Ixekizumab Solution for injection

What is this medicine?

IXEKIZUMAB (ix e KIZ ue mab) is a monoclonal antibody. It is used to treat psoriasis.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• are being treated for an infection

• have an infection that is not going away or that keeps coming back

• inflammatory bowel disease

• immune system problems

• recently received or are scheduled to receive a vaccine

• tuberculosis, a positive skin test for tuberculosis, or have recently been in close contact with someone who has tuberculosis

• an unusual or allergic reaction to ixekizumab, other medicines, foods, dyes or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection under the skin. It may be administered by a healthcare professional in a hospital or clinic setting or at home. If you get this medicine at home, you will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor of health care professional if you are unable to keep an appointment. If you give yourself the medicine and you miss a dose, take it as soon as you can. Then be sure to take your next doses on your regular schedule. Do not take double or extra doses. If you have questions about a missed injection, call your health care professional.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• live virus vaccines

This medicine may also interact with the following medications:

• cyclosporine

• inactivated vaccines

• warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

You will be tested for tuberculosis (TB) before you start this medicine. If your doctor prescribes any medicine for TB, you should start taking the TB medicine before starting this medicine. Make sure to finish the full course of TB medicine.

Call your doctor or healthcare professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine can decrease the response to a vaccine. If you need to get vaccinated, tell your healthcare professional if you have received this medicine within the last 6 months. Extra booster doses may be needed. Talk to your doctor to see if a different vaccination schedule is needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• signs and symptoms of infection like fever or chills; cough; sore throat; pain or trouble passing urine

• signs and symptoms of bowel problems like abdominal pain, diarrhea, blood in the stool, and weight loss

• white patches in the mouth or throat

• vaginal discharge, itching, or odor in women

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• nausea

• runny nose

• sinus trouble

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store the prefilled syringe or injection pen in a refrigerator between 2 to 8 degrees C (36 to 46 degrees F). Keep the syringe or the pen in the original carton until ready for use. Protect from light. Do not freeze. Do not shake. Prior to use, remove the syringe or pen from the refrigerator and use within 30 minutes. Throw away any unused medicine after the expiration date on the label.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.