Overview
11 DESCRIPTION Ixekizumab is a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody (mAb) with neutralizing activity against IL-17A. Ixekizumab is produced by recombinant DNA technology in a recombinant mammalian cell line and purified using standard technology for bioprocessing.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Ixekizumab is a humanized IgG4 monoclonal antibody 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. 12.2 Pharmacodynamics No formal pharmacodynamic studies have been conducted with TALTZ. 12.3 Pharmacokinetics The pharmacokinetic (PK) properties of ixekizumab were similar across the adult plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis indications.
Indications
- 1 INDICATIONS AND USAGE TALTZ ® is a humanized interleukin-17A antagonist indicated for the treatment of: patients aged 6 years or older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. ( 1.1 ) adults with active psoriatic arthritis. ( 1.2 ) adults with active ankylosing spondylitis. ( 1.3 ) adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation. ( 1.4 ) 1.
Common Doses
- 160 mg
- 80 mg
- 40 mg
- 20 mg
Dosage
2 DOSAGE AND ADMINISTRATION Administer by subcutaneous injection. Adult Plaque Psoriasis ( 2.2 ) Recommended dosage is 160 mg (two 80 mg injections) at Week 0, followed by 80 mg at Weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks. Pediatric Plaque Psoriasis ( 2.3 ) For patients weighing greater than 50 kg, recommended dosage is 160 mg (two 80 mg injections) at Week 0, followed by 80 mg every 4 weeks. For patients weighing 25-50 kg, recommended dosage is 80 mg at Week 0, followed by 40 mg every 4 weeks.
Contraindications
- 4 CONTRAINDICATIONS TALTZ is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients [see Warnings and Precautions ( 5.3 )] . Serious hypersensitivity reaction to ixekizumab or to any of the excipients. ( 4 )
Side Effects
- 6 ADVERSE REACTIONS The following adverse drug reactions are discussed in greater detail in other sections of the label: Infections [see Warnings and Precautions ( 5.1 )] Hypersensitivity Reactions [see Contraindications ( 4 ) and Warnings and Precautions ( 5.3 )] Eczematous Eruptions [see Warnings and Precautions ( 5.4 )] Inflammatory Bowel Disease [see Warnings and Precautions ( 5.5 )] Most common (≥1%) adverse reactions associated with TALTZ treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections. ( 6.
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.