil fumarate and generic entecavir for the full Prescribing Information.

bAvailable in tablet or powder formulation for tenofovir disoproxil fumarate, or tablet or solution formulation for entecavir. Dosage shown is for adult patients with renal impairment.

This chart does not include the complete prescribing and dosing considerations for using these medications. Please refer to the full Prescribing Information for each medication. Comparison of agents does not imply comparable clinical effectiveness, safety, or tolerability. Individual prescribing decisions should be made at the discretion of the provider.

“All NAs except TAF require dose adjustment in persons with creatinine clearance <50 mL/min.”

– AASLD 2018 Hepatitis B Guidance5

AASLD=American Association for the Study of Liver Diseases; eCrCl=estimated creatinine clearance; ESRD=end stage renal disease; HBV=hepatitis B virus; HIV=human immunodeficiency virus; NA=nucleos(t)ide analogue; TAF=tenofovir alafenamide; TDF=tenofovir disoproxil fumarate.

WUHUA JING, MD, PhD

Attending Physician
New York–Presbyterian Lower Manhattan Hospital
Researcher, Chronic hepatitis B in the Asian-American community

Review information on VEMLIDY dosing and administration, presented by Dr. Jing.

Review information on VEMLIDY dosing and administration in this presentation by Wuhua Jing, MD, PhD. Dr. Jing is an attending physician at New York–Presbyterian Lower Manhattan Hospital and has conducted research on chronic hepatitis B in the Asian-American community.

Watch a video on the pivotal clinical trial results.
  1. VEMLIDY Prescribing Information, Foster City, CA: Gilead Sciences, Inc.; February 2019.

Dosage and Administration

  • Testing prior to initiation: HIV infection.
  • Prior to or When Initiating, and During Treatment: On a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus.
  • Dosage in Adults: 1 tablet taken once daily with food.
  • Renal Impairment: Not recommended in patients with end stage renal disease (ESRD; eCrCl >15 mL/min) who are not receiving chronic hemodialysis; in patients on chronic hemodialysis, on hemodialysis days, administer VEMLIDY after completion of hemodialysis treatment.
  • Hepatic Impairment: Not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: POST TREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B

  • Discontinuation of anti-hepatitis B therapy, including VEMLIDY, may result in severe acute exacerbations of hepatitis B. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including VEMLIDY. If appropriate, resumption of anti-hepatitis B therapy may be warranted.

Warnings and Precautions

  • Risk of Development of HIV-1 Resistance in HBV/HIV-1 Coinfected Patients: Due to this risk, VEMLIDY alone should not be used for the treatment of HIV-1 infection. Safety and efficacy of VEMLIDY have not been established in HBV/HIV-1 coinfected patients. HIV antibody testing should be offered to all HBV-infected patients before initiating therapy with VEMLIDY, and, if positive, an appropriate antiretroviral combination regimen that is recommended for HBV/HIV-1 coinfected patients should be used.
  • New Onset or Worsening Renal Impairment: Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir prodrugs. In clinical trials of VEMLIDY, there have been no cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue VEMLIDY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Monitor renal function in all patients – See Dosage and Administration.
  • Lactic Acidosis and Severe Hepatomegaly with Steatosis: Fatal cases have been reported with the use of nucleoside analogs, including tenofovir DF. Discontinue VEMLIDY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.

Adverse Reactions

Most common adverse reactions (incidence ≥5%; all grades) were headache, abdominal pain, cough, back pain, fatigue, nausea, arthralgia, diarrhea, and dyspepsia.

Drug Interactions

  • Coadministration of VEMLIDY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of tenofovir and the risk of adverse reactions.
  • Coadministration of VEMLIDY is not recommended with the following: oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, or St. John’s wort. Such coadministration is expected to decrease the concentration of tenofovir alafenamide, reducing the therapeutic effect of VEMLIDY. Drugs that strongly affect P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) activity may lead to changes in VEMLIDY absorption.

Consult the full prescribing information for VEMLIDY for more information on potentially significant drug interactions, including clinical comments.

Dosage and Administration

  • Testing Prior to Initiation: HIV infection.
  • Prior to or when initiating, and during treatment: On a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus.
  • Dosage in Adults: 1 tablet taken once daily with food.
  • Renal Impairment: Not recommended in patients with end stage renal disease (ESRD; eCrCl <15 mL/min) who are not receiving chronic hemodialysis; in patients on chronic hemodialysis, on hemodialysis days, administer VEMLIDY after completion of hemodialysis treatment.
  • Hepatic Impairment: Not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment.

INDICATION

VEMLIDY is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease.

Please click here to see full Prescribing Information for VEMLIDY, including BOXED WARNING.