didates for systemic therapy or phototherapy.
2 DOSAGE AND ADMINISTRATION
2.1 Dosage
ILUMYA is administered by subcutaneous injection. The recommended dose is 100 mg at Weeks0, 4, and every twelve weeks thereafter. Each syringe contains 1 mL of 100 mg/mL tildrakizumab-asmn.
2.2 Tuberculosis Assessment Prior to Initiation of ILUMYA
eva luate patients for tuberculosis (TB) infection prior to initiating treatment with ILUMYA [seeWarnings and Precautions (5.3)].
2.3 Important Administration Instructions
ILUMYA should only be administered by a healthcare provider. Administer ILUMYAsubcutaneously. Each pre-filled syringe is for single-dose only. Inject the full amount (1 mL), whichprovides 100 mg of tildrakizumab per syringe. If a dose is missed, administer the dose as soon aspossible. Thereafter, resume dosing at the regularly scheduled interval.
2.4 Preparation and Administration of ILUMYA
Before injection, remove ILUMYA carton from the refrigerator, and let the prefilled syringe (in theILUMYA 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 removeonly 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 isa clear to slightly opalescent, colorless to slightly yellow solution. Do not use if the liquid contains visibleparticles 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) anddiscard.
• 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 thatwill 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 blueplunger is released, the safely lock will draw the needle inside the needle guard.
• Discard of any unused portion. Dispose of used syringe.
3 DOSAGE FORMS AND STRENGTHS
Injection: 100 mg/mL solution in a single-dose prefilled syringe. ILUMYA is a clear to slightlyopalescent, colorless to slightly yellow solution.
4 CONTRAINDICATIONS
ILUMYA is contraindicated in patients with a previous serious hypersensitivity reaction totildrakizumab or to any of the excipients [see Warnings and Precautions (5.1)].
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity
Cases of angioedema and urticaria occurred in ILUMYA treated subjects in clinical trials. If aserious hypersensitivity reaction occurs, discontinue ILUMYA immediately and initiate appropriate therapy[see Adverse Reactions (6.1)].
5.2 Infections
ILUMYA may increase the risk of infection. Although infections were slightly more common in theILUMYA group (23%), the difference in frequency of infections between the ILUMYA group and theplacebo group was less than 1% during the placebo-controlled period. However, subjects with a |
