Taltz Autoinjector

Ixekizumab is an immunosuppressant that reduces the effects of a chemical substance in the body that can cause inflammation.

Ixekizumab is used to treat moderate to severe plaque psoriasis (raised, silvery flaking of the skin) in adults.

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

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

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

To make sure ixekizumab is safe for you, tell your doctor if you have:

• an active or recent infection;
• Crohn's disease, ulcerative colitis; or
• tuberculosis (or if you have close contact with someone who has tuberculosis).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether ixekizumab passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Ixekizumab is not approved for use by anyone younger than 18 years old.

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

Call your doctor at once if you have:

• fever, chills, sweating, muscle pain, weight loss;
• diarrhea (may be bloody), stomach cramps;
• painful skin sores;
• cough, shortness of breath, cough with red or pink mucus;
• sores or white patches in your mouth or throat (yeast infection or "thrush");
• increased urination, pain or burning when you urinate;
• eye swelling, redness, crusting or drainage (may be signs of infection); or
• signs of a fungal infection (rash or red patches, itching, burning, cracked skin, hair loss).

Common side effects may include:

• pain or redness where the medicine was injected;
• nausea;
• ear infection; 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.

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

To make sure ixekizumab is safe for you, tell your doctor if you have:

• an active or recent infection;

• Crohn's disease, ulcerative colitis; or

• tuberculosis (or if you have close contact with someone who has tuberculosis).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether ixekizumab passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Ixekizumab is not approved for use by anyone younger than 18 years old.

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

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Ixekizumab is injected under the skin. You may be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and syringes.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

This medicine is not used daily. The first 7 doses are usually given once per week. Then an injection is given once every 4 weeks. Follow your doctor's instructions.

Your care provider will show you the best places 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 should appear as a clear to light-yellow liquid. Do not use the medicine if it looks cloudy or has particles in it. Call your pharmacist for new medication.

Do not shake the syringe or injection pen.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Ixekizumab can lower blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill.

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.

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

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Other drugs may interact with ixekizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.