Secukinumab is an immunosuppressant medicine that reduces the effects of a chemical substance in the body that can cause inflammation. It is used to improve the symptoms of some types of autoimmune conditions such as ankylosing spondylitis, chronic plaque psoriasis, psoriatic arthritis, non-radiographic axial spondyloarthritis and enthesitis-related arthritis.

Secukinumab is from a group of medicines called interleukin (IL) inhibitors, and works by blocking the activity of a protein called IL-17A.  People who have autoimmune conditions have increased levels of this protein. By blocking the protein's activity it reduces inflammation, pain, swelling and skin symptoms that you may have.

What is secukinumab used for?

Secukinumab is an immunosuppressant used to treat:

• moderate to severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy
• active psoriatic arthritis (PsA) in patients 2 years of age and older 
• adults with active ankylosing spondylitis
• adults with active non-radiographic axial spondyloarthritis (nr-axSpA) and objective signs of inflammation
• active enthesitis-related arthritis (ERA) in patients 4 years of age and older 

This medicine may improve your psoriasis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis, and enthesitis-related arthritis, but it may also lower the ability of your immune system to fight infections.

Secukinumab is a medicine that affects your immune system and may increase your risk of having serious side effects such as:

Infections. This medicine may lower the ability of your immune system to fight infections and may increase your risk of infections.

• Your healthcare provider should check you for tuberculosis (TB) before starting treatment with this medicine.
• 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 .this medicine
• Your healthcare provider should watch you closely for signs and symptoms of TB during treatment. Do not take this medicine if you have an active TB infection.

Before starting this medicine, 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
• think you have an infection or have symptoms of an infection such as:
  • fever, sweats, or chills
  • muscle aches
  • cough
  • weight loss
  • blood in your phlegm
  • Infected skin sores
  • diarrhea or stomach pain
  • burning or pain when urinating
  • needing to urinate more often than usual

Once you are using secukinumab call your healthcare provider right away if you have any of the signs of infection listed above. You should not use this medicine if you have any signs of infection, unless you are instructed to by your healthcare provider
Also read  the section below “What are the side effects of secukinumab?” for more information about side effects.

• Use this medicine exactly as prescribed by your healthcare provider.
• This medicine comes in a single-dose Sensoready pen or single-dose prefilled syringes that you or your caregiver may use at home to give injections. Your healthcare provider will decide which type of secukinumab is best for you to use at home.
• If your healthcare provider decides that you or a caregiver may give your injections at home, you should receive training on the right way to prepare and inject this medicine. Only inject secukinumab yourself, after your healthcare provider has shown you or your caregiver how to inject secukinumab.
• Children should not inject themselves with the Sensoready pen or the prefilled syringes. An adult caregiver should prepare and inject secukinumab after receiving training on the right way to prepare and inject this medicine.
• Your healthcare provider will prescribe the dose of this medicine that is right for you or your child based on their body weight.
  • If your prescribed dose of secukinumab is 75 mg, you must give 1 injection of secukinumab 75 mg/0.5 mL for each dose.
  • If your prescribed dose of secukinumab is 150 mg, you must give 1 injection of secukinumab 150 mg/mL for each dose.
  • If your prescribed dose of secukinumab is 300 mg, you must give 2 injections of secukinumab 150 mg/mL for each dose.
• This medicine is given as an injection under your skin (subcutaneous injection), in your upper legs (thighs) or stomach-area (abdomen) by you or a caregiver. A caregiver may also give you your injection into your upper outer arm.
• Do not give an injection in an area of the skin that is tender, bruised, red or hard, or in an area of skin that is affected by psoriasis.
• Each injection should be given at a different site. Do not use the 2-inch area around your navel (belly button).
• If you inject more medicine than prescribed, call your healthcare provider or go to the nearest emergency room right away.

See the detailed “Instructions for Use” which for information and diagrams on how to prepare and inject a dose of secukinumab, and how to properly throw away (dispose of) used secukinumab Sensoready pen and prefilled syringes.

Your dosage of secukinumab depends on which condition you are treating, your age, weight and sometimes how well your treatment is responding to treatment.  If you have a loading dose you will be given a weekly dose on weeks 0, 1, 2, 3 and 4 and then have injections every 4 weeks.  If you do not have a loading dose your injections will be every 4 weeks.

Do not use secukinumab if you have had a severe allergic reaction to it or any of the inactive ingredients in this preparation. See the bottom of this page for a complete list of ingredients in this product.

What should I tell my doctor before using secukinumab?

Before starting to take this medicine you should tell your healthcare provider about all of your medical conditions, including if you have any of the conditions or symptoms listed in the section “Important information” above on this page.

• have inflammatory bowel disease (Crohn’s disease or ulcerative colitis).
• are allergic to latex. The needle cap on the secukinumab Sensoready 150 mg/mL pen, 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 this medicine should not receive live vaccines. Children should be brought up to date with all vaccines before starting treatment with this medicine
• are pregnant or plan to become pregnant. It is not known if secukinumab can harm your unborn baby. You and your healthcare provider should decide if you will use secukinumab.
• are breastfeeding or plan to breastfeed. It is not known if secukinumab 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.

Secukinumab may cause serious side effects including:

• See “important information” above on this page.
• Inflammatory bowel disease. New cases of inflammatory bowel disease or “flare-ups” can happen with secukinumab, and can sometimes be serious. If you have inflammatory bowel disease (ulcerative colitis or Crohn’s disease), tell your healthcare provider if you have worsening disease symptoms during treatment with secukinumab or develop new symptoms of stomach pain or diarrhea.
• Serious allergic reactions. Get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction:
  • swelling of your face, eyelids, lips, mouth, tongue, or throat
  • feel faint
  • chest tightness
  • trouble breathing or throat tightness
  • hives (red, itchy bumps)
  • skin rash

If you have a severe allergic reaction, you should not have another injection of secukinumab.

The most common side effects of secukinumab include:

• upper respiratory infections
• cold symptoms
• diarrhea

These are not all of the possible side effects of secukinumab.

Call your healthcare provider for medical advice and about side effects. You can report side effects to FDA at 1-800-FDA-1088.

Secukinumab 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 get a new medicine, or stop a regular medicine.