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Takhzyro

Pronunciation: tak-ZYE-roe
Generic name: lanadelumab-flyo [ LAN-a-DEL-ue-mab ]
Dosage form: prefilled syringe (150 mg/1 mL, 300 mg/2 mL), single-dose vial (300 mg/2 mL)
Drug class: Hereditary angioedema agents

Medically reviewed by Melisa Puckey, BPharm. Last updated on Mar 8, 2024.

What is Takhzyro?

Takhzyro is used to prevent hereditary angioedema (HAE), Takhzyro helps to reduce the number and severity of hereditary angioedema attacks. Takhzyro works by lowering the activity of a protein called kallikrein which helps to prevent the swelling and related symptoms of HAE. Takhzyro is usually given every two weeks as an injection under the skin using a ready-to-use, prefilled syringe. The dose depends on age and can change to every 4 weeks if symptoms have improved.

Hereditary angioedema is a rare condition that causes rapid attacks of swelling in areas under the skin around the face, arms, legs, and also the throat, which can be life-threatening if it blocks off the airways. People with hereditary angioedema have high levels of a protein called bradykinin, which makes fluid leak fluid into the surrounding tissue, causing swelling attacks. Takhzyro (lanadelumab-flyo) works by blocking another protein in the blood called 'kallikrein', which in turn reduces the level of bradykinin, which helps to prevent the swelling and symptoms of angioedema.

Takhzyro approval by the FDA was originally on February 3, 2023, and it is now approved to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 2 years and older. FDA approval was supported by data from HELP Study, the  HELP OLE Study and the Phase 3 SPRING Study (NCT SHP643-301).

Takhzyro is a plasma kallikrein inhibitor (monoclonal antibody).

Takhzyro side effects

Common Takhzyro side effects

Common Takhzyro side effects may include headache, cold symptoms such as stuffy nose, sneezing, sore throat, rash; or pain, redness, or bruising where the injection was given.

Serious Takhzyro side effects

Get emergency medical help if you have signs of an allergic reaction to this medicine, such as hives, fast heartbeats, difficult breathing, feeling light-headed, or swelling of your face, lips, tongue, or throat.

This is not a complete list of side effects, and others may occur. You can call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use Takhzyro if allergic to the active ingredient lanadelumab.

This medicine is not approved for use by anyone younger than 2 years old.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Takhzyro.

Pregnancy 

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Breastfeeding 

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

How should I use Takhzyro?

Use this injection exactly as it was prescribed for you. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Takhzyro is injected under the skin every 2 to 4 weeks according to your doctors instructions. A healthcare provider may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Do not use this injection if you don't understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.

If you are using a single-dose vial (bottle), prepare your injection only when you are ready to give it within the next 2 hours.

Store in the refrigerator, do not freeze.

Do not shake.

Take the medicine out of the refrigerator and let it reach room temperature for 15 minutes before injecting your dose.

Each single-use vial (bottle) and prefilled syringe of this medicine is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using this injection.

Takhzyro dosing information

Usual Takhzyro dose for adult and pediatric patients 12 years and older for hereditary angioedema:

Initial dose: 300 mg subcutaneously once every 2 weeks.

Maintenance dose: a 4-week dosing interval may be considered if the patient is well-controlled (e.g., attack free) for more than 6 months.

Usual Takhzyro dose for pediatric patients 6 years to less than 12 years old for hereditary angioedema

Initial dose: 150 mg subcutaneously once every 2 weeks. 

Maintenance dose: a 4-week dosing interval may be considered if the patient is well-controlled (e.g., attack free) for more than 6 months.

Usual Takhzyro dose for pediatric patients 2 years to less than 6 years old dose for hereditary angioedema:

Dose: 150 mg administered subcutaneously every 4 weeks.

Self-injection is not recommended in children 2 years to less than 12 years.

Takhzyro is available as:

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Takhzyro?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect Takhzyro?

Other drugs may interact with lanadelumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Takhzyro Package Insert 

Review the Takhzyro Package Insert for more detailed information about this medicine. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

Ingredients

Active Ingredient: lanadelumab-flyo

Inactive Ingredients: citric acid monohydrate, histidine, sodium chloride, polysorbate 80 and sodium phosphate, dibasic, dihytrate.

Storage

Manufacturer

Takeda Pharmaceuticals U.S.A., Inc. Lexington, MA 02421.

Popular FAQ

Takhzyro's mechanism of action involves blocking the activity of plasma kallikrein, a protein in the body that can lead to hereditary angioedema (HAE) attacks. Inhibiting kallikrein helps to slow down the release of bradykinin, an inflammatory peptide, and reduce the number of attacks. HAE is a rare genetic condition that causes swelling in areas such as the stomach, limbs, face and throat.

Monoclonal antibodies (mAbs) are man-made proteins that mimic the natural antibodies produced by our immune systems. Monoclonal antibodies can be formulated into medicines to treat various types of illnesses, such as cancer, rheumatoid arthritis or psoriasis. Continue reading

Takhzyro (lanadelumab-flyo) is available in a prefilled, one-dose, ready-to-use syringe that takes less than one minute to administer yourself. It is easy to learn how to self-administer it, but initially, it is helpful if your nurse or healthcare provider shows you how to use it. If you are not comfortable injecting it yourself, then a caregiver can be trained to give it to you. Continue reading

Takhzyro (lanadelumab-flyo) is used to treat hereditary angioedema (HAE) in patients 2 years of age and older. Takhzyro works by blocking the activity of kallikrein, a protein in the body that can lead to HAE attacks. Blocking kallikrein helps to slow down the release of bradykinin (an inflammatory peptide) and reduce the number of HAE attacks. Continue reading

Takhzyro (lanadelumab-flyo) is a human plasma kallikrein inhibitor and blocks the protein called kallikrein. Kallikrein regulates bradykinin production, a chemical that leads to inflammation (swelling). Takhzyro is a monoclonal antibody approved in the U.S. to prevent hereditary angioedema (HAE) in patients 2 years and older. Continue reading

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.