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알글루코시다제 알파(재조합 인간 효소 산성 알파-글루코시다제)

Alglucosidase Alpha

원료 코드 M222824 국내 제품 1개 (단일제 1 · 복합제 0) DUR 성분 D001335

🌐 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 임부에서 적절한 자료 없음. 동물 시험에서 생식 독성이 나타남. 반드시 필요할 경우를 제외하고 임신 중 사용되어서는 안 됨.(용액용동결건조분말주사제)

이 성분만 든 제품 (단일제 1)

마이오자임주(알글루코시다제알파) (주)사노피-아벤티스코리아· 효소제제· 52.5밀리그램· 2012년 허가 전문

🌐 해외(미국) 정보 — 알글루코시다제 알파(재조합 인간 효소 산성 알파-글루코시다제)

미국 FDA·NLM 자료 · 2026-10-07 기준

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

Hydrolytic Lysosomal Glycogen-specific Enzyme [EPC]

미국에서 쓰이는 곳(적응증)

영어 원문 (미국 FDA 라벨)

® is a hydrolytic lysosomal glycogen-specific enzyme indicated for patients with Pompe disease (acid α-glucosidase [GAA] deficiency). LUMIZYME ® is a hydrolytic lysosomal glycogen-specific enzyme indicated for patients with Pompe disease (GAA deficiency). ( 1 )

⚠️ 박스 경고(가장 강한 경고)

영어 원문 (미국 FDA 라벨)

WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS, IMMUNE-MEDIATED REACTIONS, and RISK OF ACUTE CARDIORESPIRATORY FAILURE WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS, IMMUNE-MEDIATED REACTIONS, and RISK OF ACUTE CARDIORESPIRATORY FAILURE See full prescribing information for complete boxed warning. Hypersensitivity Reactions Including Anaphylaxis Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Initiate LUMIZYME in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue LUMIZYME and immediately initiate appropriate medical treatment, including use of epinephrine. ( 5.1 ) Immune-Mediated Reactions Immune-mediated reactions presenting as proteinuria, nephrotic syndrome, and necrotizing skin lesions have occurred in some patients following LUMIZYME treatment. Monitor patients for the development of systemic immune-mediated reactions involving skin and other organs while receiving LUMIZYME. ( 5.3 ) Risk of Acute Cardiorespiratory Failure Infantile-onset Pompe disease (IOPD) patients with compromised cardiac or respiratory function may be at risk of serious acute exacerbation of their cardiac or respiratory compromise due to fluid overload and require additional monitoring. ( 5.4 ) Hypersensitivity Reactions Including Anaphylaxis …

쓰면 안 되는 경우

영어 원문 (미국 FDA 라벨)

None. None. ( 4 )

주요 경고·주의

영어 원문 (미국 FDA 라벨)

Infusion-Associated Reactions (IARs) : If an IAR occurs, decreasing the infusion rate, temporarily stopping the infusion, and/or administration of antihistamines and/or antipyretics may ameliorate the symptoms. ( 5.2 ) Risk of Cardiac Arrhythmia and Sudden Cardiac Death during General Anesthesia for Central Venous Catheter Placement : Caution should be used when administering general anesthesia for the placement of a central venous catheter intended for LUMIZYME infusion. ( 5.5 ) Risk of Developing Anti-alglucosidase Alfa Antibodies : Patients with IOPD should have a cross-reactive immunologic material (CRIM) assessment early in their disease course and be managed by a clinical specialist knowledgeable in immune tolerance induction in Pompe disease. ( 5.6 ) 5.1 Hypersensitivity Reactions Including Anaphylaxis Hypersensitivity Reactions Including Anaphylaxis Hypersensitivity reactions including anaphylaxis have been observed in patients during and up to 3 hours after a LUMIZYME infusion. Some of the hypersensitivity reactions were life-threatening and included anaphylactic shock, cardiac arrest, respiratory arrest, respiratory distress, hypoxia, apnea, dyspnea, bradycardia, tachycardia, bronchospasm, throat tightness, hypotension, angioedema (including tongue or lip swelling, periorbital edema, and face edema), and urticaria. Other accompanying reactions included chest discomfort/pain, wheezing, tachypnea, cyanosis, decreased oxygen saturation, convulsions, pruritus, rash, …

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 LUMIZYME during pregnancy. Pregnant women and women of reproductive potential should be encouraged to enroll in the Pompe patient registry. The registry will monitor the effect of LUMIZYME on pregnant women and their offspring. For more information, visit www.registrynxt.com or call 1-800-745-4447, extension 15500. Risk Summary Data from postmarketing reports and published case reports with alglucosidase alfa use in pregnant women have not identified a LUMIZYME-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. The …

미국 제품명 Lumizyme

미국 부작용 보고(FAERS)에 많이 나온 증상

미국 FDA에 접수된 이 성분 관련 보고 2,392건 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 부적절한 제품 투여 간격inappropriate schedule of product administration204
  2. 2 발열pyrexia172
  3. 3 적응증 외 사용off label use147
  4. 4 호흡 곤란dyspnoea139
  5. 5 권태감malaise105
  6. 6 피로fatigue98
  7. 7 폐렴pneumonia97
  8. 8 낙상fall94
  9. 9 DRUG SPECIFIC ANTIBODY PRESENT88
  10. 10 URTICARIA87
  11. 11 수액 투여 관련 반응infusion related reaction83
  12. 12 발진rash83

미국 리콜 기록

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

  • 2016.04.06 · 3등급(경미) · Genzyme Corporation Labeling: Incorrect or Missing Lot and/or Exp Date

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