Cosentyx 150mg/ml Sensrdy Pen 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
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 plays a role in causing conditions like psoriasis, psoriatic arthritis, and ankylosing spondylitis. 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, the outer area of the upper arm may also be used.
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 minimize the risk of skin irritation.
Important Administration Guidelines
Avoid injecting into skin within 2 inches (5 cm) of the belly button.
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 if the color changes.
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.
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 may vary depending on the 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 or concerns, consult your doctor or pharmacist.
Storage
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 for guidance on the appropriate 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, the outer area of the upper arm may also be used.
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 minimize the risk of skin irritation.
Important Administration Guidelines
Avoid injecting into skin within 2 inches (5 cm) of the belly button.
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 if the color changes.
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.
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 may vary depending on the 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 or concerns, consult your doctor or pharmacist.
Storage
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 for guidance on the appropriate course of action.
Lifestyle & Tips
- Avoid live vaccines while on 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 bloody stools, as this could be a sign of inflammatory bowel disease.
- Maintain good hygiene to reduce the risk of infection.
- Follow proper injection technique as instructed by your healthcare provider.
- Store Cosentyx in the refrigerator, protect from light, and do not freeze.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication. For Plaque Psoriasis: 300 mg SC at Weeks 0, 1, 2, 3, 4, then every 4 weeks. For Psoriatic Arthritis/Ankylosing Spondylitis/Non-radiographic axial SpA: 150 mg SC at Weeks 0, 1, 2, 3, 4, then every 4 weeks. For Hidradenitis Suppurativa: 300 mg SC at Weeks 0, 1, 2, 3, 4, then every 2 weeks.
Dose Range:
75 - 300 mg
Condition-Specific Dosing:
Plaque Psoriasis:
300 mg SC (some patients may benefit from 150 mg). Initial loading dose: Weeks 0, 1, 2, 3, 4. Maintenance: every 4 weeks.
Psoriatic Arthritis:
150 mg SC. Initial loading dose: Weeks 0, 1, 2, 3, 4. Maintenance: every 4 weeks. For patients with coexistent moderate to severe plaque psoriasis or who are anti-TNFΞ± inadequate responders, 300 mg.
Ankylosing Spondylitis:
150 mg SC. Initial loading dose: Weeks 0, 1, 2, 3, 4. Maintenance: every 4 weeks.
Non-radiographic axial Spondyloarthritis:
150 mg SC. Initial loading dose: Weeks 0, 1, 2, 3, 4. Maintenance: every 4 weeks.
Hidradenitis Suppurativa:
300 mg SC. Initial loading dose: Weeks 0, 1, 2, 3, 4. Maintenance: every 2 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For Plaque Psoriasis (β₯6 years): β₯50 kg: 150 mg or 300 mg SC. <50 kg: 75 mg SC. Initial loading dose: Weeks 0, 1, 2, 3, 4. Maintenance: every 4 weeks. For Psoriatic Arthritis (β₯2 years): β₯50 kg: 150 mg or 300 mg SC. <50 kg: 75 mg SC. Initial loading dose: Weeks 0, 1, 2, 3, 4. Maintenance: every 4 weeks. For Enthesitis-Related Arthritis (ERA) and Juvenile Psoriatic Arthritis (JPsA) (β₯2 years): β₯50 kg: 150 mg or 300 mg SC. <50 kg: 75 mg SC. Initial loading dose: Weeks 0, 1, 2, 3, 4. Maintenance: every 4 weeks.
Adolescent:
Same as child dosing for approved indications (Plaque Psoriasis, Psoriatic Arthritis, ERA, JPsA) based on weight.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment necessary.
Moderate:
No dose adjustment necessary.
Severe:
No dose adjustment necessary.
Dialysis:
No specific recommendations; secukinumab is a large protein and not expected to be removed by dialysis.
Hepatic Impairment:
Mild:
No dose adjustment necessary.
Moderate:
No dose adjustment necessary.
Severe:
No dose adjustment necessary.
Pharmacology
Mechanism of Action
Secukinumab is a human IgG1 monoclonal antibody that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Secukinumab inhibits the release of pro-inflammatory cytokines and chemokines, and reduces the expression of adhesion molecules by blocking IL-17A, thereby reducing inflammation and clinical symptoms in conditions like psoriasis, psoriatic arthritis, and ankylosing spondylitis.
Pharmacokinetics
Absorption:
Bioavailability:
60-77% (subcutaneous)
Tmax:
6-7 days (subcutaneous)
FoodEffect:
Not applicable (subcutaneous administration, not affected by food).
Distribution:
Vd:
7.1-8.6 L (central compartment)
ProteinBinding:
Not specifically bound to plasma proteins; as a monoclonal antibody, it is catabolized like endogenous IgG.
CnssPenetration:
Limited (large molecular weight monoclonal antibody).
Elimination:
HalfLife:
22-31 days
Clearance:
0.13-0.24 L/day
ExcretionRoute:
Catabolism and elimination via reticuloendothelial system; not renally or hepatically cleared in the traditional sense.
Unchanged:
Not applicable (catabolized)
Pharmacodynamics
OnsetOfAction:
Clinical improvement observed within weeks (e.g., 3-4 weeks for psoriasis).
PeakEffect:
Peak clinical response typically seen by 12-16 weeks.
DurationOfAction:
Maintained with every 4-week dosing; half-life supports prolonged effect.
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. Many people may not experience any side effects or may only have mild ones. 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, 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. Many people may not experience any side effects or may only have mild ones. 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, 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 (e.g., high fever, chills, severe cough, shortness of breath, flu-like symptoms, warm/red/painful skin lesions)
- Symptoms of inflammatory bowel disease (e.g., persistent abdominal pain, diarrhea, bloody stools, weight loss)
- Signs of allergic reaction (e.g., rash, hives, swelling of face/lips/tongue/throat, difficulty breathing, dizziness, feeling faint)
- New or worsening joint pain or swelling (if not the primary condition being treated)
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 adjust the dosage of any medication without first consulting your doctor to ensure your safety and the effectiveness of your treatment.
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 adjust the dosage of any medication without first consulting your doctor to ensure your safety and the effectiveness of your treatment.
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. Be aware that 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 either of these infections, inform your doctor. A TB test is required before initiating treatment with this medication.
Ensure you are up to date with all recommended vaccinations before starting treatment. However, consult your doctor before receiving any vaccines, as some 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 the potential risks with your doctor. This medication can cause new or worsening inflammatory bowel disease, which can be severe in some cases.
If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to you and your baby.
Regular blood tests and other laboratory examinations are crucial, as directed by your doctor. Be aware that 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 either of these infections, inform your doctor. A TB test is required before initiating treatment with this medication.
Ensure you are up to date with all recommended vaccinations before starting treatment. However, consult your doctor before receiving any vaccines, as some 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 the potential risks with your doctor. This medication can cause new or worsening inflammatory bowel disease, which can be severe in some cases.
If you are pregnant, planning to become pregnant, or breastfeeding, consult 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 suspected overdose, contact a poison control center (1-800-222-1222) or seek emergency medical attention. Management should be supportive and directed toward the patient's symptoms.
Drug Interactions
Contraindicated Interactions
- Live vaccines (e.g., MMR, varicella, rotavirus, yellow fever, live attenuated influenza vaccine) - due to potential for infection.
Major Interactions
- Other immunosuppressants (e.g., cyclosporine, methotrexate, corticosteroids, other biologics) - increased risk of serious infections.
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening
Rationale: To rule out latent or active TB infection before initiating therapy, as secukinumab may reactivate latent TB.
Timing: Prior to initiation of therapy.
Hepatitis B Virus (HBV) screening
Rationale: To rule out active or chronic HBV infection, as reactivation has been reported with other immunosuppressants.
Timing: Prior to initiation of therapy.
Infection assessment
Rationale: To ensure no active serious infections are present before starting treatment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Signs and symptoms of infection
Frequency: Regularly throughout therapy and after discontinuation.
Target: Absence of fever, chills, malaise, new or worsening cough, dysuria, skin lesions.
Action Threshold: Prompt evaluation and potential interruption of therapy if serious infection develops.
Symptoms of inflammatory bowel disease (IBD)
Frequency: Regularly throughout therapy.
Target: Absence of new or worsening abdominal pain, diarrhea, bloody stools.
Action Threshold: Prompt evaluation and potential discontinuation if new or worsening IBD symptoms occur.
Hypersensitivity reactions
Frequency: Especially during and immediately after injection.
Target: Absence of rash, urticaria, dyspnea, hypotension, angioedema.
Action Threshold: Discontinue immediately and manage appropriately if severe reaction occurs.
Symptom Monitoring
- Signs of infection (fever, chills, malaise, persistent cough, skin redness/swelling, painful urination)
- Symptoms of inflammatory bowel disease (new or worsening abdominal pain, diarrhea, bloody stools)
- Signs of allergic reaction (rash, hives, difficulty breathing, swelling of face/lips/tongue/throat, dizziness)
- Injection site reactions (redness, swelling, pain, itching)
Special Patient Groups
Pregnancy
Limited data from clinical trials and postmarketing reports on secukinumab use in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. A pregnancy exposure registry is available (Novartis Pharmaceuticals Corporation at 1-855-840-0230). Animal studies have not shown direct harmful effects on pregnancy or fetal development.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies show no direct harm. As an IgG1 antibody, placental transfer is minimal during the first trimester.
Second Trimester:
Placental transfer of IgG1 antibodies increases during the second trimester.
Third Trimester:
Significant placental transfer of IgG1 antibodies occurs, potentially exposing the fetus to secukinumab. Consider potential effects on infant immune response, including vaccination.
Lactation
Limited data suggest that secukinumab is present in human milk. The effects of secukinumab on the breastfed infant or on milk production 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. IgG antibodies are known to be present in human milk but are generally poorly absorbed orally by the infant.
Infant Risk:
L3 (Moderately Safe - Limited human data, potential for minor, non-serious adverse effects or no effects expected due to poor oral absorption of large molecules).
Pediatric Use
Approved for pediatric plaque psoriasis (β₯6 years), psoriatic arthritis (β₯2 years), and enthesitis-related arthritis/juvenile psoriatic 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 psoriatic arthritis/ERA/JPsA have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly patients (β₯65 years) and younger adult patients. However, the number of patients aged 75 years and older was not sufficient to determine whether they respond differently from younger patients. Use with caution in elderly patients due to the generally greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Clinical Information
Clinical Pearls
- Patients should be screened for tuberculosis (TB) infection prior to initiating Cosentyx and monitored for signs and symptoms of active TB during and after treatment.
- Cosentyx may increase the risk of infections. Patients should be advised to seek medical attention if signs or symptoms of infection occur.
- Cases of new or exacerbation of inflammatory bowel disease (Crohn's disease and ulcerative colitis) have been reported. Patients should be monitored for IBD symptoms.
- Live vaccines are contraindicated during Cosentyx treatment. Patients should be up-to-date on all immunizations prior to initiating therapy.
- Patients should be trained on proper subcutaneous injection technique and needle disposal.
- Cosentyx is available in various formulations (Sensrdy Pen, Prefilled Syringe, Vial) which may have different dosing concentrations or administration methods.
Alternative Therapies
- Other IL-17 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)
- JAK inhibitors (e.g., tofacitinib, upadacitinib, baricitinib)
- PDE4 inhibitors (e.g., apremilast)
- Conventional DMARDs (e.g., methotrexate, cyclosporine, acitretin, sulfasalazine, leflunomide)
Cost & Coverage
Average Cost:
Typically >$6,000 - $10,000 per month/dose per 2x1ml pen/syringe (300mg total)
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy, and often limited to specific pharmacies).
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult 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 overdose, including the substance taken, the amount, and the time it occurred.