secukinumab

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

What is secukinumab?

Secukinumab is an immunosuppressant that is used to treat moderate to severe plaque psoriasis in adults and children at least 6 years old.

Secukinumab is also used in adults to treat psoriatic arthritis, ankylosing spondylitis, or axial spondyloarthritis.

Secukinumab may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using secukinumab?

Tell your doctor if you've had or been exposed to tuberculosis, or if you recently traveled. Some infections are more common in certain parts of the world, and you may have been exposed during travel.

Tell your doctor if you have ever had:

• an active or chronic infection;
• inflammatory bowel disease (Crohn's disease or ulcerative colitis);
• an allergy to latex; or
• if you currently have signs of infection such as fever, sweats, chills, muscle pain, cough, shortness of breath, cough with bloody mucus, weight loss, skin sores, stomach pain, diarrhea, or painful urination.

Make sure you are current on all vaccines before you start using secukinumab.

Tell your doctor if you are pregnant or breastfeeding.

How should I use secukinumab?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Secukinumab is injected under the skin.

Ask your doctor or pharmacist if you don't understand how to use an injection.

Prepare an injection only when you are ready to give it. You may need to use 2 injections to get your total dose.

Secukinumab should be clear or light-yellow. Call your pharmacist if the medicine looks cloudy, has changed colors, or has particles in it.

Your healthcare provider will show you where to inject secukinumab. Do not inject into the same place two times in a row. Avoid injecting into skin that is hard, red, bruised, swollen, tender, or affected by psoriasis. Do not inject within 2 inches of your navel (belly button).

You may get infections more easily, even serious infections. You will need frequent medical tests.

Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Take the injection pen out of the refrigerator and let it reach room temperature for 15 to 30 minutes before using. Give the injection within 1 hour after removing the medicine from a refrigerator.

Throw away a prefilled syringe or injection pen after one use, even if there is still medicine left inside.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while using secukinumab?

Avoid receiving a "live" vaccine. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

What are the possible side effects of secukinumab?

• redness, warmth, or painful sores on your skin;
• cough, shortness of breath, cough with red or pink mucus;
• increased urination, burning when you urinate;
• sores or white patches in your mouth or throat (yeast infection or "thrush");
• new or worsening diarrhea or stomach pain; or
• fever, chills, sweating, muscle pain, weight loss.

Further doses may be delayed until your infection clears up.

Common side effects may include:

• diarrhea; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect secukinumab?

Other drugs may affect secukinumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Where can I get more information?

Your doctor or pharmacist can provide more information about secukinumab.