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Full Prescribing Info

TAKHZYRO (lanadelumab-flyo) is a prescription medicine used to prevent attacks of hereditary angioedema (HAE) in people 2 years of age and older. It is not known if TAKHZYRO is safe and effective in children under 2 years of age.

How TAKHZYRO works

How does targeting kallikrein stop the reaction that leads to HAE attacks?

As you may know, people with hereditary angioedema (HAE) don’t have enough C1-inhibitor protein, or the C1-inhibitor protein doesn’t work properly. This causes another protein, plasma kallikrein, to become overactive. This increase in kallikrein activity results in too much bradykinin, the substance that causes HAE attacks. TAKHZYRO decreases kallikrein activity.

What should I know about TAKHZYRO and side effects?

The safety of TAKHZYRO was assessed in one of the longest prevention studies in HAE. See common side effects experienced by people in the study and ask your doctor any questions you have.

LEARN ABOUT possible side effects

What is TAKHZYRO?

TAKHZYRO (lanadelumab-flyo) is a prescription medicine used to prevent attacks of hereditary angioedema (HAE) in people 2 years of age and older.

It is not known if TAKHZYRO is safe and effective in children under 2 years of age.

IMPORTANT SAFETY INFORMATION

TAKHZYRO may cause serious side effects, including allergic reactions. Call your healthcare provider or get emergency help right away if you have any of the following symptoms:

wheezing
difficulty breathing
chest tightness
fast heartbeat
faintness
rash
hives

The most common side effects seen with TAKHZYRO were injection site reactions (pain, redness, and bruising), upper respiratory infection, headache, rash, dizziness, diarrhea, and muscle aches.

These are not all the possible side effects of TAKHZYRO. For more information, ask your healthcare provider or pharmacist. You may report side effects to FDA at 1-800-FDA-1088.

TAKHZYRO has not been studied in pregnant or breastfeeding women. Talk to your healthcare provider about the risk of taking TAKHZYRO if you are pregnant, plan to be pregnant, are breastfeeding, or plan to breastfeed.

Please see full Prescribing Information, including information for patients.

What is TAKHZYRO?

TAKHZYRO (lanadelumab-flyo) is a prescription medicine used to prevent attacks of hereditary angioedema (HAE) in people 2 years of age and older.

It is not known if TAKHZYRO is safe and effective in children under 2 years of age.

IMPORTANT SAFETY INFORMATION

TAKHZYRO may cause serious side effects, including allergic reactions. Call your healthcare provider or get emergency help right away if you have any of the following symptoms:

wheezing
difficulty breathing
chest tightness
fast heartbeat
faintness
rash
hives

The most common side effects seen with TAKHZYRO were injection site reactions (pain, redness, and bruising), upper respiratory infection, headache, rash, dizziness, diarrhea, and muscle aches.

These are not all the possible side effects of TAKHZYRO. For more information, ask your healthcare provider or pharmacist. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information, including information for patients.

PATIENT INFORMATION

TAKHZYRO^® (tak-ZYE-roe) (lanadelumab-flyo) injection, for subcutaneous use

Read this Patient Information before you start using TAKHZYRO and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is TAKHZYRO?

TAKHZYRO is a prescription medicine used to prevent attacks of Hereditary Angioedema (HAE) in people 2 years of age and older. It is not known if TAKHZYRO is safe and effective in children under 2 years of age.

Before you use TAKHZYRO, tell your healthcare provider about all of your medical conditions, including if you:

are pregnant or planning to become pregnant. It is not known if TAKHZYRO can harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if TAKHZYRO passes into your breastmilk. Talk to your healthcare provider about the best way to feed your baby while using TAKHZYRO.

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, or herbal supplements.

How should I use TAKHZYRO?

See the detailed Instructions for Use that comes with this patient information leaflet about the right way to prepare and inject TAKHZYRO.
Use TAKHZYRO exactly as your healthcare provider tells you to use it.
TAKHZYRO is given as an injection under your skin (subcutaneous) by you or a caregiver.
Your healthcare provider should show you or your caregiver how to prepare and inject your dose of TAKHZYRO before you inject yourself for the first time.
Do not try to inject TAKHZYRO unless you have been trained by your healthcare provider.
Self-injection is not recommended in children (2 to less than 12 years).

What are the possible side effects of TAKHZYRO?

TAKHZYRO may cause serious side effects, including allergic reactions. Allergic reactions may happen with TAKHZYRO. Call your healthcare provider or get emergency help right away if you have any of the following symptoms:

wheezing
difficulty breathing
chest tightness
fast heartbeat

faintness
rash
hives

The most common side effects of TAKHZYRO are:

injection site reactions (pain, redness, and bruising)
upper respiratory infections
headache

rash
dizziness
diarrhea
muscle aches

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of TAKHZYRO. For more information, ask your healthcare provider or pharmacist.

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

General information about the safe and effective use of TAKHZYRO.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use TAKHZYRO for a condition for which it is not prescribed. Do not give TAKHZYRO to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about TAKHZYRO that is written for health professionals.

What are the ingredients in TAKHZYRO?

Active ingredient: lanadelumab

Inactive ingredients: citric acid monohydrate, L-histidine, sodium chloride, sodium phosphate dibasic dihydrate and water for injection.

Please see full Prescribing Information and Important Safety Information. US-LANA-1881v1.0 05/23