TB) infection prior to initiating treatment with Taltz. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering Taltz. Patients receiving Taltz should be monitored closely for signs and symptoms of active TB during and after treatment.
Hypersensitivity
Serious hypersensitivity reactions, including angioedema and urticaria (each <</span> 0.1%), occurred in the Taltz group in clinical trials. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.
Inflammatory Bowel Disease
Crohn's disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group (Crohn's disease 0.1%, ulcerative colitis 0.2%) than in the placebo group (0%) during clinical trials. During Taltz treatment, monitor patients for onset or exacerbations of inflammatory bowel disease.
Immunizations
Prior to initiating therapy with Taltz, consider completion of all age appropriate immunizations according to current immunization guidelines. Live vaccines should not be given with Taltz.
ADVERSE REACTIONS
Most common adverse reactions (>1%) associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections.
See accompanying Prescribing Information and Medication Guide. See Instructions for Use included with the device.
IX HCP ISI 22MAR2016
About Taltz®
Taltz® (ixekizumab) is a humanized IgG4 monoclonal antibody that selectively binds with 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. Taltz inhibits the release of pro-inflammatory cytokines and chemokines.
About the UNCOVER Studies
The UNCOVER-1, UNCOVER-2 and UNCOVER-3 studies are double-blind, multicenter, Phase 3 studies eva luating more than 3,800 patients with moderate-to-severe plaque psoriasis from 21 countries. All three studies eva luated the safety and efficacy of different dosing regimens of Taltz (80 mg every two or four weeks, following a 160-mg starting dose) compared to placebo after 12 weeks. UNCOVER-2 and UNCOVER-3 included an additional comparator arm in which patients received U.S.-approved etanercept (50 mg twice a week) for 12 weeks. In UNCOVER-1 and UNCOVER-2, safety and efficacy of Taltz was further eva luated through 60 weeks.
About Moderate-to-Severe Plaque Psoriasis
Psoriasis is a chronic, immune disease that affects the skin.3 It occurs when the immune system sends out faulty signals that speed up the growth cycle of skin cells.3 It is the most common inflammatory disease in the United States, affecting as many as 7.5 million Americans and an estimated 125 million people worldwide.3 The most common form of psoriasis, plaque psoriasis, appears as raised, red patches covered with a silvery white buildup of dead skin cells.3 Approximately 20 percent of people with psoriasis have moderate-to-severe plaque psoriasis.
New Drugs Online Report for ixekizumab
Information
Generic Name: ixekizumab
Trade Name: Taltz
Synonym: LY2439821
Entry Type: Licence extension / variation
Development and Regulatory status
UK: Unknown
EU: Unknown
US: Unknown
UK launch Plans: Available only to registered users
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