Takhzyro

Generic name: Lanadelumab-flyo
Drug class: Hereditary angioedema agents

Usage of Takhzyro

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).

Takhzyro side effects

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.

    Before taking Takhzyro

    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.

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    How to use Takhzyro

    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.

    • 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.

    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.

    Disclaimer

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