מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
GOLIMUMAB (UNII: 91X1KLU43E) (GOLIMUMAB - UNII:91X1KLU43E)
Janssen Biotech, Inc.
golimumab
golimumab 50 mg in 4 mL
INTRAVENOUS
PRESCRIPTION DRUG
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
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.
Biologic Licensing Application
Janssen Biotech, Inc. ---------- 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 קרא את המסמך השלם
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 קרא את המסמך השלם