Ilumya

What is Ilumya?

Ilumya is a prescription medicine used to treat adults with moderate to severe plaque psoriasis who may benefit from taking injections, pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).

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

Description

Tildrakizumab-asmn is a humanized IgG1/k antibody that specifically binds to the p19 subunit of interleukin-23 (IL-23).

Tildrakizumab-asmn is produced in a recombinant Chinese hamster ovary (CHO) cell line and has an approximate molecular mass of 147 kilodaltons.

ILUMYA (tildrakizumab-asmn) injection, for subcutaneous use, is a sterile, clear to slightly opalescent, colorless to slightly yellow solution. ILUMYA is supplied in a single-dose prefilled syringe with a glass barrel and 29-gauge fixed, 1/2-inch needle.

The syringe is fitted with a passive needle guard and a needle cover.

Each 1 mL single-dose prefilled syringe contains 100 mg of tildrakizumab-asmn formulated in: L-histidine (0.495 mg), L-histidine hydrochloride monohydrate (1.42 mg), polysorbate 80 (0.5 mg), sucrose (70.0 mg), and Water for Injection, USP with a pH of 5.7-6.3.

 Mechanism of Action

Tildrakizumab is a humanized IgG1/k monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses. Tildrakizumab inhibits the release of proinflammatory cytokines and chemokines.

What is the most important information I should know about Ilumya?

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
• skin rash
• trouble breathing or throat tightness
• chest 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 have symptoms of an infection, including:

• fever, sweats, or chills
• cough
• 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

See “What are the possible side effects of Ilumya?” for more information about side effects.

Who should not use Ilumya?

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.

What should I tell my healthcare provider before using 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.
• 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.

How should I use Ilumya?

• 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.

What are the possible side effects of Ilumya?

Ilumya may cause serious side effects. See “What is the most important information I should know about Ilumya?”

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.

General information about the safe and effective use of Ilumya

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your healthcare provider for information about Ilumya that is written for health professionals.

How should I store Ilumya?

Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until the time of use. Do not freeze. Do not shake. Ilumya can be kept at room temperature at 25°C (77°F) for up to 30 days in the original carton to protect from light. Once stored at room temperature, do not place back in the refrigerator. If not used within 30 days, discard Ilumya. Do not store Ilumya above 25°C (77°F).

What are the ingredients in Ilumya?

Active ingredient: tildrakizumab-asmn

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

Label

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