SIMPONI ARIA- golimumab solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

GOLIMUMAB (UNII: 91X1KLU43E) (GOLIMUMAB - UNII:91X1KLU43E)

Saatavilla:

Janssen Biotech, Inc.

INN (Kansainvälinen yleisnimi):

golimumab

Koostumus:

golimumab 50 mg in 4 mL

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

SIMPONI ARIA, in combination with methotrexate (MTX), is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis. SIMPONI ARIA is indicated for the treatment of active psoriatic arthritis in patients 2 years of age and older. SIMPONI ARIA is indicated for the treatment of adult patients with active ankylosing spondylitis. SIMPONI ARIA is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older. None. Risk Summary There are no adequate and well-controlled trials of SIMPONI ARIA in pregnant women. Monoclonal antibodies, such as golimumab, are transported across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. There are clinical considerations for the use of SIMPONI ARIA in pregnant women [see Clinical Considerations] . In an animal reproductive study, golimumab administered by the subcutaneous route to pregnant mo

Tuoteyhteenveto:

SIMPONI ARIA ® (golimumab) Injection is a colorless to light yellow solution available in packs of 1 vial NDC 57894-350-01. Vial Each single-dose vial contains 50 mg of SIMPONI ARIA per 4 mL of solution. Storage and Handling Refrigerate SIMPONI ARIA at 36ºF to 46ºF (2ºC to 8ºC) and protect from light. Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake. If needed, SIMPONI ARIA may be stored at room temperature up to 77ºF (25ºC) for a maximum single period of 30 days in the original carton to protect from light. Once SIMPONI ARIA has been stored at room temperature, do not return the product to the refrigerator. If not used within 30 days at room temperature, discard SIMPONI ARIA.

Valtuutuksen tilan:

Biologic Licensing Application

Pakkausseloste

Janssen Biotech, Inc.
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MEDICATION GUIDE
SIMPONI ARIA ®( SIM-po-nee AHR-ee-uh )
(golimumab)
injection, for intravenous use
What is the most important information I should know about SIMPONI
ARIA?
SIMPONI ARIA is a medicine that affects your immune system. SIMPONI
ARIA can lower the ability
of your immune system to fight infections. Some people have serious
infections while receiving
SIMPONI ARIA, including tuberculosis (TB), and infections caused by
bacteria, fungi, or viruses that
spread throughout their body. Some people have died from these serious
infections.
•
Your doctor should test you for TB and hepatitis B before starting
SIMPONI ARIA.
•
Your doctor should monitor you closely for signs and symptoms of TB
during treatment with
SIMPONI ARIA.
You should not start receiving SIMPONI ARIA if you have any kind of
infection unless your doctor tells
you to.
Before receiving SIMPONI ARIA, 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.
•
get a lot of infections or have infections that keep coming back.
•
have diabetes, HIV, or a weak immune system. People with these
conditions have a higher chance
for infections.
•
have TB, or have been in close contact with someone with TB.
•
live, have lived, or traveled to certain parts of the country (such as
the Ohio and Mississippi River
valleys and the Southwest) where there is an increased chance for
getting certain kinds of fungal
infections (histoplasmosis, coccidioidomycosis, blastomycosis). These
infections may happen or
become more severe if you use SIMPONI ARIA. Ask your doctor if you do
not know if you have
lived in an area where these infections are common.
•
have or have had h

Valmisteyhteenveto

SIMPONI ARIA- GOLIMUMAB SOLUTION
JANSSEN BIOTECH, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SIMPONI ARIA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SIMPONI ARIA.
SIMPONI ARIA
(GOLIMUMAB) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2009
WARNING: SERIOUS INFECTIONS AND MALIGNANCY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SERIOUS INFECTIONS LEADING TO HOSPITALIZATION OR DEATH INCLUDING
TUBERCULOSIS (TB),
BACTERIAL SEPSIS, INVASIVE FUNGAL (SUCH AS HISTOPLASMOSIS), AND OTHER
OPPORTUNISTIC
INFECTIONS HAVE OCCURRED IN PATIENTS RECEIVING SIMPONI ARIA ( 5.1).
DISCONTINUE SIMPONI ARIA IF A PATIENT DEVELOPS A SERIOUS INFECTION OR
SEPSIS ( 5.1).
PERFORM TEST FOR LATENT TB; IF POSITIVE, START TREATMENT FOR TB PRIOR
TO STARTING
SIMPONI ARIA ( 5.1).
MONITOR ALL PATIENTS FOR ACTIVE TB DURING TREATMENT, EVEN IF INITIAL
LATENT TB TEST IS
NEGATIVE ( 5.1).
LYMPHOMA AND OTHER MALIGNANCIES, SOME FATAL, HAVE BEEN REPORTED IN
CHILDREN AND
ADOLESCENT PATIENTS TREATED WITH TNF BLOCKERS, OF WHICH SIMPONI ARIA
IS A MEMBER
( 5.2).
INDICATIONS AND USAGE
SIMPONI ARIA is a tumor necrosis factor (TNF) blocker indicated for
the treatment of:
Adult patients with moderately to severely active Rheumatoid Arthritis
(RA) in combination with
methotrexate ( 1.1)
Active Psoriatic Arthritis (PsA) in patients 2 years of age and older
( 1.2)
Adult patients with active Ankylosing Spondylitis (AS) ( 1.3)
Active polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients
2 years of age and older ( 1.4)
DOSAGE AND ADMINISTRATION
Adult patients with Rheumatoid Arthritis, Psoriatic Arthritis, and
Ankylosing Spondylitis:
2 mg/kg intravenous infusion over 30 minutes at weeks 0 and 4, and
every 8 weeks thereafter ( 2.1)
Pediatric patients with polyarticular Juvenile Idiopathic Arthritis
and Psoriatic Arthritis:
80 mg/m
intravenous infusion over 30 minutes at weeks 0 and 4, and every 8
weeks thereafter (
2.2)
Dilution of supplied SIMPONI A