선택지 정리됨
비정형 용혈성 요독증후군(aHUS): 국가별 치료 선택지
이 페이지는 한국어 임상 치료 설명을 새로 쓰지 않습니다. 권위 출처, 진료 전 정리 질문, 임상시험 검색어, 구축 상태를 보여주는 안전한 시작점입니다.
선택지 정리됨희귀·유전 질환최종 확인 2026.06
국가별 선택지
국가별 치료 선택지
공식 규제·평가 기관 출처를 바탕으로 한 국가별 승인·접근 상태입니다. 무엇이 어디에 존재하는지를 보여줄 뿐, 추천이 아닙니다.
United States
- eculizumab (Soliris); ravulizumab-cwvz (Ultomiris)[1]FDA-approvedcomplement-mediated thrombotic microangiopathy; STEC-HUS exclusion caveat; Complement C5 inhibition for aHUS / complement-mediated TMA; Ultomiris label specifies adult and pediatric patients 1 month and older. · U.S. labels do not establish individual eligibility or sequencing. Complement inhibitor therapy includes meningococcal infection risk management, vaccination/prophylaxis considerations, and REMS. STEC-HUS is outside the labeled aHUS use. Confidence/conflicts: High for U.S. regulatory status and STEC-HUS limitation; no conflict identified.
European Union
- eculizumab (Soliris); ravulizumab (Ultomiris)[2]EMA authorisedcomplement-mediated thrombotic microangiopathy; complement inhibitor-naive or eculizumab-experienced state for ravulizumab where specified; EU marketing authorization for C5 inhibition in aHUS; England/NICE access conditions for eculizumab and ravulizumab. · EMA authorization does not equal automatic country reimbursement. NICE applies to England and is tied to expert-center/cohort monitoring or commercial arrangements. Ravulizumab has not been directly compared with eculizumab in NICE's rationale. Confidence/conflicts: High for EMA/NICE claims; no conflict identified, but Germany/France reimbursement remains unverified in this batch.
Australia
- eculizumab (Soliris); ravulizumab (Ultomiris)[3]TGA-registered (Australia)complement-mediated TMA; source distinguishes aHUS from STEC-HUS in label context; complement inhibition for aHUS in Australia; ravulizumab PI/AusPAR context includes aHUS patients. · The fetched TGA sources support Australian aHUS regulator context but are not current PBS criteria. Current PI should be checked for exact ravulizumab aHUS indication wording, weight bands, and STEC-HUS limitation before patient-facing reuse. Confidence/conflicts: Medium-high for Australia eculizumab/ravulizumab aHUS regulator context; exact current ravulizumab indication wording and PBS criteria remain source-pending. No conflict identified. Availability/reimbursement outside the approving regulator not established.
Thailand
- ravulizumab (Ultomiris)[4]Approvedcomplement-mediated thrombotic microangiopathy context; source describes treatment to resolve thrombotic microangiopathy manifestations; adult and pediatric aHUS patients weighing at least 10 kg; complement-inhibitor-naive patients or eculizumab-experienced patients with response after at least 3 months. · Ravulizumab must be administered by a healthcare professional under supervision of a physician experienced in renal disorders. The label states aHUS treatment to resolve thrombotic microangiopathy manifestations should be for a minimum duration of 6 months, with longer treatment considered individually, and that higher-risk patients may require chronic therapy. It states pediatric safety and efficacy under 10 kg are not established. This entry does not establish Thai reimbursement, center availability, or diagnostic criteria beyond the label context. Confidence/conflicts: High for Thai NDI Ultomiris aHUS label content; no conflict identified. Reimbursement/access and Thailand diagnostic pathway remain unresolved.
Canada
- eculizumab (Soliris)[5]Health Canada approvedcomplement-mediated thrombotic microangiopathy; STEC-HUS excluded by label limitation; aHUS to reduce complement-mediated TMA in Canada, including pediatric aHUS authorization. · Soliris has serious meningococcal infection precautions and should not be started in patients with unresolved Neisseria meningitidis infection or without current vaccination unless prophylactic antibiotics are used as specified by label. The source does not establish provincial reimbursement or transplant-specific protocols. Confidence/conflicts: High for Canadian Soliris aHUS label and STEC-HUS limitation; reimbursement/transplant pathway remains source-pending. No conflict identified.
- ravulizumab (Ultomiris)[6]Health Canada approvedcomplement-mediated thrombotic microangiopathy; STEC-HUS excluded by label limitation; adult and pediatric patients 1 month and older with aHUS in Canada. · The monograph includes serious meningococcal infection warnings and vaccination/monitoring requirements. The RDS opened here was for a later gMG decision, so the aHUS claim is anchored to the current product monograph, not that RDS decision text. Confidence/conflicts: High for Canadian Ultomiris aHUS label; RDS is supportive for product record only, not the aHUS indication. No conflict identified. Availability/reimbursement outside the approving regulator not established.
출처
- U.S. Food and Drug Administration — official drug label · official drug label
- European Medicines Agency (EMA) — regulator product information · regulator product information
- Therapeutic Goods Administration (TGA) — Australian Product Information attachment to AusPAR · Australian Product Information attachment to AusPAR
- Thai National Drug Information / Thai FDA-MOPH — SmPC PDF / regulator drug-information repository · SmPC PDF / regulator drug-information repository
- Alexion Canada / Health Canada product monograph — official product monograph · official product monograph
- Alexion Canada / Health Canada product monograph — official product monograph · official product monograph
위 내용은 공식 규제·접근 상태일 뿐, 의학적 조언이나 추천이 아니고, 적격성을 판단하지도 않습니다. 어떤 선택지가 적합한지는 환자의 상황과 종양내과 팀에 달려 있습니다. 규제 상태는 바뀔 수 있으니 표시된 출처에서 확인하세요. 임상 세부 내용은 영문이 정본입니다. 최종 확인 2026.06.
승인된 치료 너머
임상시험 및 신흥 선택지
환자가 거주하는 국가에서 아직 승인된 표준 치료가 아닌 선택지입니다 — 연구, 임상시험, 허가 외 사용, 담당 종양내과 의사가 먼저 언급하지 않을 수 있는 초기 근거입니다. 각 항목은 근거의 강도에 따라 구분됩니다. 여기에 실린 항목은 조사하고 의료진과 상의할 정보일 뿐, 효과가 입증되었거나 안전하거나 현재 이용 가능하다는 의미가 아닙니다. 임상 세부 내용은 영문이 정본입니다.
임상시험 진행 중
- eculizumab (Soliris); ravulizumab (Ultomiris)임상시험임상시험Reported in a clinical trialJapan · complement-mediated thrombotic microangiopathy; Soliris for inhibition of TMA in aHUS; Japan eculizumab study and ravulizumab post-approval evidence context. · The PMDA document fetched is a later Soliris review report that includes existing aHUS indications; it is not the original 2013 aHUS approval review. Ravulizumab Japan status is supported here by peer-reviewed literature and multinational registry context, not direct PMDA label text in this pass. Confidence/conflicts: High for Soliris Japan aHUS approval context and Japan eculizumab study; medium for ravulizumab Japan approval until direct PMDA label/review is fetched. Pharmaceuticals and Medical Devices Agency (PMDA) — regulator review report
- eculizumab (Soliris); eculizumab biosimilar context (Epysqli / eculizumab-aagh); ravulizumab/crovalimab investigational registry context임상시험 · NCT05876351임상시험Trial only (NCT05876351)Korea · suspected or confirmed complement-mediated TMA; ADAMTS13 and STEC-HUS differential diagnosis emphasized in Korea guideline; Korea guideline first-line eculizumab for symptomatic aHUS; China eculizumab study in pediatric/adult aHUS; crovalimab investigational aHUS adult/adolescent and pediatric studies. · Korea approval/access claims rely on guideline and manufacturer biosimilar announcement, not direct MFDS label. China approval claim is manufacturer-sourced, not direct NMPA. Crovalimab registry entries do not establish routine approval. Confidence/conflicts: Medium for Korea/China local routine availability because direct MFDS/NMPA labels were not fetched; high for guideline and registry geography/status. Samsung Bioepis — manufacturer regulatory approval announcement
- aHUS Registry observation; ravulizumab (Ultomiris); crovalimab임상시험 · NCT03131219임상시험Trial only (NCT03131219)Russia · complement-mediated TMA registry context; no intervention in registry-only aHUS Registry; Observational aHUS registry; pediatric/adolescent ravulizumab study; adult/adolescent and pediatric crovalimab investigational studies. · Registry/trial participation does not establish routine national availability. Russia has registry presence but no verified Russian regulator label or reimbursement source. Thailand remains source-pending for aHUS treatment/access. Confidence/conflicts: High for registry/trial geography/status; low for routine Russia/Thailand access because direct regulator or payer sources were not verified. trial-registry listing only — does not establish approval, reimbursement, or eligibility ClinicalTrials.gov — observational registry
임상시험이나 초기 보고에 실렸다는 것은 해당 선택지가 연구되고 있다는 의미일 뿐, 효과가 있거나 특정 환자에게 안전하거나 현재 등록 가능하다는 뜻은 아닙니다. 어떤 선택지가 적합한지는 담당 종양내과 팀과 임상시험 팀이 함께 상의할 문제입니다. 최종 확인 2026.06.
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출처
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모든 선택지는 규제·평가·지침 등 공신력 있는 출처에 연결되며, 새 출처가 검증되면 계속 확장됩니다.
진료 전 정리할 정보
- Has the team differentiated aHUS/complement-mediated TMA from STEC-HUS, TTP, cobalamin C defect, or other secondary TMA causes?
- Which local pathway applies for Soliris versus Ultomiris, including REMS, vaccination, and urgent-start precautions?
- Is the discussion about acute TMA control, chronic relapse prevention, transplant recurrence risk, or switching from eculizumab to ravulizumab?
- Is the relevant decision an EMA authorization question or a national access/reimbursement question in England, France, Germany, or another EU country?