Cosentyx 150mg/ml Sensrdy Pen 1x1ml
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 inflammation in conditions like psoriasis, psoriatic arthritis, and ankylosing spondylitis. By blocking this protein, Cosentyx can help improve your symptoms, such as 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 administered into 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 damaging the skin.
Important Administration Guidelines
Do not inject into skin within 2 inches (5 cm) of the belly button.
Avoid using 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.
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.
* 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 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, but do not freeze.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
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 administered into 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 damaging the skin.
Important Administration Guidelines
Do not inject into skin within 2 inches (5 cm) of the belly button.
Avoid using 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.
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.
* 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 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, but do not freeze.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Avoid live vaccines while on Cosentyx and for a period after stopping, as your immune system may be weakened.
- Report any signs of infection (fever, chills, sore throat, cough, fatigue) to your doctor immediately.
- Inform your healthcare provider about all medications, supplements, and herbal products you are taking.
- Store Cosentyx in the refrigerator, protected from light, and do not freeze.
- Do not shake the pen or syringe.
- 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 SC at Weeks 0, 1, 2, 3, 4, then every 4 weeks. For Psoriatic Arthritis/Ankylosing Spondylitis/Non-radiographic Axial Spondyloarthritis: 150 mg SC at Weeks 0, 1, 2, 3, 4, then every 4 weeks (may increase to 300 mg for PsA if inadequate response). For Hidradenitis Suppurativa: 300 mg SC at Weeks 0, 1, 2, 3, 4, then every 2 weeks.
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 benefit from 150 mg.
Psoriatic Arthritis:
150 mg SC at Weeks 0, 1, 2, 3, 4, then every 4 weeks. For patients with an inadequate response to 150 mg, or with concomitant moderate to severe plaque psoriasis, a dose of 300 mg may be considered.
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:
Approved for pediatric plaque psoriasis (≥6 years, weighing ≥50 kg: 300 mg; <50 kg: 150 mg), pediatric psoriatic arthritis (≥2 years, weight-based dosing), and pediatric enthesitis-related arthritis (≥2 years, weight-based dosing).
Adolescent:
Approved for pediatric plaque psoriasis (≥6 years, weighing ≥50 kg: 300 mg; <50 kg: 150 mg), pediatric psoriatic arthritis (≥2 years, weight-based dosing), and pediatric enthesitis-related arthritis (≥2 years, weight-based dosing).
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No specific dose adjustment recommended based on limited data. Use with caution.
Dialysis:
No specific dose adjustment recommended. Use with caution.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No specific dose adjustment recommended based on limited data. Use with caution.
Pharmacology
Mechanism of Action
Secukinumab is a human IgG1 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.
Pharmacokinetics
Absorption:
Bioavailability:
60-77%
Tmax:
5-7 days
FoodEffect:
Not applicable (subcutaneous administration)
Distribution:
Vd:
7.1-8.6 L
ProteinBinding:
Not applicable (monoclonal antibody, not typically protein bound in the same way as small molecules)
CnssPenetration:
Limited
Elimination:
HalfLife:
22-31 days
Clearance:
0.13-0.19 L/day
ExcretionRoute:
Primarily via catabolism; not renally or hepatically cleared in the traditional sense.
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Clinical improvement seen as early as Week 3 for some indications.
PeakEffect:
Varies by indication and patient, typically within 16 weeks for maximal response.
DurationOfAction:
Maintained with regular dosing (every 2 or 4 weeks).
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ 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 immediately:
+ Rash
+ Itching
+ Dry or leathery skin
+ Small bumps or patches
+ Redness
+ Blisters
+ Peeling
+ Other skin irritation
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you're bothered by any of the following side effects or if they don't go away, contact your doctor or seek medical help:
Common cold symptoms
Nose or throat irritation
Diarrhea
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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 or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ 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 immediately:
+ Rash
+ Itching
+ Dry or leathery skin
+ Small bumps or patches
+ Redness
+ Blisters
+ Peeling
+ Other skin irritation
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you're bothered by any of the following side effects or if they don't go away, contact your doctor or seek medical help:
Common cold symptoms
Nose or throat irritation
Diarrhea
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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, cough, shortness of breath, flu-like symptoms, warm/red/painful skin, open sores on your body.
- Symptoms of inflammatory bowel disease (IBD): new or worsening diarrhea, abdominal pain, bloody stools.
- Signs of allergic reaction: rash, hives, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing, 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 initiate, discontinue, or modify 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 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 initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you have a latex allergy, consult your doctor, as some products may contain latex.
Regular blood tests and other laboratory evaluations should be performed 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, patients taking this medication may experience the reactivation of certain infections, including 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 drug.
Ensure that you are up to date with all recommended vaccinations before starting treatment with this medication. However, consult your doctor before receiving any vaccines, as some vaccines may not be effective or may increase the risk of infection when used in conjunction 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 has been associated with the development or worsening of 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 both you and your baby.
Regular blood tests and other laboratory evaluations should be performed 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, patients taking this medication may experience the reactivation of certain infections, including 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 drug.
Ensure that you are up to date with all recommended vaccinations before starting treatment with this medication. However, consult your doctor before receiving any vaccines, as some vaccines may not be effective or may increase the risk of infection when used in conjunction 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 has been associated with the development or worsening of 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 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 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).
Drug Interactions
Major Interactions
- Live vaccines (e.g., BCG, MMR, Varicella, Yellow Fever): Avoid concurrent administration due to potential for infection.
Moderate Interactions
- Non-live vaccines: May result in a diminished immune response to vaccination.
- Immunosuppressants (e.g., cyclosporine, methotrexate, corticosteroids): Potential for increased risk of infection, though often used concomitantly in clinical practice under close monitoring.
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening
Rationale: To rule out latent or active TB infection before initiating treatment, 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 secukinumab may reactivate HBV.
Timing: Prior to initiation of therapy
Complete Blood Count (CBC) with differential
Rationale: To establish baseline hematologic parameters.
Timing: Prior to initiation of therapy
Liver Function Tests (LFTs)
Rationale: To establish baseline hepatic parameters.
Timing: Prior to initiation of therapy
Routine Monitoring
Signs and symptoms of infection
Frequency: Continuously
Target: Absence of infection
Action Threshold: Promptly evaluate and treat any new infection.
New or worsening inflammatory bowel disease (IBD) symptoms
Frequency: Continuously
Target: Absence of IBD symptoms or stable disease
Action Threshold: Discontinue secukinumab if new or worsening IBD symptoms occur.
Hypersensitivity reactions
Frequency: Continuously, especially after injection
Target: Absence of allergic reaction
Action Threshold: Discontinue immediately if severe allergic reaction occurs.
Symptom Monitoring
- Fever
- Chills
- Sore throat
- Cough
- Fatigue
- Skin lesions (new or worsening)
- Diarrhea
- Abdominal pain
- Rectal bleeding
- Shortness of breath
- Swelling of face, lips, tongue, or throat
- Difficulty breathing or swallowing
- Dizziness or fainting
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. A pregnancy exposure registry is available. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data, potential risk unknown.
Second Trimester:
Limited data, potential risk unknown.
Third Trimester:
Limited data, potential risk unknown. Monoclonal antibodies are transported across the placenta in increasing amounts during the third trimester, which may affect infant immune response.
Lactation
Secukinumab is present in human milk. The effects of secukinumab on the breastfed infant and on milk production are unknown. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for secukinumab and any potential adverse effects on the breastfed infant from secukinumab or from the underlying maternal condition.
Infant Risk:
L3 (Moderate risk - no controlled studies in lactating women; potential for infant exposure and effects on immune system are unknown but possible).
Pediatric Use
Approved for pediatric plaque psoriasis (≥6 years), pediatric psoriatic arthritis (≥2 years), and pediatric enthesitis-related arthritis (≥2 years). Dosing is weight-based for some indications. Safety and effectiveness in pediatric patients younger than 2 years of age with PsA and ERA, and younger than 6 years of age with plaque psoriasis, have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly patients (≥65 years) and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Monitor for increased risk of serious infections.
Clinical Information
Clinical Pearls
- Secukinumab is a biologic agent that specifically targets IL-17A, a key cytokine in inflammatory pathways of psoriasis, psoriatic arthritis, and ankylosing spondylitis.
- Patients should be screened for tuberculosis (TB) and Hepatitis B (HBV) prior to initiation of therapy.
- Live vaccines should be avoided during treatment with secukinumab.
- Patients should be advised to report any signs or symptoms of infection promptly.
- There have been postmarketing reports of new or worsening inflammatory bowel disease (Crohn's disease and ulcerative colitis) with secukinumab. Patients should be monitored for these symptoms.
- The Sensrdy Pen is designed for ease of use, but proper injection technique should be taught and confirmed by a healthcare professional.
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)
- JAK inhibitors (e.g., Tofacitinib, Upadacitinib)
- PDE4 inhibitors (e.g., Apremilast)
- Conventional DMARDs (e.g., Methotrexate, Sulfasalazine, Leflunomide)
Cost & Coverage
Average Cost:
$6,000 - $7,500 per 150mg/ml Sensrdy Pen (2 pens per month for 300mg dose)
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy, and/or quantity limits)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information. 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.