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ILUMYA- tildrakizumab-asmn injection, solution


  1. Patient Information
  2. Serious Allergic Reactions. Get Emergency Medical Help Right Away If You Get Any Of The Following Symptoms Of A Serious Allergic Reaction:
  3. Tell Your Healthcare Provider Right Away If You Have An Infection Or Have Symptoms Of An Infection, Including:
  4. What Is Ilumya?
  5. How Will I Receive Ilumya?
  6. What Are The Possible Side Effects Of Ilumya?
  7. Active Ingredient:
  8. Inactive Ingredients:

Patient Information 

Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide).

Instruct patients and/or caregivers to read the Medication Guide before starting ILUMYA therapy and to reread the Medication Guide each time the prescription is renewed. Advise patients of the potential benefits and risks of ILUMYA.

Hypersensitivity

Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions[see Warnings and Precautions (5.1)].

Infections

Instruct patients of the importance of communicating any history of infections to the doctor and contacting their doctor if they develop any symptoms of infection[see Warnings and Precautions (5.2)].


Manufactured by: Sun Pharma Global FZE
Sharjah, U.A.E.
U.S. License No. 2092
In: Germany
U.S. Patent No. 8,404,813, 8,293,883 and 9,809,648
Tildrakizumab-asmn (active ingred.) Product of The Netherlands.


Distributed by: Sun Pharmaceutical Industries, Inc.,
Cranbury, NJ 08512


ILUMYA is a trademark of Sun Pharma Global FZE
Copyright 2019 Sun Pharma Global FZE
All rights reserved.
uspi-tildrakizumab-pfs-00002

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

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

Do not use ILUMYAif you have had a severe allergic reaction to tildrakizumab or any of the other ingredients in 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 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 of ILUMYA, schedule another appointment as soon as possible.

What Are The Possible Side Effects Of Ilumya? 

ILUMYA may cause serious side effects.

Active Ingredient: 

tildrakizumab-asmn

Inactive Ingredients: 

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

Manufactured by: Sun Pharma Global FZE
Sharjah, U.A.E.
U.S. License No. 2092
In: Germany
U.S. Patent No. 8,404,813, 8,293,883 and 9,809,648
Tildrakizumab-asmn (active ingred.) Product of The Netherlands.


Distributed by: Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512


ILUMYA is a trademark of Sun Pharma Global FZE
Copyright 2019 Sun Pharma Global FZE
All rights reserved.
usmg-tildrakizumab-pfs-00002

This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 09/2019



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