RUCONEST® (C1 esterase inhibitor [recombinant]) is 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
RUCONEST is contraindicated in patients with a history of allergy to rabbits or rabbit-derived products and for patients with a history of life-threatening immediate hypersensitivity reactions, including anaphylaxis, to C1 esterase inhibitor (C1-INH) preparations.
Monitor patients for early signs of allergic or hypersensitivity reactions (including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and/or anaphylaxis). If symptoms occur, discontinue RUCONEST and administer appropriate treatment.
Serious arterial and venous thromboembolic (TE) events have been reported with plasma-derived C1-INH products. Risk factors may include the presence of an indwelling venous catheter/access device, prior history of thrombosis, underlying atherosclerosis, use of oral contraceptives or certain androgens, morbid obesity, and immobility. Monitor patients with known risk factors for TE events during and after
Appropriately trained patients may self-administer RUCONEST upon recognition of an HAE attack. Advise patients to seek medical attention if progress of any attack makes them unable to properly prepare or administer a dose of RUCONEST. No more than 2 doses should be administered within a 24-hour period.
The serious adverse reaction reported in clinical trials was anaphylaxis. The most common adverse reactions (incidence ≥2%) were headache, nausea, and diarrhea.
Some insurance companies are instituting new policies called accumulator adjustment programs and/or maximizer programs. These can affect your participation in the RUCONEST Patient Savings Program.
Accumulator Adjustment Programs are when your insurance plan does not apply the RUCONEST Patient Savings Program to satisfy your co-payment, deductible, or co-insurance for RUCONEST.
Co-pay Maximizer Programs are when your insurance company requires you to enroll in the RUCONEST Patient Savings Program as a condition of your plan or to waive other costs associated with the insurance plan.
If your plan has these limitations, you may not be eligible for the RUCONEST Patient Savings Program, but you may be eligible for other needs-based assistance programs. Please contact RUCONEST SOLUTIONS for additional information.
If you have any questions, our team of experts is available to provide assistance. Our priority is your well-being. Please call RUCONEST SOLUTIONS for more information at 1-855-613-4HAE (4423).