TREMFYA- guselkumab injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GUSELKUMAB (UNII: 089658A12D) (GUSELKUMAB - UNII:089658A12D)

Available from:

Janssen Biotech, Inc.

INN (International Name):

Guselkumab

Composition:

Guselkumab 100 mg in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

TREMFYA is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. TREMFYA is indicated for the treatment of adult patients with active psoriatic arthritis. TREMFYA is contraindicated in patients with a history of serious hypersensitivity reaction to guselkumab or to any of the excipients [see Warnings and Precautions (5.1)] . Pregnancy Exposure Registry There is a pregnancy registry that monitors pregnancy outcomes in women exposed to TREMFYA during pregnancy. Patients should be encouraged to enroll in the registry by visiting www.mothertobaby.org/ongoing-study/tremfya-guselkumab, by calling 1-877-311-8972, or emailing [e-mail]. Risk Summary There are no available data on TREMFYA use in pregnant women to inform a drug associated risk of adverse developmental outcomes. Human IgG antibodies are known to cross the placental barrier; therefore, TREMFYA may be transmitted from the mother to the devel

Product summary:

TREMFYA ® (guselkumab) Injection is a clear and colorless to light yellow solution that may contain small translucent particles. TREMFYA is supplied as: TREMFYA is sterile and preservative-free. Discard any unused portion. Keep out of reach of children.

Authorization status:

Biologic Licensing Application

Patient Information leaflet

Janssen Biotech, Inc.
----------
MEDICATION GUIDE
TREMFYA ®(TREM FYE' AH)
(GUSELKUMAB)
INJECTION, FOR SUBCUTANEOUS USE
This Medication Guide had been approved by the U.S. Food and
Drug Administration.
Revised: 11/2023
What is the most important information I should know about TREMFYA?
TREMFYA 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 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
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
•
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 TREMFYA?" for more
information about side effects.
What is TREMFYA?
TREMFYA is a prescription medicine used to treat adults:
•
with moderate to severe plaque psoriasis who may benefit from taking
injections or pills
(systemic therapy) or phototherapy (treatment using ultraviolet or UV
light)
•
with active psoriatic arthritis (PsA).
It is not known i

Summary of Product characteristics

TREMFYA- GUSELKUMAB INJECTION
JANSSEN BIOTECH, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TREMFYA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TREMFYA.
TREMFYA
(GUSELKUMAB) INJECTION FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2017
INDICATIONS AND USAGE
TREMFYA is an interleukin-23 blocker indicated for the treatment of
adult patients with:
moderate-to-severe plaque psoriasis who are candidates for systemic
therapy or phototherapy ( 1.1)
active psoriatic arthritis. ( 1.2)
DOSAGE AND ADMINISTRATION
Plaque Psoriasis
100 mg administered by subcutaneous injection at Week 0, Week 4 and
every 8 weeks thereafter. ( 2.1)
Psoriatic Arthritis
100 mg administered by subcutaneous injection at Week 0, Week 4 and
every 8 weeks thereafter.
TREMFYA can be used alone or in combination with a conventional DMARD
(e.g., methotrexate). ( 2.2)
DOSAGE FORMS AND STRENGTHS
Injection: 100 mg/mL in a single-dose prefilled syringe or single-dose
One-Press patient-controlled injector.
( 3)
CONTRAINDICATIONS
Serious hypersensitivity reactions to guselkumab or to any of the
excipients. ( 4)
WARNINGS AND PRECAUTIONS
_Hypersensitivity Reactions_: Serious hypersensitivity reactions,
including anaphylaxis, may occur. ( 5.1)
_Infections_: TREMFYA may increase the risk of infection. Instruct
patients to seek medical advice if signs
or symptoms of clinically important chronic or acute infection occur.
If a serious infection develops,
discontinue TREMFYA until the infection resolves. ( 5.2)
_Tuberculosis (TB)_: Evaluate for TB prior to initiating treatment
with TREMFYA. ( 5.3)
ADVERSE REACTIONS
Most common (≥1%) adverse reactions associated with TREMFYA include
upper respiratory infections,
headache, injection site reactions, arthralgia, bronchitis, diarrhea,
gastroenteritis, tinea infections, and
herpes simplex infections. ( 6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT JANSSEN BIOTECH, INC.
AT 1-800-JANSSEN
(1-800-526-7736) OR FDA AT 1-800-FDA-1088 OR