INDICATION AND IMPORTANT SAFETY INFORMATION

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 phototherapy (treatment using ultraviolet or UV light).

IMPORTANT SAFETY INFORMATION

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

Do not use ILUMYA if you have had a severe allergic reaction to ILUMYA or any of its ingredients.

Get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction:

  • feel faint
  • trouble breathing or throat tightness
  • swelling of your face, eyelids, lips, mouth, tongue or throat
  • chest tightness
  • skin rash

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

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.

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

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 and diarrhea. These are not all of the possible side effects of ILUMYA. Call your doctor for medical advice about side effects.

You are encouraged to report any negative side effects of ILUMYA to FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You are also encouraged to report side effects or ADEs (adverse drug events) to our Drug Safety Department at 1-800-406-7984 or drug.safetyUSA@sunpharma.com (preferred) with as much information as available.

Please read the full Prescribing Information and Medication Guide for ILUMYA and discuss any questions with your doctor.