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Takhzyro (lanadelumab-flyo) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to prevent hereditary angioedema (HAE) attacks in adults and children ages 2 years and older.
Takhzyro is a monoclonal antibody. It blocks plasma kallikrein, a protein that helps make bradykinin. In people with HAE, too much bradykinin can cause swelling and pain. Takhzyro helps control the extra bradykinin and prevent HAE attacks.
Doctors prescribe Takhzyro to prevent HAE attacks in adults and children ages 2 years and older.
Takhzyro is given as an injection under the skin. The dosing schedule depends on the person’s age and how well their HAE is controlled.
People ages 12 years and older may give the injection themselves or have a caregiver give it. They must first be trained by a healthcare professional.
Children ages 2 to younger than 12 years should receive the injection from a healthcare provider or caregiver.
Takhzyro may be injected into the stomach area, thigh, or upper arm. The upper arm should be used only when a healthcare provider or caregiver gives the injection. Do not inject into skin that is irritated, red or discolored, bruised, or infected. Choose a spot at least 2 inches away from scars or the belly button.
The recommended starting dose for:
For people ages 12 years and older, 300 milligrams every four weeks may be considered if they have been well controlled, such as attack-free, for more than six months.
For children ages 6 to younger than 12 years, 150 milligrams every four weeks may be considered if they have been well controlled, such as attack-free, for more than six months.
This information is based on the prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.
In clinical studies, the most common side effects of Takhzyro occurred in about 10 percent to 57 percent of people. These include:
Takhzyro can cause serious side effects that may require immediate medical attention. These include:
Get medical help right away if you think you are having a serious reaction.
Takeda Pharmaceuticals U.S.A., the manufacturer of Takhzyro, offers the Takeda Patient Support Co-Pay Assistance Program. Eligible people with commercial insurance may have up to 100 percent of their out-of-pocket copay costs covered.
The Takeda Patient Support Co-Pay Assistance Program also offers help understanding insurance coverage, coordinating with your specialty pharmacy, arranging in-home injection training, and connecting you with educational and community support resources.
To learn more, visit the Takeda Patient Support Co-Pay Assistance Program website or call 866-888-0660.
Tell your doctor if you have any allergies to lanadelumab or any ingredients in Takhzyro.
Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.
If you are pregnant, planning to become pregnant, or breastfeeding while taking Takhzyro, talk with your doctor about the risks and benefits.
These answers are fact-checked by our editorial staff.
How effective is Takhzyro for HAE?
In a 26-week study of people ages 12 years and older with type 1 or type 2 HAE, the average attack rate per four weeks was 1.97 with placebo.
The average attack rate was:
Compared with placebo, these doses reduced the attack rate by 76 percent, 73 percent, and 87 percent.
During the full 26-week study, 44 percent of people taking 300 milligrams every two weeks had no attacks. This compared with 2 percent of people taking placebo.
How long does Takhzyro take to work for HAE?
The study result does not give an exact time for Takhzyro to begin preventing HAE attacks.
Takhzyro reaches its highest level in the blood within about five days. Steady blood levels are expected after about 70 days. These blood-level findings do not show exactly when a person will notice a preventive effect.
In an exploratory extension study, about 80 percent of people who had already been taking 300 milligrams every two weeks remained attack-free four weeks after receiving a single dose at study entry.
What tests or monitoring are needed with Takhzyro for HAE?
The prescribing information does not give a general schedule for routine laboratory monitoring with Takhzyro.
Takhzyro can affect a blood-clotting test called activated partial thromboplastin time (aPTT). This test measures part of the blood-clotting process. Takhzyro may make the result look higher because it can interfere with the laboratory test. In studies, these increases were not linked to abnormal bleeding.
Some people in studies also had temporary increases in liver enzymes called ALT and AST. These increases did not cause symptoms.
Before each dose, check the Takhzyro solution. Do not use it if it is discolored or has visible particles.
On myHAEteam, people share their experiences with HAE, get advice, and find support from others who understand.
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