IMPORTANT SAFETY INFORMATION
RUCONEST® (C1 esterase inhibitor [recombinant]) is contraindicated in:
- Patients with a history of allergy to rabbits or rabbit-derived products.
- Patients with a history of life-threatening immediate hypersensitivity reactions to C1 esterase inhibitor preparations, including anaphylaxis.
- Hypersensitivity: Severe hypersensitivity reactions may occur. Should symptoms occur, discontinue RUCONEST and administer appropriate treatment. Because hypersensitivity reactions may have symptoms similar to HAE attacks, treatment methods should be carefully considered.
- Thromboembolic Events: Serious arterial and venous thromboembolic (TE) events have been reported at the recommended dose of plasma-derived C1 esterase inhibitor products in patients with risk factors. 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 RUCONEST administration.
- Intravenous Use: RUCONEST is for intravenous use after reconstitution only. No more than 2 doses should be administered within a 24-hour period.
- Pregnancy and Nursing: RUCONEST has not been studied in pregnant women; therefore, it should only be used during pregnancy if clearly needed. Advise patients to notify their physician if they are breastfeeding or plan to breastfeed.
- Adverse reactions: The serious adverse reaction in clinical studies of RUCONEST was anaphylaxis.
- Common adverse reactions: The most common adverse reactions (incidence ≥2%) were headache, nausea, and diarrhea.
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