Secukinumab Injection

WHY is this medicine prescribed?

Secukinumab injection is used to treat moderate to severe plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body) in adults and children 6 years of age and older whose psoriasis is too severe to be treated by topical medications alone. It is also used in adults and children 2 years of age and older to treat psoriatic arthritis (a condition that causes joint pain and swelling and scales on the skin). Secukinumab injection is used in adults to treat ankylosing spondylitis (a condition in which the body attacks the joints of the spine and other areas, causing pain, swelling, and joint damage). It is also used in adults to treat active non-radiographic axial spondyloarthritis (a condition in which the body attacks the joints of the spine and other areas, causing pain and signs of swelling, but without changes seen on x-ray). Secukinumab is also used in the treatment of enthesitis-related arthritis (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function) in children 4 years of age and older. It is also used in adults to treat hidradenitis suppurativa (a skin disease that causes small, painful lumps to form under the skin).Secukinumab injection is in a class of medications called interleukin-17A (IL-17A) receptor inhibitors. It works by blocking the activity of interleukin-17A, a substance in the body that causes inflammation.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Secukinumab injection comes as a solution (liquid) to be injected intravenously (into a vein) over about 30 minutes by a doctor or nurse in a medical office or as a prefilled syringe and a dosing pen to inject subcutaneously (under the skin) by yourself at home. If secukinumab injection is given subcutaneously, it is usually injected once every week for the first 5 doses and then once every 4 weeks. For psoriatic arthritis, ankylosing spondylitis, and axial spondyloarthritis, it may also be injected subcutaneously or intravenously once every 4 weeks. When secukinumab injection is used to treat hidradenitis suppurativa, it is usually given subcutaneously once every week for the first 5 doses and then every 2 or 4 weeks. If you are injecting secukinumab injection yourself, follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use secukinumab injection exactly as directed. Do not inject more or less of it or inject it more often than prescribed by your doctor.

You will receive your first subcutaneous dose of secukinumab injection in your doctor's office. After that, your doctor may allow you to inject secukinumab yourself or have a friend or relative perform the injections. Your doctor or nurse will show you or a caregiver how to prepare and inject a dose of secukinumab injection at home. Before you use secukinumab injection yourself the first time, read the manufacturer's instructions for use that comes with the medication. These instructions describe how to prepare and inject a dose of secukinumab. Be sure that you understand these directions. Ask your doctor or pharmacist if you have any questions about when you should use the medication, where on your body you should inject the medication, or how to prepare and give the injection.

If you are using a prefilled syringe or a dosing pen that has been refrigerated, place the syringe or pen on a flat surface without removing the needle cap and allow it warm to room temperature for 15-45 minutes (depending on the product being used) before you are ready to inject the medication. Do not try to warm the medication by heating it in a microwave, placing it in hot water, or through any other method.

Do not shake a syringe or dosing pen that contains secukinumab.

Always look at secukinumab solution before injecting it. Check that the expiration date has not passed and that the liquid is clear and colorless or pale yellow. The liquid should not contain visible particles. Do not use a syringe or dosing pen if it is cracked or broken, if it is expired, or if the liquid is cloudy or contains large or colored particles.

Use each syringe or dosing pen only once and inject all the solution in the syringe or pen. Dispose of used syringes and pens in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

You can inject secukinumab injection anywhere on the front of your thighs (upper leg) or abdomen (stomach) except your navel and the area 2 inches (5 centimeters) around it. If another person is injecting your medication, the outer area of the upper arms also may be used. To reduce the chances of soreness or redness, use a different site for each injection. Do not inject into an area where the skin is tender, bruised, red, or hard or where you have scars or stretch marks.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with secukinumab injection. Read the information carefully and ask your doctor or pharmacist if you have any questions.

What SPECIAL PRECAUTIONS should I follow?

Before using secukinumab injection,

• tell your doctor and pharmacist if you are allergic to secukinumab injection, any other medications, latex, or any of the ingredients in secukinumab injection. Ask your pharmacist for a list of the ingredients. If you will be using the prefilled syringe or dosing pen, tell your doctor if you or the person who will be injecting the medication for you are allergic to rubber or latex.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking secukinumab. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever), ulcerative colitis (a condition that causes swelling and sores in the lining of the colon [large intestine] and rectum), or any other medical conditions.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using secukinumab injection, call your doctor.

• check with your doctor to see if you need to receive any vaccinations. It is important to have all vaccines appropriate for your age before beginning your treatment with secukinumab injection. Do not have any vaccinations during your treatment without talking to your doctor.

• you should know that secukinumab injection may decrease your ability to fight infection from bacteria, viruses, and fungi and increase the risk that you will get a serious or life-threatening infection. Tell your doctor if you often get any type of infection or if you have or think you may have any type of infection now. This includes minor infections (such as open cuts or sores), infections that come and go (such as herpes or cold sores), and chronic infections that do not go away. If you experience any of the following symptoms during or shortly after your treatment with secukinumab injection, call your doctor immediately: fever, sweats, or chills; muscle aches; shortness of breath; warm, red, or painful skin or sores on your body; diarrhea; stomach pain; frequent, urgent, or painful urination; or other signs of infection.

• you should know that using secukinumab injection increases the risk that you will develop tuberculosis (TB; a serious lung infection), especially if you are already infected with tuberculosis but do not have any symptoms of the disease. Tell your doctor if you have or have ever had TB, if you have lived in a country where TB is common, or if you have been around someone who has TB. Your doctor will perform a skin test to see if you have an inactive TB infection. If necessary, your doctor will give you medication to treat this infection before you start using secukinumab injection. If you have any of the following symptoms of TB, or if you develop any of these symptoms during your treatment, call your doctor immediately: cough, coughing up blood or mucus, weakness or tiredness, weight loss, loss of appetite, chills, fever, or night sweats.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Call your doctor to ask what to do if you miss a subcutaneous dose of secukinumab injection. Do not use a double dose to make up for a missed one.

If you miss an appointment to receive a secukinumab intravenous infusion, call your doctor.

What SIDE EFFECTS can this medicine cause?

Secukinumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• runny, stuffed nose, sneezing
• sore throat
• itching

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

• rash
• hives
• difficulty breathing or swallowing
• feeling faint
• swelling of the eyes, face, lips, tongue, throat
• chest tightness
• hoarseness
• dry, peeling, or itchy skin
• blisters, bumps, or red patches on the skin

Secukinumab injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store secukinumab injection in the refrigerator but do not freeze. Keep the prefilled syringes and dosing pens in their original cartons to protect them from light.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

Ask your pharmacist any questions you have about secukinumab injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.