TALTZ Clinical Pharmacology Card
TALTZ (ixekizumab) injection, for subcutaneous use
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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. |
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Pharmacodynamics (PD) |
No formal pharmacodynamic studies have been conducted. |
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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. |
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PK-PD Analysis |
Not reported |
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Population PK |
Age did not significantly influence the clearance of ixekizumab in adult subjects with plaque psoriasis. |
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Special Populations |
No formal trial of the effect of hepatic or renal impairment on the pharmacokinetics of ixekizumab was conducted.. |
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Drug Interactions |
Drug interaction studies have not been conducted with TALTZ. |
Source : http://pi.lilly.com/us/taltz-uspi.pdf