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플루다라빈포스페이트

Fludarabine Phosphate

원료 코드 M240201 국내 제품 2개 (단일제 2 · 복합제 0) DUR 성분 D000105

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

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이 성분만 든 제품 (단일제 2)

삼오플루다라빈주(플루다라빈포스페이트) (주)삼오제약· 항악성종양제· 50밀리그램· 2014년 허가 전문 플루다라주(플루다라빈포스페이트) (주)사노피-아벤티스코리아· 항악성종양제· 2008년 허가 전문

🌐 해외(미국) 정보 — 플루다라빈포스페이트

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).

미국에서 쓰이는 곳(적응증)

영어 원문 (미국 FDA 라벨)

Fludarabine Phosphate Injection, USP is indicated for the treatment of patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. The safety and effectiveness of Fludarabine Phosphate Injection, USP in previously untreated or non-refractory patients with CLL have not been established.

⚠️ 박스 경고(가장 강한 경고)

영어 원문 (미국 FDA 라벨)

Fludarabine should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. Fludarabine can severely suppress bone marrow function. When used at high doses in dose-ranging studies in patients with acute leukemia, fludarabine was associated with severe neurologic effects, including blindness, coma, and death. This severe central nervous system toxicity occurred in 36% of patients treated with doses approximately four times greater (96 mg/m 2 /day for 5 to 7 days) than the recommended dose. Similar severe central nervous system toxicity has been rarely (0.2%) reported in patients treated at doses in the range of the dose recommended for chronic lymphocytic leukemia. Instances of life-threatening and sometimes fatal autoimmune hemolytic anemia have been reported to occur after one or more cycles of treatment with fludarabine. Patients undergoing treatment with fludarabine should be evaluated and closely monitored for hemolysis. In a clinical investigation using fludarabine in combination with pentostatin (deoxycoformycin) for the treatment of refractory chronic lymphocytic leukemia (CLL), there was an unacceptably high incidence of fatal pulmonary toxicity. Therefore, the use of fludarabine in combination with pentostatin is not recommended.

쓰면 안 되는 경우

영어 원문 (미국 FDA 라벨)

Fludarabine Phosphate Injection, USP is contraindicated in those patients who are hypersensitive to this drug or its components.

주요 경고·주의

영어 원문 (미국 FDA 라벨)

WARNINGS: (See boxed warning) There are clear dose-dependent toxic effects seen with fludarabine. Dose levels approximately 4 times greater (96 mg/m 2 /day for 5 to 7 days) than that recommended for CLL (25 mg/m 2 /day for 5 days) were associated with a syndrome characterized by delayed blindness, coma and death. Symptoms appeared from 21 to 60 days following the last dose. Thirteen of 36 patients (36%) who received fludarabine at high doses (96 mg/m 2 /day for 5 to 7 days) developed this severe neurotoxicity. This syndrome has been reported rarely in patients treated with doses in the range of the recommended CLL dose of 25 mg/m 2 /day for 5 days every 28 days. The effect of chronic administration of fludarabine on the central nervous system is unknown; however, patients have received the recommended dose for up to 15 courses of therapy. Severe bone marrow suppression, notably anemia, thrombocytopenia and neutropenia, has been reported in patients treated with fludarabine. In a Phase I study in solid tumor patients, the median time to nadir counts was 13 days (range, 3 to 25 days) for granulocytes and 16 days (range, 2 to 32) for platelets. Most patients had hematologic impairment at baseline either as a result of disease or as a result of prior myelosuppressive therapy. Cumulative myelosuppression may be seen. While chemotherapy induced myelosuppression is often reversible, administration of fludarabine requires careful hematologic monitoring. Several instances of …

미국 부작용 보고(FAERS)에 많이 나온 증상

미국 FDA에 접수된 이 성분 관련 보고 39,094건 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 use4,350
  2. 2 약효 없음drug ineffective2,971
  3. 3 발열pyrexia2,930
  4. 4 CYTOKINE RELEASE SYNDROME2,905
  5. 5 발열성 호중구 감소증febrile neutropenia2,825
  6. 6 미승인 적응증 사용product use in unapproved indication2,243
  7. 7 호중구 감소증neutropenia2,012
  8. 8 CYTOMEGALOVIRUS INFECTION1,682
  9. 9 THROMBOCYTOPENIA1,635
  10. 10 패혈증sepsis1,542
  11. 11 ACUTE GRAFT VERSUS HOST DISEASE1,528
  12. 12 폐렴pneumonia1,457

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.

허가 취소·취하된 제품 1개 플루다라정(플루다라빈포스페이트) (주)사노피-아벤티스코리아· 항악성종양제· 2008년 허가 취하