Brodalumab Injection
Brodalumab injection (Siliq) is a biologic medication used to treat moderate to severe plaque psoriasis in adults when other systemic treatments have not worked.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Siliq (brodalumab), on the market since about 2017, is a biologic injection reserved for adults with moderate to severe plaque psoriasis that other systemic treatments have not controlled; it blocks the IL-17 receptor A, cutting off inflammatory signals that build plaques. Most people tolerate it well, mainly noticing joint aches, headache, tiredness or injection site redness. Mood matters most, because Siliq carries a boxed warning for suicidal thoughts and behavior, including completed suicides, so seek help right away for new or worsening depression, anxiety or thoughts of self-harm. That risk is why only pharmacies in the restricted Siliq REMS program can dispense it.
Clinical pearls
- Expect a tuberculosis test before your first dose, and call about fever, cough or skin sores, since Siliq raises infection risk.
- Stomach pain, diarrhea or rectal bleeding needs attention, because Siliq can trigger or worsen Crohn’s disease.
- Skip live vaccines, such as the nasal spray flu vaccine, and tell any prescriber adding warfarin or cyclosporine that you use Siliq.
- Hives, swelling or trouble breathing after an injection means emergency care, since anaphylaxis (a severe allergic reaction) can happen.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Siliq carries a serious boxed warning about suicidal thoughts and behavior, including completed suicides, in patients treated with this medication. This is the FDA's highest level of warning. Cases of suicidal ideation — and deaths by suicide — occurred during clinical trials. Before starting Siliq, your prescriber will weigh the risks carefully, especially if you have a history of depression or suicidal thoughts. You and your caregivers should watch for new or worsening depression, anxiety, mood changes, or any thoughts of suicide, and seek immediate medical attention if these occur. Because of this risk, Siliq is only dispensed through a special restricted program called the Siliq REMS Program — not all pharmacies carry it.
Patient information guide A plain-language walkthrough of Brodalumab Injection, written from its FDA label.
What Brodalumab Injection is used for
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Brodalumab injection, sold as Siliq, is approved for one main use in adults:
- Siliq treats moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy and whose disease has failed to respond — or has stopped responding — to other systemic treatments.
How Brodalumab Injection works
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Brodalumab is a human monoclonal antibody — a highly targeted lab-made protein — that locks onto a cell-surface protein called IL-17RA. This receptor is the entry point for several inflammatory signaling molecules in the IL-17 family (including IL-17A, IL-17F, and IL-17C) that are found at elevated levels in psoriatic skin plaques. By blocking IL-17RA, brodalumab shuts down those inflammatory signals and reduces the release of the pro-inflammatory molecules that drive plaque formation.
Brodalumab Injection dosage
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Siliq is given as a subcutaneous injection (a shot just under the skin) using a prefilled syringe. It is injected at the beginning of treatment, then again one week and two weeks later, and then once every two weeks on an ongoing basis. Food does not affect this medication. If an adequate response is not achieved after 12 to 16 weeks, the prescriber may decide to stop treatment.
- Let the syringe warm to room temperature for about 30 minutes before injecting
- Each syringe is single-use only — never reuse
- Follow the Instructions for Use that come with the medication, and only self-inject after training from a healthcare professional
Dosing details from the FDA-approved label
From the Brodalumab Injection prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Plaque psoriasis (recommended SILIQ dose)
- 210 mg administered by subcutaneous injection at Weeks 0, 1, and 2 followed by 210 mg every 2 weeks
- If an adequate response has not been achieved after 12 to 16 weeks of treatment, consider discontinuing therapy; continued treatment beyond 16 weeks in patients without adequate response is not likely to result in greater success
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Administer 210 mg of SILIQ by subcutaneous injection at Weeks 0, 1, and 2 followed by 210 mg every 2 weeks. ( 2.2 ) 2.1 Tuberculosis Assessment Prior to Initiation of SILIQ Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with SILIQ [see Warnings and Precautions ( 5.4 )]. 2.2 Dosage The recommended SILIQ dose is 210 mg administered by subcutaneous injection at Weeks 0, 1, and 2 followed by 210 mg every 2 weeks. If an adequate response has not been achieved after 12 to 16 weeks of treatment with SILIQ, consider discontinuing therapy. Continued treatment beyond 16 weeks in patients who have not achieved an adequate response is not likely to result in greater success. 2.3 Important Administration Instructions Administer SILIQ subcutaneously. Each prefilled syringe is for single dose only. Instruct patients to review the Medication Guide before use [see Medication Guide] . SILIQ is intended for use under the guidance and supervision of a healthcare professional. Patients may self-inject SILIQ when deemed appropriate by a healthcare professional and after proper training in subcutaneous injection technique using the prefilled syringe. Advise patients who are self-administering to inject the full dose and to read the Instructions for Use before administration [see Instructions for Use] . Do not inject SILIQ into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis. 2.4 Preparation of SILIQ Prefilled Syringe • Allow SILIQ prefilled syringe to reach room temperature (approximately 30 minutes) before injecting. Do not warm in any other way. Do not remove the gray needle cap on the prefilled syringe while allowing it to reach room temperature. • Visually inspect SILIQ for particles and discoloration prior to administration. SILIQ is a clear to slightly opalescent, colorless to slightly yellow solution. Do not use SILIQ if it is cloudy or discolored or if foreign matter is present. • Instruct patients to use the prefilled syringe and to inject the full amount (1.5 mL), which provides 210 mg of SILIQ, according to the directions provided in the Instructions for Use [see Instructions for Use].
Read the full Dosage and Administration section on DailyMed →
Brodalumab Injection side effects
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The most common side effects reported in clinical trials include:
Common side effects
- Joint pain (arthralgia)
- Headache
- Fatigue
- Diarrhea
- Sore throat or throat pain
- Nausea
- Muscle pain (myalgia)
- Injection site reactions (pain, redness, bruising, or itching)
- Influenza (flu)
- Fungal skin infections (tinea)
When to get medical help
- Call your doctor right away or seek emergency help if you have thoughts of suicide, self-harm, worsening depression, anxiety, or mood changes
- Get medical help immediately for signs of a severe allergic reaction: hives, swelling, trouble breathing, or anaphylaxis
- Tell your doctor if you develop signs of infection: fever, chills, cough, skin sores, or pain with urination
- Contact your doctor if you develop stomach pain, diarrhea, or rectal bleeding — these could be signs of Crohn's disease
- Report any new or worsening skin rash or eczema-like eruption to your doctor
- Let your doctor know if you have low white blood cell counts (neutropenia) or any signs of unusual bleeding or infection
Brodalumab Injection warnings and precautions
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Suicidal thoughts and behavior (including completed suicides) are the most critical risk with Siliq. This risk led to a boxed warning — the FDA's most serious alert — and a restricted dispensing program (Siliq REMS). Patients with a history of depression or suicidal behavior are at higher risk. Everyone taking Siliq should be monitored for mood changes, new or worsening depression, anxiety, or self-harm thoughts. Seek help immediately if these occur.
- Serious infections: Siliq lowers your immune response. Rates of fungal infections and serious infections were higher in Siliq users than in placebo groups in trials. Tell your doctor about any signs of infection.
- Tuberculosis (TB): Screening for TB is required before starting Siliq. Active TB is a contraindication; latent TB must be treated first.
- Severe allergic reactions (anaphylaxis): Have been reported post-market. Stop Siliq and get emergency help immediately.
- Crohn's disease: Siliq is contraindicated in people who already have Crohn's disease, and can trigger it in others. Discontinue if Crohn's disease develops.
- Eczematous skin eruptions: Severe eczema-like reactions have been reported, sometimes requiring hospitalization. Onset can range from days to months after the first dose.
- Live vaccines: Must be avoided while taking Siliq.
Brodalumab Injection interactions
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Siliq can affect how the body processes certain other medications, primarily through the CYP450 enzyme system:
- CYP450 substrates (e.g., warfarin, cyclosporine): Siliq may alter how these drugs are metabolized. Drugs with a narrow therapeutic range — where too much or too little causes harm — may need closer monitoring or dose adjustments when starting or stopping Siliq.
- Live vaccines: Should not be given at the same time as Siliq. No data are available on immune response to live or inactive vaccines in people on Siliq.
Interactions listed in the FDA-approved label
From the Brodalumab Injection prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- CYP450 substrates: The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g., IL-1, IL-6, IL-10, TNFα, IFN) during chronic inflammation, and treatment with SILIQ may modulate serum levels of some cytokines. Upon initiation or discontinuation of SILIQ in patients receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for effect (e.g., for warfarin) or drug concentration (e.g., for cyclosporine) and consider dosage modification of the CYP450 substrate.
Read the label’s full interactions text
7 DRUG INTERACTIONS CYP450 Substrates The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g., IL-1, IL-6, IL-10, TNFα, IFN) during chronic inflammation. Treatment with SILIQ may modulate serum levels of some cytokines. Therefore, upon initiation or discontinuation of SILIQ in patients who are receiving concomitant drugs which are CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for effect (e.g., for warfarin) or drug concentration (e.g., for cyclosporine) and consider dosage modification of the CYP450 substrate [see Clinical Pharmacology ( 12.3 )].
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Brodalumab Injection
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- Crohn's disease: Siliq is contraindicated — do not use if you have this condition
- Allergy to brodalumab or Siliq ingredients: Contraindicated if you've had a serious reaction before
- History of depression or suicidal thoughts: Must be discussed with your prescriber before starting
- Active TB infection: Siliq cannot be started until TB is properly treated
- Chronic or recurring infections: Risks and benefits should be carefully weighed
- Pregnancy: No human safety data; brodalumab (as an IgG antibody) can cross the placenta. Discuss with your doctor.
- Breastfeeding: Brodalumab was detected in the milk of lactating monkeys; no human data exist. Weigh the benefits of breastfeeding against potential risk.
- Children: Safety and effectiveness in pediatric patients have not been established
- Older adults (65+): No meaningful difference in safety or efficacy was observed in clinical trials, though the number of older patients studied was small
- Liver or kidney disease: No dedicated studies have been conducted; discuss with your prescriber
What Brodalumab Injection does in the body
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Elevated levels of inflammatory signaling molecules — including IL-17A, IL-17C, and IL-17F — are found in psoriatic skin plaques. By blocking the IL-17RA receptor, brodalumab reduces the activity of these molecules. During treatment, serum IL-17A levels actually rise (measured at weeks 12, 24, and 48), likely because the drug blocks the receptor rather than clearing the molecule itself. The exact connection between these measurable changes and brodalumab's clinical effect on skin is not fully understood.
How your body processes Brodalumab Injection
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After a subcutaneous injection, brodalumab reaches peak blood levels in about 3 days, and with regular dosing every two weeks, steady-state concentrations are reached by week 4. The drug's bioavailability (the amount that reaches the bloodstream) is approximately 55% when injected under the skin. Like other IgG antibodies, brodalumab is broken down by the body into small peptides and amino acids through normal protein-degradation pathways — it is not processed by the liver's drug-metabolizing enzymes in the conventional sense. People with higher body weight tend to have lower trough (between-dose) drug levels, and age does not significantly affect how the body clears brodalumab.
How to store Brodalumab Injection
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• Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light and physical damage during storage. stored at room temperature up to a maximum of 77°F (25°C) in the original carton for a maximum single period of 14 days with protection from light an…
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Brodalumab Injection: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Brodalumab Injection — the kind of thing our pharmacy team would talk through with you at the counter.
Why do I have to go through a special program just to get this medication?
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What kind of side effects should I actually expect day-to-day?
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Is it normal for my doctor to check me for TB before I start?
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Can I get my regular vaccines while on Siliq?
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What should I watch for as far as my mood or mental health?
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How long before I see if this medication is working?
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Is Brodalumab Injection available over the counter?
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When was Brodalumab Injection first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Brodalumab Injection on HelloPharmacist
Brodalumab Injection forms and strengths (how it comes)
Brodalumab Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Brodalumab Injection inactive ingredients by manufacturer.
Injection
How this form is used
- Siliq is used to treat moderate to severe plaque psoriasis in adults who have not responded to or lost response to other systemic therapies
- Siliq is intended for adults who are candidates for systemic therapy or phototherapy
- Siliq is injected subcutaneously (under the skin); allow the prefilled syringe to reach room temperature for about 30 minutes before injecting — do not warm it any other way
- Siliq is given at weeks 0, 1, and 2, then once every two weeks; each prefilled syringe is for a single use only
- Siliq should not be injected into skin that is tender, bruised, red, hard, thick, scaly, or affected by psoriasis
- Siliq should be visually inspected before use — do not use if the solution is cloudy, discolored, or contains particles
Brodalumab Injection on the U.S. market: products, makers and brands
How Brodalumab Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 1 Brodalumab Injection product record with the FDA, mostly as injection; the earliest marketing or approval year on record is 2017. Brand names on the directory include Siliq; the rest are generics.
How widely Brodalumab Injection is used (Medicaid data)
A general measure of how commonly Brodalumab Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Brodalumab Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Brodalumab Injection prescribed? Of the 1,601 medications we measure, Brodalumab Injection ranks #1,431 by Medicaid prescriptions — more than 11% of them.
Utilization by Brodalumab Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
1.5 ML brodalumab 140 MG/ML Prefilled Syringe
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1872256
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Brodalumab Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 4 listed Brodalumab Injection NDCs with Medicaid activity.
Compare Brodalumab Injection products
A representative set of FDA-listed product records for Brodalumab Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 210 mg | Subcutaneous | Bausch Health US LLC | BLA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Brodalumab Injection NDCs →
Brodalumab Injection side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Brodalumab Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Brodalumab Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Brodalumab Injection FDA approval history
How Brodalumab Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Brodalumab Injection recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Brodalumab recalls since July 2021.
✅No Brodalumab recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1872251 1 dose form · 1 strength
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Dose form (SCDF) Prefilled Syringe RxCUI 1872255No current FDA listingClinical drug / strength (SCD) 1.5 ML brodalumab 140 MG/MLRxCUI 1872256
Look up RxCUI 1872251 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Brodalumab Injection supply and shortage status
Whether Brodalumab Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Brodalumab Injection brand names
Brodalumab Injection is sold under one brand name in the FDA directory — Siliq. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Brodalumab Injection: manufacturers and labelers
One company lists Brodalumab Injection products with the FDA. By number of product records, the largest are Bausch Health US LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Brodalumab Injection drug class (RxNorm)
Brodalumab Injection belongs to the Interleukin-17 Receptor A Antagonist class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Brodalumab Injection page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Bausch Health US LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →