Ilumya reduces the effects of a substance in the body that can cause inflammation.

Ilumya injection is a prescription medicine used to treat moderate to severe psoriasis in adults who may benefit from receiving injections, pills, or treatment using ultraviolet or UV light phototherapy).

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

Ilumya affects your immune system. You may get infections more easily. Call your doctor if you have a fever, chills, aches, cough, shortness of breath, skin sores, diarrhea, weight loss, or burning when you urinate.

Ilumya is given as an injection under your skin (subcutaneous injection) in areas of your body such as your thighs, stomach area (abdomen), or upper arm.

A healthcare provider will administer your Ilumya injection.

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

Usual Adult Dose of Ilumya for Plaque Psoriasis:

100 mg subcutaneously at Weeks 0 and 4, and every 12 weeks thereafter

Comments:
-Evaluate patients for tuberculosis (TB) infection prior to initiating therapy.

Use: For adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy

Administration advice:
-Ilumya should only be administered by a healthcare provider.
-Before injection, remove carton from the refrigerator, and let the prefilled syringe (in the carton with the lid closed) sit at room temperature for 30 minutes.
-Follow the instructions on the carton to remove the prefilled syringe correctly, and remove only when ready to inject. Do not pull off the needle cover until you are ready to inject.
-Inspect the syringe visually for particulate matter and discoloration prior to administration. The product is a clear to slightly opalescent, colorless to slightly yellow solution. Do not use if the liquid contains visible particles or the syringe is damaged. Air bubbles may be present; there is no need to remove them.
-Choose an injection site with clear skin and easy access (such as abdomen, thighs, or upper arm). Do not administer 2 inches around the navel or where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis. Do not inject into scars, stretch marks, or blood vessels.
-While holding the body of the syringe, pull the needle cover straight off (do not twist) and discard.
-Inject the full amount (1 mL), which provides 100 mg of drug per syringe.
-Press down the blue plunger until it can go no further. This activates the safety mechanism that will ensure full retraction of the needle after the injection is given.
-Remove the needle from the skin entirely before letting go of the blue plunger. After the blue plunger is released, the safely lock will draw the needle inside the needle guard.
-If a dose is missed, administer the dose as soon as possible; thereafter, resume dosing at the regularly scheduled interval.

You should not be treated with Ilumya if you are allergic to tildrakizumab

Tell your doctor if you have a chronic infection, or if you are scheduled to receive any vaccine.

Tell your doctor if you have ever had tuberculosis, or if anyone in your household has tuberculosis.

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

It may not be safe to breast-feed while using tildrakizumab. Ask your doctor about any risk.

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

If you miss a follow-up appointment and do not receive your dose, schedule another appointment as soon as possible.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not receive a "live" vaccine while using Ilumya. The vaccine may not work as well and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

Get emergency medical help if you have signs of an allergic reaction to Ilumya: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

• fever, chills, sweating;

• skin sores;

• muscle pain;

• increased urination, pain or burning when you urinate;

• stomach pain, diarrhea, weight loss; or

• cough, shortness of breath, coughing up pink or red mucus.

Common Ilumya side effects may include:

• pain, itching, rash, redness, swelling, bruising, or bleeding where the medicine was injected;

• diarrhea; 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.

Other drugs may interact with tildrakizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.