What is the most important information I should know about lanadelumab?
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.
What is lanadelumab?
Lanadelumab 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).
Lanadelumab is used to prevent attacks of hereditary angioedema (HAE) in people who are at least 12 years old.
Lanadelumab may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before using lanadelumab?
You should not use lanadelumab if you are allergic to it.
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.
Lanadelumab is not approved for use by anyone younger than 12 years old.
How should I use lanadelumab?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Lanadelumab 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 lanadelumab 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 lanadelumab.
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 lanadelumab?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What are the possible side effects of lanadelumab?
Get emergency medical help if you have signs of an allergic reaction: hives; fast heartbeats, difficult breathing, feeling light-headed; swelling of your face, lips, tongue, or throat.
Common side effects may include:
- 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 lanadelumab?
Other drugs may affect 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.
Where can I get more information?
Your pharmacist can provide more information about lanadelumab.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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