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FDA Approves Ilumya

The U.S. Food and Drug Administration (FDA) has approved Ilumya (tildrakizumab-asmn), an interleukin-23 antagonist indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Medication Guide

Read this Patient Information carefully before you start treatment. This information does not take the place of talking with your doctor about your medical condition or your treatment.

Important information

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, and may treat you for TB before you begin treatment 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. 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 Ilumya side effects for more information about side effects.

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 this medicine is safe and effective in children under 18 years of age.

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. See the end of this Medication Guide for a complete list of ingredients.

Before receiving 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 Important information.
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 will I receive 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, schedule another appointment as soon as possible.

Ilumya side effects

Ilumya may cause serious side effects. See Important information.

The most common side effects include:

upper respiratory infections
injection site reactions
diarrhea

These are not all of the possible side effects. 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 that is written for health professionals.