STELARA- ustekinumab injection, solution STELARA- ustekinumab solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

ustekinumab (UNII: FU77B4U5Z0) (ustekinumab - UNII:FU77B4U5Z0)

Commercializzato da:

Janssen Biotech, Inc.

INN (Nome Internazionale):

ustekinumab

Composizione:

ustekinumab 45 mg in 0.5 mL

Via di somministrazione:

SUBCUTANEOUS

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

STELARA® is indicated for the treatment of patients 6 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. STELARA® is indicated for the treatment of patients 6 years or older with active psoriatic arthritis. STELARA® is indicated for the treatment of adult patients with moderately to severely active Crohn's disease. STELARA® is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis. STELARA® is contraindicated in patients with clinically significant hypersensitivity to ustekinumab or to any of the excipients [see Warnings and Precautions (5.5)]. Risk Summary Limited data on the use of STELARA® in pregnant women are insufficient to inform a drug associated risk [see Data] . In animal reproductive and developmental toxicity studies, no adverse developmental effects were observed after administration of ustekinumab to pregnant monkeys at exposures greater than 100 times the human exposure at the maximu

Dettagli prodotto:

STELARA® (ustekinumab) injection is a sterile, preservative-free, colorless to light yellow solution and may contain a few small translucent or white particles. It is supplied as individually packaged, single-dose prefilled syringes or single-dose vials. For Subcutaneous Use Prefilled Syringes Each prefilled syringe is equipped with a 27 gauge fixed ½ inch needle, a needle safety guard, and a needle cover that contains dry natural rubber. Single-dose Vial For Intravenous Infusion Single-dose Vial Storage and Stability STELARA® vials and prefilled syringes must be refrigerated at 2°C to 8°C (36°F to 46°F). Store STELARA® vials upright. Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake. If needed, individual prefilled syringes may be stored at room temperature up to 30°C (86°F) for a maximum single period of up to 30 days in the original carton to protect from light. Record the date when the prefilled syringe is first removed from the refrigerator on the carton in the space provided. Once a syringe has been stored at room temperature, it should not be returned to the refrigerator. Discard the syringe if not used within 30 days at room temperature storage. Do not use STELARA® after the expiration date on the carton or on the prefilled syringe.

Stato dell'autorizzazione:

Biologic Licensing Application

Foglio illustrativo

STELARA- USTEKINUMAB SOLUTION
Janssen Biotech, Inc.
----------
This Medication Guide has been approved by the U.S.
Food and Drug Administration
Revised: 07/2022
MEDICATION GUIDE
STELARA® (stel ar' a)
(ustekinumab)
injection, for subcutaneous or intravenous use
What is the most important information I should know about STELARA?
STELARA is a medicine that affects your immune system. STELARA can
increase your risk of having
serious side effects, including:
Serious infections. STELARA may lower the ability of your immune
system to fight infections and may
increase your risk of infections. Some people have serious infections
while taking STELARA, including
tuberculosis (TB), and infections caused by bacteria, fungi, or
viruses. Some people have to be hospitalized
for treatment of their infection.
•
Your doctor should check you for TB before starting STELARA.
•
If your doctor feels that you are at risk for TB, you may be treated
with medicine for TB before you
begin treatment with STELARA and during treatment with STELARA.
•
Your doctor should watch you closely for signs and symptoms of TB
while you are being treated
with STELARA.
You should not start taking STELARA if you have any kind of infection
unless your doctor says it is okay.
Before starting STELARA, tell your doctor if you:
•
think you have an infection or have symptoms of an infection such as:
•
fever, sweat, or chills
•
muscle aches
•
cough
•
shortness of breath
•
blood in phlegm
•
weight loss
•
warm, red, or painful skin or sores on your
body
•
diarrhea or stomach pain
•
burning when you urinate or urinate more
often than normal
•
feel very tired
•
are being treated for an infection or have any open cuts.
•
get a lot of infections or have infections that keep coming back.
•
have TB, or have been in close contact with someone with TB.
After starting STELARA, call your doctor right away if you have any
symptoms of an infection (see above).
These may be signs of infections such as chest infections, or skin
infections or shin

Scheda tecnica

STELARA- USTEKINUMAB INJECTION, SOLUTION
STELARA- USTEKINUMAB SOLUTION
JANSSEN BIOTECH, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
STELARA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR STELARA .
STELARA (USTEKINUMAB) INJECTION, FOR SUBCUTANEOUS OR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2009
RECENT MAJOR CHANGES
Indications and Usage, Psoriatic arthritis (1.2)
07/2022
Dosage and Administration (2.1, 2.2)
07/2022
INDICATIONS AND USAGE
STELARA is a human interleukin-12 and -23 antagonist indicated for the
treatment of:
Adult patients with:
_moderate to severe plaque psoriasis (Ps)_ who are candidates for
phototherapy or systemic therapy.
(1.1)
_active psoriatic arthritis (PsA)_. (1.2)
_moderately to severely active Crohn's disease (CD)_. (1.3)
_moderately to severely active ulcerative colitis._ (1.4)
Pediatric patients 6 years and older with:
_moderate to severe plaque psoriasis_, who are candidates for
phototherapy or systemic therapy. (1.1)
_active psoriatic arthritis (PsA)_. (1.2)
DOSAGE AND ADMINISTRATION
Psoriasis Adult Subcutaneous Recommended Dosage (2.1):
WEIGHT RANGE (KILOGRAMS)
DOSAGE REGIMEN
less than or equal to 100 kg
45 mg administered subcutaneously initially and 4
weeks later, followed by 45 mg administered
subcutaneously every 12 weeks
greater than 100 kg
90 mg administered subcutaneously initially and 4
weeks later, followed by 90 mg administered
subcutaneously every 12 weeks
Psoriasis Pediatric Patients (6 to 17 years old) Subcutaneous
Recommended Dosage (2.1):
Weight-based dosing is recommended at the initial dose, 4 weeks later,
then every 12 weeks thereafter.
WEIGHT RANGE (KILOGRAMS)
DOSE
less than 60 kg
0.75 mg/kg
60 kg to 100 kg
45 mg
greater than 100 kg
90 mg
Psoriatic Arthritis Adult Subcutaneous Recommended Dosage (2.2):
The recommended dosage is 45 mg administered subcutaneously initially
and 4 weeks later, followed
by 45 mg administered subcutaneously every 12 weeks.
For patients with co-existent