Lanadelumab-flyo injection is used to prevent swelling and painful attacks of hereditary angioedema (HAE; an inherited condition that causes episodes of swelling in the hands, feet, face, airway, or intestines) in adults and children 2 years of age or older. Lanadelumab-flyo is in a class of medications called monoclonal antibodies. It works by blocking the action of a certain natural substance in the body that causes swelling and pain associated with HAE.

Lanadelumab-flyo comes as a solution (liquid) to be injected subcutaneously (under the skin). Initially, when lanadelumab-flyo injection is used in adults and children 6 years of age or older, it is usually given once every 2 weeks. After 6 months, it may be given every 4 weeks depending on how you respond to the medication. When lanadelumab-flyo injection is used in children 2 to 6 years of age, it is usually given once every 4 weeks. Your doctor will decide how often you are to use lanadelumab-flyo based on your body's response to this medication. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use lanadelumab-flyo exactly as directed. Do not use more or less of it or take it more often than prescribed by your doctor.

Your doctor may decide that you or your caregiver can perform the injections at home. Your doctor will show you or the person who will be injecting the medication how to inject it. You or the person who will be injecting the medication should also read the written instructions for use that come with the medication. Be sure to ask your doctor or pharmacist if you have any questions about how to inject the medication.

Lanadelumab-flyo injection comes in single-use prefilled syringes and vials. Allow the syringe and vial to warm to room temperature for 15 minutes away from direct sunlight before you inject the medication. Do not try to warm the medication by heating it in a microwave, placing it in hot water, or through any other method. Use each syringe, needle, or vial only once and inject all the solution in the syringe or vial. Dispose of used syringes, needles, and vials in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

Always look at lanadelumab-flyo solution before injecting it. Check that the expiration date has not passed and that the liquid is clear to almost clear and colorless to slightly yellow and does not contain visible particles. Do not use lanadelumab-flyo injection if it is expired or if the liquid is cloudy or contains particles. Do not shake it.

You can inject lanadelumab-flyo anywhere on the front of your thighs (upper leg) or abdomen (stomach) except your navel and the area 2 inches (5 centimeters) around it. If a caregiver injects the medication, the back of the upper arm may also be used. To reduce the chances of soreness or redness, use a different site for each injection. Do not inject into an area where the skin is tender, bruised, red, or hard or where you have scars or stretch marks. Give each injection at least 1 inch (2.5 centimeters) away from a spot that you have already used and at least 2 inches (5 centimeters) away from any scars.

Lanadelumab-flyo injection may help control your condition, but does not cure it. Continue to use lanadelumab-flyo injection even if you feel well. Do not stop using lanadelumab-flyo injection without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Before using lanadelumab-flyo injection,

• tell your doctor and pharmacist if you are allergic to lanadelumab-flyo, any other medications, or any of the ingredients in lanadelumab-flyo injection. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you have or have ever had any other medical conditions.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding.

Call your doctor to ask what to do if you miss a dose of lanadelumab-flyo injection.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep this medication in the carton it came in, tightly closed, and out of reach of children. Store it in a refrigerator and protect from light. Do not freeze it. Medication from single-use vials that has been prepared in a syringe may be stored at room temperature and used within 2 hours or in a refrigerator and used within 8 hours. Dispose of any medication that is outdated or no longer needed.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Lanadelumab-flyo may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• injection site pain, bruising, or redness
• headache
• muscle pain
• dizziness
• diarrhea
• cough, runny nose, sore throat, or other cold symptoms

Some side effects can be serious. If you experience any of these symptoms call your doctor immediately:

• rash; itching; hives; swelling of your face, mouth, tongue, or throat; chest pain; fast heartbeat; fainting; or difficulty swallowing or breathing

Lanadelumab-flyo may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Keep all appointments with your doctor and the laboratory.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are using lanadelumab-flyo injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Takhzyro®