ANDEMBRY transforms HAE management by targeting the pathway at the top
CSL Behring is pleased to announce FDA approval of ANDEMBRY, a once-monthly factor Xlla inhibitor prescription medication used to prevent attacks of hereditary angioedema (HAE) in people 12 years and older.
ANDEMBRY® (garadacimab-gxii) injection, for subcutaneous use, is a prescription medication used to prevent attacks of hereditary angioedema (HAE) in people 12 years and older.
It is not known if ANDEMBRY is safe and effective in children under 12 years of age.
What should I tell my healthcare provider before using ANDEMBRY?
Before using ANDEMBRY, tell your healthcare provider about any medical condition you may have, especially if you are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. It is not known if ANDEMBRY can harm your unborn baby or if ANDEMBRY passes into breastmilk. Talk to your healthcare provider about the best way to
feed your baby while using ANDEMBRY.
Tell your healthcare provider about all medications you take, including prescription medicines, over-the-counter treatments, vitamins, and herbal supplements.
How should I use ANDEMBRY?
Use ANDEMBRY exactly as instructed by your healthcare provider. Detailed instructions for use can be found in the patient information section of the full prescribing information.
ANDEMBRY 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 ANDEMBRY before you inject yourself for the first time. Do not try to inject ANDEMBRY unless you have been trained by your healthcare provider.
What are the possible side effects of ANDEMBRY?
The most common side effects of ANDEMBRY include:
Redness, itchiness, and bruising (injection-site reactions)
Stomach (abdominal) pain
Runny or stuffy nose, sneezing, watery eyes (nasopharyngitis)
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
You can also report side effects to CSL Behring's Pharmacovigilance Department at 1-866-915-6958.
Important Safety Information
ANDEMBRY® (garadacimab-gxii) injection, for subcutaneous use, is a prescription medication used to prevent attacks of hereditary angioedema (HAE) in people 12 years and older.
It is not known if ANDEMBRY is safe and effective in children under 12 years of age.
Before using ANDEMBRY, tell your healthcare provider about any medical condition you may have, especially if you are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. It is not known if ANDEMBRY can harm your unborn baby or if ANDEMBRY passes into breastmilk. Talk to your healthcare provider about the best way to
feed your baby while using ANDEMBRY.
Tell your healthcare provider about all medications you take, including prescription medicines, over-the-counter treatments, vitamins, and herbal supplements.
Use ANDEMBRY exactly as instructed by your healthcare provider. Detailed instructions for use can be found in the patient information section of the full prescribing information.
ANDEMBRY 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 ANDEMBRY before you inject yourself for the first time. Do not try to inject ANDEMBRY unless you have been trained by your healthcare provider.
The most common side effects of ANDEMBRY include:
Redness, itchiness, and bruising (injection-site reactions)
Stomach (abdominal) pain
Runny or stuffy nose, sneezing, watery eyes (nasopharyngitis)