SIMPONI- golimumab injection, solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Janssen Biotech, Inc.

INN (International namn):

golimumab

Sammansättning:

golimumab 50 mg in 0.5 mL

Administreringssätt:

SUBCUTANEOUS

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

SIMPONI, in combination with methotrexate, is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis. SIMPONI, alone or in combination with methotrexate, is indicated for the treatment of adult patients with active psoriatic arthritis. SIMPONI is indicated for the treatment of adult patients with active ankylosing spondylitis. SIMPONI is indicated in adult patients with moderately to severely active ulcerative colitis who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine for: - inducing and maintaining clinical response - improving endoscopic appearance of the mucosa during induction - inducing clinical remission - achieving and sustaining clinical remission in induction responders [see Clinical Studies (14.4)]. None. Risk Summary There are no adequate and well-controlled trials of SIMPONI in pregnant women. Monocl

Produktsammanfattning:

SIMPONI (golimumab) Injection is a preservative-free, sterile, clear to slightly opalescent, colorless to light yellow solution for subcutaneous use in a single-dose prefilled autoinjector (contains a prefilled glass syringe) or single-dose prefilled glass syringe. The Type 1 glass syringe has a coated stopper. The fixed stainless steel needle (5 bevel, 27G, ½ inch) is covered with a needle shield to prevent leakage of the solution through the needle and to protect the needle during handling prior to subcutaneous administration. The needle shield is made of a dry natural rubber containing latex. Storage and Handling Refrigerate SIMPONI at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light until the time of use. Do not freeze. Do not shake. Do not use SIMPONI beyond the expiration date (EXP) on the carton or the expiration date on the prefilled syringe (observed through the viewing window) or the prefilled SmartJect autoinjector. If needed, SIMPONI may be stored at room temperature up to 77°F (25°C) for a maximum single period of 30 days in the original carton to protect from light. Once a syringe or autoinjector 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.

Bemyndigande status:

Biologic Licensing Application

Bipacksedel

Janssen Biotech, Inc.
----------
This Medication Guide has been approved by the
U.S. Food and Drug Administration.
Revised: May 2018
MEDICATION GUIDE
SIMPONI ®(SIM-po-nee)
(golimumab)
injection, for subcutaneous use
What is the most important information I should know about SIMPONI?
SIMPONI is a medicine that affects your immune system. SIMPONI can
lower the ability of your
immune system to fight infections. Some people have serious infections
while taking SIMPONI,
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.
•
Your doctor should monitor you closely for signs and symptoms of TB
during treatment with
SIMPONI.
You should not start taking SIMPONI if you have any kind of infection
unless your doctor says it is
okay.
Before starting SIMPONI, 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. Ask your doctor if you do not
know if you have lived
in an area where these infections

Produktens egenskaper

SIMPONI- GOLIMUMAB INJECTION, SOLUTION
JANSSEN BIOTECH, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SIMPONI SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SIMPONI.
SIMPONI (GOLIMUMAB) INJECTION, FOR SUBCUTANEOUS 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 ( 5.1)
DISCONTINUE SIMPONI 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 ( 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 IS A
MEMBER ( 5.2)
INDICATIONS AND USAGE
SIMPONI 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) alone, or in combination with
methotrexate ( 1.2)
Active ankylosing spondylitis (AS) ( 1.3)
Moderate to severe Ulcerative colitis (UC) with an inadequate response
or intolerant to prior treatment
or requiring continuous steroid therapy ( 1.4)
inducing and maintaining clinical response
improving endoscopic appearance of the mucosa during induction
inducing clinical remission
achieving and sustaining clinical remission in induction responders
DOSAGE AND ADMINISTRATION
RA, PsA, and AS: 50 mg administered by subcutaneous injection once a
month ( 2.1)
UC: 200 mg initially administered by subcutaneous injection at Week 0,
followed by 100 mg at Week 2
and then 100 mg every 4 weeks (