Secukinumab (sek-ue-KIN-ue-mab)

Treats plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, enthesitis-related arthritis, and hidradenitis suppurativa.

Brand Name(s):

Cosentyx, Cosentyx UnoReady Pen 300MG/2ML

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed into a vein or as a shot under your skin, usually in the upper arms, stomach, or thighs.
• If secukinumab is injected into a vein, it must be given slowly, so the IV will have to stay in place for at least 30 minutes.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• Secukinumab comes in 6 forms: a Sensoready® pen, an UnoReady® pen, a 300 mg/2 mL prefilled syringe, a 150 mg/mL prefilled syringe, a 75 mg/0.5 mL prefilled syringe for children (these 5 forms may be used at home), and a vial (which is to be used only in the hospital or doctor's office). Your doctor will tell you which dosage form you should use.
• Allow the medicine to warm to room temperature for 15 to 30 minutes (for Sensoready® pen, 150 mg/mL prefilled syringe, and 75 mg/0.5 mL prefilled syringe) and 30 to 45 minutes (for UnoReady® pen and 300 mg/2 mL prefilled syringe) before you use it.
• Do not use the medicine if it is cloudy, discolored, or has particles in it. Do not shake the medicine.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are red, bruised, tender, hard, or affected by psoriasis.
• Use a new needle and syringe each time you inject your medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Call your doctor or pharmacist for instructions.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. Keep the medicine in the original carton until you are ready to use it. Use the medicine within 1 hour after you take it out of the refrigerator.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how secukinumab works. Tell your doctor about all other medicines you are using.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. You should not receive live vaccines while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have inflammatory bowel disease (including Crohn disease or ulcerative colitis) or an allergy to latex.
• This medicine may cause you to get infections more easily (including mouth, skin, or upper respiratory tract infections). Tell your doctor if you have any type of infection before you start treatment. Take precautions to avoid illness. Wash your hands often.
• This medicine may cause the following problems:
  • New or worsening inflammatory bowel disease
  • Serious skin reactions, including atopic dermatitis-like eruptions, dyshidrotic eczema, and erythroderma
• You will need to have a skin test for tuberculosis (TB) before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive TB skin test or has been exposed to TB.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, crusting, dryness, irritation, itching, peeling, redness, scaling, or swelling of the skin
• Burning feeling when you urinate, change in how much or how often you urinate
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Severe stomach pain, diarrhea
• Sores or white patches on your lips, mouth, or throat

If you notice these less serious side effects, talk with your doctor:

• Pain, itching, burning, swelling, or a lump under your skin where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088