Takhzyro (lanadelumab)
An approved treatment for Hereditary Angioedema.
Drug facts
The same compound appears under different names depending on the context. Here is how to identify Lanadelumab wherever you encounter it, plus the key facts at a glance.
- Generic name
- Lanadelumab
- Brand name
- Takhzyro
- Development code
- DX-2930
- Drug class
- Plasma kallikrein inhibitor (monoclonal antibody)
- Manufacturer
- Takeda
- How it's taken
- A subcutaneous injection that patients or caregivers can give at home.
A self-injected antibody, given every 2 or 4 weeks, that prevents hereditary angioedema attacks.
Takhzyro cut attacks by 87% versus placebo in its pivotal trial and is approved for prophylaxis from age 2.
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Where Lanadelumab fits
The most established injectable prophylaxis for HAE and the comparator newer options are measured against. It sits alongside Orladeyo (oral, daily), Andembry (monthly injection, a different target) and Dawnzera (an antisense drug every 4 to 8 weeks) as the preventive choices, with Ekterly and older injectables covering acute attacks.
How Lanadelumab works
In hereditary angioedema, a shortage or malfunction of C1-inhibitor lets an enzyme called plasma kallikrein run unchecked. Kallikrein cleaves a protein in the blood to release bradykinin, which makes blood vessels leak fluid into tissue, and the result is the painful, sometimes airway-threatening swelling of an attack. Lanadelumab is an antibody that binds plasma kallikrein and stops it working, so bradykinin is not produced and attacks do not start. Because it is an antibody with a long half-life, one injection provides weeks of protection.
Side effects and safety
- Hypersensitivity reactions. stop treatment if a severe one occurs
The label's one warning is hypersensitivity reactions, with the instruction to stop treatment if a severe one occurs. The most common reactions, in at least 10% of patients, were injection site reactions, upper respiratory infections, headache, rash, dizziness, diarrhea and muscle pain. Suspected reactions can be reported to Takeda at 1-877-825-3327.
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 Lanadelumab
A subcutaneous injection that patients or caregivers can give at home. From age 12: 300mg every 2 weeks, with every 4 weeks an option for some patients once attacks are controlled. Ages 6 to 11: 150mg every 2 weeks, given by a healthcare provider or caregiver, with every 4 weeks an option. Ages 2 to 5: 150mg every 4 weeks.
Starting Takhzyro? Your first 90 daysWhat happens before the first fill, the dose steps, the required tests and who to call, from the label and the drugmaker's own program.Prescribing Takhzyro? REMS, monitoring and prior authorization criteria for prescribers
Availability and cost
Only available as the brand-name product.
A chronic monoclonal antibody for a rare disease, dosed every 2 to 4 weeks for life. Costs are in the range of other biologic prophylaxis for HAE, and the every-4-weeks interval halves the drug quantity for patients who qualify for it.
Help paying for Takhzyro
With private insurance, the drugmaker's copay card can lower what you pay for Takhzyro. 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 November 9, 2026. Pick your insurance below to see which offers fit you.
- Copay help
Co-pays may be covered at 100% up to the program maximum for patients enrolled in Takeda Patient Support with commercial insurance.
For: private insurance · source - Insurance and case manager help
Insurance navigation, coordination of first shipment, and community resources.
The official page does not say who qualifies. Ask the program. · source
Good to know: No free-drug program described.
Charity funds for Hereditary Angioedema
- From a charity · The Assistance FundHereditary Angioedema (HAE) fundOpen
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
- From a charity · US Hereditary Angioedema AssociationChris Whalen HAEA Compassion Fund fundApply directly
Pays for: Travel to care for HAE-related reasons (e.g. seeing a specialist).
The foundation says: “Status not shown on page”
Access and eligibility
Approved for prophylaxis in adults and children aged 2 and older. It is a preventive medicine and not a treatment for an attack in progress; patients still need an on-demand therapy for breakthrough attacks. The pivotal trial required at least 1 attack a month, so it is aimed at patients who get attacks regularly rather than those with rare, mild disease.
Source: FDA Drugs@FDA (BLA 761090)
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
The HELP trial (NCT02586805) randomized 125 patients aged 12 and older with type I or II HAE, all of whom had at least 1 attack per 4 weeks during run-in, to placebo or 1 of 3 lanadelumab regimens for 26 weeks. The approved dose of 300mg every 2 weeks reduced the attack rate by 87% relative to placebo (95% CI 76% to 93%), from 1.97 to 0.26 attacks a month; 300mg every 4 weeks reduced it by 73% and 150mg every 4 weeks by 76%.
Attacks needing acute treatment fell 87% and moderate or severe attacks 83% on the every-2-weeks dose. Most patients had type I disease, 65% had a history of laryngeal attacks, and 56% had been on prior long-term prophylaxis.
Development history
Developed by Dyax as DX-2930, which Shire acquired in 2016, and approved by the FDA on August 23, 2018 as the first monoclonal antibody for HAE prophylaxis. Takeda acquired Shire in 2019. The label was later extended down to age 2.
Explore Hereditary Angioedema trials
Other Hereditary Angioedema treatments
Common questions about Lanadelumab
▸What is Lanadelumab (Takhzyro)?
A self-injected antibody, given every 2 or 4 weeks, that prevents hereditary angioedema attacks. Takhzyro cut attacks by 87% versus placebo in its pivotal trial and is approved for prophylaxis from age 2.
▸How does Lanadelumab work?
In hereditary angioedema, a shortage or malfunction of C1-inhibitor lets an enzyme called plasma kallikrein run unchecked. Kallikrein cleaves a protein in the blood to release bradykinin, which makes blood vessels leak fluid into tissue, and the result is the painful, sometimes airway-threatening swelling of an attack. Lanadelumab is an antibody that binds plasma kallikrein and stops it working, so bradykinin is not produced and attacks do not start. Because it is an antibody with a long half-life, one injection provides weeks of protection.
▸What are the side effects of Lanadelumab?
The label's one warning is hypersensitivity reactions, with the instruction to stop treatment if a severe one occurs. The most common reactions, in at least 10% of patients, were injection site reactions, upper respiratory infections, headache, rash, dizziness, diarrhea and muscle pain. Suspected reactions can be reported to Takeda at 1-877-825-3327.
▸How is Lanadelumab taken?
A subcutaneous injection that patients or caregivers can give at home. From age 12: 300mg every 2 weeks, with every 4 weeks an option for some patients once attacks are controlled. Ages 6 to 11: 150mg every 2 weeks, given by a healthcare provider or caregiver, with every 4 weeks an option. Ages 2 to 5: 150mg every 4 weeks.
▸Is Lanadelumab FDA approved?
Yes, Lanadelumab (Takhzyro) is FDA approved (2018) for the treatment of Hereditary Angioedema.
▸What is Takhzyro approved for?
Takhzyro (lanadelumab) is approved for prophylaxis, meaning prevention, of hereditary angioedema attacks in adults and children aged 2 and older. It was first approved on August 23, 2018. It does not treat an attack that has already started.
▸How well does Takhzyro prevent attacks?
In the 26-week HELP trial of 125 patients, the approved dose of 300mg every 2 weeks reduced attacks by 87% compared with placebo, from about 2 attacks a month to about 1 every 4 months. Every-4-weeks dosing reduced attacks by 73-76%.
▸How often is Takhzyro injected?
Every 2 weeks at 300mg for patients 12 and older, with an every-4-weeks schedule an option for some patients once attacks are controlled. Children aged 6 to 11 receive 150mg every 2 weeks and children aged 2 to 5 receive 150mg every 4 weeks. Patients and caregivers can give the injection at home.
▸What are the side effects of Takhzyro?
The most common were injection site reactions, upper respiratory infections, headache, rash, dizziness, diarrhea and muscle pain. The label's one warning is for hypersensitivity reactions, which call for stopping the drug if severe.
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.
- Takeda / FDA · 2026-08. TAKHZYRO (lanadelumab-flyo) injection, for subcutaneous use: US Prescribing Information. https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=TAKHZYRO
- U.S. Food and Drug Administration · 2018-08-23. TAKHZYRO approval, BLA 761090, August 23 2018. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761090
- ClinicalTrials.gov. Efficacy and Safety Study of DX-2930 to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE (HELP). https://clinicaltrials.gov/study/NCT02586805