IMPORTANT SAFETY INFORMATION

Do not use RUCONEST if you have experienced life-threatening immediate hypersensitivity reactions, including anaphylaxis, to RUCONEST or to any other C1 esterase inhibitor (C1-INH) product. Call your healthcare professional or the emergency department right away if you experience: wheezing, difficulty breathing, chest tightness, turning blue (look at lips and gums), fast heartbeat, swelling, faintness, rash or hives. A serious side effect of life-threatening hypersensitivity (anaphylaxis) was reported in a clinical study.

Do not use RUCONEST if you have a known or suspected allergy to rabbits or rabbit-derived products. Tell your healthcare provider about all your medical conditions, including if you have a known allergy to rabbits. Before starting RUCONEST, tell your healthcare provider about any other medications you are taking, as some medications, such as birth control pills and certain androgens, can increase risk of clotting problems. Blood clots have occurred in patients receiving plasma-derived C1-INH product. Also tell your healthcare provider if you are pregnant, breastfeeding, or planning to do so.

The most common side effects patients experienced during clinical studies include headache, nausea and diarrhea. These are not all the possible side effects of RUCONEST. Tell your healthcare provider about any side effect that bothers you or does not go away. You can also report negative side effects to Pharming Medical Affairs at (800) 930-5221, or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

If symptoms persist, a second dose of RUCONEST may be taken at your recommended dose. Do not take more than two doses within 24 hours.

For more information, please see the full Prescribing Information including the Patient Product Information.