Medically reviewed on August 24, 2018
Generic Name: lanadelumab-flyo
Dosage Form: Injection
Date of Approval: August 23, 2018
Company: Shire plc
Treatment for: Hereditary Angioedema
FDA Approves Takhzyro
The U.S. Food and Drug Administration (FDA) has approved Takhzyro (lanadelumab-flyo) injection, plasma kallikrein inhibitor (monoclonal antibody) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years of age and older.
Read this Patient Information before you start treatment 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 12 years of age and older. It is not known if this medicine is safe and effective in children under 12 years of age.
Before using Takhzyro
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 during treatment.
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 leaflet that comes with your prescription about the right way to prepare and inject Takhzyro.
- Use this medicine 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 efore you inject yourself for the first time.
- Do not try to inject a dose unless you have been trained by your healthcare provider.
Takhzyro side effects
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:
- difficulty breathing
- chest tightness
- fast heartbeat
The most common side effects include:
- injection site reactions (pain, redness, and bruising)
- upper respiratory infections
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. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to the 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 this medicine for a condition for which it is not prescribed. Do not give it 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 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.