오픈드럭 OpenDrug · 오픈블로그 의약품 정보

골리무맙(유전자재조합, 숙주 : Sp2/0-Ag14, 벡터 : p1860, p1865)

Golimumab

원료 코드 M255195 국내 제품 3개 (단일제 3 · 복합제 0) DUR 성분 D000077

🌐 미국 FDA 자료(영문 라벨·부작용 보고·리콜)가 있습니다. 한국어는 AI 번역 참고용이니 원문을 함께 확인하세요. 해외 정보 보기

⚠️ DUR 안전사용 기준

  • 🤰 임부금기 2등급 "임부에 대한 안전성 미확립. 동물실험에서 태반통과 보고."(용액주사제/유화주사제/용액용분말주사제/서방성현탁액용분말주사제/용액용동결건조분말주사제/현탁액용동결건조분말주사제/서방성현탁액용동결건조분말주사제/리포좀화현탁액용동결건조분말주사제/현탁액주사제/서방성현탁액성주사제)

이 성분만 든 제품 (단일제 3)

심퍼니주(골리무맙, 유전자재조합) (주)한국얀센· 자격요법제(비특이성면역억제제를 포함)· 50밀리그램· 2015년 허가 전문 심퍼니오토인젝터주(골리무맙, 유전자재조합) (주)한국얀센· 자격요법제(비특이성면역억제제를 포함)· 100밀리그램· 2013년 허가 전문 심퍼니프리필드시린지주(골리무맙, 유전자재조합) (주)한국얀센· 자격요법제(비특이성면역억제제를 포함)· 100밀리그램· 2012년 허가 전문

광고

🌐 해외(미국) 정보 — 골리무맙(유전자재조합, 숙주 : Sp2/0-Ag14, 벡터 : p1860, p1865)

미국 FDA·NLM 자료 · 2026-10-04 기준

이 성분은 한국어 번역이 없습니다(검수 전 자동 번역 게시는 멈춰 두었습니다). 아래는 미국 FDA 원문입니다 — 원문 라벨(DailyMed).

Tumor Necrosis Factor Blocker [EPC]

미국에서 쓰이는 곳(적응증)

영어 원문 (미국 FDA 라벨)

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. 1.2 Psoriatic Arthritis (PsA) SIMPONI ARIA is indicated for the treatment of active psoriatic arthritis in patients 2 years of age and older. 1.3 Ankylosing Spondylitis (AS) SIMPONI ARIA is indicated for the treatment of adult patients with active ankylosing spondylitis. 1.4 Polyarticular Juvenile Idiopathic Arthritis (pJIA) SIMPONI ARIA is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older.

⚠️ 박스 경고(가장 강한 경고)

영어 원문 (미국 FDA 라벨)

WARNING: SERIOUS INFECTIONS and MALIGNANCY 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 ). SERIOUS INFECTIONS Patients treated with SIMPONI ARIA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue SIMPONI ARIA if a patient develops a serious infection. Reported infections with TNF blockers, of which SIMPONI ARIA is a member, include: Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Test …

쓰면 안 되는 경우

영어 원문 (미국 FDA 라벨)

None. None ( 4 )

주요 경고·주의

영어 원문 (미국 FDA 라벨)

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. Cases of other malignancies have been observed among patients receiving TNF blockers ( 5.2 ). Congestive Heart Failure: Worsening, or new onset, may occur. Stop SIMPONI ARIA if new or worsening symptoms occur ( 5.3 ). Demyelinating Disorders: Exacerbation or new onset may occur ( 5.4 ). Lupus-like Syndrome: Discontinue SIMPONI ARIA if symptoms develop ( 5.5 ). Hypersensitivity Reactions: Serious systemic hypersensitivity reactions including anaphylaxis may occur ( 5.11 ). 5.1 Serious Infections Patients treated with SIMPONI ARIA are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, or parasitic organisms including aspergillosis, …

임신·특수 환자

영어 원문 (미국 FDA 라벨)

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. However, this study had important limitations ( see Data ). 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 …

미국 제품명 SIMPONI ARIA

미국 부작용 보고(FAERS)에 많이 나온 증상

미국 FDA에 접수된 이 성분 관련 보고 12,308건 가운데 많이 적힌 증상입니다. 보고 수는 약 때문이라는 증거가 아니며, 많이 쓰는 약일수록 많아집니다. 증상 이름의 한국어는 AI 번역(참고용)이라 영어 원어를 함께 적었습니다.

  1. 1 약효 없음drug ineffective3,851
  2. 2 통증pain2,899
  3. 3 류마티스 관절염rheumatoid arthritis2,861
  4. 4 적응증 외 사용off label use2,859
  5. 5 피로fatigue2,705
  6. 6 원형 탈모alopecia2,544
  7. 7 발진rash2,467
  8. 8 전신 홍반성 루푸스systemic lupus erythematosus2,464
  9. 9 유천포pemphigus2,431
  10. 10 복부 불편감abdominal discomfort2,430
  11. 11 설통glossodynia2,398
  12. 12 과민반응hypersensitivity2,371

미국 리콜 기록

FDA 리콜 기록이 없습니다.

출처: 미국 FDA openFDA(라벨·FAERS·리콜), 미국 국립의학도서관 RxNorm · DailyMed 원문 라벨. 한국어는 오픈드럭 서버 AI(gemma)가 자동 번역한 참고용(사람 검수 전)으로 오역이 있을 수 있으니 반드시 원문을 확인하세요.