Simponi 100 mg solution for injection PFP

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 ) 1.1 Rheumatoid Arthritis (RA) SIMPONI ARIA, in combination with methotrexate (MTX), is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis. …

• 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
• Pediatric patients with polyarticular Juvenile Idiopathic Arthritis and Psoriatic Arthritis: 80 mg/m 2 intravenous infusion over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter Dilution of supplied SIMPONI ARIA solution with 0.9% Sodium Chloride Injection, USP is required prior to administration
• Alternatively, 0.45% Sodium Chloride Injection, USP can also be used Dosage
• Adults with Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis The SIMPONI ARIA dosage regimen is 2 mg per kg given as an intravenous infusion over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter
• Follow the dilution and administration instructions for SIMPONI ARIA [see Dosage and Administration ]
• For patients with rheumatoid arthritis (RA), SIMPONI ARIA should be given in combination with methotrexate
• The efficacy and safety of switching between intravenous and subcutaneous formulations and routes of administration have not been established
• Dosage
• Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis and Psoriatic Arthritis The SIMPONI ARIA dosage regimen, based on body surface area (BSA), is 80 mg/m 2 given as an intravenous infusion over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter
• Follow the dilution and administration instructions for SIMPONI ARIA [see Dosage and Administration ] . …

Injection: 50 mg/4 mL (12.5 mg/mL) colorless to light yellow solution in a single-dose vial. Injection: 50 mg/4 mL (12.5 mg/mL) solution in a single-dose vial ( 3 )

• Safety and effectiveness of SIMPONI ARIA for active polyarticular juvenile idiopathic arthritis and PsA have been established
• Pediatric patients 2 years and older
• Use of SIMPONI ARIA in these age groups is supported by evidence from adequate and well-controlled studies of SIMPONI ARIA
• Adults with RA and PsA, pharmacokinetic data from adult patients with RA and PsA and
• Pediatric patients with JIA with active polyarthritis, and safety data from a clinical study in 127
• Pediatric patients 2 to < 18 years of age with JIA with active polyarthritis. …

In Trial RA, the number of patients ages 65 or older was too small to make comparisons with younger SIMPONI ARIA-treated patients. Because there is a higher incidence of infections in the geriatric population in general, caution should be used in treating geriatric patients with SIMPONI ARIA.

• See FDA-approved patient labeling (Medication Guide)
• Advise patients of the potential benefits and risks of SIMPONI ARIA
• Instruct patients to read the Medication Guide before starting SIMPONI ARIA therapy and to read it each time the prescription is renewed
• Infections Inform patients that SIMPONI ARIA may lower the ability of their immune system to fight infections
• Instruct the patient of the importance of contacting their doctor if they develop any symptoms of infection, including tuberculosis, invasive fungal infections, and hepatitis B reactivation
• Malignancies Patients should be counseled about the risk of lymphoma and other malignancies while receiving SIMPONI ARIA. …

• None
• None

Biologics, including abatacept and anakinra: Increased risk of serious infections ( 5.1 , 5.6 , 5.7 , 5.8 , 7.2 ). Live vaccines should not be given with SIMPONI ARIA ( 5.10 , 7.3 ). 7.1 Methotrexate SIMPONI ARIA should be used with MTX for the treatment of RA [see Clinical Studies (14.1) ] . Following IV administration, concomitant administration of methotrexate decreases the clearance of SIMPONI ARIA by approximately 9% based on population pharmacokinetics (PK) analysis. In addition, concomitant administration of methotrexate decreases the SIMPONI ARIA clearance by reducing the development of antibodies to golimumab. …

Serious Infections: Do not start SIMPONI ARIA during an active infection. If an infection develops, monitor carefully, and stop SIMPONI ARIA if infection becomes serious ( 5.1 ). Invasive Fungal Infections: For patients who develop a systemic illness on SIMPONI ARIA, consider empiric antifungal therapy for those who reside in or travel to regions where mycoses are endemic ( 5.1 ). Hepatitis B Reactivation: Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop SIMPONI ARIA and begin anti-viral therapy ( 5.1 ). Malignancies: More cases of lymphoma have been observed among patients receiving TNF blockers compared with patients in the control groups. …

The most serious adverse reactions were: Serious Infections [see Warnings and Precautions (5.1) ] Malignancies [see Warnings and Precautions (5.2) ] Most common adverse reactions (incidence ≥ 3%) are: upper respiratory tract infection, alanine aminotransferase increased, viral infection, aspartate aminotransferase increased, neutrophil count decreased, bronchitis, hypertension, and rash ( 6.1 ). 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 www.fda.gov/medwatch. …

8.1 Pregnancy Risk Summary Available data from postmarketing case reports with golimumab use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. An observational study of northern European births observed similar unadjusted rates of major birth defects in infants exposed in utero to golimumab compared to no treatment or non-biologic systemic therapy. …

In a clinical study, 5 patients received single infusions of up to 1000 mg of SIMPONI ARIA without serious adverse reactions or other significant reactions.

Refrigerate SIMPONI ARIA at 36 ⁰F to 46 ⁰F (2 ⁰C to 8 ⁰C) 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. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.