TALTZ (ixekizumab) injection, for subcutaneous use 


Mechanism of Action

Ixekizumab is a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody (mAb) that selectively binds with the interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Ixekizumab inhibits the release of proinflammatory cytokines and chemokines.

Pharmacodynamics (PD)

No formal pharmacodynamic studies have been conducted.

Pharmacokinetics (PK)

Ixekizumab exhibited dose-proportional pharmacokinetics in subjects with plaque psoriasis over a dose range from 5 mg to 160 mg following subcutaneous administration.

 Iixekizumab bioavailability ranged from 60% to 81% following subcutaneous injection in subjects with plaque psoriasis. Administration of ixekizumab via injection in the thigh achieved a higher bioavailability relative to that achieved using other injection sites including the arm and abdomen.

 Mean systemic clearance was 0.39 L/day and the mean half-life was 13 days in subjects with plaque psoriasis.

 Mean volume of distribution at steady-state was 7.11 L  in subjects with plaque psoriasis. Clearance and volume of distribution increase as body weight increases.

PK-PD Analysis

Not reported

Population PK

Age did not significantly influence the clearance of ixekizumab in adult subjects with plaque psoriasis. 

Special Populations

No formal trial of the effect of hepatic or renal impairment on the pharmacokinetics of ixekizumab was conducted..

Drug Interactions

Drug interaction studies have not been conducted with TALTZ.

Source : http://pi.lilly.com/us/taltz-uspi.pdf

 

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s