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Hereditary angioedema (HAE): options by country

Sourced options by country plus visit-prep questions for Hereditary angioedema (HAE). Each line links to its regulator, HTA, or guideline source. This page maps options; it does not recommend or rank them.

Options mappedRare diseaseLast checked June 2026

What this page does

Maps options by country

It maps sourced options by country alongside diagnosis wording, stage, test results, specialists, and trial-search terms.

What it does not do

Does not choose treatment

It does not rank treatments, recommend a choice, or decide clinical fit.

Where it comes from

Built on trusted sources

Every option links to a trusted regulator, HTA, or guideline source, and the list grows as new sources pass verification.

Information to gather before the next visit

  • Is the immediate need acute attack rescue, short-term procedure prophylaxis, or long-term prevention?
  • Does the diagnosis fit HAE type I/II, HAE with normal C1-INH, acquired angioedema, or another swelling disorder?
  • Which prophylaxis route and monitoring issues matter locally: injection training, oral therapy, aPTT interference, QTc/drug-interaction risk, or rescue medication access?
  • Is the attack involving the airway, abdomen, face, extremities, or another site requiring urgent evaluation?

Trial-search terms to discuss

Hereditary angioedema (HAE) clinical trial

Options by country

Treatments by country

Regulatory and access status by country, from official sources. It shows what exists and where — not a recommendation.

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.

Sources

  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

This is official regulatory and access status only — not medical advice, not a recommendation, and not a statement about eligibility. Whether any option fits depends on your situation and your oncology team. Status changes over time; confirm the current position with the linked source. Last checked 2026-06-12.

Beyond approved care

In clinical trials & emerging options

Options that are not — or not yet — an approved standard where you live: studies, clinical trials, off-label use, and early evidence that your own oncologist may not raise. Each is labeled by how strong the evidence is. A listing here is information to research and discuss with your team; it does not mean a treatment is proven, safe for you, or available today.

In clinical trials

A clinical-trial listing or early report shows an option is being studied — not that it works, that it is safe for any one person, or that a site is enrolling today. Whether any of these fits is a conversation for your oncology team and the trial team. Last checked 2026-06-12.