HAEGARDA®

HAEGARDA® is a plasma-derived concentrate of C1 Esterase Inhibitor (Human) (C1-INH) indicated for routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in patients 6 years of age and older.

HAEGARDA® is contraindicated in individuals who have experienced life-threatening hypersensitivity reactions, including anaphylaxis, to C1-INH preparations or its excipients

HAEGARDA® is intended for self (or caregiver)-administration after reconstitution at a dose of 60 International Units (IU) per kg body weight by subcutaneous (S.C.) injection twice weekly (every 3 or 4 days). The patient or caregiver should be trained on how to administer HAEGARDA. HAEGARDA is provided as a freeze-dried powder for reconstitution with Sterile Water for Injection, USP.

For subcutaneous injection only.

• Train the patient or caregiver on how to self-administer HAEGARDA.
• Do not mix HAEGARDA with other medicinal products.
• Visually inspect the final solution for particles and discoloration prior to administration, and whenever solution and container permit. Do not use if particles or discoloration is observed.
• Attach the syringe containing the reconstituted HAEGARDA solution to a hypodermic needle or subcutaneous infusion set and administer by subcutaneous injection. Adapt the rate of administration to the comfort level of the patient.
• Inject in the abdominal area or other subcutaneous injection sites. Rotate injection sites so that the same site is not used repeatedly.
• Administer HAEGARDA at room temperature and within 8 hours after reconstitution. Following administration, discard any unused solution and all administration equipment in an appropriate manner as per local requirements.