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질루코플란나트륨

Zilucoplan Sodium

원료 코드 M285032 국내 제품 1개 (단일제 1 · 복합제 0)

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

이 성분만 든 제품 (단일제 1)

질브리스큐프리필드시린지주16.6밀리그램(질루코플란나트륨) 한국유씨비제약(주)· 자격요법제(비특이성면역억제제를 포함)· 2024년 허가 전문

🌐 해외(미국) 정보 — 질루코플란나트륨

미국 FDA·NLM 자료 · 2026-10-06 기준

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

Complement Inhibitor [EPC]

미국에서 쓰이는 곳(적응증)

영어 원문 (미국 FDA 라벨)

is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. ZILBRYSQ is a complement inhibitor indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. ( 1 )

⚠️ 박스 경고(가장 강한 경고)

영어 원문 (미국 FDA 라벨)

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS ZILBRYSQ, a complement inhibitor, increases the risk of serious infections caused by Neisseria meningitidis [see Warnings and Precautions (5.1) ] . Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early. Complete or update vaccination for meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 weeks prior to the first dose of ZILBRYSQ, unless the risks of delaying therapy outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccination against meningococcal bacteria in patients receiving a complement inhibitor. See Warnings and Precautions (5.1) for additional guidance on the management of the risk of serious infections caused by meningococcal bacteria. Patients receiving ZILBRYSQ are at increased risk for invasive disease caused by Neisseria meningitidis , even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious meningococcal infections and evaluate immediately if infection is suspected. Because of the risk of serious meningococcal infections, ZILBRYSQ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called ZILBRYSQ REMS [see Warnings and Precautions (5.2) ] . …

쓰면 안 되는 경우

영어 원문 (미국 FDA 라벨)

is contraindicated for initiation in patients with unresolved serious Neisseria meningitidis infection [see Warnings and Precautions (5.1) ] . ZILBRYSQ is contraindicated for initiation in patients with unresolved serious Neisseria meningitidis infection. ( 4 )

주요 경고·주의

영어 원문 (미국 FDA 라벨)

Other Infections: Use caution when administering ZILBRYSQ to patients with any other systemic infection. ( 5.3 ) Pancreatitis and pancreatic cysts have been reported in patients treated with ZILBRYSQ. Discontinue ZILBRYSQ in patients with suspected pancreatitis and initiate appropriate management until pancreatitis is ruled out or has resolved. ( 5.4 ) 5.1 Serious Meningococcal Infections ZILBRYSQ, a complement inhibitor, increases a patient's susceptibility to serious, life-threatening, or fatal infections caused by meningococcal bacteria (septicemia and/or meningitis) in any serogroup, including non-groupable strains. Life-threatening and fatal meningococcal infections have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors. The initiation of ZILBRYSQ treatment is contraindicated in patients with unresolved serious Neisseria meningitidis infection. Complete or update meningococcal vaccination (for serogroups A, C, W, Y and B) at least 2 weeks prior to administration of the first dose of ZILBRYSQ, according to current ACIP recommendations for patients receiving a complement inhibitor. Revaccinate patients in accordance with ACIP recommendations considering the duration of ZILBRYSQ therapy. Note that ACIP recommends an administration schedule in patients receiving complement inhibitors that differs from the administration schedule in the vaccine prescribing information. If urgent ZILBRYSQ therapy is indicated in a patient who is not up …

임신·특수 환자

영어 원문 (미국 FDA 라벨)

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ZILBRYSQ during pregnancy. Patients or healthcare providers may contact UCBCares at 1-844-599-CARE (2273) or email [email protected], so that information about the exposure of ZILBRYSQ during pregnancy and/or breastfeeding can be collected. Risk Summary There are no available data on ZILBRYSQ use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Administration of zilucoplan to pregnant monkeys resulted in increases in embryofetal death at maternal exposures similar to …

미국 제품명 ZILBRYSQ

미국 부작용 보고(FAERS)에 많이 나온 증상

미국 FDA에 접수된 이 성분 관련 보고 817건 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 MYASTHENIA GRAVIS296
  2. 2 약효 없음drug ineffective176
  3. 3 제품 용량 누락 문제product dose omission issue129
  4. 4 INJECTION SITE PAIN95
  5. 5 피로fatigue75
  6. 6 설사diarrhoea63
  7. 7 HOSPITALISATION62
  8. 8 MYASTHENIA GRAVIS CRISIS42
  9. 9 체중 감소weight decreased40
  10. 10 적응증 외 사용off label use37
  11. 11 두통headache35
  12. 12 권태감malaise35

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.