pharmacopeia
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Boxed warning

POSTTREATMENT 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 [see Warnings and Precautions (5.1) ] . WARNING: POSTTREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B See full prescribing information for complete boxed warning. Discontinuation of anti-hepatitis B therapy may result in severe acute exacerbations of hepatitis B. Hepatic function should be monitored closely in patients who discontinue VEMLIDY. If appropriate, resumption of anti-hepatitis B therapy may be warranted. ( 5.1 )

Mechanism of action

Sourced from openFDA

Tenofovir alafenamide is an antiviral drug against the hepatitis B virus [see Microbiology (12.4) ] .

Nucleoside Reverse Transcriptase

Indications

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  • VEMLIDY is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults and pediatric patients 6 years of age and older and weighing at least 25 kg with compensated liver disease [see Clinical Studies (14) ] . VEMLIDY is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor and is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 6 years of age and older and weighing at least 25 kg with compensated liver disease.ICD-10: B18.1

Contraindications

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  • None. None.contraindicated

Dosage & administration

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Testing: Prior to initiation of VEMLIDY, test patients for HIV infection. VEMLIDY alone should not be used in patients with HIV infection. Prior to or when initiating VEMLIDY, and during treatment on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. Also assess serum phosphorus in patients with chronic kidney disease. ( 2.1 ) Recommended dosage: 25 mg (one tablet) taken orally once daily with food. ( 2.2 ) Renal Impairment: VEMLIDY is not recommended in patients with estimated creatinine clearance below 15 mL per minute who are not receiving chronic hemodialysis. In patients on chronic hemodialysis, on hemodialysis days, administer VEMLIDY after hemodialysis. ( 2.3 ) Hepatic Impairment: VEMLIDY is not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment. ( 2.4 ) 2.1 Testing Prior to Initiation of VEMLIDY Prior to initiation of VEMLIDY, patients should be tested for HIV-1 infection. VEMLIDY alone should not be used in patients with HIV-1 infection [see Warnings and Precautions (5.2) ] . Prior to or when initiating VEMLIDY, and during treatment with VEMLIDY 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 [see Warnings and Precautions (5.3) ].

Warnings & precautions

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HBV and HIV-1 coinfection: VEMLIDY alone is not recommended for the treatment of HIV-1 infection. HIV-1 resistance may develop in these patients. ( 5.2 ) New onset or worsening renal impairment: Prior to or when initiating VEMLIDY, and during treatment on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. Also assess serum phosphorus in patients with chronic kidney disease. ( 5.3 ) Lactic acidosis/severe hepatomegaly with steatosis: Discontinue treatment in patients who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity. ( 5.4 ) 5.1 Severe Acute Exacerbation of Hepatitis B after Discontinuation of Treatment Discontinuation of anti-hepatitis B therapy, including VEMLIDY, may result in severe acute exacerbations of hepatitis B. Patients who discontinue VEMLIDY should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment. If appropriate, resumption of anti-hepatitis B therapy may be warranted. 5.2 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, VEMLIDY alone is not recommended for the treatment of HIV-1 infection. The safety and efficacy of VEMLIDY have not been established in patients coinfected with HBV and HIV-1.

Adverse reactions

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The following adverse reactions are discussed in other sections of the labeling: Severe Acute Exacerbation of Hepatitis B [see Warnings and Precautions (5.1) ] New Onset or Worsening of Renal Impairment [see Warnings and Precautions (5.3) ] Lactic Acidosis/Severe Hepatomegaly with Steatosis [see Warnings and Precautions (5.4) ] Most common adverse reaction (incidence greater than or equal to 10%, all grades) is headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adult Subjects with Chronic Hepatitis B and Compensated Liver Disease The safety assessment of VEMLIDY was based on pooled data through the Week 96 data analysis from 1298 subjects in two randomized, double-blind, active-controlled trials, Trial 108 and Trial 110, in adult subjects with chronic hepatitis B and compensated liver disease. A total of 866 subjects received VEMLIDY 25 mg once daily [see Clinical Studies (14.2) ] .

Use in specific populations

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8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VEMLIDY during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no statistically significant difference in the overall risk of birth defects for tenofovir alafenamide (TAF) compared with the background rate for major birth defects of 2.7% in the U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP) (see Data ). The rate of miscarriage is not reported in the APR. The estimated background rate of miscarriage in clinically recognized pregnancies in the U.S. general population is 15% to 20%. In animal studies, no adverse developmental effects were observed when tenofovir alafenamide was administered during the period of organogenesis at exposure equal to or 51 times (rats and rabbits, respectively) the tenofovir alafenamide exposure at the recommended daily dose of VEMLIDY (see Data ). No adverse effects were observed in the offspring when TDF was administered through lactation at tenofovir exposures of approximately 12 times the exposure at the recommended daily dosage of VEMLIDY.

Pharmacokinetics

Sourced from openFDA
Metabolism
The pharmacokinetic properties of VEMLIDY are provided in Table 5. The multiple dose PK parameters of tenofovir alafenamide and its metabolite tenofovir are provided in Table 6.

Overdosage

Sourced from openFDA

If overdose occurs, monitor patient for evidence of toxicity. Treatment of overdosage with VEMLIDY consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient. Tenofovir is efficiently removed by hemodialysis with an extraction coefficient of approximately 54%.

Approval history

Sourced from openFDA
  • Nov 5, 2015NDANDA207561Gilead Sciences Inc
  • Mar 1, 2016NDANDA208351Gilead Sciences Inc
  • Apr 4, 2016NDANDA208215Gilead Sciences Inc
  • Nov 10, 2016NDANDA208464Gilead Sciences Inc
  • Feb 7, 2018NDANDA210251Gilead Sciences Inc
  • Jul 17, 2018NDANDA210455Janssen Prods

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
41,643 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Bone Density Decreased13,75233%
  2. 2Chronic Kidney Disease7,86319%
  3. 3Bone Loss7,25517%
  4. 4Osteonecrosis7,12417%
  5. 5Tooth Loss6,89217%
  6. 6Multiple Fractures6,59216%
  7. 7Renal Failure6,32515%
  8. 8Osteoporosis6,03514%
  9. 9Pain5,69814%
  10. 10Renal Injury5,40113%
  11. 11Emotional Distress5,39813%
  12. 12Anxiety5,04512%
  13. 13Anhedonia4,73311%
  14. 14Skeletal Injury4,65911%
  15. 15Osteopenia3,9519.5%

Clinical trials

View JSON

The 10 most recently updated of 379 ClinicalTrials.gov registrations naming Tenofovir Alafenamide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Tenofovir Alafenamide work?
Tenofovir alafenamide is an antiviral drug against the hepatitis B virus [see Microbiology (12.4) ] .
What is Tenofovir Alafenamide used for?
According to FDA labeling, Tenofovir Alafenamide carries indications including: VEMLIDY is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults and pediatric patients 6 years of age and older and weighing at least 25 kg with compensated liver disease [see Clinical Studies (14) ] . VEMLIDY is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor and is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 6 years of age and older and weighing at least 25 kg with compensated liver disease.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Tenofovir Alafenamide?
Tenofovir Alafenamide is classified as Nucleoside and nucleotide reverse transcriptase inhibitors, Nucleoside Reverse Transcriptase Inhibitors, Decreased Reverse Transcription to DNA.
What are the brand names for Tenofovir Alafenamide?
Tenofovir Alafenamide is marketed under brand names including Biktarvy, Descovy, Genvoya, Odefsey, Symtuza, Vemlidy.
What are the contraindications for Tenofovir Alafenamide?
Tenofovir Alafenamide labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.
Note. Data for tenofovir-alafenamide is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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