Siliq 210/1.5 Inj, 1.5ml
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
Immunosuppressant; Psoriasis Agent
Pharmacologic Class
Interleukin-17 Receptor A Antagonist
Pregnancy Category
Not available
FDA Approved
Feb 2017
DEA Schedule
Not Controlled
Overview
What is this medicine?
Siliq (brodalumab) is an injectable medicine used to treat moderate to severe plaque psoriasis in adults. It works by blocking a specific protein in your body that causes inflammation, which helps to reduce the redness, scaling, and itching of 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. After administering the dose, discard any remaining medication. 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 proper 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 can 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 compensate for a missed dose.
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. After administering the dose, discard any remaining medication. 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 proper 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 can 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 compensate for a missed dose.
Lifestyle & Tips
- Do not receive any live vaccines while taking Siliq.
- Report any new or worsening signs of infection (e.g., fever, chills, cough, skin sores) to your doctor immediately.
- It is very important to tell your doctor right away if you experience any changes in mood, thoughts of harming yourself, or any unusual behavior.
- Avoid close contact with people who are sick or have infections.
- Keep all appointments with your doctor for monitoring and follow-up.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
210 mg subcutaneously at Week 0, Week 1, and Week 2, followed by 210 mg every 2 weeks.
Dose Range:
210 - 210 mg
Condition-Specific Dosing:
Plaque Psoriasis:
210 mg subcutaneously at Week 0, Week 1, and Week 2, followed by 210 mg every 2 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment necessary.
Moderate:
No dosage adjustment necessary.
Severe:
No dosage adjustment necessary.
Dialysis:
No specific recommendations; Brodalumab is a monoclonal antibody and not renally cleared.
Hepatic Impairment:
Mild:
No dosage adjustment necessary.
Moderate:
No dosage adjustment necessary.
Severe:
No specific recommendations; caution advised due to lack of 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 IL-17A/F heterodimer to the receptor. By blocking the IL-17RA, brodalumab prevents the signaling of these pro-inflammatory cytokines, thereby reducing inflammation and clinical symptoms associated with plaque psoriasis.
Pharmacokinetics
Absorption:
Bioavailability:
55%
Tmax:
3 days
FoodEffect:
Not applicable (subcutaneous administration)
Distribution:
Vd:
5.6 L
ProteinBinding:
Not applicable (monoclonal antibody, does not bind to plasma proteins in a specific manner)
CnssPenetration:
Limited
Elimination:
HalfLife:
10.9 days
Clearance:
0.29 L/day
ExcretionRoute:
Not renally or hepatically cleared in the traditional sense; eliminated via catabolism.
Unchanged:
Not applicable (undergoes degradation)
Pharmacodynamics
OnsetOfAction:
Within 1-2 weeks (clinical improvement)
PeakEffect:
12-16 weeks (maximal clinical response)
DurationOfAction:
Maintained with bi-weekly dosing
Safety & Warnings
BLACK BOX WARNING
Suicidal Ideation and Behavior, including Completed Suicide: Patients with psoriasis may have an increased risk of depression and suicidality. Brodalumab treatment is associated with an increased risk of suicidal ideation and behavior. A causal association between treatment with Brodalumab and increased risk of suicidal ideation and behavior has not been established. Brodalumab is available only through a restricted program called the Siliq REMS Program.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 attention immediately:
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 changed sputum production
+ Pain while urinating
+ 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 right away:
+ 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. Many people may not experience any 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, contact 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 attention immediately:
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 changed sputum production
+ Pain while urinating
+ 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 right away:
+ 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. Many people may not experience any 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, contact 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:
- Thoughts of suicide or self-harm
- New or worsening depression or anxiety
- Agitation or restlessness
- Fever, chills, body aches, or flu-like symptoms
- Persistent cough or shortness of breath
- Skin redness, warmth, or pus
- Painful or frequent urination
- Severe abdominal pain, persistent diarrhea, or bloody stools
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, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication in combination with your other medications and health conditions.
Remember, do not start, stop, or change the dosage 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, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication in combination with your other medications and health conditions.
Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
It is crucial that you inform all of 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. While taking this medication, you may be at a higher risk of developing infections. To minimize this risk, practice good hygiene by washing your hands frequently and avoid 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 increase your risk of infection or reduce their effectiveness when taken concurrently with this drug.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is essential to discuss the benefits and risks of this medication with your doctor, as they will need to weigh the potential effects on both you and your baby.
Before initiating treatment with this drug, you will need to undergo a tuberculosis (TB) test. While taking this medication, you may be at a higher risk of developing infections. To minimize this risk, practice good hygiene by washing your hands frequently and avoid 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 increase your risk of infection or reduce their effectiveness when taken concurrently with this drug.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is essential to discuss the benefits and risks of this medication with your doctor, as they will need to weigh the potential effects on both 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 suspected overdose, contact a poison control center (e.g., 1-800-222-1222 in the US) or seek emergency medical attention. Management should be supportive and directed at treating symptoms.
Drug Interactions
Contraindicated Interactions
- Live vaccines (concurrent administration)
Major Interactions
- Immunosuppressants (increased risk of infection)
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening
Rationale: To rule out latent or active TB infection before initiating treatment, as immunosuppression may reactivate TB.
Timing: Prior to initiation of therapy
Assessment for suicidal ideation and behavior
Rationale: Brodalumab carries a Black Box Warning for suicidal ideation and behavior; baseline assessment is crucial.
Timing: Prior to initiation of therapy
Screening for inflammatory bowel disease (IBD)
Rationale: Brodalumab is contraindicated in patients with Crohn's disease.
Timing: Prior to initiation of therapy
Routine Monitoring
Monitoring for new or worsening suicidal ideation and behavior
Frequency: At each visit, especially during the initial weeks of treatment and with dose changes.
Target: Absence of suicidal thoughts or behaviors.
Action Threshold: Any report of suicidal ideation, mood changes, or behavioral changes requires immediate evaluation and potential discontinuation.
Monitoring for signs and symptoms of infection
Frequency: Regularly throughout treatment.
Target: Absence of fever, chills, malaise, or localized signs of infection.
Action Threshold: If a serious infection develops, discontinue Brodalumab until the infection resolves.
Monitoring for new or worsening inflammatory bowel disease symptoms
Frequency: Regularly throughout treatment.
Target: Absence of abdominal pain, diarrhea, weight loss, or other IBD symptoms.
Action Threshold: If new or worsening IBD symptoms occur, discontinue Brodalumab.
Symptom Monitoring
- Suicidal thoughts or behavior (e.g., thoughts of harming oneself, mood changes, agitation, depression)
- Signs of infection (e.g., fever, chills, body aches, persistent cough, skin lesions, painful urination)
- Symptoms of inflammatory bowel disease (e.g., abdominal pain, diarrhea, bloody stools, weight loss)
- New or worsening joint pain
- Unusual bruising or bleeding
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of Brodalumab in pregnant women. Monoclonal antibodies are known to cross the placental barrier, particularly in the third trimester. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data; potential for immune-mediated effects on fetal development is theoretical.
Second Trimester:
Limited data; potential for immune-mediated effects on fetal development is theoretical.
Third Trimester:
Increased placental transfer of IgG antibodies, potentially leading to fetal exposure and immune suppression in the neonate.
Lactation
It is unknown whether Brodalumab is excreted in human milk. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Brodalumab and any potential adverse effects on the breastfed infant from Brodalumab or from the underlying maternal condition. Consider the half-life of Brodalumab (approximately 10.9 days) when assessing potential infant exposure.
Infant Risk:
Low to moderate risk. Potential for infant exposure and theoretical risk of immune suppression, though oral absorption of intact antibodies by the infant is generally low.
Pediatric Use
The safety and effectiveness of Brodalumab 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 subjects (65 years and over) and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. No dosage adjustment is necessary based on age. Monitor for increased risk of infections.
Clinical Information
Clinical Pearls
- Brodalumab is part of a REMS (Risk Evaluation and Mitigation Strategy) program due to the risk of suicidal ideation and behavior. Prescribers and patients must enroll in the Siliq REMS Program.
- Patients should be screened for tuberculosis (TB) prior to initiation of therapy and monitored for signs and symptoms of active TB during and after treatment.
- Brodalumab 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) immediately.
- Avoid concurrent use with live vaccines. Patients should be up-to-date on all immunizations prior to initiating Brodalumab.
- Clinical response can be rapid, with significant improvement seen within weeks for many patients.
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)
- Topical therapies (e.g., corticosteroids, vitamin D analogs)
Cost & Coverage
Average Cost:
Approximately $5,000 - $7,000 per 210 mg/1.5 mL prefilled syringe
Insurance Coverage:
Specialty Tier (requires prior authorization and often step therapy)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. When you receive this medication, you will also get a Medication Guide, which is a valuable resource that provides additional information. Please read this guide carefully and review it again whenever you refill your prescription. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide crucial information, including the name of the medication taken, the amount, and the time it occurred, to help healthcare professionals provide the best possible care.