Cosentyx

Cosentyx (secukinumab) is a prescription medicine used to treat plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and other inflammatory autoimmune conditions to help reduce skin lesions, joint pain, swelling, and spine inflammation.

Cosentyx is usually given as a subcutaneous injection (under the skin), most often once a month after a series of starting doses. It can also be given as an intravenous (IV) infusion for adults with psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis (nr-axSpA).

Cosentyx's generic name is secukinumab.

Cosentyx works 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 used to treat plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, hidradenitis suppurativa, and enthesitis-related arthritis, in specific patient groups. Cosentyx is prescribed to reduce inflammation, improve symptoms, and help control flare-ups in these long-term immune-mediated conditions.

Cosentyx is FDA-approved to be used to treat:

• 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 and children 12 years of age and older.
• Non-radiographic axial spondyloarthritis (nr-axSpA): Active disease in adults with objective signs of inflammation.
• Enthesitis-related arthritis (ERA): Active disease in children 4 years and older.
• Hidradenitis suppurativa (HS): Moderate to severe disease in adults and pediatric patients 12 years and older.

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.

Immunizations: Before starting Cosentyx, make sure you are up to date on all recommended vaccines for your age. Because Cosentyx can affect your immune system, you should avoid live vaccines during treatment.

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.

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
• 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.

Common Cosentyx side effects

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

Serious side effects

Serious side effects can include infections, allergic reactions, skin rashes (eczematous eruptions), and worsening of certain inflammatory bowel conditions. Patients should review side effects carefully and talk with a healthcare provider about new or worsening symptoms.

Hypersensitivity reactions

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.

Infections

You may get serious bacterial, viral, and fungal opportunistic 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:

• redness, warmth, or painful sores on your skin
• cough, shortness of breath, or 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
• fever, chills, sweating, muscle pain, weight loss

Cases of Hepatitis B virus reactivation have occurred using this medicine. Cosentyx is not recommended for use in patients with active viral hepatitis.

Further doses may be delayed until your infection clears up.

Tuberculosis (TB)

Before starting this medicine, you will be evaluated for tuberculosis (TB). If your healthcare provider feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment and during treatment with Cosentyx.

Your healthcare provider will monitor you closely for signs and symptoms of TB during treatment. Cosentyx should not be used if you have an active TB infection.

Inflammatory bowel disease (IBD)

Cosentyx should be used with caution in patients with inflammatory bowel disease (IBD). In clinical trials, cases of IBD were observed as an adverse reaction.

Eczematous eruptions

Severe eczematous eruptions have been reported in patients receiving Cosentyx, and some cases required hospitalization. Time to onset varied, occurring from days to months after the first dose. Discontinuation of this medicine may be necessary to resolve the eczematous eruption. However, some patients were successfully treated for eczematous eruptions without discontinuing Cosentyx.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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 or syringe out of the refrigerator and let it reach room temperature before use. Allow 15 to 30 minutes for the Sensoready pen and the 150 mg/mL and 75 mg/0.5 mL prefilled syringes, or 30 to 45 minutes for the UnoReady pen. Leave the cap on while it warms up. 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. Depending on which pen or syringe you are prescribed, you may need two injections to get your full 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.
• You can inject into the front of your thighs (upper leg) or your abdomen (stomach), avoiding your navel and the area 2 inches (5 centimeters) around it. A caregiver or healthcare provider can also inject into your upper outer arm. Do not inject into the same place two times in a row. Avoid injecting into 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. Tell your healthcare provider straight away if you develop signs of an infection during treatment.

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.

The usual adult Cosentyx dose is 300 mg for plaque psoriasis and hidradenitis suppurativa, and 150 mg for psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis. Most people start with one injection a week for five weeks, then move to one dose every 4 weeks. Children are dosed by body weight, usually 75 mg or 150 mg.

Your doctor decides your Cosentyx dose based on which condition you are being treated for, your age, and your weight.

Cosentyx dose by condition (subcutaneous injection)

Cosentyx can also be given as an intravenous infusion, but only to adults with psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis. See the intravenous dose below.

How often is Cosentyx given?

Cosentyx is usually given once a week for the first five weeks, at Weeks 0, 1, 2, 3, and 4, then once every 4 weeks after that. The five starting doses are called loading doses.

For psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis, Cosentyx can also be started without loading doses. In that case it is given every 4 weeks from the beginning. Your doctor decides which approach suits you.

Loading doses are always used for plaque psoriasis, hidradenitis suppurativa, enthesitis-related arthritis, and for all doses given to children.

Cosentyx dose for each condition

Usual adult dose for plaque psoriasis

The usual dose is 300 mg given as a subcutaneous injection at Weeks 0, 1, 2, 3, and 4, then 300 mg every 4 weeks.

Each 300 mg dose is given either as one 300 mg injection using the UnoReady pen, or as two 150 mg injections. For some people, a dose of 150 mg on the same schedule may be enough.

Usual pediatric dose for plaque psoriasis (6 years and older)

The dose is based on body weight and is given at Weeks 0, 1, 2, 3, and 4, then every 4 weeks.

• Under 50 kg (110 pounds): 75 mg
• 50 kg or more: 150 mg

Cosentyx has not been shown to be safe and effective for plaque psoriasis in children under 6 years old.

Usual adult dose for psoriatic arthritis

The usual dose is 150 mg, given either at Weeks 0, 1, 2, 3, and 4 and then every 4 weeks, or every 4 weeks from the start with no loading doses.

If psoriatic arthritis stays active, the dose may be increased to 300 mg every 4 weeks. Adults who also have moderate to severe plaque psoriasis use the plaque psoriasis dose instead. Cosentyx can be used with or without methotrexate.

Usual pediatric dose for psoriatic arthritis (2 years and older)

The dose is based on body weight and is given at Weeks 0, 1, 2, 3, and 4, then every 4 weeks.

• 15 kg to under 50 kg (33 to 110 pounds): 75 mg
• 50 kg or more: 150 mg

Cosentyx can be used with or without methotrexate. It has not been shown to be safe and effective in children under 2 years old or under 15 kg (33 pounds).

Usual adult dose for ankylosing spondylitis

The usual dose is 150 mg, given either at Weeks 0, 1, 2, 3, and 4 and then every 4 weeks, or every 4 weeks from the start with no loading doses. If ankylosing spondylitis stays active, the dose may be increased to 300 mg every 4 weeks.

Usual pediatric dose for ankylosing spondylitis (12 years and older)

The dose is based on body weight and is given at Weeks 0, 1, 2, 3, and 4, then every 4 weeks.

• Under 50 kg (110 pounds): 75 mg
• 50 kg or more: 150 mg

Cosentyx has not been shown to be safe and effective for ankylosing spondylitis in children under 12 years old.

Usual adult dose for non-radiographic axial spondyloarthritis

The usual dose is 150 mg, given either at Weeks 0, 1, 2, 3, and 4 and then every 4 weeks, or every 4 weeks from the start with no loading doses.

Usual pediatric dose for enthesitis-related arthritis (4 years and older)

The dose is based on body weight and is given at Weeks 0, 1, 2, 3, and 4, then every 4 weeks.

• 15 kg to under 50 kg (33 to 110 pounds): 75 mg
• 50 kg or more: 150 mg

For this condition Cosentyx is given only as a subcutaneous injection, not as an infusion. It has not been shown to be safe and effective in children under 4 years old or under 15 kg (33 pounds).

Usual adult dose for hidradenitis suppurativa

The usual dose is 300 mg given at Weeks 0, 1, 2, 3, and 4, then 300 mg every 4 weeks. If the response is not good enough, the dose may be increased to 300 mg every 2 weeks.

Usual pediatric dose for hidradenitis suppurativa (12 years and older)

The dose is based on body weight and is given at Weeks 0, 1, 2, 3, and 4, then every 4 weeks.

• 30 kg to under 90 kg (66 to 198 pounds): 150 mg
• 90 kg or more: 300 mg

Cosentyx has not been shown to be safe and effective for hidradenitis suppurativa in children under 12 years old or under 30 kg (66 pounds).

Cosentyx intravenous (IV) dose

Intravenous Cosentyx is only for adults with psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis. It is given by a healthcare provider, and the dose is worked out from your body weight. IV dosing has not been established in children.

Doses above 300 mg per infusion are not recommended for the 1.75 mg/kg maintenance dose. Each infusion is diluted first and given over about 30 minutes.

Can your Cosentyx dose be changed?

Yes. Your doctor may raise your dose if your condition stays active. In psoriatic arthritis and ankylosing spondylitis the dose can go from 150 mg to 300 mg every 4 weeks. In hidradenitis suppurativa, the 300 mg dose can be moved from every 4 weeks to every 2 weeks.

Your dose does not need to be adjusted for kidney or liver problems, and no separate dose is set for older adults. Studies of how kidney or liver impairment affects secukinumab levels have not been done.

Doses may be delayed if you develop an infection.

Subcutaneous injection

• Cosentyx UnoReady pen: 300 mg/2 mL.
• Cosentyx Sensoready pen and single-dose prefilled syringe: 150 mg/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).

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

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

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.

If you are taking a medicine that is a CYP450 substrate, particularly one with a narrow therapeutic index, your doctor may monitor how well it is working or check its level in your blood when you start or stop Cosentyx. The dose of that medicine may need to be adjusted.

This is not a complete list. Other medicines may interact with Cosentyx, including some that are not listed here. To check for interactions with Cosentyx, click on the link below.

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 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.

• 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 and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) 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 and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) 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.

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, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 80, trehalose dihydrate, and sterile water for injection.

Latex: If you have a latex allergy, let your doctor or pharmacist know before using Cosentyx. The removable cap on the Sensoready pen and on the 150 mg/mL and 75 mg/0.5 mL prefilled syringes contains natural rubber latex, which may cause an allergic reaction in people sensitive to latex.

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