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미토마이신씨

Mitomycin C

원료 코드 M020052 국내 제품 2개 (단일제 2 · 복합제 0) DUR 성분 D000531

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

⚠️ DUR 안전사용 기준

  • 🤰 임부금기 1등급 동물실험에서 기형발생 보고.(용액주사제/유화주사제/용액용분말주사제/서방성현탁액용분말주사제/용액용동결건조분말주사제/현탁액용동결건조분말주사제/서방성현탁액용동결건조분말주사제/리포좀화현탁액용동결건조분말주사제/현탁액주사제/서방성현탁액성주사제)

이 성분만 든 제품 (단일제 2)

한국유나이티드미토마이신씨주10밀리그람 한국유나이티드제약(주)· 주로 악성종양에 작용하는 것· 10밀리그램· 1997년 허가 전문 한국유나이티드미토마이신씨주 한국유나이티드제약(주)· 주로 악성종양에 작용하는 것· 2밀리그램· 1992년 허가 전문

🌐 해외(미국) 정보 — 미토마이신씨

미국 FDA·NLM 자료 · 2026-10-05 기준

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

Alkylating Drug [EPC]

미국에서 쓰이는 곳(적응증)

영어 원문 (미국 FDA 라벨)

Mitomycin for Injection, USP is not recommended as single-agent, primary therapy. It has been shown to be useful in the therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed. Mitomycin is not recommended to replace appropriate surgery and/or radiotherapy.

⚠️ 박스 경고(가장 강한 경고)

영어 원문 (미국 FDA 라벨)

Mitomycin should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available. Bone marrow suppression, notably thrombocytopenia and leukopenia, which may contribute to overwhelming infections in an already compromised patient, is the most common and severe of the toxic effects of mitomycin (see “ WARNINGS ” and “ ADVERSE REACTIONS ” Sections). Hemolytic Uremic Syndrome (HUS) a serious complication of chemotherapy, consisting primarily of microangiopathic hemolytic anemia, thrombocytopenia, and irreversible renal failure, has been reported in patients receiving systemic mitomycin. The syndrome may occur at any time during systemic therapy with mitomycin as a single agent or in combination with other cytotoxic drugs; however, most cases occur at doses ≥ 60 mg of mitomycin. Blood product transfusion may exacerbate the symptoms associated with this syndrome. The incidence of the syndrome has not been defined.

쓰면 안 되는 경우

영어 원문 (미국 FDA 라벨)

Mitomycin is contraindicated in patients who have demonstrated a hypersensitive or idiosyncratic reaction to it in the past. Mitomycin is contraindicated in patients with thrombocytopenia, coagulation disorder, or an increase in bleeding tendency due to other causes.

주요 경고·주의

영어 원문 (미국 FDA 라벨)

Patients being treated with mitomycin must be observed carefully and frequently during and after therapy. The use of mitomycin results in a high incidence of bone marrow suppression, particularly thrombocytopenia and leukopenia. Therefore, the following studies should be obtained repeatedly during therapy and for at least 8 weeks following therapy: platelet count, white blood cell count, differential, and hemoglobin. The occurrence of a platelet count below 100,000/mm 3 or a WBC below 4,000/mm 3 or a progressive decline in either is an indication to withhold further therapy until blood counts have recovered above these levels. Patients should be advised of the potential toxicity of this drug, particularly bone marrow suppression. Deaths have been reported due to septicemia as a result of leukopenia due to the drug. Patients receiving mitomycin should be observed for evidence of renal toxicity. Mitomycin should not be given to patients with a serum creatinine greater than 1.7 mg percent. Usage in Pregnancy Safe use of mitomycin in pregnant women has not been established. Teratological changes have been noted in animal studies. The effect of mitomycin on fertility is unknown.

임신·특수 환자

영어 원문 (미국 FDA 라벨)

Usage in Pregnancy Safe use of mitomycin in pregnant women has not been established. Teratological changes have been noted in animal studies. The effect of mitomycin on fertility is unknown.

미국 제품명 MUTAMYCIN, JELMYTO, ZUSDURI, Mitosol

미국 부작용 보고(FAERS)에 많이 나온 증상

미국 FDA에 접수된 이 성분 관련 보고 3,418건 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 적응증 외 사용off label use379
  2. 2 오심nausea170
  3. 3 설사diarrhoea158
  4. 4 발진rash122
  5. 5 피로fatigue121
  6. 6 약효 없음drug ineffective113
  7. 7 THROMBOCYTOPENIA110
  8. 8 구토vomiting109
  9. 9 호중구 감소증neutropenia108
  10. 10 PANCYTOPENIA103
  11. 11 발열pyrexia102
  12. 12 DISEASE PROGRESSION100

미국 리콜 기록

FDA 리콜(회수) 기록 1건 중 최근 1건 — 특정 회사·제조번호 제품의 회수로, 국내 제품과는 관계없을 수 있습니다.

  • 2013.07.31 · 1등급(심각) · Mobius Therapeutics LLC Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.

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.