Veloxis announced that the Food and Drug Administration (FDA) has approved updates to the Envarsus XR (tacrolimus extended-release tablets) labeling regarding pharmacokinetics (PK) and pharmacogenomics (PG) data from the ASERTAA trial. 

The ASERTAA trial evaluated tacrolimus PK in African-American kidney transplant patients. This patient population typically has poorer outcomes vs. other ethnic groups due in part to their expression of the CYP3A5*1 genotype, which is present in about 80% of African-Americans. Patients with this genotype tend to metabolize tacrolimus much faster and require higher doses. 

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The study demonstrated that patients treated with Envarsus XR obtained therapeutic drug levels with a 30% lower peak concentration and 20% lower average dose vs. tacrolimus immediate-release despite genotype status. Also, patients with the CYP3A5*1 genotype taking tacrolimus immediate-release reached a peak concentration as high as 26ng/mL.

The approved labeling now includes ethnicity-specific dosing and genotyping guidance for Envarsus XR. The PK of Envarsus XR when converted from tacrolimus immediate-release shows that an 80% dose conversion factor is appropriate for African-American patients. 

Envarsus XR is indicated for the prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus immediate-release formulations, in combination with other immunosuppressants. It is available as 0.75mg, 1mg, and 4mg strength extended-release tablets.

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