Siliq 210mg/1.5ml Inj, 2x1.5ml
WARNING: Patients who take this drug may be at a greater risk of having thoughts or actions of suicide. Some people taking this drug have committed suicide. The risk may be greater in people who have had these thoughts or actions in the past. Call the doctor right away if signs like depression, nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur. @ COMMON USES: It is used to treat plaque psoriasis.
Drug Class
Psoriasis agent, Interleukin inhibitor
Pharmacologic Class
Interleukin-17 Receptor A (IL-17RA) Antagonist
Pregnancy Category
Not available
FDA Approved
Feb 2017
DEA Schedule
Not Controlled
Overview
What is this medicine?
Siliq is an injectable medicine used to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy and who have failed to respond or have lost response to other systemic therapies. It works by blocking a specific protein in your body that causes inflammation and skin problems associated with psoriasis.
How to Use This Medicine
Proper Administration of This Medication
To ensure safe and effective use, follow your doctor's instructions and read all accompanying information carefully. This medication is administered via injection into the fatty tissue of the skin, typically in the thigh, abdominal area, or upper arm. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Before use, if the medication has been refrigerated, allow it to reach room temperature for approximately 30 minutes. Do not heat the medication.
Important Administration Guidelines
Avoid injecting into skin within 2 inches (5 cm) of the navel.
Do not inject into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.
Avoid injecting into skin affected by psoriasis.
Do not shake the medication.
The solution should be colorless to faintly yellow; do not use if the color changes.
The product may contain small white particles, but do not use if the solution appears cloudy, is leaking, or contains large lumps, flakes, or other particles.
Single-Use Prefilled Syringe
Each prefilled syringe is intended for a single use only. Discard any remaining medication after administration. Dispose of needles in a designated needle/sharp disposal container. Do not reuse needles or other items. When the disposal box is full, follow local regulations for its disposal. If you have questions, consult your doctor or pharmacist.
Storage and Disposal
Store the medication in a refrigerator to maintain its potency. Do not freeze. Keep the medication in its original container, protected from light. If necessary, you may store it at room temperature (up to 77°F or 25°C) for up to 14 days. Record the date you remove the medication from the refrigerator. If stored at room temperature and not used within 14 days, discard the medication.
Missed Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or extra doses.
To ensure safe and effective use, follow your doctor's instructions and read all accompanying information carefully. This medication is administered via injection into the fatty tissue of the skin, typically in the thigh, abdominal area, or upper arm. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Before use, if the medication has been refrigerated, allow it to reach room temperature for approximately 30 minutes. Do not heat the medication.
Important Administration Guidelines
Avoid injecting into skin within 2 inches (5 cm) of the navel.
Do not inject into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.
Avoid injecting into skin affected by psoriasis.
Do not shake the medication.
The solution should be colorless to faintly yellow; do not use if the color changes.
The product may contain small white particles, but do not use if the solution appears cloudy, is leaking, or contains large lumps, flakes, or other particles.
Single-Use Prefilled Syringe
Each prefilled syringe is intended for a single use only. Discard any remaining medication after administration. Dispose of needles in a designated needle/sharp disposal container. Do not reuse needles or other items. When the disposal box is full, follow local regulations for its disposal. If you have questions, consult your doctor or pharmacist.
Storage and Disposal
Store the medication in a refrigerator to maintain its potency. Do not freeze. Keep the medication in its original container, protected from light. If necessary, you may store it at room temperature (up to 77°F or 25°C) for up to 14 days. Record the date you remove the medication from the refrigerator. If stored at room temperature and not used within 14 days, discard the medication.
Missed Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or extra doses.
Lifestyle & Tips
- Maintain good hygiene to reduce the risk of infections.
- Avoid live vaccines while on Siliq.
- Report any signs of infection (fever, chills, cough, skin sores) to your doctor immediately.
- Monitor for and report any changes in mood, feelings of depression, or thoughts of harming yourself to your doctor or a mental health professional right away.
- Follow proper injection technique as instructed by your healthcare provider.
- Keep all appointments for follow-up and monitoring tests.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
210 mg subcutaneously at Week 0, 1, and 2, then every 2 weeks
Dose Range:
210 - 210 mg
Condition-Specific Dosing:
Plaque Psoriasis:
210 mg subcutaneously at Week 0, 1, and 2, then every 2 weeks
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment recommended
Moderate:
No dose adjustment recommended
Severe:
No specific dose adjustment recommended; use with caution due to limited data
Dialysis:
No specific dose adjustment recommended; use with caution due to limited data
Hepatic Impairment:
Mild:
No dose adjustment recommended
Moderate:
No dose adjustment recommended
Severe:
No specific dose adjustment recommended; use with caution due to limited data
Pharmacology
Mechanism of Action
Brodalumab is a human monoclonal antibody that selectively binds to the interleukin-17 receptor A (IL-17RA) and inhibits the binding of IL-17A, IL-17F, and the IL-17A/F heterodimer to the receptor. By blocking the IL-17RA, brodalumab prevents the activation of the IL-17 pathway, which is involved in inflammatory and immune responses, including those in plaque psoriasis.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 55%
Tmax:
3 to 10 days
FoodEffect:
Not applicable (subcutaneous administration)
Distribution:
Vd:
Approximately 5.6 L
ProteinBinding:
Not extensively studied, typical for monoclonal antibodies (binds to target receptor)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 10.9 days (range 6.3 to 13.5 days)
Clearance:
Approximately 20.3 mL/day/kg
ExcretionRoute:
Not a primary route of elimination; catabolized
Unchanged:
Not applicable (catabolized)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 2-4 weeks
PeakEffect:
Maximum clinical response typically observed by Week 12-16
DurationOfAction:
Maintained with bi-weekly dosing
Safety & Warnings
BLACK BOX WARNING
Suicidal Ideation and Behavior, including completed suicides, have occurred in patients treated with Siliq. Patients with a history of depression and/or suicidality were not excluded from Siliq clinical trials. A causal association between treatment with Siliq and increased risk of suicidal ideation and behavior has not been established. Siliq is available only through a restricted program called the Siliq REMS Program.
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of Crohn's disease, including:
+ Bloody stools
+ Constipation or diarrhea
+ Fever
+ Loss of bowel control
+ Decreased appetite
+ Painful diarrhea
+ Stomach pain or cramps
+ Sudden need to have a bowel movement
+ Tiredness
+ Weight loss
Signs of infection, such as:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or discolored sputum
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Warm, red, or painful skin or sores on the body
Excessive sweating
Muscle pain or weakness
Shortness of breath
Frequent urination
Severe skin problems resembling eczema, which can occur within days to months after the first dose. These may require hospitalization. If you experience any of the following, contact your doctor immediately:
+ Rash
+ Itching
+ Dry or leathery skin
+ Small bumps or patches
+ Redness
+ Blisters
+ Peeling
+ Other skin irritation
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people experience no side effects or only mild ones. If you're bothered by any of the following side effects or if they persist, contact your doctor or seek medical help:
Joint pain
Headache
Mouth pain
Throat pain
Upset stomach
* Irritation at the injection site
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of Crohn's disease, including:
+ Bloody stools
+ Constipation or diarrhea
+ Fever
+ Loss of bowel control
+ Decreased appetite
+ Painful diarrhea
+ Stomach pain or cramps
+ Sudden need to have a bowel movement
+ Tiredness
+ Weight loss
Signs of infection, such as:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or discolored sputum
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Warm, red, or painful skin or sores on the body
Excessive sweating
Muscle pain or weakness
Shortness of breath
Frequent urination
Severe skin problems resembling eczema, which can occur within days to months after the first dose. These may require hospitalization. If you experience any of the following, contact your doctor immediately:
+ Rash
+ Itching
+ Dry or leathery skin
+ Small bumps or patches
+ Redness
+ Blisters
+ Peeling
+ Other skin irritation
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people experience no side effects or only mild ones. If you're bothered by any of the following side effects or if they persist, contact your doctor or seek medical help:
Joint pain
Headache
Mouth pain
Throat pain
Upset stomach
* Irritation at the injection site
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- New or worsening thoughts of suicide or self-harm
- Severe allergic reactions (difficulty breathing, swelling of face/lips/tongue/throat, severe rash)
- Signs of serious infection (fever, chills, persistent cough, shortness of breath, skin redness/swelling/pain, burning urination)
- New or worsening symptoms of inflammatory bowel disease (e.g., persistent abdominal pain, diarrhea, weight loss, blood in stool)
- Unusual bleeding or bruising
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have been diagnosed with Crohn's disease, a condition that affects the digestive system.
If you have tuberculosis (TB), a bacterial infection that primarily affects the lungs.
This list is not exhaustive, and it is crucial to discuss all your medications, health conditions, and concerns with your doctor. Please provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or supplements you are using
Vitamins you are taking
* Any health problems you have, including pre-existing conditions
Your doctor will help you determine whether it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have been diagnosed with Crohn's disease, a condition that affects the digestive system.
If you have tuberculosis (TB), a bacterial infection that primarily affects the lungs.
This list is not exhaustive, and it is crucial to discuss all your medications, health conditions, and concerns with your doctor. Please provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or supplements you are using
Vitamins you are taking
* Any health problems you have, including pre-existing conditions
Your doctor will help you determine whether it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Always carry your patient safety card with you.
Before initiating treatment with this drug, you will need to undergo a tuberculosis (TB) test. As this medication may increase your risk of developing infections, it is crucial to practice good hygiene by washing your hands frequently and avoiding close contact with individuals who have infections, colds, or the flu.
Prior to receiving any vaccinations, consult with your doctor to discuss potential interactions with this medication. Certain vaccines may not be effective or may increase your risk of infection when taken with this drug.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is vital to discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
Before initiating treatment with this drug, you will need to undergo a tuberculosis (TB) test. As this medication may increase your risk of developing infections, it is crucial to practice good hygiene by washing your hands frequently and avoiding close contact with individuals who have infections, colds, or the flu.
Prior to receiving any vaccinations, consult with your doctor to discuss potential interactions with this medication. Certain vaccines may not be effective or may increase your risk of infection when taken with this drug.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is vital to discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been identified in clinical trials. Doses up to 700 mg subcutaneously have been administered without dose-limiting toxicity.
What to Do:
In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted. Call 1-800-222-1222 for Poison Control.
Drug Interactions
Major Interactions
- Live vaccines (e.g., MMR, varicella, rotavirus, yellow fever): Avoid concurrent administration due to potential for infection.
Moderate Interactions
- Other immunosuppressants (e.g., cyclosporine, methotrexate): Increased risk of infection; use with caution.
- Non-live vaccines: May reduce immune response to vaccination.
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening
Rationale: To rule out latent or active TB infection before initiating treatment, as biologics can reactivate latent TB.
Timing: Prior to initiation of Siliq
Mental health assessment
Rationale: To assess for history of depression, suicidal ideation, or other psychiatric disorders due to the Boxed Warning.
Timing: Prior to initiation of Siliq
Inflammatory Bowel Disease (IBD) screening
Rationale: To assess for history or symptoms of Crohn's disease, as Siliq is contraindicated in patients with Crohn's disease.
Timing: Prior to initiation of Siliq
Routine Monitoring
Signs and symptoms of infection
Frequency: Regularly throughout treatment
Target: Absence of fever, chills, malaise, localized redness/swelling/pain
Action Threshold: Report any signs of infection immediately; consider interrupting treatment if serious infection develops.
New or worsening suicidal ideation or behavior
Frequency: Regularly throughout treatment
Target: Absence of suicidal thoughts, plans, or behaviors
Action Threshold: Immediately refer to a mental health professional; consider discontinuing Siliq if new or worsening suicidal ideation or behavior occurs.
New or worsening symptoms of inflammatory bowel disease (IBD)
Frequency: Regularly throughout treatment
Target: Absence of abdominal pain, diarrhea, weight loss, rectal bleeding
Action Threshold: Evaluate for IBD; discontinue Siliq if IBD is diagnosed.
Symptom Monitoring
- Signs of infection (fever, chills, persistent cough, skin lesions, burning urination)
- Mood changes, new or worsening depression, thoughts of self-harm or suicide
- New or worsening abdominal pain, diarrhea, weight loss, rectal bleeding (suggestive of IBD)
- Unusual bruising or bleeding
- Severe allergic reactions (rash, hives, difficulty breathing, swelling of face/lips/tongue/throat)
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of Siliq in pregnant women. Brodalumab is an IgG antibody and is expected to cross the placenta. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies did not show direct harm.
Second Trimester:
Limited human data; potential for placental transfer increases.
Third Trimester:
Potential for placental transfer is highest; consider potential effects on neonatal immune response.
Lactation
It is not known whether brodalumab is excreted in human milk or if it has effects on the breastfed infant or milk production. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Siliq and any potential adverse effects on the breastfed infant from Siliq or from the underlying maternal condition.
Infant Risk:
Unknown; potential for infant exposure to brodalumab and effects on infant immune system.
Pediatric Use
The safety and effectiveness of Siliq in pediatric patients (under 18 years of age) have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly patients (65 years and older) and younger adult patients, but greater sensitivity of some older individuals cannot be ruled out. No dose adjustment is necessary.
Clinical Information
Clinical Pearls
- Siliq is associated with a Boxed Warning for suicidal ideation and behavior; it is only available through a restricted program (Siliq REMS Program) to ensure appropriate patient selection and monitoring.
- Patients must be screened for tuberculosis (TB) prior to initiation of Siliq and monitored for signs and symptoms of active TB during and after treatment.
- Siliq is contraindicated in patients with Crohn's disease due to observed worsening of Crohn's disease in clinical trials.
- Patients should be advised to report any new or worsening symptoms of inflammatory bowel disease (e.g., abdominal pain, diarrhea, weight loss, rectal bleeding) immediately.
- Avoid live vaccines during Siliq treatment.
- Patients should be educated on proper subcutaneous injection technique and storage of the medication.
Alternative Therapies
- Other IL-17 inhibitors (e.g., secukinumab, ixekizumab)
- IL-23 inhibitors (e.g., guselkumab, risankizumab, tildrakizumab)
- TNF-alpha inhibitors (e.g., adalimumab, etanercept, infliximab, certolizumab pegol)
- Oral systemic agents (e.g., methotrexate, cyclosporine, apremilast)
- Phototherapy (e.g., UVB, PUVA)
Cost & Coverage
Average Cost:
High (typically several thousand USD) per 2x1.5ml syringe
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy, and/or quantity limits)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the quantity, and the time it occurred.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the quantity, and the time it occurred.