Tildrakizumab-asmn 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 people whose psoriasis is too severe to be treated by topical medications alone. Tildrakizumab-asmn injection is in a class of medications called monoclonal antibodies. It works by stopping the action of certain natural substances in the body that cause the symptoms of psoriasis.

Tildrakizumab-asmn injection comes as a prefilled syringe to be injected subcutaneously (under the skin) in the stomach area, thigh, or upper arm by a doctor or nurse. It is usually injected once every 4 weeks for the first two doses and then once every 12 weeks.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with tildrakizumab-asmn injection and each time you receive an injection. 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.

Before taking tildrakizumab-asmn injection,

• tell your doctor and pharmacist if you are allergic to tildrakizumab-asmn, any other medications, or any of the ingredients in tildrakizumab-asmn 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. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using tildrakizumab-asmn 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 tildrakizumab-asmn injection. Also tell your doctor if you have recently received any vaccinations. Do not have any vaccinations during your treatment without talking to your doctor.
• you should know that tildrakizumab-asmn injection may decrease your ability to fight infection from bacteria, viruses, and fungi and increase the risk that you will get an 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 tildrakizumab-asmn injection, call your doctor immediately: fever, sweats, or chills, muscle aches, shortness of breath, cough, warm, red, or painful skin or sores on your body, diarrhea, stomach pain, frequent, urgent, or painful urination, or other signs of infection.
• you should know that using tildrakizumab-asmn 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 tildrakizumab-asmn 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.

If you miss an appointment with your doctor to receive a dose of tildrakizumab-asmn injection, schedule another appointment as soon as possible.

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.

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

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

• diarrhea
• cough, sore throat, runny or stuffed nose
• redness, itching, swelling, bruising, bleeding, or pain near the spot where tildrakizumab-asmn was injected

Some side effects can be serious. If you experience any of these symptoms call your doctor immediately or get emergency medical treatment:

• hives or rash
• swelling of face, eyelids, lips, mouth, tongue or throat; trouble breathing; throat or chest tightness; feeling faint

Tildrakizumab-asmn 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).

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

Keep all appointments with your doctor.

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.

• Ilumya®