- Rheumatoid Arthritis (RA) – with methotrexate
- Psoriatic Arthritis (PsA)
- Ankylosing Spondylitis (AS)
Dose:
Simponi (Subcutaneous):
- RA, PsA, AS:50 mg SC once monthly,For RA: Use with methotrexate
Simponi Aria (Intravenous):
- RA, PsA, AS:2 mg/kg IV over 30 minutes at 0 and 4 weeks, then every 8 weeks,Given with methotrexate for RA
- Ulcerative Colitis (UC) – moderate to severe (adults only)
Dose:
Induction: 200 mg SC at week 0, 100 mg at week 2
Maintenance: 100 mg SC every 4 weeks
- Subcutaneous (SC):
- Auto-injector or prefilled syringe: 50 mg/0.5 mL, 100 mg/1 mL
- IV formulation (Simponi Aria):
- Vial: 50 mg/4 mL
- SC injections: Administer once a month, rotate sites (thigh, abdomen, upper arm)
- IV infusions: Must be given by a healthcare provider
- Refrigerate both forms; bring SC to room temperature before use
- Do not shake or freeze
- Class: Human IgG1κ monoclonal antibody
- Mechanism of Action:
- Binds TNF-α, preventing interaction with receptors → reduces inflammation
- ↓ cytokine activity → ↓ immune cell activation and migration
- Half-life: ~14 days
- Onset: Weeks 2–6
- Excretion: Not fully characterized
- Upper respiratory infections
- Injection site reactions
- Headache
- Fatigue
- Nausea
- Dizziness
- Moderate to severe heart failure (NYHA Class III/IV, for IV formulation)
- Active severe infections
- Hypersensitivity to golimumab or components
- Avoid live vaccines
- Avoid combination with other biologics (e.g., adalimumab, etanercept)
- May be used with methotrexate or NSAIDs
- Monitor closely with immunosuppressants (↑ infection risk)
Drug Status
Availability | |
Pregnancy | |
Breastfeeding | |
Schedule |
BRAND NAME | STRENGTH | FORMULATION | PACK SIZE | MANUFACTURER | DISTRIBUTOR |
---|---|---|---|---|---|
Simponi | 50mg/0.5mL | Injection | 1’s | Janssen Biologics | Janssen Biologics |
Simponi | 100mg/mL | Injection | 1’s | Janssen Biologics | Janssen Biologics |