Classes
DEA Class; Rx
Common Brand Names; Siliq
- Antipsoriatics, Systemic;
- Interleukin Inhibitors;
- Monoclonal Antibodies
Description
Injectable human IgG2 monoclonal antibody that binds to the interleukin-17 receptor A (IL-17RA), preventing IL-17 cytokines from activating the receptor
For adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy and who have not responded to other treatments
Suicidal ideation and behavior, including completed suicides, have occurred; patients with a history of suicidality or depression have an increased risk; drug carries a boxed warning regarding this risk; prescribers and patients must register in the SILIQ REMS Program
Indications
Indicated for the treatment of moderate to severe plaque psoriasis in patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies.
Indicated for moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies
Contraindications
Crohn disease
Adverse Effects
- Headache (3.5%)
- Arthralgia (3.3%)
- Fungal infections (2.4%)
- Injection site reaction (1.3%)
- Fatigue (1.1%)
- Diarrhea (1.1%)
- Oropharyngeal pain (1.1%)
- Nausea (1.1%)
- Serious infections (0.5%)
- Influenza (0.5%)
- Neutropenia (0.5%)
- Tinea infections (0.2%)
- Conjunctivitis
- Candida infections
Warnings
Suicidal ideation and behavior, including 4 completed suicides, occurred in subjects treated in the psoriasis clinical trials; there were no completed suicides in the 12-week placebo-controlled portion of the trials; brodalumab users with a history of suicidality or depression had an increased incidence of suicidal ideation and behavior as compared with users without such a history (see Black Box Warnings)
Available only through a restricted access program (see Black Box Warnings)
May increase risk of infections; in patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing; if a patient develops a serious infection or is not responding to standard therapy for the infection, monitor the patient closely and discontinue the drug until the infection resolves
Evaluate patients for TB before initiating; do not administer to patients with active TB; initiate treatment for latent TB prior to administering brodalumab; closely monitor patients for signs and symptoms of active TB during and after treatment
In psoriasis trials, which excluded subjects with active Crohn disease, Crohn disease occurred in 1 subject during treatment and led to brodalumab discontinuation; in other trials, exacerbation of Crohn disease was observed with brodalumab (see Contraindications)
Pregnancy and Lactation
There are no human data regarding use in pregnant women to inform a drug-associated risk
Unknown if distributed in human breast milk
Maximum Dosage
210 mg/dose subcutaneously; maintenance therapy every 2 weeks.
210 mg/dose subcutaneously; maintenance therapy every 2 weeks.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Brodalumab
solution for SC injection
- 210mg/1.5mL (single-dose prefilled syringe)
