Pronunciation:

lan-a-DEL-ue-mab - flyo

Brand Names:

• Takhzyro

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Immune Modulator

Pharmacologic—

Lanadelumab

Uses of This Medicine:

Lanadelumab-flyo injection is used to prevent hereditary angioedema (HAE) attacks. HAE is a rare disease that causes swelling of the face, hands, feet, throat, stomach, bowels, or genitals.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of lanadelumab-flyo injection in children younger than 2 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lanadelumab-flyo injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine:

This medicine is given as a shot under your skin in the stomach, thigh, or upper arm. It may sometimes be given at home to patients who do not need to be in the hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use this medicine.

If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself or your child a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems. Do not inject into skin areas that are bruised, infected, irritated, red, tender, swollen, or painful.

This medicine comes with a patient information leaflet and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions about:

• How to prepare the injection.
• The proper use of disposable syringes.
• How to give the injection.
• How long the injection can be stored at home.

Allow the medicine to warm to room temperature for 15 minutes before using it. Do not warm it by using a heat source (eg, hot water or microwave) or in any other way. Do not shake.

Check the liquid in the vial. It should be colorless or slightly yellow. Do not use this medicine if it is cloudy, discolored, or if it has particles in it. Do not use the prefilled syringe if it has been damaged or cracked.

Use a new needle and syringe each time you inject your medicine.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (solution):
  • For hereditary angioedema:
    • Adults and children 12 years of age and older—At first, 300 milligrams (mg) injected under the skin every 2 weeks. 300 mg every 4 weeks may also be given if the patient is well controlled (attack free) for more than 6 months.
    • Children 6 to less than 12 years of age—At first, 150 mg injected under the skin every 4 weeks. 150 mg every 4 weeks may also be given if the patient is well controlled (attack free) for more than 6 months.
    • Children 2 to less than 6 years of age—150 mg injected under the skin every 4 weeks.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.

Missed dose—

Call your doctor or pharmacist for instructions.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Keep it in its original container. Protect from light. Do not use it if it has been frozen or thawed.

Use this medicine within 2 hours after preparing it at room temperature. You may also refrigerate the prepared dosing syringe and use it within 8 hours.

Throw away used syringes in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure that the medicine is working properly and to check for unwanted effects.

Make sure to use this medicine regularly. HAE attacks are life-threatening and require immediate medical attention. Carefully follow all of your doctor's instructions.

This medicine may cause serious allergic reactions, which can be life-threatening and require immediate medical attention. Call your doctor or nurse right away if you or your child have a rash, itching, hives, hoarseness, chest tightness, lightheadedness, dizziness or fainting, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Rash

Less common

Chest tightness

fast heartbeat

fever

hives, itching

hoarseness

irritation

joint pain, stiffness, or swelling

redness of the skin

swelling of the eyelids, face, lips, hands, or feet

trouble breathing or swallowing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

body aches or pain

chills

cough

difficulty in moving

dizziness

ear congestion

headache

loss of voice

muscle ache, cramps, pain, or stiffness

sneezing

stuff or runny nose

sore throat

unusual tiredness or weakness

Less common

Diarrhea

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.