Ixekizumab Injection

WHY is this medicine prescribed?

Ixekizumab injection is used to treat moderate to severe plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body) in adults and children 6 years of age and older whose psoriasis is too severe to be treated by topical medications alone. It is also used alone or in combination with certain medications such as methotrexate (Rasuvo, Trexall, others) to treat psoriatic arthritis (a condition that causes joint pain and swelling and scales on the skin) in adults. Ixekizumab injection is also used to treat ankylosing spondylitis (a condition in which the body attacks the joints of the spine and other areas, causing pain and joint damage) in adults. It is also used to treat active non-radiographic axial spondyloarthritis (a condition in which the body attacks the joints of the spine and other areas causing pain and signs of swelling, but without changes seen on x-ray) in adults, Ixekizumab injection is in a class of medications called monoclonal antibodies. It works by blocking the action of a certain natural substance in the body that causes the symptoms of psoriasis.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Ixekizumab injection comes as a solution (liquid) in a prefilled syringe and as a prefilled autoinjector to inject subcutaneously (under the skin). To treat plaque psoriasis in adults, it is usually given as two injections for the first dose, followed by one injection every 2 weeks for the next 6 doses, and then one injection every 4 weeks. To treat plaque psoriasis in children, it is usually given as one or two injections for the first dose, depending on the weight of the child, followed by one injection every 4 weeks. To treat psoriatic arthritis or ankylosing spondylitis, it is usually given as two injections for the first dose, followed by one injection every 4 weeks. To treat non-radiographic axial spondyloarthritis, it is usually given as one injection every 4 weeks.

You may receive your first dose of ixekizumab injection in your doctor's office. If you are an adult, your doctor may allow you or a caregiver to perform the ixekizumab injections at home after your first dose. If you have vision or hearing problems, you will need a caregiver to give you injections. If your child weighs 110 pounds (50 kg) or less, ixekizumab injection must be given in a doctor's office. If your child weighs more than 110 pounds, your doctor may allow a caregiver to perform the injections at home. Ask your doctor or pharmacist to show you or the person who will be injecting the medication how to inject and prepare it.

Use each syringe or autoinjector only once and inject all the solution in the syringe or autoinjector. Dispose of used syringes and autoinjector in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

Remove the prefilled syringe or autoinjector from the refrigerator. Place it on a flat surface without removing the needle cap and allow it warm to room temperature for 30 minutes before you are ready to inject the medication. Do not try to warm the medication by heating it in a microwave, placing it in hot water, leaving it in sunlight, or through any other method.

Do not shake a syringe or autoinjector that contains ixekizumab.

Always look at ixekizumab solution before injecting it. Check that the expiration date has not passed and that the liquid is clear or slightly yellow. The liquid should not contain visible particles. Do not use a syringe or autoinjector if it is cracked or broken, if it is expired or frozen, or if the liquid is cloudy or contains small particles.

You can inject ixekizumab injection anywhere on the front of your thighs (upper leg) or abdomen (stomach) except your navel and the area 1 inch (2.5 centimeters) around it. If you have a caregiver to inject the medication, the back of the upper arm may also be used. To reduce the chances of soreness or redness, use a different site for each injection. Do not inject into an area where the skin is tender, bruised, red, or hard or where you have scars or stretch marks. Do not inject ixekizumab into an area affected by psoriasis.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide and Instructions for Use) when you begin treatment with ixekizumab injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide, or the manufacturer's website to obtain the Medication Guide and the Instructions for Use.

What SPECIAL PRECAUTIONS should I follow?

Before using ixekizumab injection,

• tell your doctor and pharmacist if you are allergic to ixekizumab, any other medications, or any of the ingredients in ixekizumab injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Teril), cyclosporine (Gengraf, Neoral, Sandimmune), quinidine (in Nuedexta), sirolimus (Rapamune), tacrolimus (Astagraf, Envarsus, Prograf), and warfarin (Coumadin, Jantoven). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with ixekizumab injection, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor if you have an infection or if you have or have ever had an inflammatory bowel disease (IBD; a group of conditions that cause swelling of the lining of the intestines) such as Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) or ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum).

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using ixekizumab injection, call your doctor.

• check with your doctor to see if you need to receive any vaccinations. It is important to have all vaccines appropriate for your age before beginning your treatment with ixekizumab injection. Do not have any vaccinations during your treatment without talking to your doctor.

• you should know that ixekizumab injection may decrease your ability to fight infection from bacteria, viruses, and fungi and increase the risk that you will get a serious or life-threatening infection. Tell your doctor if you often get any type of infection or if you have or think you may have any type of infection now. This includes minor infections (such as open cuts or sores), infections that come and go (such as herpes or cold sores), and chronic infections that do not go away. If you experience any of the following symptoms during or shortly after your treatment with ixekizumab injection, call your doctor immediately: fever, sweats, or chills, muscle aches, shortness of breath, warm, red, or painful skin or sores on your body, diarrhea, stomach pain, frequent, urgent, or painful urination, or other signs of infection. Your doctor will probably delay your treatment with ixekizumab injection if you have an infection.

• you should know that using ixekizumab injection increases the risk that you will develop tuberculosis (TB; a serious lung infection), especially if you are already infected with tuberculosis but do not have any symptoms of the disease. Tell your doctor if you have or have ever had TB, if you have lived in a country where TB is common, or if you have been around someone who has TB. Your doctor will perform a skin test to see if you have an inactive TB infection. If necessary, your doctor will give you medication to treat this infection before you start using ixekizumab injection. If you have any of the following symptoms of TB, or if you develop any of these symptoms during your treatment, call your doctor immediately: cough, coughing up blood or mucus, weakness or tiredness, weight loss, loss of appetite, chills, fever, or night sweats.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Use the missed dose as soon as you remember it and then continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Ixekizumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• red, itchy, or watery eyes
• stuffy or runny nose
• redness or pain at the injection site
• abdominal pain
• diarrhea (with or without blood)
• weight loss

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, stop using ixekizumab injection and call your doctor immediately or get emergency medical treatment:

• feeling faint
• swelling of the face, eyelids, tongue, or throat
• difficulty swallowing or breathing
• tightness in the chest or throat
• rash
• hives

Ixekizumab injection may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in to protect it from light, tightly closed, and out of reach of children. Store ixekizumab injection in the refrigerator, but do not freeze it. If needed, you may store ixekizumab injection at room temperature for up to 5 days in the original carton to protect it from light. Once stored at room temperature, do not return ixekizumab injection to the refrigerator. Discard ixekizumab injection if it is not used within 5 days at room temperature.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Ixekizumab autoinjector has glass parts and should be handled carefully. If the autoinjector falls on a hard surface, do not use it.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.