Approved indication
Siliq is approved in the United States for moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and who have failed to respond or have lost response to other systemic therapies.

Off-label uses
Clinicians may sometimes use brodalumab off label for other inflammatory skin conditions such as hidradenitis suppurativa or rare psoriasis variants, but evidence comes mainly from small open-label studies and case reports, so these uses are considered experimental and not FDA-approved.

Efficacy expectations

• Onset: Some patients notice improvement within 2–4 weeks; the main assessment of benefit is usually at about 12–16 weeks, and treatment is often stopped if there is not an adequate response by then.
• Typical outcomes: In large clinical trials of plaque psoriasis, roughly 80–86% of patients on the approved 210 mg every-2-weeks regimen achieved at least 75% improvement in skin severity (PASI 75) by week 12, and about 35–45% achieved completely clear skin (PASI 100).
• Comparison to similar drugs: Brodalumab produces very high skin-clearance rates that are at least comparable to, and for complete clearance often higher than, older biologics like ustekinumab; overall efficacy is in the top tier among modern IL-17–targeting psoriasis therapies.

Durability of response
For patients who respond, long-term extension studies show that high levels of skin clearance can often be maintained for years with continued dosing every 2 weeks.

Typical dosing
For adults with moderate to severe plaque psoriasis, the recommended dose is 210 mg by subcutaneous injection at Weeks 0, 1, and 2, followed by 210 mg every 2 weeks as ongoing maintenance, with response usually reassessed after about 12–16 weeks.

How to take the medicine

• Siliq is given as an injection under the skin using a single-dose prefilled syringe; it is not given into a vein or muscle.
• Common injection sites are the front of the thighs, the abdomen (avoiding a 2-inch circle around the navel), or the outer upper arm (if injected by another person).
• Rotate injection sites and avoid areas that are tender, bruised, red, hard, scarred, or covered by thick psoriatic plaques.
• The syringe should be taken out of the refrigerator and allowed to reach room temperature (about 30 minutes) before use; do not warm it in any other way, and do not shake it.

Special dosing instructions

• Before starting Siliq, you should be evaluated for tuberculosis and for any active or recurrent infections, and your clinician will review your mental health history.
• If there is not an adequate improvement in psoriasis after 12–16 weeks, continuing Siliq is unlikely to lead to better results and your prescriber may stop it.
• No standard dose adjustments are defined for kidney or liver impairment, but your clinician may individualize treatment based on your overall health and other medicines.

Missed dose guidance
If you miss a dose, inject it as soon as you remember unless it is almost time for your next scheduled dose; do not inject two doses at once, and contact your prescriber or pharmacist for help resetting your schedule.

Overdose
If more than the prescribed amount is injected, or if an extra dose is given by mistake, contact your clinician or Poison Control (1-800-222-1222 in the U.S.) or seek emergency care; there is no specific antidote, so treatment focuses on monitoring and managing any side effects or infections.

Common side effects

• Common effects (in at least about 1 in 100 patients) include joint pain, headache, fatigue, diarrhea, nausea, sore throat or mouth pain, muscle pain, flu-like illness, injection site redness or pain, mild decreases in white blood cells (neutropenia), and mild fungal infections such as tinea (athlete’s foot or ringworm).
• These usually start in the first weeks to months of treatment, are often mild to moderate, and may improve with time or simple supportive care.

Serious or rare adverse effects

• Suicidal thoughts and behavior (boxed warning): Suicidal ideation, suicide attempts, and completed suicides occurred in clinical trials; it is not clear that Siliq causes these events, but the risk is taken seriously and the drug is only available through the SILIQ REMS program.
• Serious infections: Siliq can lower the body’s ability to fight infections and may increase the risk of serious bacterial, viral, or fungal infections, including those requiring hospitalization.
• Inflammatory bowel disease: New or worsening Crohn’s disease has been reported; Siliq is contraindicated in patients with Crohn’s disease and should be stopped if it develops.
• Severe eczematous eruptions: Some patients develop intense, widespread eczema-like rashes that may require discontinuation.
• Allergic reactions: Rarely, serious hypersensitivity reactions, including anaphylaxis, can occur, with symptoms such as hives, trouble breathing, and swelling of the face or throat.

Warnings and precautions

• Mood and behavior: Tell your clinician about any history of depression, anxiety, or suicidal thoughts; you and your caregivers should watch for mood changes, new or worsening depression, or suicidal thinking and seek urgent care if these occur.
• Infections and tuberculosis: You should be screened for tuberculosis before starting Siliq; active serious infections should be treated and under control before use, and Siliq is usually paused if a serious infection develops.
• Crohn’s disease: Do not use Siliq if you have Crohn’s disease; report new abdominal pain, diarrhea, weight loss, or blood in the stool promptly.
• Vaccines: Avoid live vaccines while on Siliq; inactivated vaccines are generally preferred but may be less effective, so timing should be discussed with your clinician.
• Pregnancy and breastfeeding: Human data are very limited; Siliq is typically used in pregnancy or while breastfeeding only if the expected benefits clearly outweigh potential risks, and effective contraception is often advised during treatment and for about 12 weeks after the last dose.
• Children and older adults: Safety and effectiveness are not established in pediatric patients; in adults 65 and older, no major differences were seen in trials, but data are limited so careful monitoring is recommended.
• Liver and kidney disease: No formal dose adjustment guidelines exist, but because Siliq affects the immune system, clinicians use extra caution in people with significant organ disease or multiple other medicines.

Safety compared with other biologics
Overall rates of serious infection and allergic reactions are similar to many other biologic psoriasis therapies, but Siliq is distinctive in having a boxed warning for suicidal ideation and behavior and a specific contraindication in Crohn’s disease, which makes careful patient selection and monitoring especially important.

Reporting side effects and safety updates
Patients and clinicians can report suspected side effects to the FDA MedWatch program (online or by phone at 1-800-FDA-1088) or to the manufacturer’s safety line; current safety information and any new warnings are posted on the FDA and product websites.

Drug and vaccine interactions

• Live vaccines: Live vaccines (such as measles-mumps-rubella, varicella, live shingles, yellow fever, and oral typhoid) should generally be avoided during Siliq treatment; needed live vaccines are usually given before starting therapy.
• Other immunosuppressants: Using Siliq together with other strong immune-suppressing drugs (e.g., other biologic agents, JAK inhibitors, cyclosporine, tacrolimus, or long-term high-dose corticosteroids) can raise the risk of serious infections and is usually avoided or used only with close specialist supervision.
• CYP450 substrates: By altering inflammatory cytokine levels, Siliq can change the metabolism of certain drugs that depend on liver enzymes (CYP450), especially those with a narrow therapeutic range such as warfarin or cyclosporine; your clinician may monitor drug levels or effects more closely and adjust doses if needed when Siliq is started or stopped.
• Routine medicines and supplements: Many common medications, vitamins, and supplements can be used with Siliq, but you should always give your prescriber an up-to-date list so they can screen for interactions and overlapping immune suppression.

Food, alcohol, and procedures

• Siliq is not known to have direct interactions with specific foods, and it can be taken without regard to meals because it is injected.
• Alcohol does not have a known direct interaction with Siliq, but heavy drinking can impair immune function and liver health, so moderation and discussion with your clinician are advisable, especially if you have liver disease or take other liver‑affecting drugs.
• There are no specific restrictions for imaging tests (such as CT or MRI), but if you are having surgery or an invasive procedure, your surgeon and dermatologist/rheumatologist may coordinate the timing of Siliq doses to reduce infection risk.

Precautions and when use may be unsafe

• Do not use Siliq if you have Crohn’s disease, a history of serious allergic reaction to brodalumab, or active serious infection that is not under control.
• Use extreme caution and close monitoring if you have a history of depression, anxiety, or suicidal thoughts or behavior.
• People with chronic or recurrent infections, a history of tuberculosis, significant immune system problems, or certain cancers require individualized risk–benefit assessment before starting Siliq.
• Tell your clinician if you are pregnant, planning pregnancy, or breastfeeding, as data are limited and the drug is generally reserved for situations where benefits clearly outweigh potential risks.

Monitoring while on Siliq

• Baseline and, when appropriate, follow-up testing for tuberculosis.
• Regular clinical checks for signs of infection (fever, cough, painful skin lesions), new or worsening bowel symptoms, and new rashes.
• Ongoing assessment of mood and behavior for any signs of depression, anxiety, or suicidal thoughts.
• In some patients, periodic blood tests (such as complete blood count and, when indicated, drug levels for interacting medicines like warfarin or cyclosporine) may be done to monitor for neutropenia or drug–drug interactions.

Q: What is Siliq prescribed for?
A: Siliq is prescribed for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy and whose psoriasis did not respond adequately to, or lost response to, other systemic treatments.

Q: How long does it take for Siliq to start working?
A: Some people notice improvement within 2–4 weeks, but the main benefit is usually assessed around 12 weeks, and if there is not enough improvement by 12–16 weeks your clinician may recommend stopping Siliq.

Q: Can I give Siliq injections to myself at home?
A: Yes, many patients self-inject Siliq using the prefilled syringe after a healthcare professional has trained them on the correct subcutaneous injection technique and how to store and handle the syringes safely.

Q: Why does Siliq carry a suicide warning and require a REMS program?
A: In clinical trials, some patients taking Siliq experienced suicidal thoughts, behaviors, or completed suicides, so the FDA requires a boxed warning and a restricted REMS program; this means you and your prescriber must review mental health risks and you should report any mood changes or suicidal thoughts immediately.

Q: Can I get vaccines while I am on Siliq?
A: You should avoid live vaccines while using Siliq, but most inactivated vaccines (like standard flu or COVID-19 shots) can be given; your healthcare provider will help plan the timing of any needed vaccinations.

Q: Is Siliq safe during pregnancy or breastfeeding?
A: Because there are very limited data in pregnant or breastfeeding people, Siliq is usually used only if the potential benefit clearly outweighs the risks, and effective contraception is often recommended during treatment and for a period after the last dose; discuss family-planning and breastfeeding plans with your clinician before starting therapy.

Storage
Store Siliq prefilled syringes in the refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light and physical damage; do not freeze or shake, and keep away from heat.

If needed, a syringe can be kept at room temperature up to 77°F (25°C) for a single period of up to 14 days in the original carton; once it has been at room temperature, do not return it to the refrigerator and discard it if not used within 14 days.

Handling and disposal

• Each prefilled syringe is for single use only; do not reuse it and discard it even if some medicine remains.
• After injection, place the used syringe immediately into an FDA-cleared sharps disposal container; do not throw loose needles or syringes into household trash or recycling.
• Follow local or state guidelines for disposing of sharps containers, and keep all syringes and sharps containers out of reach of children and pets.