Ixekizumab (ix-ee-KIZ-ue-mab)

Treats psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis.

Brand Name(s):

Taltz

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. This medicine is usually given in the upper arms, stomach, or thighs.
• 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.
• Allow the medicine to warm to room temperature for 30 minutes 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. Use a dose as soon as you remember. If it is almost time for your next dose, wait until then and use a regular dose. Do not use extra medicine to make up for a missed dose.
• 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. You may also store this medicine at room temperature up to 30°C for up to 5 days. Do not put it back in the refrigerator once stored at room temperature. Throw away any unused medicine after 5 days.

Drugs and Foods to Avoid:

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

• 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. You should receive all your vaccines before starting treatment with this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have an inflammatory bowel disease (including Crohn disease, ulcerative colitis).
• This medicine may cause new or worsening inflammatory bowel disease.
• This medicine may cause you to get infections more easily (including eye, mouth, skin, or upper respiratory tract infections). Tell your doctor if you have any type of infection (including tuberculosis) before you start treatment with this medicine. Take precautions to avoid illness. Wash your hands often.
• 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
• Change in how much or how often you urinate, painful urination
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Pain, redness, swelling, dryness, or itching of the eyes
• Severe stomach pain, diarrhea, nausea
• Skin itching or scaling
• 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