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Bradykinin B2 receptor antagonist

Firazyr (icatibant)

An approved treatment for Hereditary Angioedema.

FDA Approved (2011)by Takeda
Preclinical
Phase 1
Phase 2
Phase 3
Approved
2011

Drug facts

The same compound appears under different names depending on the context. Here is how to identify Icatibant wherever you encounter it, plus the key facts at a glance.

Generic name
Icatibant
Brand name
Firazyr
Development code
HOE 140
Drug class
Bradykinin B2 receptor antagonist
Manufacturer
Takeda
How it's taken
Injected under the skin of the belly as a 30mg dose from a prefilled syringe, pushed slowly over at least 30 seconds, and people can inject themselves after training.

A shot under the skin of the belly that people with hereditary angioedema (HAE) can give themselves to treat an attack as it starts. It is approved for adults 18 and older, and generic icatibant, often cheaper, has been approved since 2019.

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Where Icatibant fits

One of several on-demand treatments for HAE attacks, and one that people can inject themselves at home. Generic icatibant has been sold since 2019, and Ekterly (sebetralstat), approved in July 2025, is a pill for attacks from age 12.

How Icatibant works

In HAE, people lack enough working C1 inhibitor, a protein that keeps bradykinin in check. During an attack, bradykinin builds up and makes small blood vessels leak, causing swelling of the skin, gut or throat. Icatibant blocks the receptor bradykinin acts on, so the leaking slows and the swelling eases. It treats attacks after they start and does not prevent them.

Side effects and safety

What patients report
Label warnings
  • Throat attacks. After injecting for swelling of the throat or tongue, go to the emergency room right away, because airway swelling can become life-threatening.
Most common in trials
Injection site reactions such as redness, swelling or burning (97% against 33% on placebo)Fever (4% against 0%)Raised liver enzymes (4% against 0%)Dizziness (3% against 1%)
What gets monitored
  • Training on self-injection before the first home use
  • Emergency care for any throat swelling
Report a suspected reaction to Takeda at 1-877-825-3327 or FDA MedWatch at 1-800-FDA-1088, or to the FDA at 1-800-FDA-1088.
In context

Firazyr has no boxed warning and no contraindications. Its one warning is that a throat (laryngeal) attack needs emergency care right away, even after an injection. Almost everyone in the trials had a reaction at the injection site, such as redness, swelling or burning. Fever, raised liver enzymes and dizziness were less common.

This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.

Taking Icatibant

Injected under the skin of the belly as a 30mg dose from a prefilled syringe, pushed slowly over at least 30 seconds, and people can inject themselves after training. If symptoms do not ease or come back, another dose can be given at least 6 hours later, with no more than 3 doses in 24 hours.

Availability and cost

Generic available

Generic versions may be available at a lower cost. Ask your pharmacist.

Help paying for Firazyr

With private insurance, the drugmaker's copay card can lower what you pay for Firazyr. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE, but charity funds often can. Of the 3 charity funds for Hereditary Angioedema, 1 was open on October 19, 2026. Pick your insurance below to see which offers fit you.

Your insurance
From the drugmaker
Firazyr (Icatibant)
  • Insurance and case manager help

    Insurance navigation, specialty pharmacy coordination and in-home injection training by a nurse.

    The official page does not say who qualifies. Ask the program. · source
  • Copay help

    Enrolled patients with commercial insurance, including Marketplace plans, can get help with up to 100% of out-of-pocket copay costs, up to an annual maximum. Not usable when any part of the prescription is covered by Medicare, Medicare Advantage, Medicaid, TRICARE or a state pharmaceutical assistance program. Takeda may reduce help for patients in copay maximizer plans.

    For: private insurance · source

Good to know: Call 1-866-888-0660, weekdays 8:30am-8pm ET. Generic icatibant has been available since 2019 and may cost less; ask the pharmacist.

Checked on the drugmaker's official pages on October 24, 2026. Programs change; confirm with the program before you rely on it.

Charity funds for Hereditary Angioedema

  • From a charity · The Assistance Fund
    Hereditary Angioedema (HAE) fund
    Open

    Pays for: Copays, coinsurance, deductibles and other health-related expenses.

  • From a charity · US Hereditary Angioedema Association
    Chris Whalen HAEA Compassion Fund fund
    Apply directly

    Pays for: Travel to care for HAE-related reasons (e.g. seeing a specialist).

    The foundation says: “Status not shown on page”
Status as each foundation showed it on October 19, 2026.

Every program and charity fund for Hereditary Angioedema →

More ways to get help paying for treatment →

Insurance said no? Your Insurer Denied a Rare Disease Drug and Fewer Than 1 in 100 People Appeal, So Here Is the Playbook · 14 min read

Access and eligibility

Manufacturer
Takeda
Eligibility requirement

Approved to treat acute hereditary angioedema attacks in adults 18 and older. Its safety and effectiveness under 18 have not been established. It treats attacks and is not a preventive medicine.

Source: Takeda Patient Support (Firazyr)

Access program details are provided for informational purposes and may vary based on insurance coverage, geographic location, and individual circumstances. Confirm current eligibility directly with the manufacturer or your specialty pharmacy.

Clinical trial results

Approval rested on FAST-3 (NCT00912093), which enrolled 98 adults having an HAE attack and compared Firazyr with placebo. For the typical patient, symptoms eased by half in 2 hours on Firazyr against nearly 20 hours on placebo. That gap had less than a 1 in 1,000 chance of being a fluke. Only 7% on Firazyr needed rescue medicine, against 40% on placebo. Later, when patients knew they were getting Firazyr, 93% of attacks were treated with a single shot.

Development history

Shire won FDA approval for Firazyr on August 25, 2011 for acute HAE attacks in adults, and Takeda now sells it after buying Shire. The first generic icatibant, from Teva, was approved on July 15, 2019, and several more have followed. Firazyr has no US approval for children under 18.

Ask anything about Icatibant
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Other Hereditary Angioedema treatments

HAE attacks can be treated on demand with icatibant (Firazyr and generics), Kalbitor (ecallantide), Ekterly (sebetralstat, approved July 3, 2025), or C1 inhibitor infusions such as Berinert and Ruconest. Separate medicines prevent attacks, including Takhzyro, Orladeyo, Andembry, Dawnzera and C1 inhibitor products. Most people with HAE keep an on-demand treatment on hand even when they take a preventive one.

Common questions about Icatibant

▸What is Icatibant (Firazyr)?

A shot under the skin of the belly that people with hereditary angioedema (HAE) can give themselves to treat an attack as it starts. It is approved for adults 18 and older, and generic icatibant, often cheaper, has been approved since 2019.

▸How does Icatibant work?

In HAE, people lack enough working C1 inhibitor, a protein that keeps bradykinin in check. During an attack, bradykinin builds up and makes small blood vessels leak, causing swelling of the skin, gut or throat. Icatibant blocks the receptor bradykinin acts on, so the leaking slows and the swelling eases. It treats attacks after they start and does not prevent them.

▸What are the side effects of Icatibant?

Firazyr has no boxed warning and no contraindications. Its one warning is that a throat (laryngeal) attack needs emergency care right away, even after an injection. Almost everyone in the trials had a reaction at the injection site, such as redness, swelling or burning. Fever, raised liver enzymes and dizziness were less common.

▸How is Icatibant taken?

Injected under the skin of the belly as a 30mg dose from a prefilled syringe, pushed slowly over at least 30 seconds, and people can inject themselves after training. If symptoms do not ease or come back, another dose can be given at least 6 hours later, with no more than 3 doses in 24 hours.

▸Is Icatibant FDA approved?

Yes, Icatibant (Firazyr) is FDA approved (2011) for the treatment of Hereditary Angioedema.

▸Is there a generic Firazyr?

Yes, generic icatibant has been FDA-approved since July 15, 2019, when Teva's version was approved, and several companies now make it. Ask your pharmacist or insurer whether the generic costs less for you.

▸Can children use Firazyr?

Not in the US yet, because Firazyr is approved only for adults 18 and older. Ekterly (sebetralstat), Kalbitor (ecallantide), Berinert and Ruconest are approved for teens, so ask your HAE specialist which fits.

▸How fast does Firazyr work?

In the main trial, symptoms eased by half in a median of 2 hours, against nearly 20 hours on placebo. A second dose can be given at least 6 hours later if needed, up to 3 doses a day.

Sources and references

Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.

  1. U.S. National Library of Medicine, DailyMed · 2025-07-07. FIRAZYR (icatibant) injection: prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ed6657ca-ab68-477a-9968-e12dc928b540
  2. U.S. Food and Drug Administration. Drugs@FDA: icatibant brand and generic approvals. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022150
  3. ClinicalTrials.gov. FAST-3: icatibant for acute attacks of hereditary angioedema. https://clinicaltrials.gov/study/NCT00912093
  4. Takeda. FIRAZYR patient support and copay assistance. https://www.firazyr.com/

This page is for informational purposes only and does not constitute medical advice. Drug information is sourced from public databases and peer-reviewed literature and may not reflect the most recent updates. Always discuss treatment options with your healthcare provider. Last reviewed: October 2026.

Follow Firazyr by email

We'll email you when Firazyr's FDA label changes, when the FDA acts on it, and when new trials for Hereditary Angioedema open. Unsubscribe anytime.

You'll get new recruiting trials, changes to trials, FDA decisions and condition news for Hereditary Angioedema. Turn any of these off from the link in every email.

We never share your email. Unsubscribe anytime. Privacy policy · Check any health site