다카르바진

Dacarbazine

원료 코드 M086213 국내 제품 2개 (단일제 2 · 복합제 0) DUR 성분 D000691

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이 성분만 든 제품 (단일제 2)

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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)

Dacarbazine for Injection, USP is indicated in the treatment of metastatic malignant melanoma. In addition, dacarbazine is also indicated for Hodgkin's disease as a second-line therapy when used in combination with other effective agents.

⚠️ 박스 경고(가장 강한 경고)

영어 원문 (미국 FDA 라벨)

It is recommended that dacarbazine be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. 1.Hemopoietic depression is the most common toxicity with dacarbazine (see WARNINGS ). 2.Hepatic necrosis has been reported (see WARNINGS ). 3.Studies have demonstrated this agent to have a carcinogenic and teratogenic effect when used in animals. 4.In treatment of each patient, the physician must weigh carefully the possibility of achieving therapeutic benefit against the risk of toxicity.

쓰면 안 되는 경우

영어 원문 (미국 FDA 라벨)

Dacarbazine is contraindicated in patients who have demonstrated a hypersensitivity to it in the past.

주요 경고·주의

영어 원문 (미국 FDA 라벨)

Hemopoietic depression is the most common toxicity with dacarbazine and involves primarily the leukocytes and platelets, although, anemia may sometimes occur. Leukopenia and thrombocytopenia may be severe enough to cause death. The possible bone marrow depression requires careful monitoring of white blood cells, red blood cells, and platelet levels. Hemopoietic toxicity may warrant temporary suspension or cessation of therapy with dacarbazine. Hepatic toxicity accompanied by hepatic vein thrombosis and hepatocellular necrosis resulting in death, has been reported. The incidence of such reactions has been low; approximately 0.01% of patients treated. This toxicity has been observed mostly when dacarbazine has been administered concomitantly with other anti-neoplastic drugs; however, it has also been reported in some patients treated with dacarbazine alone. Anaphylaxis can occur following the administration of dacarbazine.

임신·특수 환자

영어 원문 (미국 FDA 라벨)

Pregnancy Teratogenic effects; Pregnancy Category C Dacarbazine has been shown to be teratogenic in rats when given in doses 20 times the human daily dose on day 12 of gestation. Dacarbazine when administered in 10 times the human daily dose to male rats (twice weekly for 9 weeks) did not affect the male libido, although female rats mated to male rats had higher incidence of resorptions than controls. In rabbits, dacarbazine daily dose 7 times the human daily dose given on Days 6 to 15 of gestation resulted in fetal skeletal anomalies. There are no adequate and well-controlled studies in pregnant women. Dacarbazine should be used during pregnancy only if the potential benefit justifies the …

미국 부작용 보고(FAERS)에 많이 나온 증상

미국 FDA에 접수된 이 성분 관련 보고 7,411건 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 발열성 호중구 감소증febrile neutropenia643
  2. 2 적응증 외 사용off label use613
  3. 3 호중구 감소증neutropenia504
  4. 4 발열pyrexia387
  5. 5 약효 없음drug ineffective335
  6. 6 DISEASE PROGRESSION313
  7. 7 말초신경병증neuropathy peripheral300
  8. 8 오심nausea280
  9. 9 빈혈anaemia254
  10. 10 미승인 적응증 사용product use in unapproved indication239
  11. 11 구토vomiting237
  12. 12 설사diarrhoea227

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.