오픈드럭 OpenDrug · 오픈블로그 의약품 정보

이노투주맙오조가마이신

Inotuzumab Ozogamicin

원료 코드 M268719 국내 제품 1개 (단일제 1 · 복합제 0) DUR 성분 D001413

🌐 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 랫트의 배태자 발생시험에서 최대권장용량의 약 0.4배에서 태자 성장지연, 최대권장용량의 약 2배에서 흡수증가 및 생존 태자체중 감소와 골화지연으로 입증된 태자 성장지연을 포함한 배태자 독성 관찰(용액용동결건조분말주사제)

이 성분만 든 제품 (단일제 1)

베스폰사주(이노투주맙오조가마이신) 한국화이자제약(주)· 항악성종양제· 1밀리그램· 2019년 허가 전문

🌐 해외(미국) 정보 — 이노투주맙오조가마이신

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).

CD22-directed Immunoconjugate [EPC]

미국에서 쓰이는 곳(적응증)

영어 원문 (미국 FDA 라벨)

is indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older . BESPONSA is a CD22-directed antibody and cytotoxic drug conjugate indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older. ( 1 )

⚠️ 박스 경고(가장 강한 경고)

영어 원문 (미국 FDA 라벨)

WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME) and INCREASED RISK OF POST-HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) NON-RELAPSE MORTALITY WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME) and INCREASED RISK OF POST- HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) NON-RELAPSE MORTALITY See full prescribing information for complete boxed warning. • Hepatotoxicity, including fatal and life-threatening VOD occurred in patients who received BESPONSA. ( 5.1 ) • A higher post-HSCT non-relapse mortality rate occurred in patients receiving BESPONSA ( 5.2 ) HEPATOTOXICITY, INCLUDING VOD • Hepatotoxicity, including fatal and life-threatening VOD occurred in patients with relapsed or refractory acute lymphoblastic leukemia (ALL) who received BESPONSA. The risk of VOD was greater in patients who underwent HSCT after BESPONSA treatment; use of HSCT conditioning regimens containing 2 alkylating agents and last total bilirubin level ≥ upper limit of normal (ULN) before HSCT were significantly associated with an increased risk of VOD. • Other risk factors for VOD in patients treated with BESPONSA included ongoing or prior liver disease, prior HSCT, increased age, later salvage lines, and a greater number of BESPONSA treatment cycles. • Elevation of liver tests may require dosing interruption, dose reduction, or permanent discontinuation of BESPONSA. …

쓰면 안 되는 경우

영어 원문 (미국 FDA 라벨)

None. None ( 4 )

주요 경고·주의

영어 원문 (미국 FDA 라벨)

• Myelosuppression: Monitor complete blood counts; for signs and symptoms of infection; bleeding/hemorrhage; or other effects of myelosuppression during treatment; manage appropriately. ( 5.3 ) • Infusion related reactions: Monitor for infusion related reactions during and for at least 1 hour after infusion ends. ( 5.4 ) • QT interval prolongation: Obtain electrocardiograms (ECGs) and electrolytes at baseline and monitor during treatment. Monitor more frequently when using concomitant mediations known to prolong QT interval. ( 5.5 ) • Embryo-fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. ( 5.6 , 8.1 , 8.3 ) 5.1 Hepatotoxicity, Including Hepatic Veno-occlusive Disease (VOD) (also known as Sinusoidal Obstruction Syndrome) BESPONSA can cause hepatotoxicity, including VOD. In adult patients in the INO-VATE ALL trial, hepatotoxicity, including severe, life-threatening, and sometimes fatal hepatic VOD occurred in 23/164 patients (14%) in the BESPONSA arm during or following treatment or following a HSCT after completion of treatment. VOD occurred up to 56 days after the final dose during treatment or during follow-up without an intervening HSCT. The median time from subsequent HSCT to onset of VOD was 15 days (range: 3-57 days). In the BESPONSA arm, among the 79 patients who proceeded to a subsequent HSCT, VOD occurred in 18/79 patients (23%), and among all 164 patients treated, …

임신·특수 환자

영어 원문 (미국 FDA 라벨)

8.1 Pregnancy Risk Summary Based on its mechanism of action and findings from animal studies [see Clinical Pharmacology (12.1) , Nonclinical Toxicology (13.1) ] , BESPONSA can cause embryo-fetal harm when administered to a pregnant woman . There are no available data on BESPONSA use in pregnant women to inform a drug-associated risk. In rat embryo-fetal development studies, inotuzumab ozogamicin caused embryo-fetal toxicity at maternal systemic exposures that were ≥ 0.4 times the exposure in patients at the maximum recommended dose, based on AUC [see Data ] . Advise patients of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth …

미국 제품명 Besponsa

미국 부작용 보고(FAERS)에 많이 나온 증상

미국 FDA에 접수된 이 성분 관련 보고 2,937건 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 사망death343
  2. 2 발열성 호중구 감소증febrile neutropenia265
  3. 3 VENOOCCLUSIVE LIVER DISEASE258
  4. 4 적응증 외 사용off label use226
  5. 5 발열pyrexia192
  6. 6 NEOPLASM PROGRESSION155
  7. 7 THROMBOCYTOPENIA148
  8. 8 ACUTE LYMPHOCYTIC LEUKAEMIA RECURRENT145
  9. 9 약효 없음drug ineffective141
  10. 10 패혈증sepsis136
  11. 11 CYTOKINE RELEASE SYNDROME133
  12. 12 VENOOCCLUSIVE DISEASE132

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.