Ilumya

Ilumya is used to treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic treatment (injections or pills) or phototherapy (ultraviolet [UV] light therapy). Ilumya is given as an injection under the skin (subcutaneous).

Ilumya (tildrakizumab-asmn) works by binding to the p19 subunit of interleukin-23 (IL-23), a protein involved in inflammation, and blocks it from reaching its receptor. This lowers the release of inflammatory proteins, which helps calm an overactive immune system and improve plaque psoriasis symptoms. Ilumya belongs to the drug class called interleukin inhibitors. it may also be called a monoclonal antibody.

Ilumya received FDA approval on March 20, 2018. There is no generic.

Serious side effects

Ilumya may cause serious side effects, including:

• Serious allergic reactions. Get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction: feel faint swelling of your face, eyelids, lips, mouth, tongue, or throat chest tightness skin rash trouble breathing or throat tightness
• Infections. Ilumya is a medicine that may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with Ilumya and may treat you for TB before you begin treatment with Ilumya if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with Ilumya.

Tell your healthcare provider right away if you have an infection or develop symptoms of an infection, including:

• fever, sweats, or chills cough or shortness of breath blood in your phlegm (mucus) muscle aches warm, red, or painful skin or sores on your body different from your psoriasis weight loss diarrhea or stomach pain burning when you urinate or urinating more often than normal.

Common side effects

The most common side effects of Ilumya include:

• upper respiratory infections
• injection site reactions
• diarrhea

These are not all of the possible side effects of Ilumya. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Do not use Ilumya if you have had a severe allergic reaction to tildrakizumab or any of the other ingredients in Ilumya. See the end of this Medication Guide for a complete list of ingredients in Ilumya.

Before receiving Ilumya, tell your healthcare provider about all of your medical conditions, including if you:

• have any of the conditions or symptoms listed in the section "What is the most important information I should know about Ilumya?"
• have an infection that does not go away, or that keeps coming back
• have TB or have been in close contact with someone with TB
• recently received or are scheduled to receive a vaccine (immunization). You should avoid receiving live vaccines during treatment with Ilumya.
• are pregnant or plan to become pregnant. It is not known if Ilumya can harm your unborn baby. There is a pregnancy exposure registry for women who become pregnant during treatment with or are exposed to Ilumya during pregnancy. If you become pregnant during treatment with Ilumya, you can enroll in the pregnancy registry. The purpose of this registry is to collect information about the health of women exposed to Ilumya and their baby. Talk with your healthcare provider or call 1-866-626-6847 to enroll in this registry or visit https://mothertobaby.org/ongoing-study/Ilumya-tildrakizumab-asmn
• are breastfeeding or plan to breastfeed. It is not known if Ilumya passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

It is not known if Ilumya is safe and effective in children under 18 years of age.

• Ilumya should only be given to you by a healthcare provider.
• 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.
• If you miss a follow-up appointment and do not receive your dose of Ilumya, schedule another appointment as soon as possible.

Active ingredient: tildrakizumab-asmn

Inactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sucrose, and Water for Injection, USP.

Ilumya (tildrakizumab-asmn) is manufactured by Sun Pharmaceutical Industries Limited, Mumbai, Maharashtra, India 400 063. U.S. License No. 2092.