NUCALA Clinical Pharmacology Card
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