Classes
DEA Class; Rx
Common Brand Names; Taltz
- Interleukin Inhibitors
Description
Subcutaneous humanized IgG4 monoclonal antibody that selectively targets interleukin-17A (IL-17A)
Used to treat moderate to severe plaque psoriasis in patients 6 years and older, used in adults for psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis
As with other interleukin inhibitors, may increase risk of infection
Indications
Indicated for the treatment of moderate to severe plaque psoriasis in patients who are candidates for systemic therapy or phototherapy.
Indicated for moderate-to-severe plaque psoriasis
Indicated for active psoriatic arthritis
Indicated for active ankylosing spondylitis
Indicated for active non-radiographic axial spondyloarthritis with objective signs of inflammation
Contraindications
Hypersensitivity reaction (eg, anaphylaxis) to drug or excipients
Adverse Effects
- Injection site reactions (17%)
- Upper respiratory tract infections (14%)
- Thrombocytopenia, Grade 1 (3%)
- Nausea (2%)
- Tinea infections (2%)
- Serious hypersensitivity reactions
- Serious infections
- Neutropenia
- Rhinitis
- Oral candidiasis
- Urticaria
- Influenza
- Conjunctivitis
- Inflammatory bowel disease
- Angioedema
Warnings
Serious hypersensitivity reactions reported, including angioedema and urticaria; anaphylaxis reported, some requiring hospitalization; if a serious hypersensitivity reaction occurs, discontinue drug immediately and initiate appropriate therapy
Patients receiving treatment may be at increased risk of inflammatory bowel disease; in clinical trials, Crohn’s disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in treated group than placebo control group; during treatment, monitor for onset or exacerbation of inflammatory bowel disease and if IBD occurs, discontinue therapy and initiate appropriate medical management
Pregnancy and Lactation
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to this medication during pregnancy
There are no available data on presence of this drug in human milk, effects on breastfed infant, or on milk production
Maximum Dosage
160 mg/dose subcutaneously initially, then 80 mg/dose subcutaneously for maintenance therapy for psoriasis, psoriatic arthritis, and ankylosing spondyloarthritis; for non-radiographic axial spondyloarthritis 80 mg/dose subcutaneously.
160 mg/dose subcutaneously initially, then 80 mg/dose subcutaneously for maintenance therapy for psoriasis, psoriatic arthritis, and ankylosing spondyloarthritis; for non-radiographic axial spondyloarthritis 80 mg/dose subcutaneously.
more than 50 kg: 160 mg/dose subcutaneously initially, then 80 mg/dose subcutaneously for maintenance therapy of plaque psoriasis; safety and efficacy have not been established for psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis.
25 to 50 kg: 80 mg/dose subcutaneously initially, then 40 mg/dose subcutaneously for maintenance therapy of plaque psoriasis; safety and efficacy have not been established for psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis.
less than 25 kg: 40 mg/dose subcutaneously initially, then 20 mg/dose subcutaneously for maintenance therapy of plaque psoriasis; safety and efficacy have not been established for psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis.
6 years or older and more than 50 kg: 160 mg/dose subcutaneously initially, then 80 mg/dose subcutaneously for maintenance therapy of plaque psoriasis; safety and efficacy have not been established for psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis.
6 years or older and 25 to 50 kg: 80 mg/dose subcutaneously initially, then 40 mg/dose subcutaneously for maintenance therapy of plaque psoriasis; safety and efficacy have not been established for psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis.
6 years or older and less than 25 kg: 40 mg/dose subcutaneously initially, then 20 mg/dose subcutaneously for maintenance therapy of plaque psoriasis; safety and efficacy have not been established for psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis.
1 to 5 years: Safety and efficacy have not been established.
Not indicated.
Not indicated.
How supplied
Ixekizumab
prefilled autoinjector, single-dose
- 80mg/mL
prefilled syringe, single-dose
- 80mg/mL
