warnings

What is the most important information I should know about Ixekizumab (Taltz Autoinjector)?

You should not use ixekizumab if you are allergic to it.

Tell your doctor if you have ever had:

an active or recent infection;
Crohn's disease, ulcerative colitis;
tuberculosis (or if you have close contact with someone who has tuberculosis); or
if you have recently received or are scheduled to receive a vaccine.

Tell your doctor if you are pregnant or breastfeeding.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of ixekizumab on the baby.

Ixekizumab is not approved for use by anyone younger than 6 years old.

Side Effects

What are the side effects of Ixekizumab (Taltz Autoinjector)?

Get emergency medical help if you have signs of an allergic reaction: rash; chest tightness, difficult breathing; feeling like you might pass out; swelling of your face, eyelids, lips, mouth, tongue, or throat.

Call your doctor at once if you have:

diarrhea (may be bloody), stomach cramps;
easy bruising, purple or red spots under your skin;
fever, chills, muscle pain;
painful skin sores;
cough, shortness of breath, cough with red or pink mucus;
increased urination, pain or burning when you urinate;
sores or white patches in your mouth or throat (yeast infection or "thrush"); or
signs of tuberculosis: fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired.

Common side effects may include:

pain or redness where the medicine was injected;
nausea;
fungal infections; 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.

Dosage Guidelines & Tips

How to take Ixekizumab (Taltz Autoinjector)?

Use Ixekizumab (Taltz Autoinjector) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Before you start treatment with ixekizumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

People with active tuberculosis should not take this medicine. Your healthcare provider may treat you for tuberculosis before you begin treatment with ixekizumab if you currently have tuberculosis or if you had tuberculosis.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Ixekizumab is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

The timing of your injections will depend on the condition being treated. Follow your doctor's dosing instructions very carefully.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

This medicine is not used daily. Your first dose may be given as 2 injections at the same time. Later doses are then given once every 2 to 4 weeks.

Ixekizumab doses are based on weight in children treated for moderate-to-severe plaque psoriasis. Your child's dose needs may change if the child gains or loses weight.

Prepare an injection only when you are ready to use it. Ixekizumab should appear as a clear to light-yellow liquid. Do not use the medicine if it looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medication.

Do not shake the syringe or injection pen.

Your healthcare provider will show you where on your body to inject ixekizumab. Use a different place each time you give an injection. Do not inject into the same place two times in a row. Do not give an injection into a skin area with active psoriasis, or skin that is red, bruised, or tender.

Ixekizumab can increase your risk of bleeding or infection. You will need frequent medical tests.

Store this medicine in the original container in a refrigerator. Protect from light and do not freeze. Do not use the medicine if it has become frozen.

Before injecting your dose, take the injection pen or prefilled syringe out of the refrigerator and leave it at room temperature for 30 minutes. Do not heat the medicine in a microwave or under hot water, and do not leave it in direct sunlight.

If needed, you may store ixekizumab at room temperature in its original carton, protected from light. Do not return the medicine to the refrigerator. Throw away any ixekizumab kept at room temperature if you have not used it within 5 days.

Each single-use injection pen or prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

What should I do if I missed a dose of Ixekizumab (Taltz Autoinjector)?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.