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/
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.
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/
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.
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
.png)
No hay comentarios:
Publicar un comentario