22/09/2023
Important Safety Information
HAEGARDA®, C1 Esterase Inhibitor Subcutaneous (Human), is an injectable medicine used to prevent swelling and/or painful attacks in patients 6 years of age and older with Hereditary Angioedema (HAE).
A healthcare professional can teach you (or caregiver) to self-administer HAEGARDA for prophylaxis. Do not use HAEGARDA to treat an acute HAE attack once it starts; work with your physician to plan for attacks if they occur.
Do not use HAEGARDA if you have previously experienced life-threatening immediate hypersensitivity reactions, such as shock, to HAEGARDA or other C1-INH products.
Immediately report any symptoms of allergic reactions to HAEGARDA, including hives, chest tightness, wheezing, difficulty breathing, turning blue, faintness, facial swelling and fast heartbeat.
Before starting HAEGARDA, tell your healthcare provider about all medical conditions you have-including pregnancy or nursing; a history of heart disease or stroke; an indwelling catheter/access device in a vein; or immobilization for a sustained period. Also tell your physician about any other medications you are taking, as some medications, such as birth control pills and certain androgens, can increase risk of clotting problems. High doses of C1-INH have been known to increase the risk of blood clots.
Immediately report to your physician or an emergency room if you have any of the following symptoms of a blood clot: pain or swelling of arm or leg, with warmth or discoloration over the affected area; unexplained shortness of breath; chest pain or discomfort that worsens on deep breathing; rapid pulse; and numbness or weakness on one side of the body.
In clinical studies, the most common side effects reported with HAEGARDA were injection-site reactions (pain, redness, swelling); hypersensitivity (itching and rash), dizziness, and nasal symptoms, including stuffy or runny nose and sneezing. These are not the only side effects possible with HAEGARDA. Tell your healthcare provider about any side effect that bothers you or does not go away.
Because HAEGARDA is made from human blood, the risk that it may transmit infectious agents, including viruses and theoretically, the agents of Creutzfeldt-Jakob Disease (CJD) and its variant form (VCJD), cannot be completely eliminated.
Please see full prescribing information (https://bit.ly/HGD-PI) for HAEGARDA, including the patient product information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://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.
