Cosentyx

What is Cosentyx?

Cosentyx (secukinumab) is a prescription medicine used to treat plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and other inflammatory autoimmune conditions.

Cosentyx helps reduce skin lesions, joint pain, swelling, and spine inflammation by blocking interleukin-17A (IL-17A), a protein involved in immune and inflammatory responses. Cosentyx is a monoclonal antibody that acts as an interleukin-17A antagonist.

Cosentyx is administered once a month as a subcutaneous injection (under the skin), after an initial loading period. It can also be given as an intravenous (IV) Infusion for adults with psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis (nr-axSpA).

What is Cosentyx used for?

Cosentyx is FDA-approved to be used for:

• Plaque psoriasis: Moderate to severe, affecting large or multiple areas of the body, in patients 6 years and older who are candidates for systemic therapy or phototherapy.
• Psoriatic arthritis (PsA): Active disease in patients 2 years and older.
• Ankylosing spondylitis (AS): Active disease in adults.
• Non-radiographic axial spondyloarthritis (nr-axSpA): Active disease in adults with objective signs of inflammation.
• Enthesitis-related arthritis (ERA): Active disease in patients 4 years and older.
• Hidradenitis suppurativa (HS): Moderate to severe disease in adults.

Cosentyx FDA approval was first granted on January 21, 2015, for plaque psoriasis, and since then, its use has expanded to include these listed conditions.

How does Cosentyx work?

Cosentyx is an IL-17A antagonist. 

In autoimmune diseases, the immune system becomes overactive and produces excessive IL-17A, a cytokine (protein) that promotes inflammation, pain, and tissue damage.

Cosentyx works by binding to and blocking IL-17A, preventing it from triggering the inflammatory response. This helps calm the immune system, reduce inflammation, and relieve symptoms associated with these chronic conditions.

Cosentyx targets the underlying cause of inflammation rather than just masking symptoms.

Cosentyx side effects

Common Cosentyx side effects may include diarrhea and cold symptoms such as a stuffy nose, sneezing, and sore throat.

Serious Cosentyx side effects

Get emergency medical help if you have signs of an allergic reaction to Cosentyx with symptoms of hives, chest tightness, difficulty breathing, feeling like you might pass out, swelling of your face, lips, tongue, or throat.

This medicine can cause serious bacterial, viral, and fungal opportunistic infections. Call your doctor right away if you have signs of infection, such as

• redness, warmth, or painful sores on your skin;
• cough, shortness of breath, cough with red or pink mucus;
• increased urination, burning when you urinate;
• sores or white patches in your mouth or throat (yeast infection or “thrush”);
• new or worsening diarrhea or stomach pain; or
• fever, chills, sweating, muscle pain, weight loss.

Cases of Hepatitis B virus reactivation have occurred using this medicine.

Further doses may be delayed until your infection clears up.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects.

Warnings

You may get infections more easily while using Cosentyx, as it lowers your immune system’s ability to fight infections. Call your doctor right away if you have signs of infection such as fever, chills, sweats, muscle aches, skin sores, stomach pain, diarrhea, burning when you urinate, weight loss, cough, shortness of breath, or a cough with red or pink mucus.

Tell your doctor if you have an active infection or have ever been diagnosed with tuberculosis or inflammatory bowel disease before using this medicine.

Before using this medicine

You should not use Cosentyx if you are allergic to the active ingredients, secukinumab, or any of the inactive ingredients contained in the medicine.

Latex allergy. You should not handle the needle cap of the Cosentyx Sensoready pen, or the 75 mg/0.5 mL or 150 mg/mL prefilled syringes if you are sensitive to latex.

Tell your doctor if you’ve had or been exposed to tuberculosis, or if you recently traveled. Some infections are more common in certain parts of the world, and you may have been exposed during travel.

To make sure you can safely use Cosentyx, tell your doctor if you have ever had:

• an active or chronic infection;
• inflammatory bowel disease (Crohn’s disease or ulcerative colitis);
• an allergy to latex; or
• if you currently have signs of infection such as fever, sweats, chills, muscle pain, cough, shortness of breath, cough with bloody mucus, weight loss, skin sores, stomach pain, diarrhea, or painful urination.

Make sure you are current on all vaccines before you start using this medicine. You should not have any vaccinations during your treatment with Cosentyx without first talking to your doctor.

Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Cosentyx can harm your unborn baby. You and your healthcare provider should decide if you will use this medicine.

Breastfeeding

Tell your doctor or healthcare professional if you are breastfeeding or plan to breastfeed. It is not known if Cosentyx passes into your breast milk.

How should I use Cosentyx?

Subcutaneous Cosentyx

Cosentyx subcutaneous injection can be self-administered or administered by a caregiver in your own home. Pediatric patients should not self-administer this medicine; an adult caregiver can inject this medicine after proper training in subcutaneous injection technique.

Subcutaneous Cosentyx instructions

• Take the injection pen out of the refrigerator and let it reach room temperature for 15 to 30 minutes before use. Give the injection within 1 hour after removing the medicine from the refrigerator.  Do not try to warm the medication by heating it in a microwave, placing it in hot water, or using any other method. 
• Prepare an injection only when you are ready to give it. You may need to use 2 injections to get your total dose.
• The solution should be clear or light yellow. Call your pharmacist if the liquid in your vial, pen, or syringe looks cloudy, has changed colors, or has particles in it.
• Do not shake the syringe or dosing pen.
• The injection can be given anywhere on the front of your thighs (upper leg), upper outer arms, or abdomen (stomach) except your navel and the area 2 inches (5 centimeters) around it. Do not inject into the same place two times in a row. Avoid injecting into the skin that is hard, red, bruised, swollen, tender, or affected by psoriasis. 
• Throw away a prefilled syringe or injection pen after one use, even if there is still medicine left inside.
• Do not reuse a needle or syringe. Place them in a puncture-proof “sharps” container and dispose of them following state or local laws. Keep out of the reach of children and pets.

Intravenous Cosentyx

Cosentyx can also be administered as an intravenous infusion by your healthcare professional (HCP) for adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS), or non-radiographic axial spondyloarthritis (nr-axSPA). Cosentyx intravenous infusion should be administered over a period of 30 minutes

General information

You may get infections more easily, even serious infections. You will need frequent medical tests.

Use Cosentyx exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Ask your doctor or pharmacist if you don’t understand how to use an injection.

Cosentyx Dosing Information

Cosentyx is supplied as a Sensoready pen, UnoReady Pen prefilled syringe, or single-dose vial.

Intravenous dosing (administered by a healthcare provider)

Intravenous dosing can be used for psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis. Dilute before use. Administer infusion over 30 minutes.

• With a loading dose: 6 mg/kg initially at week 0 followed by 1.75 mg/kg every 4 weeks thereafter (maximum 300mg per infusion).
• Without a loading dose: 1.75 mg/kg every 4 weeks (maximum 300mg per infusion).

Subcutaneous dosing

Usual Adult Cosentyx Dose for Plaque Psoriasis

Dose:

• 300 mg subcutaneously at weeks 0, 1, 2, 3, and 4 followed by 300 mg every 4 weeks.
• Each 300 mg dose is given as 2 subcutaneous injections of 150 mg.
• For some patients, a dose of 150 mg subcutaneously may be acceptable.

Use: Moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

Usual Pediatric Dose for Plaque Psoriasis (6 years and older)

Dose:

• Dose is based on body weight, given by subcutaneous injection at Weeks 0, 1, 2, 3, and 4, followed by dosing every 4 weeks.
• Body weight less than 50kg: recommended dose is 75mg.
• Body weight is greater than or equal to 50kg: recommended dose 150mg.
• Safety and effectiveness of Cosentyx in pediatric patients with plaque psoriasis below the age of 6 years have not been established.

Use: Moderate to severe plaque psoriasis in pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy.

Usual Adult Dose for Psoriatic Arthritis

Dose:

• With a loading dose: 150 mg subcutaneously at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter.
• Without a loading dose: 150 mg subcutaneously every 4 weeks; if the patient continues to have active psoriatic arthritis, consider increasing the dose to 300 mg subcutaneously every 4 weeks.

Comments:

• For psoriatic arthritis patients with coexistent moderate to severe plaque psoriasis, use the dosage for plaque psoriasis.
• This drug may be administered with or without methotrexate.

Use: Active psoriatic arthritis.

Usual Pediatric Dose for Psoriatic Arthritis (2 years and older)

Dose:

• Dose is based on body weight, given by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 followed by dosing every 4 weeks.
• Body weight 15 kg to less than 50kg: recommended dose is 75mg
• Body weight is greater than or equal to 50kg: recommended dose 150mg.
• The safety and effectiveness of Cosentyx in pediatric patients below the age of 2 years and with a body weight of less than 15 kg (33 pounds) have not been established.

Comment: This drug may be administered with or without methotrexate.

Use: Active psoriatic arthritis in patients 2 years and older.

Usual Adult Dose for Ankylosing Spondylitis

Dose:

• With a loading dose: 150 mg subcutaneously at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter.
• Without a loading dose: 150 mg subcutaneously every 4 weeks.

Comment: If a patient continues to have active AS, consider a dosage of 300 mg every 4 weeks.

Uses: For active ankylosing spondylitis.

Usual Adult Dose for Non-Radiographic Axial Spondyloarthritis

Dose:

• The loading dosage is 150 mg at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter
• Without a loading dosage is 150 mg every 4 weeks

Use: Active non-radiographic axial spondyloarthritis (nr-axSpA) in adult patients who have objective signs of inflammation.

Usual Dose for Enthesitis-Related Arthritis 

Dose:

• Dose is based on body weight, given by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 followed by dosing every 4 weeks.
• Body weight 15 kg to less than 50kg: the recommended dose is 75mg
• Body weight is greater than or equal to 50kg: recommended dose 150mg.

Use: Active enthesitis-related arthritis (ERA) in patients 4 years of age and older.

Usual Adult Dose for Hidradenitis Suppurativa

Dose:

• Recommended dosage is 300 mg administered by subcutaneous injection at Weeks 0, 1, 2, 3 and 4 and every 4 weeks thereafter.
• If a patient does not adequately respond, consider increasing the dosage to 300 mg every 2 weeks. 

Use: moderate to severe hidradenitis suppurativa (HS) in adults

Cosentyx products

Subcutaneous Injection

• Cosentyx Sensoready pen: 150 mg/mL single dose.
• Cosentyx UnoReady pen and single-dose prefilled syringe: 300 mg/2 mL.
• Cosentyx prefilled syringe (for pediatric patients less than 50 kg): 75 mg/0.5 mL single dose.

Intravenous Infusion

• Cosentyx injection: 125 mg/5 mL in a single-dose vial (healthcare professional use only)

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of Cosentyx.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while using Cosentyx?

Avoid receiving a “live” vaccine. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

What other drugs will affect Cosentyx?

Cosentyx may interact with other products, so tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take and keep a list to show your healthcare provider and pharmacist when you start a new medicine or stop a regular medicine.

When starting or stopping this medicine, patients who are receiving a CYP450 substrate medicine, particularly those with a narrow therapeutic index,  your therapeutic effect or drug concentration monitored, and you may need to have a dosage adjustment of the CYP450 substrate. To check for interactions with Cosentyx, click on the link below.

Cosentyx Package Insert 

HCPs and patients often use the Cosentyx Package Insert (PI) for more detailed information about this medicine. The Package Insert contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interactions, and more. Discuss any medical questions you have with your HCP (health care professional). This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called Cosentyx Prescribing Information (PI) or FDA label.

Cosentyx J code

Cosentyx J code is J3247 (1 mg, intravenous).
J codes are used for medicines that are not taken orally and include injections, inhalations, and chemotherapies. J codes are important for accurate and consistent coding for billing and reimbursement purposes.

The J code is only required for the intravenous infusion.

Your physician will need the Cosentyx J code when filling out forms for your intravenous infusion treatment.

Storage

• Store this medicine in a refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze this medicine.
• Keep this medicine in the original carton until ready for use to protect it from light.
• If necessary, the Sensoready pen, Unoready pen, and prefilled syringes may be stored at room temperature, up to 86°F (30°C), for up to 4 days.   
• Write the date the medicine was removed from the refrigerator in the space provided on the carton.
• If unused and stored below 30°C (86°F), the Sensoready pen, Unoready pen, and prefilled syringes may be returned to the refrigerator only one time. Throw them away if they have been kept outside of the refrigerator and have not been used in over 4 days.
• Do not shake this medicine.
• Keep all medicines out of the reach of children.

Ingredients

Active ingredient: secukinumab.

Inactive ingredients:

Cosentyx Sensoready pen and prefilled syringe: L-histidine/histidine hydrochloride monohydrate, L-methionine, polysorbate 80, trehalose dihydrate, and sterile water for injection.

Cosentyx Vial: L-histidine/histidine hydrochloride monohydrate, polysorbate 80, and sucrose.

Latex: Do not handle the needle cap of the Cosentyx Sensoready pen, or the 75 mg/0.5 mL or 150 mg/mL prefilled syringes if you are sensitive to latex.

Consentyx Manufacturer

Cosentyx manufacturer Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936.

Cosentyx Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Cosentyx.Cosentyx (secukinumab) – Novartis Pharmaceuticals Corporation

Formulation type	Strength
Autoinjector	150 mg/mL
Autoinjector	300 mg/2 mL
Pre-Filled Syringe	150 mg/mL
Pre-Filled Syringe	300 mg/2 mL Discontinued
Pre-Filled Syringe	75 mg/0.5 mL
Single-Dose Vial	125 mg/5 mL
Single-Dose Vial	150 mg Discontinued