Taltz Ixekizumab Injection

1. Indications and Usage
Moderate to Severe Plaque Psoriasis:
Indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Psoriatic Arthritis:
Indicated for the treatment of adult patients with active psoriatic arthritis. It may be used alone or in combination with methotrexate or other DMARDs.
Ankylosing Spondylitis:
Indicated for the treatment of adult patients with active ankylosing spondylitis.
2. Dosage and Administration
Route of Administration:
Subcutaneous Injection ONLY.
Plaque Psoriasis Dosage:
Loading Dose: 160 mg (two 80 mg injections) at Week 0.
Induction: 80 mg at Weeks 2, 4, 6, 8, 10, and 12.
Maintenance: 80 mg every 4 weeks starting at Week 14.
Psoriatic Arthritis / Ankylosing Spondylitis Dosage:
Loading Dose: 160 mg at Week 0.
Maintenance: 80 mg every 4 weeks.
Preparation:
Allow the pre-filled syringe/pen to reach room temperature (approx. 30 minutes) before injection. Do not shake.
3. Mechanism of Action
IL-17A Inhibition:
Ixekizumab is a humanized IgG4 monoclonal antibody that selectively binds to interleukin-17A (IL-17A).
Physiological Effect:
It blocks the interaction of IL-17A with the IL-17 receptor, thereby inhibiting the release of pro-inflammatory cytokines and chemokines involved in the pathogenesis of psoriasis and spondyloarthritis.
4. Safety and Warnings
Infections:
May increase the risk of infections and predispose patients to invasive fungal infections (e.g., candidiasis). Evaluate for tuberculosis (TB) prior to initiation.
Inflammatory Bowel Disease (IBD):
Ixekizumab can cause new onset or exacerbation of Crohn’s disease and ulcerative colitis.
Hypersensitivity:
Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported. Discontinue if serious allergic reactions occur.
5. Adverse Reactions
Most Common:
Injection site reactions (erythema, pain, swelling), nasopharyngitis, upper respiratory tract infections, and oral candidiasis.
6. Drug Interactions
Live Vaccines:
Avoid the use of live vaccines during treatment.
CYP450 Substrates:
Chronic inflammation can alter CYP enzyme formation. As an IL-17A antagonist, Ixekizumab may normalize CYP enzyme formation. Monitor drugs with a narrow therapeutic index (e.g., cyclosporine, warfarin) upon initiation or discontinuation.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Ixekizumab.
Storage:
Store in a refrigerator at 2-8°C. Do not freeze or shake. Keep in the original carton to protect from light.