SOLIRIS (eculizumab): The first treatment specifically approved for PNH

For US Healthcare Professionals

Presentation of PNH

PNH presentation is highly variable, and definitive diagnosis can be delayed for as long as 3 to 10 years1

The most common signs and symptoms of PNH are2-7

Presentation of PNH

Although hemolysis is chronic in PNH,8 hemoglobinuria — often considered a classic feature — is a presenting symptom in only 26% of cases.2

PNH should be in your differential when patients present with these signs and symptoms.

Next: Screening for PNH

IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS MENINGOCOCCAL INFECTION

SOLIRIS® increases the risk of meningococcal infections.

Vaccinate patients with a meningococcal vaccine at least 2 weeks prior to receiving the first dose of SOLIRIS; revaccinate according to current medication guidelines for vaccine use.

Monitor patients for early signs of meningococcal infections, evaluate immediately if infection is suspected, and treat with antibiotics if necessary.

The effect of withdrawal of anticoagulant therapy during SOLIRIS treatment has not been established. Therefore, treatment with SOLIRIS should not alter anticoagulant management.

SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING INCLUDING WARNINGS, PRECAUTIONS, AND ADVERSE REACTIONS.

The most frequent adverse events observed in clinical studies were headache, nasopharyngitis, back pain, nausea, fatigue, and cough.

Please see important safety information (including boxed warning) as well as the complete prescribing information.

References:
1. Hillmen P, Lewis SM, Bessler M, Luzzatto L, Dacie JV. Natural history of paroxysmal nocturnal hemoglobinuria. N Engl J Med. 1995;333:1253-1258.
2. Parker C, Omine M, Richards S, et al. Diagnosis and management of paroxysmal nocturnal hemoglobinuria. Blood. 2005;106:3699-3709.
3. Luzzatto L, Gianfaldoni G. Recent advances in biological and clinical aspects of paroxysmal nocturnal hemoglobinuria. Int J Hematol. 2006;84:104-112.
4. Besa EC. Paroxysmal nocturnal hemoglobinuria. eMedicine. August 2006;1-11. Available at: http://www.emedicine.com/med/topic2696.htm Accessed: 5/17/2007.
5. Rother RP, Bell L, Hillmen P, Gladwin MT. The clinical sequelae of intravascular hemolysis and extracellular plasma hemoglobin. JAMA. 2005;293:1653-1662.
6. Hillmen P, Young NS, Schubert J, et al. The complement inhibitor eculizumab in paroxysmal nocturnal hemoglobinuria. N Engl J Med. 2006;355:1233-1243.
7. Rosse WF, Hillmen P, Schrieber AD. Immune-mediated hemolytic anemia. Hematology. (Am Soc Hematol Educ Program) January 2004:48-62.
8. Hill A, Hillmen SJ, Elebute D, et al. Sustained response and long-term safety of eculizumab in paroxysmal nocturnal hemoglobinuria. Blood. 2005;106:2559-2565.