Generic name: lanadelumab-flyo (LAN a DEL ue mab)
Brand name: Takhzyro
Drug class: Hereditary angioedema agents
Takhzyro (lanadelumab-flyo) 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 12 years old.
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 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 breast-feed while using this medicine. Ask your doctor about any risk.
Takhzyro is not approved for use by anyone younger than 12 years old.
How should I use Takhzyro?
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.
Prepare your injection only when you are ready to give it within the next 2 hours.
Store in the refrigerator, do not freeze.
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) 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.
Dosing information
Usual Adult Dose for Hereditary Angioedema:
Initial dose: 300 mg subcutaneously once every 2 weeks; a 4-week dosing interval may be considered if the patient is well-controlled (e.g., attack free) for more than 6 months.
Use: To prevent attacks of hereditary angioedema (HAE).
Usual Pediatric Dose for Hereditary Angioedema:
12 Years or Older:
Initial dose: 300 mg subcutaneously once every 2 weeks; a 4-week dosing interval may be considered if the patient is well-controlled (e.g., attack free) for more than 6 months.
Use: To prevent attacks of hereditary angioedema (HAE).
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 Takhzyro?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
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.
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.