Lanadelumab (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). Lanadelumab is used to prevent attacks of hereditary angioedema (HAE) in patients who are 2 years of age and older.

People with hereditary angioedema have high levels of a substance called bradykinin, lanadelumab works by reducing the level of bradykinin, which helps to prevent the swelling and related symptoms of angioedema. Hereditary angioedema is an immune system condition that causes rapid swelling under the skin in areas such as the face, throat, arms, and legs. An attack of hereditary angioedema can be life-threatening if the swelling around the throat presses against the airway.

Lanadelumab-flyo (Brand name: 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).

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

Your healthcare provider should show you or your caregiver, how to prepare and inject your dose of lanadelumab before you inject yourself for the first time. Do not try to inject this medicine unless you have been trained by your healthcare provider.

• Take the medicine out of the refrigerator and let it reach room temperature for 15 minutes before injecting your dose.
• Do not shake.
• If using the Single-Dose Vial (bottle) prepare your injection only when you are ready to give it within the next 2 hours.
• Lanadelumab is given as an injection under your skin (subcutaneous) by healthcare provider, a caregiver or yourself.
• For detailed instructions with diagrams on how to use the prefilled syringe or single-dose glass vial, click here Instructions for Use
• Each Single-Dose Vial 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.

Usual 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 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 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.

You should not use lanadelumab if you are allergic to it or any of the inactive ingredients. For a full list of ingredients in Takhzyro see the Ingredients section at the bottom of this page.

Lanadelumab 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 lanadelumab.

Pregnancy

• If you are pregnant or planning to become pregnant. It is not known if lanadelumab can harm your unborn baby.
• Tell your doctor if you are pregnant or plan to become pregnant.

Breastfeeding

• If you are breastfeeding or plan to breastfeed. It is not known if lanadelumab passes into your breastmilk. 
• Talk to your healthcare provider about the best way to feed your baby while using this  medicine.

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.

The most common lanadelumab side effects are:

• injection site reactions (pain, redness, and bruising)
• upper respiratory infections
• headache
• rash
• dizziness
• diarrhea
• muscle aches.

Lanadelumab may cause serious side effects, including allergic reactions. Allergic reactions may happen with lanadelumab. Call your healthcare provider or get emergency help right away if you have any of the following symptoms of allergic reactions:

• wheezing
• difficulty breathing
• chest tightness
• fast heartbeat
• faintness
• rash
• hives

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 affect 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.