Cosentyx 150mg/ml Pf Syr 1ml
It is used to treat plaque psoriasis. It is used to treat some types of arthritis.It is used to treat ankylosing spondylitis.It is used to treat a skin problem called hidradenitis suppurativa.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Immunosuppressant
Pharmacologic Class
Interleukin-17A (IL-17A) Inhibitor; Monoclonal Antibody
Pregnancy Category
Not available
FDA Approved
Jan 2015
DEA Schedule
Not Controlled
Overview
What is this medicine?
Cosentyx is a medicine that helps reduce inflammation in your body. It works by blocking a specific protein called IL-17A, which is involved in causing inflammation in conditions like psoriasis, psoriatic arthritis, and certain types of spinal arthritis. It is given as an injection under the skin.
How to Use This Medicine
Proper Administration of This Medication
To ensure safe and effective use, follow your doctor's instructions and read all provided information carefully. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh or in the belly area. If someone else is administering the injection, it may also be given in the outer area of the upper arm.
If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique. Before and after use, wash your hands thoroughly. Rotate the injection site with each dose to avoid tissue damage.
Important Administration Guidelines
Do not inject into skin within 2 inches (5 cm) of the belly button.
Avoid injecting into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.
Do not inject into skin affected by psoriasis.
Check the solution for cloudiness, leakage, or particles before use. The solution should be colorless to faint yellow; do not use if the color has changed.
Do not shake the medication.
If the medication has been dropped or is broken, do not use it.
Preparing the Medication for Use
Before administering the injection, remove the medication from the refrigerator and allow it to reach room temperature. The time required for this process varies by product, ranging from 15 to 30 minutes or 30 to 45 minutes. Be sure to follow the specific instructions for your product. Do not heat the medication.
Disposal and Storage
Each prefilled pen or syringe is for single use only. After administering the dose, discard the used pen or syringe and any remaining medication. Dispose of needles and other sharp objects in a designated needle/sharp disposal box. Do not reuse needles or other items. When the disposal box is full, follow local regulations for proper disposal. If you have any questions, consult your doctor or pharmacist.
Storage Instructions
Store the medication in a refrigerator at a temperature that does not exceed freezing point.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
To ensure safe and effective use, follow your doctor's instructions and read all provided information carefully. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh or in the belly area. If someone else is administering the injection, it may also be given in the outer area of the upper arm.
If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique. Before and after use, wash your hands thoroughly. Rotate the injection site with each dose to avoid tissue damage.
Important Administration Guidelines
Do not inject into skin within 2 inches (5 cm) of the belly button.
Avoid injecting into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.
Do not inject into skin affected by psoriasis.
Check the solution for cloudiness, leakage, or particles before use. The solution should be colorless to faint yellow; do not use if the color has changed.
Do not shake the medication.
If the medication has been dropped or is broken, do not use it.
Preparing the Medication for Use
Before administering the injection, remove the medication from the refrigerator and allow it to reach room temperature. The time required for this process varies by product, ranging from 15 to 30 minutes or 30 to 45 minutes. Be sure to follow the specific instructions for your product. Do not heat the medication.
Disposal and Storage
Each prefilled pen or syringe is for single use only. After administering the dose, discard the used pen or syringe and any remaining medication. Dispose of needles and other sharp objects in a designated needle/sharp disposal box. Do not reuse needles or other items. When the disposal box is full, follow local regulations for proper disposal. If you have any questions, consult your doctor or pharmacist.
Storage Instructions
Store the medication in a refrigerator at a temperature that does not exceed freezing point.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Avoid live vaccines while taking Cosentyx and for several months after stopping it. Discuss any vaccinations with your doctor.
- Report any signs of infection (e.g., fever, chills, persistent cough, skin sores) to your doctor immediately.
- Inform your doctor if you have a history of inflammatory bowel disease (Crohn's disease or ulcerative colitis) or if you develop new or worsening symptoms of IBD.
- Store Cosentyx in the refrigerator; do not freeze. Protect from light.
- Do not shake the prefilled syringe or pen.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication. For most indications (e.g., Psoriatic Arthritis, Ankylosing Spondylitis, Non-radiographic axial SpA): 150 mg subcutaneous injection at Weeks 0, 1, 2, 3, 4, then every 4 weeks. For Plaque Psoriasis and Hidradenitis Suppurativa, higher doses (300 mg) are common.
Dose Range:
150 - 300 mg
Condition-Specific Dosing:
Plaque Psoriasis:
300 mg SC at Weeks 0, 1, 2, 3, 4, then every 4 weeks. Some patients may respond to 150 mg. For patients with co-existing psoriatic arthritis, 300 mg is recommended.
Psoriatic Arthritis:
150 mg SC at Weeks 0, 1, 2, 3, 4, then every 4 weeks. For patients who are TNF inhibitor inadequate responders or with co-existing moderate to severe plaque psoriasis, 300 mg is recommended.
Ankylosing Spondylitis:
150 mg SC at Weeks 0, 1, 2, 3, 4, then every 4 weeks.
Non-radiographic axial Spondyloarthritis:
150 mg SC at Weeks 0, 1, 2, 3, 4, then every 4 weeks.
Hidradenitis Suppurativa:
300 mg SC at Weeks 0, 1, 2, 3, 4, then every 2 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For Plaque Psoriasis (β₯6 years, β₯50 kg): 150 mg SC at Weeks 0, 1, 2, 3, 4, then every 4 weeks. (<50 kg): 75 mg SC at Weeks 0, 1, 2, 3, 4, then every 4 weeks. For Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-Related Arthritis (ERA) (β₯2 years): Weight-based dosing (75 mg or 150 mg) similar to pediatric plaque psoriasis.
Adolescent:
Dosing for plaque psoriasis, JPsA, and ERA is weight-based, similar to children. For other indications, adult dosing may apply based on weight and maturity.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment necessary.
Moderate:
No dose adjustment necessary.
Severe:
No dose adjustment necessary. Limited data, but monoclonal antibodies are not primarily renally cleared.
Dialysis:
No specific recommendations. Not expected to be removed by dialysis.
Hepatic Impairment:
Mild:
No dose adjustment necessary.
Moderate:
No dose adjustment necessary.
Severe:
No dose adjustment necessary. Limited data, but monoclonal antibodies are not primarily hepatically cleared.
Pharmacology
Mechanism of Action
Secukinumab is a human IgG1/ΞΊ monoclonal antibody that selectively binds to and neutralizes interleukin-17A (IL-17A). IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Secukinumab inhibits the interaction of IL-17A with its receptor, thereby inhibiting the release of pro-inflammatory cytokines and chemokines and reducing the inflammatory response implicated in the pathogenesis of plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and hidradenitis suppurativa.
Pharmacokinetics
Absorption:
Bioavailability:
77% (subcutaneous)
Tmax:
6 days (single dose)
FoodEffect:
Not applicable (subcutaneous administration)
Distribution:
Vd:
7.1 to 8.6 L (central compartment)
ProteinBinding:
Not applicable (monoclonal antibody, not typically protein bound in the same way as small molecules)
CnssPenetration:
Limited
Elimination:
HalfLife:
27 days (mean terminal half-life)
Clearance:
0.13 to 0.19 L/day (systemic clearance)
ExcretionRoute:
Catabolism and elimination via reticuloendothelial system.
Unchanged:
Not applicable (catabolized)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 3-4 weeks for psoriasis, longer for other indications.
PeakEffect:
Peak clinical response varies by indication, often observed after 16-24 weeks of treatment.
DurationOfAction:
Maintained with regular dosing (e.g., every 4 weeks).
Safety & Warnings
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 immediately or seek emergency medical attention:
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 infection, including:
+ 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 dizziness or fainting
Severe skin problems resembling eczema, which can occur within days to months after the first dose. These may require hospital treatment. 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you're bothered by any of the following side effects or if they persist, contact your doctor:
Signs of a common cold
Nose or throat irritation
Diarrhea
This is not an exhaustive list of possible side effects. If you have questions or concerns, don't hesitate to reach out to 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 immediately or seek emergency medical attention:
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 infection, including:
+ 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 dizziness or fainting
Severe skin problems resembling eczema, which can occur within days to months after the first dose. These may require hospital treatment. 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you're bothered by any of the following side effects or if they persist, contact your doctor:
Signs of a common cold
Nose or throat irritation
Diarrhea
This is not an exhaustive list of possible side effects. If you have questions or concerns, don't hesitate to reach out to 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:
- Signs of serious infection: fever, chills, body aches, persistent cough, shortness of breath, warm/red/painful skin, unusual fatigue.
- Symptoms of inflammatory bowel disease: new or worsening abdominal pain, persistent diarrhea, bloody stools, unexplained weight loss.
- Signs of allergic reaction: rash, hives, swelling of your face, lips, tongue, or throat, difficulty breathing, dizziness, feeling faint.
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 currently have an infection or have been diagnosed with tuberculosis (TB).
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.
You should also share information about any existing health problems, as this will help your doctor determine if it is safe for you to take this medication.
* Do not start, stop, or modify the dosage of any medication without first consulting your doctor to ensure your safety and the effectiveness of your treatment plan.
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 currently have an infection or have been diagnosed with tuberculosis (TB).
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.
You should also share information about any existing health problems, as this will help your doctor determine if it is safe for you to take this medication.
* Do not start, stop, or modify the dosage of any medication without first consulting your doctor to ensure your safety and the effectiveness of your treatment plan.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you have a latex allergy, consult with your doctor, as some products may contain latex.
Regular blood tests and other laboratory evaluations should be performed as directed by your doctor. While taking this medication, you may be at a higher risk of developing infections, some of which can be severe or life-threatening. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or flu.
Additionally, certain infections, such as tuberculosis (TB) and hepatitis B, may reactivate in patients taking this medication. If you have a history of either of these infections, inform your doctor. A TB test will be required before initiating treatment with this drug.
Ensure that you are up to date with all recommended vaccinations before starting treatment with this medication. However, consult with your doctor before receiving any vaccines, as some vaccines may not be effective or may increase the risk of infection when taken with this medication.
If you have a history of inflammatory bowel disease, such as ulcerative colitis or Crohn's disease, discuss this with your doctor, as this medication may exacerbate or trigger new cases of inflammatory bowel disease, which can be severe.
If you are pregnant, plan to become pregnant, or are breastfeeding, consult with your doctor to discuss the potential benefits and risks of this medication to you and your baby.
Regular blood tests and other laboratory evaluations should be performed as directed by your doctor. While taking this medication, you may be at a higher risk of developing infections, some of which can be severe or life-threatening. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or flu.
Additionally, certain infections, such as tuberculosis (TB) and hepatitis B, may reactivate in patients taking this medication. If you have a history of either of these infections, inform your doctor. A TB test will be required before initiating treatment with this drug.
Ensure that you are up to date with all recommended vaccinations before starting treatment with this medication. However, consult with your doctor before receiving any vaccines, as some vaccines may not be effective or may increase the risk of infection when taken with this medication.
If you have a history of inflammatory bowel disease, such as ulcerative colitis or Crohn's disease, discuss this with your doctor, as this medication may exacerbate or trigger new cases of inflammatory bowel disease, which can be severe.
If you are pregnant, plan to become pregnant, or are breastfeeding, consult with your doctor to discuss the potential benefits and risks of this medication to you and your baby.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been reported in clinical trials. Doses up to 30 mg/kg (approximately 2000-3000 mg) have been administered intravenously 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 immediately. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Contraindicated Interactions
- Live vaccines (e.g., BCG, measles, mumps, rubella, polio, rotavirus, yellow fever, varicella, zoster, typhoid)
Major Interactions
- Other immunosuppressants (e.g., cyclosporine, methotrexate, corticosteroids) - increased risk of infection, use with caution.
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening
Rationale: To rule out latent or active TB infection before initiating treatment, as secukinumab may increase the risk of TB reactivation.
Timing: Prior to initiation of therapy.
Hepatitis B Virus (HBV) screening
Rationale: To rule out active or chronic HBV infection, as secukinumab may increase the risk of HBV reactivation.
Timing: Prior to initiation of therapy.
Clinical evaluation for signs of infection
Rationale: To ensure patient is free of active serious infections before starting treatment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Signs and symptoms of infection
Frequency: Regularly during treatment and for several months after discontinuation.
Target: Absence of fever, chills, cough, fatigue, skin lesions, etc.
Action Threshold: Prompt evaluation and treatment if signs/symptoms of infection develop; consider temporary or permanent discontinuation of secukinumab.
Signs and symptoms of inflammatory bowel disease (IBD)
Frequency: Regularly during treatment.
Target: Absence of new or worsening abdominal pain, diarrhea, bloody stools, weight loss.
Action Threshold: If new onset or worsening IBD symptoms occur, discontinue secukinumab and refer for appropriate evaluation.
Hypersensitivity reactions
Frequency: Monitor during and after injection.
Target: Absence of rash, urticaria, dyspnea, hypotension, angioedema.
Action Threshold: Discontinue immediately if a serious allergic reaction occurs and initiate appropriate medical therapy.
Symptom Monitoring
- Signs of serious infection (e.g., persistent fever, chills, cough, shortness of breath, skin warmth/redness/pain, fatigue)
- Symptoms of inflammatory bowel disease (e.g., new or worsening abdominal pain, diarrhea, bloody stools, weight loss)
- Symptoms of hypersensitivity/allergic reaction (e.g., rash, hives, swelling of face/lips/tongue/throat, difficulty breathing, dizziness, fainting)
Special Patient Groups
Pregnancy
There is a pregnancy exposure registry for Cosentyx. Limited data from observational studies and postmarketing reports have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Secukinumab is an IgG1 antibody and is expected to cross the placenta, particularly during the third trimester. Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally lower exposure to monoclonal antibodies in the first trimester.
Second Trimester:
Increasing placental transfer of IgG antibodies.
Third Trimester:
Highest placental transfer of IgG antibodies, potentially leading to infant exposure and immunosuppression.
Lactation
Secukinumab is present in human milk. The effects of secukinumab on the breastfed infant and on milk production are unknown. The developmental and health benefits of breastfeeding should be considered along with the motherβs clinical need for Cosentyx and any potential adverse effects on the breastfed infant from Cosentyx or from the underlying maternal condition. Consider the infant's potential for immunosuppression.
Infant Risk:
Low to moderate risk. Monitor breastfed infants for signs of infection.
Pediatric Use
Approved for pediatric plaque psoriasis (β₯6 years) and juvenile psoriatic arthritis/enthesitis-related arthritis (β₯2 years). Dosing is weight-based. Safety and effectiveness in pediatric patients younger than 6 years for plaque psoriasis and younger than 2 years for JPsA/ERA have not been established. Increased risk of infections should be considered.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly subjects (β₯65 years) and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. No dose adjustment is necessary. Monitor for increased risk of infections.
Clinical Information
Clinical Pearls
- Secukinumab is a biologic agent that specifically targets IL-17A, a key cytokine in inflammatory diseases. It is not a general immunosuppressant like corticosteroids.
- Patients should be screened for latent tuberculosis and hepatitis B before starting treatment.
- Live vaccines are contraindicated during treatment with secukinumab and for several months after discontinuation.
- Patients should be educated on the signs and symptoms of serious infections and inflammatory bowel disease, and instructed to seek immediate medical attention if these occur.
- The 150mg/ml prefilled syringe is a common formulation, but some indications require 300mg, which may involve two 150mg injections or a 300mg pen/syringe.
- Adherence to the initial loading dose regimen is crucial for achieving rapid and sustained clinical response.
Alternative Therapies
- Other IL-17A inhibitors (e.g., Ixekizumab, Brodalumab)
- TNF-alpha inhibitors (e.g., Adalimumab, Etanercept, Infliximab, Certolizumab, Golimumab)
- IL-12/23 inhibitors (e.g., Ustekinumab)
- IL-23 inhibitors (e.g., Guselkumab, Risankizumab, Tildrakizumab)
- Oral small molecules (e.g., Apremilast, Tofacitinib, Upadacitinib, Deucravacitinib)
- Conventional DMARDs (e.g., Methotrexate, Sulfasalazine, Leflunomide) for psoriatic arthritis/spondyloarthritis
Cost & Coverage
Average Cost:
Varies significantly, typically several thousand USD per 150mg/ml prefilled 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's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. 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 detailed information about the incident, including the medication taken, the amount, and the time it occurred.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. 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 detailed information about the incident, including the medication taken, the amount, and the time it occurred.