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For adults with active non-radiographic axial spondyloarthritis

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What is non-radiographic axial spondyloarthritis (nr-axSpA)?

Nr-axSpA is a type of inflammatory arthritis of the spine that is undetectable on an X-ray. It is part of a family of diseases called axial spondyloarthritis (axSpA). AxSpA includes 2 underdiagnosed conditions: nr-axSpA and ankylosing spondylitis (AS). In both conditions, inflammation in the spinal joints can cause chronic back pain, stiffness, fatigue, and reduced mobility. If left untreated, this inflammation can cause irreversible damage.

non.ra.dio.graph.ic

(pronounced non-ray-dee-oh-graf-ick)

 

means no visible damage on X-rays

ax.i.al

(pronounced ak-see-al)

 

refers to the part of the skeleton that includes the spine and SI (sacroiliac) joints

spon.dyl.o.ar.thri.tis

(pronounced spahn-dil-o-ar-thright-iss)

 

a family of chronic conditions characterized by inflammation in the spine and joints

What are the symptoms of nr-axSpA?

Nr-axSpA leads to symptoms like pain and stiffness in the lower back and spine, as well as possible pain in the neck, hips, and buttocks. Other symptoms include pain at night, stiffness upon waking, fatigue, and loss of mobility.

Graphic of magnifying glass, human and diagnostic points for non-radiographic axial spondyloarthritis.

How is nr-axSpA diagnosed?

Nr-axSpA is difficult to diagnose because the damage to the spine cannot be seen on an X-ray. Many people live with it for years before it gets diagnosed. Nr-axSpA is only diagnosed by a doctor, like a rheumatologist. A rheumatologist will typically look at how inflammation is affecting your entire body, assess your history, and then run a variety of tests, including physical exams, imaging, and lab tests.


Why choose a rheumatologist? Rheumatologists are doctors that treat many diseases that are difficult to diagnose, like diseases of the spine and autoimmune diseases. A rheumatologist could help you understand more about your back pain, and if you may be suffering from mechanical back pain or inflammatory back pain.

What is the difference between non-radiographic axial spondyloarthritis and ankylosing spondylitis?

The main difference between non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS) is that nr-axSpA may not show visible spinal damage on an X-ray, while AS damage may be visible. Scroll down to learn more about the other differences between these 2 conditions.

nr-axSpA

AS

Tap to see IMPORTANT SAFETY INFORMATION AND APPROVED USES

IMPORTANT SAFETY INFORMATION

Do not use COSENTYX if you have had a severe allergic reaction to secukinumab or any of the other ingredients in COSENTYX. See the Medication Guide for a complete list of ingredients.

What is the most important information I should know about COSENTYX?

COSENTYX is a medicine that affects your immune system. COSENTYX may increase your risk of having serious side effects such as…

Do not use COSENTYX if you have had a severe allergic reaction to secukinumab or any of the other ingredients in COSENTYX. See the Medication Guide for a complete list of ingredients.

What is the most important information I should know about COSENTYX?

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 died from these infections.

  • Your doctor should check you for tuberculosis (TB) before starting treatment with COSENTYX.

  • If your doctor 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 doctor 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 doctor 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

  • think you have an infection or have symptoms of an infection such as: fevers, 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 doctor right away if you have any signs of infection listed above. Do not use COSENTYX if you have any signs of infection unless you are instructed to by your doctor.

What are the possible side effects of COSENTYX?

COSENTYX may cause serious side effects, including: 

Serious allergic reactions

Serious allergic reactions can occur. Get emergency medical help right away if you get any of the following symptoms: feeling faint; swelling of your face, eyelids, lips, mouth, tongue, or throat; trouble breathing or throat tightness; chest tightness; skin rash or hives (red, itchy bumps).

If you have a severe allergic reaction, do not give another injection of COSENTYX.

Inflammatory bowel disease

New cases of inflammatory bowel disease or "flare-ups" can happen with COSENTYX, and can sometimes be serious. If you have inflammatory bowel disease (ulcerative colitis or Crohn's disease), tell your doctor if you have worsening disease symptoms during treatment with COSENTYX or develop new symptoms of stomach pain or diarrhea.

Severe skin reactions that look like eczema can happen during treatment with COSENTYX from days to months after your first dose and can sometimes lead to hospitalization. Your doctor may temporarily stop treatment with COSENTYX if you develop severe skin reactions. Tell your doctor if you have any of the following signs or symptoms: redness or rash; itching; small bumps or patches; your skin is dry or feels like leather; blisters on the hands or feet that ooze or become crusty or skin peeling.

The most common side effects of COSENTYX include: cold symptoms, diarrhea, and upper respiratory tract infections.

These are not all of the possible side effects of COSENTYX. Call your doctor for medical advice about side effects.

Before using COSENTYX, tell your doctor if you:

  • have any of the conditions or symptoms listed above for infections.

  • have inflammatory bowel disease (Crohn's disease or ulcerative colitis).

  • are allergic to latex. The needle cap on the COSENTYX Sensoready® pen, and 150 mg/mL and 75 mg/0.5 mL prefilled syringes 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.

  • have any other medical conditions and all the medicines you take, including prescription and over‑the‑counter medicines, vitamins, and herbal supplements. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.

  • are pregnant or plan to become pregnant. It is not known if COSENTYX can harm your unborn baby. You and your doctor should decide if you will use COSENTYX.

  • are breastfeeding or plan to breastfeed. It is not known if COSENTYX passes into your breast milk.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch , or call 1-800-FDA-1088.

Please see full Prescribing Information, including Medication Guide.

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INDICATIONS

COSENTYX® (secukinumab) is a prescription medicine used to treat:

  • people 6 years of age and older with moderate to severe plaque psoriasis (PsO) that involves large areas or many areas of the body, and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light alone or with systemic therapy)…

COSENTYX® (secukinumab) is a prescription medicine used to treat:

  • people 6 years of age and older with moderate to severe plaque psoriasis (PsO) that involves large areas or many areas of the body, and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light alone or with systemic therapy)

  • people 2 years of age and older with active psoriatic arthritis (PsA)

  • adults with active ankylosing spondylitis (AS)

  • adults with active non-radiographic axial spondyloarthritis (nr-axSpA) and objective signs of inflammation 

  • people 4 years of age and older with active enthesitis-related arthritis (ERA)

  • adults with moderate to severe hidradenitis suppurativa (HS)

*Limitations apply. Valid only for those with private insurance. Program provides up to $16,000 annually for the cost of COSENTYX and up to $150 per infusion (up to $1,950 annually) for the cost of administration. Co-pay support for infusion administration cost not available in Rhode Island or Massachusetts. Offer not valid under Medicare, Medicaid, or any other federal or state program. Novartis reserves the right to rescind, revoke, or amend this program without notice. See complete Terms & Conditions for details.