Takhzyro is a monoclonal antibody that works by reducing the activity of an enzyme that is uncontrolled in people with hereditary angioedema (a rare genetic immune system disorder). Takhzyro is used to prevent attacks of hereditary angioedema (HAE) in people who are at least 2 years old.

People with hereditary angioedema have high levels of a substance called bradykinin, Takhzyro (lanadelumab-flyo) works by reducing  the level of bradykinin, which helps to prevent the swelling and related symptoms of angioedema.

Takhzyro injection is FDA-approved for patients who are 2 years of age and older to prevent attacks of hereditary angioedema. FDA approval was supported by data from HELP Study, the  HELP OLE Study and the Phase 3 SPRING Study (NCT SHP643-301).

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.

Use Takhzyro 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. 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 Takhzyro 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 Takhzyro.

• 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.

• 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.

• Dose: 150 mg administered subcutaneously every 4 weeks.
• Self-injection is not recommended in children 2 years to less than 12 years.

You should not use Takhzyro if you are allergic to lanadelumab.

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

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

Takhzyro 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.

Call your doctor for instructions if you miss a dose.

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

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

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

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.

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

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.