Simponi
E850003
Simponi is a prescription biologic medication (golimumab) used to treat autoimmune inflammatory conditions such as rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis by blocking tumor necrosis factor (TNF).
Observed surface forms (1)
| Surface form | Occurrences |
|---|---|
| Simponi Aria | 1 |
Statements (49)
| Predicate | Object |
|---|---|
| instanceOf |
biologic medication
ⓘ
brand name drug ⓘ tumor necrosis factor inhibitor ⓘ |
| administrationFrequency | once monthly for subcutaneous formulation ⓘ |
| approvalBy |
European Medicines Agency
NERFINISHED
ⓘ
U.S. Food and Drug Administration NERFINISHED ⓘ |
| combinationTherapyWith | methotrexate ⓘ |
| commonAdverseEffect |
headache
ⓘ
injection site reaction ⓘ upper respiratory tract infection ⓘ |
| contraindication |
history of hypersensitivity to golimumab
ⓘ
severe active infections ⓘ |
| developer | Janssen Biotech NERFINISHED ⓘ |
| drugClass |
TNF inhibitor
ⓘ
biologic disease-modifying antirheumatic drug ⓘ monoclonal antibody ⓘ |
| firstFDAApprovalYear | 2009 ⓘ |
| formulation |
autoinjector pen
ⓘ
intravenous infusion solution ⓘ prefilled syringe ⓘ |
| hasActiveIngredient | golimumab ⓘ |
| hasATCCode | L04AB06 ⓘ |
| hasBlackBoxWarning |
malignancy risk
ⓘ
serious infections ⓘ |
| indicatedFor |
active ankylosing spondylitis
ⓘ
active psoriatic arthritis ⓘ moderate to severe active rheumatoid arthritis ⓘ moderately to severely active ulcerative colitis ⓘ |
| legalStatusEU | prescription only ⓘ |
| legalStatusUS | prescription only ⓘ |
| manufacturer | Janssen Biotech NERFINISHED ⓘ |
| marketingAuthorizationHolder | Janssen Biotech NERFINISHED ⓘ |
| mechanismOfAction | tumor necrosis factor alpha blockade ⓘ |
| ownedBy | Johnson & Johnson NERFINISHED ⓘ |
| pregnancyCategoryUS | B ⓘ |
| regulatoryStatus | prescription only ⓘ |
| requires | prescription ⓘ |
| routeOfAdministration |
intravenous infusion
ⓘ
subcutaneous injection ⓘ |
| seriousAdverseEffect |
congestive heart failure exacerbation
ⓘ
hepatitis B reactivation ⓘ opportunistic infections ⓘ tuberculosis ⓘ |
| targets | tumor necrosis factor alpha NERFINISHED ⓘ |
| treats |
ankylosing spondylitis
ⓘ
non-radiographic axial spondyloarthritis ⓘ psoriatic arthritis ⓘ rheumatoid arthritis ⓘ ulcerative colitis ⓘ |
Referenced by (4)
Full triples — surface form annotated when it differs from this entity's canonical label.
this entity surface form:
Simponi Aria