NUCALA® (Mepolizumab) for subcutaneous (SC) injection for Severe Asthma Aged 12 Years and Older

 

Mechanism of Action Interleukin-5 (IL-5) antagonist monoclonal antibody (IgG1 kappa), responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils
Pharmacodynamics (PD) Blood eosinophils decreased in a dose-dependent manner for doses 12.5 mg SC, 125 mg SC, 250 mg SC
Pharmacokinetics (PK) Exhibited approximately dose-proportional pharmacokinetics over a dose range of 12.5 to 250 mg. in subjects with asthma

 Accumulation approximately 2-fold at steady state

 Approximately 80% is absorbed following SC administration in the arm

 Central volume of distribution of mepolizumab in patients with asthma is estimated to be 3.6 L for a 70-kg individual

 Mean terminal half-life ranged from 16 to 22 days

Proteolytic enzymatic degradation that is widely distributed in the body

PK-PD Analysis Have not been reported
Population PK There was no significant effect of race and gender on mepolizumab clearance

There was no significant effect of age on mepolizumab clearance, ranging in age from 12 to 82 years

Special Populations No clinical trials have been conducted to investigate the effect of renal impairment or hepatic impairment on the pharmacokinetics of mepolizumab
Drug Interactions No formal drug interaction studies have been conducted

Source : http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125526Orig1s000Lbl.pdf

 

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