Allergy and immunology
Hereditary angioedema (HAE): 6 drugs compared for prescribers
Andembry, Dawnzera, Ekterly, Firazyr, Orladeyo, Takhzyro side by side on what each first fill waits on, what the label requires you to monitor and what an insurer asks to see, with FDA decisions, label changes and open trials for hereditary angioedema (HAE). 3 other FDA-approved medicines for hereditary angioedema have no prescribing guide here yet and are listed below.
When to suspect hereditary angioedema (HAE) and what to test →The 6 hereditary angioedema (HAE) prescribing guides
One page per drug with the dispensing gate, prior authorization documentation, dosing, monitoring and interactions, each line sourced.
The 6 drugs with a prescribing guide, side by side
Each cell is a summary of that drug's prescribing guide, which carries the full detail and a source on every line. Insurer thresholds are one public policy shown as an example; plans differ.
| Andembrygaradacimab-gxii | Dawnzeradonidalorsen | Ekterlysebetralstat | Firazyricatibant | Orladeyoberotralstat | Takhzyrolanadelumab-flyo | |
|---|---|---|---|---|---|---|
| Label dated | June 30, 2025 | August 31, 2026 | April 1, 2026 | July 7, 2025 | October 23, 2026 | September 18, 2026 |
| Starting dose | 400mg subcutaneously, given as two 200mg injections. | 80mg subcutaneously every 4 weeks, in adult and pediatric patients 12 years of age and older. | 600mg (two 300mg tablets) orally, for adults and pediatric patients 12 and older. | 30mg subcutaneously in the abdominal area, over at least 30 seconds. | 150mg orally once daily with food, as a capsule or one 150mg pellet packet. | 300mg subcutaneously every 2 weeks, by the patient or caregiver. 300mg every 4 weeks may be considered if well controlled (e.g., attack free) for more than 6 months. |
| Dispensing gate | No REMS; referral form to ANDEMBRY Connect by electronic form or fax, prior authorization, specialty pharmacy shipment, and injection training before the first self-injection | No REMS; Patient Enrollment and Prescription Form by fax or an e-prescription, prior authorization, patient contact with the Ionis Every Step Specialty Pharmacy before it ships, and injection training before the first dose | No REMS, no boxed warning, no contraindications and no baseline labs in the label; KalVista's enrollment path is the KalVista Cares Start Form, benefits investigation and prior authorization, then a specialty pharmacy | No REMS; prescription and Takeda Patient Support Start Form (online or fax), prior authorization, specialty pharmacy dispensing, and self-injection training before the first attack treated at home | No REMS; Start Form to Empower Patient Services (CareMed Specialty Pharmacy only), prior authorization with C1-INH function and C4 results, and a required pharmacist counseling call before the first shipment | No REMS; Start Form (the prescription) by fax or online, prior authorization, specialty pharmacy dispensing, and injection training before the first self-injection |
| Required monitoring | No scheduled lab monitoring in the label; aPTT may be prolonged by assay interference, and PT or INR rose in some patients, none with bleeding events; no warnings and precautions | No scheduled lab monitoring in the label; watch for hypersensitivity including anaphylaxis; platelet reductions and ALT, AST and GGT increases were seen in trials; not recommended in moderate or severe hepatic impairment | No laboratory monitoring in the label; the dose depends on CYP3A4 co-medication and Child-Pugh class, and severe laryngeal attacks were not treated in KONFIDENT | No scheduled lab monitoring in the label; counsel on laryngeal attacks and immediate medical attention; injection site reactions in 97%; repeat dosing at 6 hours or more, maximum 3 doses in 24 hours | No required labs; GI effects mostly early and self-limiting; no doses above the prescribed once-daily dose (QTc); review CYP2D6, CYP3A4 and P-gp interactions; weight-based pellet dose under 12 | No scheduled lab monitoring in the label; watch for hypersensitivity; aPTT may be prolonged by assay interference; reassess attack control before considering q4wk dosing after more than 6 months |
| Example PA threshold | Cigna example: age 12 or older; HAE type I or II with functional C1-INH under 50% and low C4, both documented; allergist, immunologist or HAE specialist; employer plans step through Haegarda and Takhzyro; no concomitant preventive HAE therapy | Cigna example: age 12 or older, HAE type I or II with functional C1-INH under 50% and low C4, both documented; allergist, immunologist or HAE specialist; Haegarda and Takhzyro tried first on employer plans; no concomitant preventive HAE therapy | Cigna example: age 12 or older, HAE type I or II with functional C1-INH below 50% of normal and low C4, both documented, an HAE specialist, and for adults a trial of generic icatibant or a prior attack treated with Ekterly | Cigna example: HAE type I or II with functional C1-INH under 50% and low C4, both documented; allergist, immunologist or HAE specialist; generic icatibant before brand Firazyr; up to 30mg per injection, no more than three times daily | Cigna example: age 2 or older, HAE type I or II with functional C1-INH under 50% of normal and low C4, documented; allergist, immunologist or HAE specialist; no combination prophylaxis | Cigna example: HAE type I or II with functional C1-INH under 50% and low C4, both documented; allergist, immunologist or HAE specialist; labeled dosing; no concomitant preventive HAE therapy |
| Support line | ANDEMBRY Connect, 1-844-423-4273, Monday to Friday 8 AM to 8 PM ET; referral fax 1-866-415-2162; co-pay support for commercial patients under program terms; QuickStart 1-month supply at no cost, up to 2 months for eligible patients | Ionis Every Step, 1-844-444-4305, Monday to Friday 8 AM to 8 PM ET; enrollment form fax 1-877-558-0007; commercial copay as little as $0 per prescription; Quick Start free drug during the insurance approval process; one-dose Free Trial Program for new patients | KalVista Cares, 1-844-432-3322, Monday to Friday 8:30 am to 8 pm ET; Start Form online or by fax to 1-844-432-9525; co-pay as little as $0 for commercial plans; QuickStart | Takeda Patient Support, 1-866-888-0660, Monday to Friday 8:30 AM to 8:00 PM ET; enroll at TakedaPatientSupport.com/HCP or by faxed Start Form; co-pay help up to 100% of out-of-pocket co-pay costs to an annual maximum for commercial plans | Empower Patient Services 1-866-536-7693 (fax 1-844-336-7693), CareMed NCPDP 3306986, copay to as little as $0 for commercial plans, Quick Start while PA is pending | Takeda Patient Support, 1-866-888-0660, Monday to Friday 8:30 AM to 8:00 PM ET; Start Form fax 1-855-663-7284; co-pay help up to 100% of out-of-pocket costs to an annual maximum for commercial plans; Quick Start up to 2 months free while benefits are verified |
- Label dated
- June 30, 2025
- Starting dose
- 400mg subcutaneously, given as two 200mg injections.
- Dispensing gate
- No REMS; referral form to ANDEMBRY Connect by electronic form or fax, prior authorization, specialty pharmacy shipment, and injection training before the first self-injection
- Required monitoring
- No scheduled lab monitoring in the label; aPTT may be prolonged by assay interference, and PT or INR rose in some patients, none with bleeding events; no warnings and precautions
- Example PA threshold
- Cigna example: age 12 or older; HAE type I or II with functional C1-INH under 50% and low C4, both documented; allergist, immunologist or HAE specialist; employer plans step through Haegarda and Takhzyro; no concomitant preventive HAE therapy
- Support line
- ANDEMBRY Connect, 1-844-423-4273, Monday to Friday 8 AM to 8 PM ET; referral fax 1-866-415-2162; co-pay support for commercial patients under program terms; QuickStart 1-month supply at no cost, up to 2 months for eligible patients
- Label dated
- August 31, 2026
- Starting dose
- 80mg subcutaneously every 4 weeks, in adult and pediatric patients 12 years of age and older.
- Dispensing gate
- No REMS; Patient Enrollment and Prescription Form by fax or an e-prescription, prior authorization, patient contact with the Ionis Every Step Specialty Pharmacy before it ships, and injection training before the first dose
- Required monitoring
- No scheduled lab monitoring in the label; watch for hypersensitivity including anaphylaxis; platelet reductions and ALT, AST and GGT increases were seen in trials; not recommended in moderate or severe hepatic impairment
- Example PA threshold
- Cigna example: age 12 or older, HAE type I or II with functional C1-INH under 50% and low C4, both documented; allergist, immunologist or HAE specialist; Haegarda and Takhzyro tried first on employer plans; no concomitant preventive HAE therapy
- Support line
- Ionis Every Step, 1-844-444-4305, Monday to Friday 8 AM to 8 PM ET; enrollment form fax 1-877-558-0007; commercial copay as little as $0 per prescription; Quick Start free drug during the insurance approval process; one-dose Free Trial Program for new patients
- Label dated
- April 1, 2026
- Starting dose
- 600mg (two 300mg tablets) orally, for adults and pediatric patients 12 and older.
- Dispensing gate
- No REMS, no boxed warning, no contraindications and no baseline labs in the label; KalVista's enrollment path is the KalVista Cares Start Form, benefits investigation and prior authorization, then a specialty pharmacy
- Required monitoring
- No laboratory monitoring in the label; the dose depends on CYP3A4 co-medication and Child-Pugh class, and severe laryngeal attacks were not treated in KONFIDENT
- Example PA threshold
- Cigna example: age 12 or older, HAE type I or II with functional C1-INH below 50% of normal and low C4, both documented, an HAE specialist, and for adults a trial of generic icatibant or a prior attack treated with Ekterly
- Support line
- KalVista Cares, 1-844-432-3322, Monday to Friday 8:30 am to 8 pm ET; Start Form online or by fax to 1-844-432-9525; co-pay as little as $0 for commercial plans; QuickStart
- Label dated
- July 7, 2025
- Starting dose
- 30mg subcutaneously in the abdominal area, over at least 30 seconds.
- Dispensing gate
- No REMS; prescription and Takeda Patient Support Start Form (online or fax), prior authorization, specialty pharmacy dispensing, and self-injection training before the first attack treated at home
- Required monitoring
- No scheduled lab monitoring in the label; counsel on laryngeal attacks and immediate medical attention; injection site reactions in 97%; repeat dosing at 6 hours or more, maximum 3 doses in 24 hours
- Example PA threshold
- Cigna example: HAE type I or II with functional C1-INH under 50% and low C4, both documented; allergist, immunologist or HAE specialist; generic icatibant before brand Firazyr; up to 30mg per injection, no more than three times daily
- Support line
- Takeda Patient Support, 1-866-888-0660, Monday to Friday 8:30 AM to 8:00 PM ET; enroll at TakedaPatientSupport.com/HCP or by faxed Start Form; co-pay help up to 100% of out-of-pocket co-pay costs to an annual maximum for commercial plans
- Label dated
- October 23, 2026
- Starting dose
- 150mg orally once daily with food, as a capsule or one 150mg pellet packet.
- Dispensing gate
- No REMS; Start Form to Empower Patient Services (CareMed Specialty Pharmacy only), prior authorization with C1-INH function and C4 results, and a required pharmacist counseling call before the first shipment
- Required monitoring
- No required labs; GI effects mostly early and self-limiting; no doses above the prescribed once-daily dose (QTc); review CYP2D6, CYP3A4 and P-gp interactions; weight-based pellet dose under 12
- Example PA threshold
- Cigna example: age 2 or older, HAE type I or II with functional C1-INH under 50% of normal and low C4, documented; allergist, immunologist or HAE specialist; no combination prophylaxis
- Support line
- Empower Patient Services 1-866-536-7693 (fax 1-844-336-7693), CareMed NCPDP 3306986, copay to as little as $0 for commercial plans, Quick Start while PA is pending
- Label dated
- September 18, 2026
- Starting dose
- 300mg subcutaneously every 2 weeks, by the patient or caregiver. 300mg every 4 weeks may be considered if well controlled (e.g., attack free) for more than 6 months.
- Dispensing gate
- No REMS; Start Form (the prescription) by fax or online, prior authorization, specialty pharmacy dispensing, and injection training before the first self-injection
- Required monitoring
- No scheduled lab monitoring in the label; watch for hypersensitivity; aPTT may be prolonged by assay interference; reassess attack control before considering q4wk dosing after more than 6 months
- Example PA threshold
- Cigna example: HAE type I or II with functional C1-INH under 50% and low C4, both documented; allergist, immunologist or HAE specialist; labeled dosing; no concomitant preventive HAE therapy
- Support line
- Takeda Patient Support, 1-866-888-0660, Monday to Friday 8:30 AM to 8:00 PM ET; Start Form fax 1-855-663-7284; co-pay help up to 100% of out-of-pocket costs to an annual maximum for commercial plans; Quick Start up to 2 months free while benefits are verified
Other FDA-approved medicines for hereditary angioedema
These have no Trial Friend prescribing guide yet, so they are not in the comparison above. Some are approved for a different form or use of the condition than the guides above, and each drug page gives its indication. The list comes from Trial Friend's audited list of FDA labels that name this condition, built October 21, 2026.
- Berinert / Cinryze / HaegardaC1 esterase inhibitor (human)
- Danazol
- Kalbitorecallantide
FDA decisions for hereditary angioedema (HAE)
From the Trial Friend FDA decision calendar, which records each date from the sponsor's or the FDA's own announcement.
- April 23, 2027Deucrictibant, NDA, PharvarisPending
- March 10, 2027Lonvo-z (lonvoguran ziclumeran), BLA, Intellia TherapeuticsPending
Recent label changes
What changed in each label revision, from the FDA's approval letters and the labels' own revision lists.
- October 2026Orladeyo. On October 16, 2026, the FDA aligned the capsule label with newly approved pellet labeling. BioCryst announced on October 21, 2026 that this adds a 150mg pellet packet for people 12 and older. FDA letter
- August 2026Takhzyro. The FDA approved removing the single-dose vial from the label, leaving the 150mg and 300mg prefilled syringes. The same change added hives at the injection site to side effects reported since approval. FDA letter
- April 2026Ekterly. The prescribing information is marked revised April 2026, and the Patient Information is marked issued April 2026. Drugs@FDA lists no labeling supplement for it, and the approved use is still ages 12 and older. Drugs@FDA record
- December 2025Orladeyo. Orladeyo pellets were approved for children 2 to under 12, dosed by weight, under a separate application. Later that month the capsule label was aligned with the new pellet label. FDA letter
- August 2025Dawnzera. The FDA first approved Dawnzera on August 21st to prevent HAE attacks in people 12 and older. The approval letter requires Ionis to finish 2 extension trials that look for liver injury, and a 2-year rat study of tumor risk. FDA letter
- July 2025Ekterly. Ekterly tablets were first approved on July 3, 2025, for treating acute HAE attacks in adults and children 12 and older. FDA letter
- June 2025Firazyr. The prescribing information, Patient Information and Instructions for Use all carry a June 2025 revision date. This label lists no recent major changes. FDA label
- June 2025Andembry. The FDA first approved Andembry on June 16th to prevent HAE attacks in adults and children 12 and older. The approval letter names a 200mg prefilled autoinjector and a 200mg prefilled syringe. FDA letter
Open trials
Questions prescribers ask about Hereditary angioedema (HAE)
Which Hereditary angioedema (HAE) drugs require a REMS?
This answer covers Andembry, Dawnzera, Ekterly, Firazyr, Orladeyo and Takhzyro, the drugs with a prescribing guide here, and not the 3 other approved medicines listed on this page. None of the 6 Hereditary angioedema (HAE) drugs on this page has a REMS: Andembry, Dawnzera, Ekterly, Firazyr, Orladeyo and Takhzyro. Each prescribing guide lists what does gate the first fill.
What monitoring do Hereditary angioedema (HAE) drugs require?
This answer covers Andembry, Dawnzera, Ekterly, Firazyr, Orladeyo and Takhzyro, the drugs with a prescribing guide here, and not the 3 other approved medicines listed on this page. Andembry: No scheduled lab monitoring in the label; aPTT may be prolonged by assay interference, and PT or INR rose in some patients, none with bleeding events; no warnings and precautions. Dawnzera: No scheduled lab monitoring in the label; watch for hypersensitivity including anaphylaxis; platelet reductions and ALT, AST and GGT increases were seen in trials; not recommended in moderate or severe hepatic impairment. Ekterly: No laboratory monitoring in the label; the dose depends on CYP3A4 co-medication and Child-Pugh class, and severe laryngeal attacks were not treated in KONFIDENT. Firazyr: No scheduled lab monitoring in the label; counsel on laryngeal attacks and immediate medical attention; injection site reactions in 97%; repeat dosing at 6 hours or more, maximum 3 doses in 24 hours. Orladeyo: No required labs; GI effects mostly early and self-limiting; no doses above the prescribed once-daily dose (QTc); review CYP2D6, CYP3A4 and P-gp interactions; weight-based pellet dose under 12. Takhzyro: No scheduled lab monitoring in the label; watch for hypersensitivity; aPTT may be prolonged by assay interference; reassess attack control before considering q4wk dosing after more than 6 months.
What do insurers require before covering Andembry, Dawnzera, Ekterly, Firazyr, Orladeyo and Takhzyro?
Each answer below is one public insurer policy, an example rather than every plan. Andembry: Cigna example: age 12 or older; HAE type I or II with functional C1-INH under 50% and low C4, both documented; allergist, immunologist or HAE specialist; employer plans step through Haegarda and Takhzyro; no concomitant preventive HAE therapy. Dawnzera: Cigna example: age 12 or older, HAE type I or II with functional C1-INH under 50% and low C4, both documented; allergist, immunologist or HAE specialist; Haegarda and Takhzyro tried first on employer plans; no concomitant preventive HAE therapy. Ekterly: Cigna example: age 12 or older, HAE type I or II with functional C1-INH below 50% of normal and low C4, both documented, an HAE specialist, and for adults a trial of generic icatibant or a prior attack treated with Ekterly. Firazyr: Cigna example: HAE type I or II with functional C1-INH under 50% and low C4, both documented; allergist, immunologist or HAE specialist; generic icatibant before brand Firazyr; up to 30mg per injection, no more than three times daily. Orladeyo: Cigna example: age 2 or older, HAE type I or II with functional C1-INH under 50% of normal and low C4, documented; allergist, immunologist or HAE specialist; no combination prophylaxis. Takhzyro: Cigna example: HAE type I or II with functional C1-INH under 50% and low C4, both documented; allergist, immunologist or HAE specialist; labeled dosing; no concomitant preventive HAE therapy.
Which support programs start Hereditary angioedema (HAE) patients on therapy?
This answer covers Andembry, Dawnzera, Ekterly, Firazyr, Orladeyo and Takhzyro, the drugs with a prescribing guide here, and not the 3 other approved medicines listed on this page. Andembry: ANDEMBRY Connect, 1-844-423-4273, Monday to Friday 8 AM to 8 PM ET; referral fax 1-866-415-2162; co-pay support for commercial patients under program terms; QuickStart 1-month supply at no cost, up to 2 months for eligible patients. Dawnzera: Ionis Every Step, 1-844-444-4305, Monday to Friday 8 AM to 8 PM ET; enrollment form fax 1-877-558-0007; commercial copay as little as $0 per prescription; Quick Start free drug during the insurance approval process; one-dose Free Trial Program for new patients. Ekterly: KalVista Cares, 1-844-432-3322, Monday to Friday 8:30 am to 8 pm ET; Start Form online or by fax to 1-844-432-9525; co-pay as little as $0 for commercial plans; QuickStart. Firazyr: Takeda Patient Support, 1-866-888-0660, Monday to Friday 8:30 AM to 8:00 PM ET; enroll at TakedaPatientSupport.com/HCP or by faxed Start Form; co-pay help up to 100% of out-of-pocket co-pay costs to an annual maximum for commercial plans. Orladeyo: Empower Patient Services 1-866-536-7693 (fax 1-844-336-7693), CareMed NCPDP 3306986, copay to as little as $0 for commercial plans, Quick Start while PA is pending. Takhzyro: Takeda Patient Support, 1-866-888-0660, Monday to Friday 8:30 AM to 8:00 PM ET; Start Form fax 1-855-663-7284; co-pay help up to 100% of out-of-pocket costs to an annual maximum for commercial plans; Quick Start up to 2 months free while benefits are verified.
A reference for licensed professionals, checked on November 11, 2026. Labels and plan policies change; the label on DailyMed and the plan's current policy govern. Not medical advice. For patients: the Hereditary angioedema (HAE) page and the first 90 days pages for Andembry, Dawnzera, Ekterly, Firazyr, Orladeyo, Takhzyro.