Cosentyx 150mg/ml Pf Syr 2x1ml
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
Immunosuppressants, Monoclonal Antibodies
Pharmacologic Class
Interleukin-17A (IL-17A) Inhibitors
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 plays a role in conditions like psoriasis, psoriatic arthritis, and certain types of arthritis in the spine. By blocking this protein, Cosentyx helps to reduce skin plaques, joint pain, and stiffness.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. 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 giving you the injection, it may 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. Avoid injecting within 2 inches (5 cm) of the belly button.
Important Safety Precautions
Do not use the medication if the solution appears cloudy, is leaking, or contains particles. The solution should be colorless to faintly yellow; do not use it if the color changes. Avoid injecting into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks. Psoriatic skin areas should also be avoided.
Do not shake the medication. If the device has been dropped or is damaged, do not use it. Before administering the dose, 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 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 below freezing. If you miss a dose, contact your doctor for guidance on what to do next.
To use this medication correctly, follow your doctor's instructions and read all the information provided. 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 giving you the injection, it may 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. Avoid injecting within 2 inches (5 cm) of the belly button.
Important Safety Precautions
Do not use the medication if the solution appears cloudy, is leaking, or contains particles. The solution should be colorless to faintly yellow; do not use it if the color changes. Avoid injecting into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks. Psoriatic skin areas should also be avoided.
Do not shake the medication. If the device has been dropped or is damaged, do not use it. Before administering the dose, 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 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 below freezing. If you miss a dose, contact your doctor for guidance on what to do next.
Lifestyle & Tips
- Avoid live vaccines while taking Cosentyx.
- Report any signs of infection (fever, chills, persistent cough, skin sores) to your doctor immediately.
- Report any new or worsening stomach pain, diarrhea, or blood in your stool.
- Store Cosentyx in the refrigerator (2Β°C to 8Β°C / 36Β°F to 46Β°F) in its original carton to protect from light. Do not freeze.
- Allow the prefilled syringe or pen to reach room temperature for 15-30 minutes before injecting. Do not warm it in any other way.
- Follow proper injection technique as instructed by your healthcare provider.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication. For Psoriasis: 300 mg (two 150 mg injections) SC at Weeks 0, 1, 2, 3, and 4, then every 4 weeks. For Psoriatic Arthritis/Ankylosing Spondylitis/Non-radiographic Axial Spondyloarthritis: 150 mg SC at Weeks 0, 1, 2, 3, and 4, then every 4 weeks. Some patients with PsA may benefit from 300 mg.
Dose Range:
150 - 300 mg
Condition-Specific Dosing:
Plaque Psoriasis:
300 mg SC at Weeks 0, 1, 2, 3, and 4, then every 4 weeks. For some patients, 150 mg may be sufficient.
Psoriatic Arthritis:
150 mg SC at Weeks 0, 1, 2, 3, and 4, then every 4 weeks. For patients who are TNF-alpha inhibitor inadequate responders or have concomitant moderate to severe plaque psoriasis, 300 mg may be considered.
Ankylosing Spondylitis:
150 mg SC at Weeks 0, 1, 2, 3, and 4, then every 4 weeks.
Non-radiographic Axial Spondyloarthritis:
150 mg SC at Weeks 0, 1, 2, 3, and 4, then every 4 weeks.
Enthesitis-Related Arthritis (ERA):
150 mg SC at Weeks 0, 1, 2, 3, and 4, then every 4 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For Enthesitis-Related Arthritis (ERA) in patients β₯4 years and weighing β₯50 kg: 150 mg SC at Weeks 0, 1, 2, 3, and 4, then every 4 weeks. For patients weighing <50 kg: 75 mg SC at Weeks 0, 1, 2, 3, and 4, then every 4 weeks. For Plaque Psoriasis in patients β₯6 years and weighing β₯50 kg: 150 mg SC at Weeks 0, 1, 2, 3, and 4, then every 4 weeks. For patients weighing <50 kg: 75 mg SC at Weeks 0, 1, 2, 3, and 4, then every 4 weeks.
Adolescent:
Dosing as per adult recommendations for weight-based dosing in pediatric indications (e.g., β₯50 kg for ERA/Plaque Psoriasis).
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific recommendations; secukinumab is a large protein and not expected to be removed by dialysis.
Hepatic Impairment:
Mild:
No adjustment
Moderate:
No adjustment
Severe:
No adjustment
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 associated with psoriasis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and enthesitis-related arthritis.
Pharmacokinetics
Absorption:
Bioavailability:
60-77% (subcutaneous)
Tmax:
6-7 days (single dose)
FoodEffect:
Not applicable (subcutaneous administration)
Distribution:
Vd:
7.1-8.6 L (central compartment)
ProteinBinding:
Not applicable (monoclonal antibody, not extensively protein bound in the traditional sense)
CnssPenetration:
Limited
Elimination:
HalfLife:
22-31 days (mean terminal half-life)
Clearance:
0.13-0.19 L/day
ExcretionRoute:
Catabolism (reticuloendothelial system)
Unchanged:
Not applicable (catabolized)
Pharmacodynamics
OnsetOfAction:
Clinical improvement observed as early as Week 3 for psoriasis, Week 4 for psoriatic arthritis/ankylosing spondylitis.
PeakEffect:
Varies by endpoint; typically by Week 12-16 for maximal response in psoriasis, and sustained response in other indications.
DurationOfAction:
Maintained with regular dosing (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 experience any of the following side effects or any other symptoms that bother you or 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, contact your doctor. For medical advice about side effects, you can also call your doctor. Additionally, you can 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 experience any of the following side effects or any other symptoms that bother you or 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, contact your doctor. For medical advice about side effects, you can also call your doctor. Additionally, you can 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, painful urination.
- Symptoms of inflammatory bowel disease: persistent diarrhea, severe abdominal pain, blood in stool, unexplained weight loss.
- Signs of allergic reaction: rash, hives, swelling of face/lips/tongue/throat, difficulty breathing, dizziness, feeling faint.
- New or worsening joint pain or swelling.
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 health conditions and medications with your doctor.
To ensure your safety, please disclose all of the following to your doctor and pharmacist:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
All your health problems, including any medical conditions or diseases
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm it is safe to do so. This will help prevent any potential interactions or adverse effects.
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 health conditions and medications with your doctor.
To ensure your safety, please disclose all of the following to your doctor and pharmacist:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
All your health problems, including any medical conditions or diseases
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm it is safe to do so. This will help prevent any potential interactions or adverse effects.
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 your doctor, as some products may contain latex.
Regular blood tests and other laboratory examinations are crucial, as directed by your doctor. This medication may increase your 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, be aware that this medication can reactivate certain infections, such as tuberculosis (TB) and hepatitis B. If you have a history of these infections, inform your doctor, and undergo a TB test before starting treatment.
Ensure you are up-to-date with all recommended vaccinations before beginning treatment with this medication. However, consult your doctor before receiving any vaccines, as some may not be effective or may increase the risk of infection when used concurrently with this drug.
If you have a history of inflammatory bowel disease, such as ulcerative colitis or Crohn's disease, discuss the potential risks with your doctor, as this medication can exacerbate or trigger new cases of these conditions.
If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Regular blood tests and other laboratory examinations are crucial, as directed by your doctor. This medication may increase your 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, be aware that this medication can reactivate certain infections, such as tuberculosis (TB) and hepatitis B. If you have a history of these infections, inform your doctor, and undergo a TB test before starting treatment.
Ensure you are up-to-date with all recommended vaccinations before beginning treatment with this medication. However, consult your doctor before receiving any vaccines, as some may not be effective or may increase the risk of infection when used concurrently with this drug.
If you have a history of inflammatory bowel disease, such as ulcerative colitis or Crohn's disease, discuss the potential risks with your doctor, as this medication can exacerbate or trigger new cases of these conditions.
If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both 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 suspected overdose, monitor the patient for any signs or symptoms of adverse reactions and administer appropriate symptomatic treatment. Call 1-800-222-1222 (Poison Control Center) for further guidance.
Drug Interactions
Major Interactions
- Live vaccines (e.g., BCG, measles, mumps, rubella, polio, rotavirus, yellow fever, varicella, zoster, typhoid). Co-administration is not recommended due to potential for infection.
Moderate Interactions
- Immunosuppressants (e.g., cyclosporine, methotrexate): Potential for increased risk of infection. Use with caution.
- Other biologics targeting the immune system: Increased risk of infection and serious adverse events. Avoid concomitant use.
Confidence Interactions
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening (latent and active)
Rationale: Secukinumab may increase the risk of infection, including reactivation of latent TB. Patients should be evaluated for TB infection prior to initiating treatment.
Timing: Prior to initiation of therapy
Hepatitis B and C screening
Rationale: Although not specifically required, good clinical practice for immunosuppressive therapies.
Timing: Prior to initiation of therapy
Inflammatory Bowel Disease (IBD) history
Rationale: Secukinumab has been associated with new onset or exacerbation of IBD. Assess patient history.
Timing: Prior to initiation of therapy
Routine Monitoring
Signs and symptoms of infection (e.g., fever, cough, malaise, skin lesions)
Frequency: Regularly throughout treatment and for several weeks after discontinuation
Target: Absence of infection
Action Threshold: Promptly evaluate and treat any signs of serious infection; consider temporary or permanent discontinuation of secukinumab.
Signs and symptoms of inflammatory bowel disease (e.g., abdominal pain, diarrhea, weight loss)
Frequency: Regularly throughout treatment
Target: Absence of IBD symptoms
Action Threshold: If new onset or exacerbation of IBD occurs, discontinue secukinumab and initiate appropriate medical management.
Injection site reactions
Frequency: At each visit or as reported by patient
Target: Minimal or no reaction
Action Threshold: Educate patient on proper injection technique; manage symptoms if severe.
Symptom Monitoring
- Signs of infection (fever, chills, persistent cough, shortness of breath, skin warmth/redness/pain, painful urination)
- Symptoms of inflammatory bowel disease (persistent diarrhea, abdominal pain, blood in stool, weight loss)
- Symptoms of allergic reaction (rash, hives, swelling of face/lips/tongue/throat, difficulty breathing)
- Injection site reactions (redness, swelling, pain, itching at injection site)
Special Patient Groups
Pregnancy
Limited data on secukinumab use in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. Human IgG antibodies are known to cross the placental barrier; therefore, secukinumab may be transferred from the mother to the developing fetus. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data, theoretical risk of immune modulation.
Second Trimester:
Increased placental transfer of IgG antibodies, potential for fetal exposure.
Third Trimester:
Highest placental transfer of IgG antibodies, potential for fetal exposure and impact on neonatal immune system.
Lactation
Limited data from published literature suggest that secukinumab is present in human milk at low levels. The effects of local gastrointestinal exposure and the limited systemic exposure in the breastfed infant are unknown. Consider the developmental and health benefits of breastfeeding 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.
Infant Risk:
Low risk due to large molecular weight (unlikely to pass into milk in significant amounts) and likely degradation in infant GI tract if ingested. Monitor infant for signs of infection.
Pediatric Use
Approved for pediatric patients aged β₯4 years with Enthesitis-Related Arthritis (ERA) and β₯6 years with moderate to severe plaque psoriasis. Dosing is weight-based. Safety and effectiveness in pediatric patients with other indications or younger ages have not been established.
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.
Clinical Information
Clinical Pearls
- Secukinumab is an IL-17A inhibitor, distinct from TNF inhibitors, offering an alternative mechanism of action for patients who fail other biologics.
- Patients should be screened for latent tuberculosis (TB) before starting treatment and monitored for signs of active TB during therapy.
- Increased risk of infections, particularly upper respiratory tract infections and candidiasis (oral/mucocutaneous). Educate patients on symptoms and hygiene.
- There is a reported risk of new onset or exacerbation of inflammatory bowel disease (Crohn's disease or ulcerative colitis). Patients with a history of IBD should be monitored closely.
- Live vaccines are contraindicated during secukinumab treatment. Patients should complete all age-appropriate immunizations prior to initiation.
- The 150 mg/ml prefilled syringe/pen is designed for patient self-administration after proper training. Ensure patients understand proper storage and injection technique.
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)
- PDE4 inhibitors (e.g., Apremilast)
- JAK inhibitors (e.g., Tofacitinib, Upadacitinib)
- Conventional DMARDs (e.g., Methotrexate, Cyclosporine, Acitretin, Sulfasalazine, Leflunomide)
Cost & Coverage
Average Cost:
Price varies significantly; typically several thousand USD per 150 mg/ml prefilled syringe/pen
Insurance Coverage:
Specialty Tier (requires prior authorization and often step therapy)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, we encourage you 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. When seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.