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Hereditary angioedema (HAE): 국가별 선택지

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선택지 정리됨희귀·유전 질환최종 확인 2026.06

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임상시험 검색어

Hereditary angioedema (HAE) clinical trial

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

  • icatibant (Firazyr); sebetralstat (Ekterly)[1]FDA-approvedbradykinin-mediated HAE attack context; On-demand treatment of acute HAE attacks. · Firazyr label advises immediate medical attention for laryngeal attacks due to airway-obstruction risk. Ekterly age scope is 12 years and older. This cell does not establish coverage for C1-INH or ecallantide options not fully fetched in this pass. Confidence/conflicts: High for U.S. acute-treatment label claims; no conflict identified.
  • icatibant (Firazyr); sebetralstat (Ekterly)[1]FDA-approvedbradykinin-mediated HAE attack context; On-demand treatment of acute HAE attacks. · Firazyr label advises immediate medical attention for laryngeal attacks due to airway-obstruction risk. Ekterly age scope is 12 years and older. This cell does not establish coverage for C1-INH or ecallantide options not fully fetched in this pass. Confidence/conflicts: High for U.S. acute-treatment label claims; no conflict identified.
  • lanadelumab-flyo (Takhzyro); berotralstat (Orladeyo); garadacimab-gxii (Andembry)[2]FDA-approvedC1 inhibitor deficiency/dysfunction implied for classic HAE; bradykinin/contact-system pathway; normal-C1-INH subtype caveat for some EU sources; Long-term prophylaxis / prevention of HAE attacks; not acute on-demand treatment for Orladeyo or Takhzyro. · Labels do not rank prophylactic choices. Orladeyo has explicit acute-attack limitation and QTc-related higher-dose warning. Takhzyro and Andembry include hypersensitivity or laboratory-test caveats. Eligibility depends on age, diagnosis subtype, attack burden, prior therapies, and payer criteria. Confidence/conflicts: High for U.S. prophylaxis label claims; no conflict identified.
  • lanadelumab-flyo (Takhzyro); berotralstat (Orladeyo); garadacimab-gxii (Andembry)[2]FDA-approvedC1 inhibitor deficiency/dysfunction implied for classic HAE; bradykinin/contact-system pathway; normal-C1-INH subtype caveat for some EU sources; Long-term prophylaxis / prevention of HAE attacks; not acute on-demand treatment for Orladeyo or Takhzyro. · Labels do not rank prophylactic choices. Orladeyo has explicit acute-attack limitation and QTc-related higher-dose warning. Takhzyro and Andembry include hypersensitivity or laboratory-test caveats. Eligibility depends on age, diagnosis subtype, attack burden, prior therapies, and payer criteria. Confidence/conflicts: High for U.S. prophylaxis label claims; no conflict identified.

European Union

  • lanadelumab (Takhzyro); berotralstat (Orladeyo); garadacimab (Andembry); conestat alfa (Ruconest); C1 inhibitor human (Cinryze)[3]EMA authorisedC1 esterase inhibitor deficiency / HAE type I-II where stated; normal-C1-INH caveat for Andembry; EU-approved acute/on-demand treatment, procedure prophylaxis, and routine prophylaxis; England pathway for HAE-C1-INH. · EMA authorization is not the same as reimbursement in Germany/France or the UK. The NHS England algorithm uses attack-frequency, age, response, route, rescue-pack, and specialist-care considerations. Andembry source notes possible reduced effectiveness in HAE with normal C1-INH. Confidence/conflicts: High for EU/England source claims; Germany/France reimbursement not verified.
  • lanadelumab (Takhzyro); berotralstat (Orladeyo); garadacimab (Andembry); conestat alfa (Ruconest); C1 inhibitor human (Cinryze)[3]EMA authorisedC1 esterase inhibitor deficiency / HAE type I-II where stated; normal-C1-INH caveat for Andembry; EU-approved acute/on-demand treatment, procedure prophylaxis, and routine prophylaxis; England pathway for HAE-C1-INH. · EMA authorization is not the same as reimbursement in Germany/France or the UK. The NHS England algorithm uses attack-frequency, age, response, route, rescue-pack, and specialist-care considerations. Andembry source notes possible reduced effectiveness in HAE with normal C1-INH. Confidence/conflicts: High for EU/England source claims; Germany/France reimbursement not verified.

Australia

  • garadacimab (Andembry)[4]TGA-registered (Australia)C1-INH HAE / C1 esterase inhibitor deficiency or dysfunction; routine prevention of recurrent HAE attacks in patients aged 12 years and older with C1-INH HAE in Australia. · TGA registration does not establish PBS subsidy, acute rescue access, or diagnosis requirements. The PI states acute breakthrough attacks require individualized treatment with an approved rescue medicine. Confidence/conflicts: High for Australian registration and indication; PBS/access criteria remain source-pending. No conflict identified. Availability/reimbursement outside the approving regulator not established.

Thailand

  • icatibant acetate / icatibant (Firazyr)[5]EMA authorisedC1-esterase-inhibitor deficiency as specified in the indication; acute attack treatment for HAE with C1-esterase-inhibitor deficiency in adults, adolescents, and children aged 2 years and older; source says use is under guidance of a healthcare professional. · The label states no regimen can be recommended for children younger than 2 years or weighing less than 12 kg because safety and efficacy are not established. Patients with laryngeal attacks should be managed in an appropriate medical institution after injection until discharge is considered safe. Caregiver/self-administration decisions should be made by a physician experienced in HAE diagnosis and treatment. This entry does not establish Thai reimbursement or emergency stocking availability. Confidence/conflicts: High for Thai NDI Firazyr acute-attack label content; no conflict identified. Thai reimbursement/access and exact emergency distribution remain unresolved.
  • lanadelumab (Takhzyro)[6]EMA authorisedHAE context; source notes no available clinical data for lanadelumab in HAE patients with normal C1-INH activity; routine prevention of recurrent HAE attacks in patients aged 12 years and older; source states initiation should be supervised by a physician experienced in HAE management. · The label states Takhzyro is not intended for treatment of acute HAE attacks and that breakthrough attacks should be treated individually with approved rescue medication. Safety and efficacy in children under 12 years are not established, and no data are available. The source also notes no available clinical data for HAE with normal C1-INH activity. This entry does not establish Thai reimbursement, stocking, or rescue-medication access. Confidence/conflicts: High for Thai NDI Takhzyro HAE prevention label content; no conflict identified. Thai reimbursement/access remains unresolved.

Canada

  • berotralstat (Orladeyo)[7]Health Canada approvedC1-INH deficiency/dysfunction type I or II context described in Health Canada RDS; routine prevention of HAE attacks in adults/adolescents in Canada. · Product monograph warns against use for acute attacks and notes additional doses or higher-than-recommended doses are not recommended due to QT prolongation potential. Public reimbursement was not established from the fetched regulator sources. Confidence/conflicts: High for Canadian Orladeyo prophylaxis indication; reimbursement remains source-pending. No conflict identified.
  • garadacimab (Andembry)[8]Health Canada approvedHAE; Health Canada SBD notes typical C1-INH deficiency/dysfunction mechanism and uncertainty for normal C1-INH function; routine prevention of HAE attacks in patients aged 12 years and older in Canada. · SBD notes residual uncertainty in adolescent patients and normal C1-INH function due to small sample sizes, though not deemed a major concern by Health Canada. Reimbursement and provincial implementation are separate. Confidence/conflicts: High for Canadian approval and marketed status; normal-C1-INH uncertainty and reimbursement remain flagged. No conflict identified.
  • icatibant acetate (Firazyr)[9]ApprovedC1-esterase inhibitor deficiency; on-demand treatment of acute HAE attacks in Canada. · The monograph warns that patients with laryngeal symptoms or swelling causing breathing difficulty should seek medical attention immediately after administration. Children under 2 years or weighing less than 12 kg lack an established regimen in the cited monograph. Confidence/conflicts: High for Canadian acute-attack indication and controlled-distribution caveats; reimbursement remains source-pending. No conflict identified.
  • icatibant acetate (Firazyr)[9]ApprovedC1-esterase inhibitor deficiency; on-demand treatment of acute HAE attacks in Canada. · The monograph warns that patients with laryngeal symptoms or swelling causing breathing difficulty should seek medical attention immediately after administration. Children under 2 years or weighing less than 12 kg lack an established regimen in the cited monograph. Confidence/conflicts: High for Canadian acute-attack indication and controlled-distribution caveats; reimbursement remains source-pending. No conflict identified.
  • lanadelumab (Takhzyro)[10]Health Canada approvedbradykinin/kallikrein pathway; C1-INH status not fully specified in monograph excerpt; routine prevention of HAE attacks in Canada. · The current monograph expands beyond the older SBD age framing. Acute attack treatment should remain available because Takhzyro is not for acute attacks. Confidence/conflicts: High for current Canadian prophylaxis indication; older SBD age scope differs from current monograph due to later label expansion. Reimbursement remains source-pending.

출처

  1. U.S. Food and Drug Administration — official drug label · official drug label
  2. U.S. Food and Drug Administration — official drug label · official drug label
  3. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  4. Therapeutic Goods Administration (TGA) — prescription medicine registration page · prescription medicine registration page
  5. Thai National Drug Information / Thai FDA-MOPH — SmPC/package-insert PDF / regulator drug-information repository · SmPC/package-insert PDF / regulator drug-information repository
  6. Thai National Drug Information / Thai FDA-MOPH — SmPC/package-insert PDF / regulator drug-information repository · SmPC/package-insert PDF / regulator drug-information repository
  7. Health Canada product monograph repository / BioCryst — official product monograph · official product monograph
  8. Health Canada Drug and Health Products Portal — Summary Basis of Decision · Summary Basis of Decision
  9. Health Canada product monograph repository / Takeda — official product monograph · official product monograph
  10. Health Canada product monograph repository / Takeda — 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 2026-06-12.