Recommended Evaluation and Immunization Prior to Treatment Initiation

• Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with ILUMYA [see Warnings and Precautions (5.3)].
• Consider completion of all age appropriate immunizations according to current immunization guidelines. [see Warnings and Precautions (5.4)]

Dosage

ILUMYA is administered by subcutaneous injection. The recommended dosage is 100 mg at Weeks 0, 4, and every 12 weeks thereafter. Each syringe contains 1 mL of 100 mg/mL tildrakizumab-asmn.

Important Administration Instructions

ILUMYA should only be administered by a healthcare provider. Administer ILUMYA subcutaneously. Each pre-filled syringe is for single-dose only. Inject the full amount (1 mL), which provides 100 mg of tildrakizumab per syringe. If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regularly scheduled interval.

Preparation and Administration of ILUMYA

Before injection, remove ILUMYA carton from the refrigerator, and let the prefilled syringe (in the ILUMYA carton with the lid closed) sit at room temperature for 30 minutes.

Follow the instructions on the ILUMYA 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 ILUMYA visually for particulate matter and discoloration prior to administration. ILUMYA 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. Also 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 ILUMYA subcutaneously as recommended [see Dosage and Administration (2.3)].
• 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 safety lock will draw the needle inside the needle guard.

• Discard any unused portion. Dispose of used syringe.