Lanadelumab

Generic name: Lanadelumab [ LAN-a-DEL-ue-mab ]
Brand name: Takhzyro
Dosage forms: Subcutaneous injection. Single-dose prefilled syringe (150 mg/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 lanadelumab?

Lanadelumab (Takhzyro) is used to prevent hereditary angioedema (HAE), lanadelumab helps to reduce the number and severity of hereditary angioedema attacks. Lanadelumab works by lowering the activity of a protein called kallikrein which helps to prevent the swelling and related symptoms of HAE. Lanadelumab 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. 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.

Lanadelumab 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).

Lanadelumab is a plasma kallikrein inhibitor (monoclonal antibody).

Before taking this medicine

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.

How should I use lanadelumab?

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.

Lanadelumab dosing information

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.

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.

Lanadelumab side effects

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.

Related/similar drugs

What other drugs will affect lanadelumab?

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.

Lanadelumab Package Insert

Review the Takhzyro Package Insert for more detailed information about lanadelumab. 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

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

Manufacturer

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

Lanadelumab 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 lanadelumab.

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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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