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Siliq
brodalumab
Black Box Warnings .
Appropriate Use
restricted distribution program (Siliq REMS) due to risk of suicidality; prescribers, pharmacies must be certified and patients must sign a patient-prescriber agreement form; 1-855-511-6135 or www.siliqems.com for more information
Suicidality
incr. risk of suicidality in patients with history of depression and/or suicidal ideation; weigh risk vs. benefit; advise patients and caregivers to seek medical attention for suicidality, new onset or worsening depression, anxiety, or other mood changes
Adult Dosing .
Dosage forms: INJ (pre-filled syringe): 210 mg per 1.5 mL
Restricted Distribution in US
- [1-855-511-6135 or www.siliqrems.com for more information]
psoriasis, moderate-severe plaque
- [210 mg SC q2wk]
- Start: 210 mg SC x1 on wk 0, 1, 2, then q2wk; Info: consider D/C if inadequate response after 12-16 wk
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- Crohn disease
- Crohn disease history
- infection, active
- TB infection, active
- caution: infection, chronic
- caution: infection, recurrent
- caution: infection risk
- caution: TB infection, latent
- caution: TB infection risk
- caution: depression
- caution: depression history
- caution: suicidality history
Drug Interactions .
Overview
brodalumab
IL-17 antagonist
- immunomodulatory effects
- caution advised with narrow therapeutic index drugs; chronic inflammatory conditions may alter metabolic enzyme formation; tx with immune modulators may reverse this effect, resulting in altered levels of concomitant drugs
Contraindicated
Avoid/Use Alternative
Monitor/Modify Tx
Caution Advised
Adverse Reactions .
Serious Reactions
- hypersensitivity reaction
- anaphylaxis
- shock
- eczematous eruption, severe
- suicidality
- infection, serious
- Crohn disease exacerbation
- neutropenia
Common Reactions
- infection
- arthralgia
- headache
- fatigue
- diarrhea
- oropharyngeal pain
Safety/Monitoring .
Monitoring Parameters
TB test at baseline, then active TB signs/symptoms during and after tx D/C
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; no known risk of embryo-fetal toxicity based on animal data at up to 26x MRHD
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for brodalumab: unknown; CYP450: unknown
Excretion: for brodalumab: unknown; Half-life: unknown
Subclass: Interleukin-17 (IL-17) Antagonists ; Psoriasis, Systemic Agents
Mechanism of Action
for brodalumab: selectively binds to IL-17RA and inhibits IL-17 cytokine-induced responses including release of pro-inflammatory cytokines and chemokines (monoclonal antibody)
Formulary .
No Formulary Selected
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