What is the most important information I should know about TREMFYA®?
TREMFYA® is a prescription medicine that may cause serious side effects,
including:
-
Serious Allergic Reactions. Stop using TREMFYA® and get
emergency medical help right away if you develop any of the following symptoms
of a serious allergic reaction:
- fainting, dizziness, feeling lightheaded (low blood pressure)
- swelling of your face, eyelids, lips, mouth, tongue or throat
- trouble breathing or throat tightness
- chest tightness
- skin rash, hives
- itching
-
Infections. TREMFYA® 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 TREMFYA® and may treat you for TB before
you begin treatment with TREMFYA® 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 TREMFYA®.
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
- blood in your phlegm (mucus)
- burning when you urinate or urinating more often than normal
-
Liver problems. Your healthcare provider may stop treatment with TREMFYA® if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms:
- unexplained rash
- vomiting
- tiredness (fatigue)
- yellowing of the skin or the whites of your eyes
- nausea
- stomach pain (abdominal)
- loss of appetite
- dark urine
Do not use TREMFYA® if you have had a serious allergic
reaction to guselkumab or any of the ingredients in TREMFYA®.
Before using TREMFYA®, 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
TREMFYA®?”
- 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.
-
have recently received or are scheduled to receive an immunization (vaccine).
You should avoid receiving live vaccines during treatment with TREMFYA®.
-
are pregnant or plan to become pregnant. It is not known if TREMFYA® can
harm your unborn baby.
Pregnancy Registry: If you become pregnant during treatment
with TREMFYA®, talk to your healthcare provider about registering in the
pregnancy exposure registry for TREMFYA®. You can enroll by visiting
www.mothertobaby.org/ongoing-study/tremfya-guselkumab, by calling 1-877-311-8972, or emailing
MotherToBaby@health.ucsd.edu. The purpose of this registry is to collect information about the safety of
TREMFYA® during pregnancy.
-
are breastfeeding or plan to breastfeed. It is not known if TREMFYA® 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.
What are the possible side effects of TREMFYA®?
TREMFYA® may cause serious side effects. See “What is the most important
information I should know about TREMFYA®?”
The most common side effects of TREMFYA® include:
respiratory tract infections, headache, injection site reactions, joint pain
(arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections,
herpes simplex infections, stomach pain, and bronchitis.
These are not all the possible side effects of TREMFYA®. Call your doctor for
medical advice about side effects.
Use TREMFYA® exactly as your healthcare provider tells you to use it.
Please read the full
Prescribing Information, including
Medication Guide, for TREMFYA® and discuss any questions that you have with your doctor.
You are encouraged to report negative side effects of prescription drugs to the
FDA. Visit
www.fda.gov/medwatch, or call
1-800-FDA-1088.
TREMFYA® is available as a 100 mg/mL subcutaneous injection.
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