Secukinumab Injection

pronounced as (sek'' ue kin' ue mab)

Brand Name(s): Cosentyx®

Why is this medicine prescribed?

Secukinumab injection is used to treat the following:

  • plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body)
  • psoriatic arthritis (a condition that causes joint pain and swelling and scales on the skin)
  • ankylosing spondylitis (a condition in which the body attacks the joints of the spine and other areas causing pain and joint damage)
  • 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)
  • enthesitis-related arthritis (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function)
  • 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) in single-dose, prefilled syringes and dosing pens to inject subcutaneously (under the skin). Your doctor will tell you how often to use secukinumab injection based on your condition and age.

Use secukinumab injection exactly as directed. Do not inject more or less of it or inject it more often than prescribed by your doctor.

Secukinumab injection solution may also be injected intravenously (into a vein) over about 30 minutes by a doctor or nurse in a healthcare setting.

You will receive your first subcutaneous dose of secukinumab injection in your doctor's office. After that, you may be allowed to give the injections at home. Before you use secukinumab injection yourself the first time, read the written instructions that come with the medication. Ask your doctor or pharmacist to show you or your caregiver how to inject it.

If you are using secukinumab injection that has been refrigerated, place it on a flat surface. Do not remove the needle cap. Allow it to warm to room temperature for 15 to 45 minutes (depending on the product being used). Do not 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 be free of 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. 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 stomach except your navel (belly button) and the area 2 inches (5 centimeters) around it. If a caregiver is giving the injection, the back 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.

You will be given the Medication Guide when you begin treatment with secukinumab injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm to obtain the Medication Guide.

What special precautions should I follow?

Before using secukinumab injection,

  • tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
  • 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. 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 infections and increase the risk that you will get an 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, 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.

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 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
  • diarrhea

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; itching; feeling faint or lightheaded; swelling of the face, eyes, lips, mouth, throat, or tongue; trouble breathing or swallowing; hoarseness; or chest or throat tightness
  • dry, peeling, or itchy skin; or 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 ( https://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.

Secukinumab injection may also be stored at room temperature for up to 4 days. Discard prefilled syringes and dosing pens that have been stored at room temperature for more than 4 days.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

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.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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