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 4, 2025.

What is Takhzyro?

Takhzyro (lanadelumab-flyo) is a monoclonal antibody used to prevent hereditary angioedema (HAE) attacks in patients aged 2 years and older.  It is a long-acting subcutaneous injection used to help reduce the frequency and severity of HAE attacks.

Takhzyro works (mechanism of action) by inhibiting plasma kallikrein, an enzyme that contributes to bradykinin overproduction, which causes swelling episodes in HAE patients. Reducing Kallikrein levels helps decrease the number of HAE attacks. Takhzyro belongs to the drug class plasma kallikrein inhibitors.

Takhzyro is administered as a subcutaneous injection.

Takhzyro clinical trials and FDA approval

Takhzyro is FDA-approved for preventing hereditary angioedema (HAE) attacks in adults and pediatric patients aged 2 years and older.

In Phase III HELP (Hereditary Angioedema Long-term Prophylaxis) Study (NCT02741596) Takhzyro patients had:

• 87% reduction in of mean HAE attack rate (reduction vs baseline) 
• Nearly 70% of patients experienced an attack‐free period of ≥12 months

The Phase III HELP OLE study followed 212 Takhzyro patients over a mean of 29.6 months.

Takhzyro side effects

Common Side Effects

Common Takhzyro side effects may include: 

• Headache (33%), 
• Rash (4%)
• Dizziness (4%)
• Diarrhea (4%)
• Muscle pain (11%)
• cold symptoms such as stuffy nose, sneezing, sore throat (44%)
• Injection site reaction including rash; or pain, redness, or bruising (56%).

These common side effects occurred in Trial 1 when Takhzyro 300mg was given every 2 weeks.

Serious Side Effects

Get emergency medical help if you have signs of an allergic reaction to this medicine, such as 

• Hives
• Rapid heart rate
• Difficulty breathing
• Lightheadedness
• Swelling of the 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

Related/similar drugs

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 injection 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 injection.

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 Takhhzyro 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.

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:

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:

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:

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:

• 150 mg/1 mL in a single-dose prefilled syringe  
• 300 mg/2 mL in a single-dose prefilled syringe 
• 300 mg/2 mL solution in a single-dose vial

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 this medicine?

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

What other drugs will affect this medicine?

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 

HCPs and patients often use the Takhzyro Package Insert (PI) for more detailed information about this medicine. The Package Insert (prescribing information) contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your HCP (health care professional). 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.

The Package Insert is sometimes called Takhzyro Prescribing Information (PI) or FDA label.

Ingredients

Active Ingredient: lanadelumab-flyo

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

Storage

• Store the prefilled syringes and vials refrigerated at 36°F to 46°F (2°C to 8°C).
• Do not freeze.
• Keep the prefilled syringe and vial in the original carton to protect from light.’

Takhzyro Manufacturer

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

Takhzyro Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Takhzyro.

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Further information

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

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