Indication for RUCONEST
RUCONEST® is a C1 esterase inhibitor (recombinant) indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE). Effectiveness in clinical studies was not established in HAE patients with laryngeal attacks.
Important Safety Information about RUCONEST
RUCONEST® (C1 esterase inhibitor [recombinant]) is not for everyone. Do not take RUCONEST if you have a known history of allergy to rabbits or products from rabbits. Do not take RUCONEST if you have a history of life-threatening immediate allergic reactions to C1 esterase inhibitor preparations, including anaphylaxis.
If you experience hives, pale red, raised, itchy bumps (urticaria), tightness of the chest, wheezing, low blood pressure (hypotension), and/or anaphylaxis during or after injection of RUCONEST, discontinue RUCONEST and immediately contact your doctor. These may be signs and symptoms of allergic reactions.
Products similar to RUCONEST have been associated with thromboembolic events. Before taking RUCONEST, please notify your doctor if you have an indwelling venous catheter/access device, history of blood clot (thrombosis), been told you have thickening of the walls of your arteries (atherosclerosis), use oral contraceptives (i.e. estrogen or progesterone), are extremely overweight and have significant difficulty moving around.
If you are pregnant, planning to become pregnant, or nursing, talk to your healthcare provider before taking RUCONEST.
The most common RUCONEST side effects in clinical studies include: headache, nausea, and diarrhea. Serious side effect anaphylaxis has been reported in RUCONEST clinical studies.
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.
For product information, adverse event reports, and product complaint reports, please contact:
Salix Product Information Call Center
Please see complete Prescribing Information for RUCONEST.
RUCONEST is a registered trademark of Pharming Group NV.
Manufactured by Pharming Group NV, Darwinweg 24, NL-2333 CR Leiden, The Netherlands.
Distributed and marketed by Santarus, Inc. a wholly owned subsidiary of Salix Pharmaceuticals, Inc.
The information contained on this page is intended for US residents, healthcare providers, and pharmacists only.
Ruconest is a registered trademark of Pharming Intellectual Property B.V. used under license.