Cosentyx Unoready 300mg/2ml Autoinj
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
Pregnancy Category
Not available
FDA Approved
Jan 2015
DEA Schedule
Not Controlled
Overview
What is this medicine?
Cosentyx (secukinumab) 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 ankylosing spondylitis. It is given as an injection under the skin.
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. To minimize the risk of irritation, rotate the injection site with each use.
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 (30 to 45 minutes). Do not heat the medication.
Single-Use Devices
Each prefilled pen or syringe is for one 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.
Storage and Disposal
Store the medication in a refrigerator, but do not freeze. If you have any questions or concerns, consult your doctor or pharmacist.
Missing a 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. To minimize the risk of irritation, rotate the injection site with each use.
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 (30 to 45 minutes). Do not heat the medication.
Single-Use Devices
Each prefilled pen or syringe is for one 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.
Storage and Disposal
Store the medication in a refrigerator, but do not freeze. If you have any questions or concerns, consult your doctor or pharmacist.
Missing a Dose
If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Avoid live vaccines while on this medication.
- Report any signs of infection (fever, chills, persistent cough) to your doctor immediately.
- Report any new or worsening stomach pain, diarrhea, or blood in your stool.
- Store medication in the refrigerator, do not freeze. Protect from light.
- Follow proper injection technique as instructed by your healthcare provider.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication. For plaque psoriasis: 300 mg subcutaneously at Weeks 0, 1, 2, 3, and 4, followed by 300 mg every 4 weeks. For psoriatic arthritis/ankylosing spondylitis/non-radiographic axial spondyloarthritis: 150 mg subcutaneously at Weeks 0, 1, 2, 3, and 4, followed by 150 mg every 4 weeks. Some patients with psoriatic arthritis may benefit from 300 mg. For hidradenitis suppurativa: 300 mg subcutaneously at Weeks 0, 1, 2, 3, and 4, followed by 300 mg every 4 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.
Psoriatic Arthritis:
150 mg SC at Weeks 0, 1, 2, 3, 4, then every 4 weeks. May increase to 300 mg if inadequate response.
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 4 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For plaque psoriasis (≥6 years and ≥50 kg): 300 mg SC at Weeks 0, 1, 2, 3, 4, then every 4 weeks. For plaque psoriasis (≥6 years and <50 kg): 150 mg SC at Weeks 0, 1, 2, 3, 4, then every 4 weeks. For psoriatic arthritis (≥2 years): 75 mg or 150 mg based on weight.
Adolescent:
Dosing as per child or adult guidelines depending on weight and indication.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No specific adjustment recommended, but caution and close monitoring advised due to limited data.
Dialysis:
No specific adjustment recommended, but caution and close monitoring advised due to limited data.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No specific adjustment recommended, but caution and close monitoring advised due to limited data.
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 associated with diseases like plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis.
Pharmacokinetics
Absorption:
Bioavailability:
60-77%
Tmax:
6-7 days
FoodEffect:
Not applicable (subcutaneous administration)
Distribution:
Vd:
7.1-8.6 L
ProteinBinding:
Not applicable (monoclonal antibody)
CnssPenetration:
Limited
Elimination:
HalfLife:
22-31 days
Clearance:
0.13-0.19 L/day
ExcretionRoute:
Not applicable (catabolized)
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Clinical improvement seen as early as Week 3 for some indications (e.g., psoriasis).
PeakEffect:
Typically observed by Week 16 for full therapeutic effect.
DurationOfAction:
Maintained with every 4-week dosing.
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 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 include:
+ 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 experience no side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Signs of a common cold
Nose or throat irritation
Diarrhea
Reporting Side Effects
This list is not exhaustive, and you may experience other 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 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 include:
+ 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 experience no side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Signs of a common cold
Nose or throat irritation
Diarrhea
Reporting Side Effects
This list is not exhaustive, and you may experience other 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 (e.g., high fever, chills, persistent cough, shortness of breath, skin warmth/redness/pain)
- Symptoms of inflammatory bowel disease (e.g., new or worsening abdominal pain, persistent diarrhea, blood in stool, weight loss)
- Signs of allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing, dizziness)
- Severe injection site reactions (e.g., spreading redness, severe pain, pus)
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 concerns with your doctor.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your complete medical history, including any health problems you have
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any medication, consult with your doctor to confirm it is safe to do so.
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 concerns with your doctor.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your complete medical history, including any health problems you have
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any medication, consult with your doctor to confirm it is safe to do so.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests and other laboratory evaluations should be performed as directed by your doctor to monitor your condition.
As this medication may increase your risk of developing infections, it is crucial to take precautions to minimize this risk. Some infections can be severe or even life-threatening. To reduce your risk of infection, wash your hands frequently and avoid close contact with individuals who have infections, colds, or flu.
Additionally, be aware that certain infections, such as tuberculosis (TB) and hepatitis B, may reactivate in patients taking this type of medication. If you have a history of either of these infections, inform your doctor. A TB test is required before initiating treatment with this drug.
Before starting treatment, ensure that you are up to date with all recommended vaccinations. 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 the potential risks and benefits 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 with your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
As this medication may increase your risk of developing infections, it is crucial to take precautions to minimize this risk. Some infections can be severe or even life-threatening. To reduce your risk of infection, wash your hands frequently and avoid close contact with individuals who have infections, colds, or flu.
Additionally, be aware that certain infections, such as tuberculosis (TB) and hepatitis B, may reactivate in patients taking this type of medication. If you have a history of either of these infections, inform your doctor. A TB test is required before initiating treatment with this drug.
Before starting treatment, ensure that you are up to date with all recommended vaccinations. 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 the potential risks and benefits 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 with 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 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).
Drug Interactions
Contraindicated Interactions
- Live vaccines (e.g., BCG, measles, mumps, rubella, varicella, yellow fever, rotavirus, oral typhoid, live attenuated influenza vaccine) - due to potential for infection.
Moderate Interactions
- Non-live vaccines (e.g., inactivated influenza, pneumococcal) - may result in a diminished immune response to vaccination. Consider administering non-live vaccines prior to initiating secukinumab or during a treatment holiday if feasible.
Confidence Interactions
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening (e.g., PPD or IGRA)
Rationale: To rule out latent or active TB infection before initiating an immunosuppressive agent.
Timing: Prior to initiation of therapy.
Hepatitis B Virus (HBV) screening
Rationale: To assess for active or chronic HBV infection, as reactivation can occur with immunosuppression.
Timing: Prior to initiation of therapy.
Complete Blood Count (CBC) with differential
Rationale: To establish baseline hematologic parameters, though significant changes are rare.
Timing: Prior to initiation of therapy.
Liver function tests (LFTs)
Rationale: To establish baseline liver function, though significant changes are rare.
Timing: Prior to initiation of therapy.
Routine Monitoring
Signs and symptoms of infection (e.g., fever, cough, malaise)
Frequency: Regularly, at each patient visit and patient self-monitoring.
Target: Absence of infection.
Action Threshold: Prompt evaluation and treatment if infection suspected; consider temporary discontinuation of secukinumab.
Symptoms of inflammatory bowel disease (IBD) (e.g., new or worsening abdominal pain, diarrhea, blood in stool)
Frequency: Regularly, at each patient visit and patient self-monitoring.
Target: Absence of IBD symptoms.
Action Threshold: Prompt evaluation if IBD symptoms develop or worsen; consider discontinuation if IBD is confirmed.
Injection site reactions
Frequency: Regularly, at each patient visit and patient self-monitoring.
Target: Minimal or no reaction.
Action Threshold: Educate patient on proper injection technique; manage symptoms if severe.
Symptom Monitoring
- Signs of serious infection (e.g., persistent fever, chills, severe cough, shortness of breath)
- Symptoms of inflammatory bowel disease (e.g., new or worsening abdominal pain, diarrhea, blood in stool)
- Signs of allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)
- Injection site reactions (e.g., 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. 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.
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. Due to its large molecular weight, transfer into milk is expected to be low, and oral absorption by the infant is unlikely.
Infant Risk:
Low risk (L3)
Pediatric Use
Approved for plaque psoriasis in patients ≥6 years of age and for psoriatic arthritis in patients ≥2 years of age. Dosing is weight-based for some pediatric indications. 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 patients (≥65 years) and younger patients, but greater sensitivity of some older individuals cannot be ruled out. No dose adjustment is necessary.
Clinical Information
Clinical Pearls
- Secukinumab is a biologic agent that specifically targets IL-17A, a key cytokine in inflammatory diseases.
- Patients should be screened for tuberculosis (TB) and Hepatitis B (HBV) before starting therapy.
- Live vaccines are contraindicated during treatment with secukinumab.
- Patients should be advised to report any signs of infection or new/worsening inflammatory bowel disease symptoms.
- The 300mg/2ml autoinjector is designed for patient self-administration after proper training.
- Adherence to the loading dose regimen is crucial for achieving rapid and sustained response in many patients.
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, 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:
Highly variable, typically several thousand USD per month per 300mg/2ml autoinjector
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. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, 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 details about the overdose, including the medication taken, the amount, and the time it occurred.