Secukinumab

What it is used for

COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older.

active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. 1.1 Plaque Psoriasis COSENTYX ® is indicated for the treatment of moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy.

1.2 Psoriatic Arthritis COSENTYX is indicated for the treatment of active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. 1.3 Ankylosing Spondylitis COSENTYX is indicated for the treatment of active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older.

1.4 Non-Radiographic Axial Spondyloarthritis COSENTYX is indicated for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in adult patients with objective signs of inflammation. 1.5 Enthesitis-Related Arthritis COSENTYX is indicated for the treatment of active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older.

1.6 Hidradenitis Suppurativa COSENTYX is indicated for the treatment of moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older.

The most important thing to know

COSENTYX is a medicine that affects your immune system. COSENTYX may increase your risk of having serious side effects such as: Infections. COSENTYX may lower the ability of your immune system to fight infections and may increase your risk of infections. Some people have had serious infections during treatment with COSENTYX, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses.

Some people have died from these infections. Your healthcare provider should check you for TB before starting treatment with COSENTYX. If your healthcare provider feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with COSENTYX and during treatment with COSENTYX. Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with COSENTYX.

Do not use COSENTYX if you have an active TB infection. Before starting COSENTYX, tell your healthcare provider if you: are being treated for an infection have an infection that does not go away or that keeps coming back have TB or have been in close contact with someone with TB have or have had Hepatitis B think you have an infection or have symptoms of an infection such as: ◦ fever, sweats, or chills ◦ muscle aches ◦ cough ◦ shortness of breath ◦ blood in your phlegm ◦ weight loss ◦ warm, red, or painful skin or sores on your body ◦ diarrhea or stomach pain ◦ burning when you urinate or urinate more often than normal After starting COSENTYX, call your healthcare provider right away if you have any of the signs of infection listed above.

Do not use COSENTYX if you have any signs of infection unless you are instructed to by your healthcare provider. See “

Side effects, and when to stop

” for more information about side effects. What is COSENTYX? COSENTYX is a prescription medicine used to treat: adults and children 6 years of age and older with moderate to severe plaque psoriasis (PsO) who may benefit from taking injections or medicines by mouth (systemic therapy) or phototherapy (treatment using ultraviolet or UV light) adults and children 2 years of age and older with active psoriatic arthritis (PsA) adults and children 12 years of age and older with active ankylosing spondylitis (AS) adults with active non-radiographic axial spondyloarthritis (nr-axSpA) and objective signs of inflammation children 4 years of age and older with active enthesitis-related arthritis (ERA) adults and children 12 years of age and older with moderate to severe hidradenitis suppurativa (HS) It is not known if COSENTYX is safe and effective in children: under 6 years of age with PsO under 2 years of age or weighing less than 33 pounds (15 kg) with active PsA under 12 years of age with AS under 4 years of age or weighing less than 33 pounds (15 kg) with active ERA under 12 years of age or weighing less than 66 pounds (30 kg) with HS Who should not use COSENTYX?

Do not use COSENTYX if you have had a serious allergic reaction to secukinumab or any of the other ingredients in COSENTYX. See the end of this Medication Guide for a complete list of ingredients in COSENTYX. Before using COSENTYX, tell your healthcare provider about all of your medical conditions, including if you: have any of the conditions or symptoms listed in the section “What is the most important information I should know about COSENTYX?” have inflammatory bowel disease (Crohn’s disease or ulcerative colitis).

are allergic to latex. The removable needle cap on the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains latex. have recently received or are scheduled to receive an immunization (vaccine). People who take COSENTYX should not receive live vaccines. Children should be brought up to date with all vaccines before starting COSENTYX.

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 COSENTYX. are breastfeeding or plan to breastfeed. It is not known if COSENTYX passes into your breast milk. 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. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine. How will I receive COSENTYX? When administered subcutaneously (under your skin) Read the detailed “Instructions for Use” that comes with your COSENTYX for information on how to prepare and inject a dose of COSENTYX, and how to properly throw away (dispose of) used COSENTYX.

Use COSENTYX exactly as prescribed by your healthcare provider. COSENTYX comes in a single-dose UnoReady pen, single-dose Sensoready pen, or single-dose prefilled syringes (300 mg/2 mL, 150 mg/mL, 75 mg/0.5 mL) that you or your caregiver may use at home to give injections. Your healthcare provider will decide which type of COSENTYX and which dose is right for you.

If your healthcare provider decides that you or a caregiver may give your injections of COSENTYX at home, you should receive training on the right way to prepare and inject COSENTYX. Do not try to inject COSENTYX yourself until you or your caregiver has been shown how to inject COSENTYX by your healthcare provider. Children should not inject themselves with COSENTYX.

An adult caregiver should prepare and inject COSENTYX after receiving training on the right way to prepare and inject COSENTYX. Do not handle the removable needle cap of the COSENTYX Sensoready pen or prefilled syringes (150 mg/mL, 75 mg/0.5 mL) if you are sensitive to latex. COSENTYX is given as an injection under your skin (subcutaneous injection) in your upper legs

Storing it

Store COSENTYX in a refrigerator between 36°F to 46°F (2°C to 8°C). Keep COSENTYX in the original carton until ready for use to protect from light. If you use COSENTYX Sensoready pen or prefilled syringes (150 mg/mL, 75 mg/0.5 mL): It may be stored at room temperature, up to 86°F (30°C), for up to 4 days. Write the date it was removed from and returned to the refrigerator in the space provided on the carton.

Throw it away if it has been stored outside of the refrigerator over 4 days. It may be returned to the refrigerator only 1 time and must be stored between 36°F to 46°F (2°C to 8°C) until you use it or until it expires. Do not freeze COSENTYX. Do not shake COSENTYX. Throw away any expired or unused COSENTYX. Keep COSENTYX and all medicines out of the reach of children.