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FDA Hepatitis Updates provide information about FDA Hepatitis product approval, safety warnings, medical product labeling changes, notices of upcoming meetings, and notices about proposed regulatory guidances.


February 6, 2019
FDA recently approved changes to the VEMILIDY product labeling to include information regarding the use in adult patients with creatine clearance below 15 mL per minute (end-stage-renal disease) who are receiving chronic hemodialysis. Additionally, a Postmarketing Experience subsection was added to the ADVERSE REACTIONS section. The specific changes are summarized below.
 
2.3 Dosage in Patients with Renal Impairment

No dosage adjustment of VEMLIDY is required in patients with estimated creatinine clearance greater than or equal to 15 mL per minute, or in patients with end stage renal disease (ESRD; estimated creatinine clearance below 15 mL per minute) who are receiving chronic hemodialysis. On days of hemodialysis, administer VEMLIDY after completion of hemodialysis treatment.

VEMLIDY is not recommended in patients with ESRD who are not receiving chronic hemodialysis.

6             ADVERSE REACTIONS

6.2         Postmarketing Experience

The following events have been identified during post approval use of VEMLIDY. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Skin and Subcutaneous Tissue Disorders

Angioedema, urticaria

8             USE IN SPECIFIC POPULATIONS

8.6         Renal Impairment

No dosage adjustment of VEMLIDY is required in patients with mild, moderate, or severe renal impairment, or in patients with ESRD (estimated creatinine clearance below 15 mL per minute) who are receiving chronic hemodialysis. On days of hemodialysis, administer VEMLIDY after completion of hemodialysis treatment.

The pharmacokinetics and safety of tenofovir alafenamide were studied in HIV-1 infected adults with ESRD (estimated creatinine clearance below 15 mL per minute by Cockcroft-Gault method) receiving chronic hemodialysis in an open-label trial of 55 subjects who received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide 150/150/200/10 mg. Tenofovir alafenamide 10 mg, given in this combination, achieves similar exposures as tenofovir alafenamide 25 mg alone. The safety profile of subjects in this trial was consistent with that expected in patients with ESRD on chronic hemodialysis and HIV-1 infection.

VEMLIDY is not recommended in patients with ESRD (estimated creatinine clearance below 15 mL per minute by Cockcroft-Gault method) who are not receiving chronic hemodialysis as the safety of VEMLIDY has not been established in this population.
 

The updated label will soon be available at drugs@fda or DailyMed
 
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration

Elizabeth Thompson
Division of Antiviral Products
Food and Drug Administration

Michael Stanfield Jr.
Division of Antiviral Products
Food and Drug Administration
 
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