What is PNH?

PNH is an acquired mutation that causes some or all of your body’s red blood cells (RBCs) to be destroyed by a process called hemolysis.1-3 PNH is a complex disease with signs and symptoms that are nonspecific, unpredictable, and often similar to those of other diseases. In addition, PNH presents uniquely in each person. If you have PNH, some or all of your RBCs may be missing an important protective protein. Without this protein, RBCs are prone to destruction by a part of your body’s defense system called complement.1-3

Even though you can’t feel it, hemolysis is constant, silent, and can be life threatening.4 Like other chronic diseases, such as diabetes or hypertension, PNH can result in serious health problems if not treated. Common symptoms associated with PNH include stomach pain, difficulty swallowing, anemia, shortness of breath, and tiredness (fatigue). More serious complications can include blood clots, kidney failure, and damage to vital organs. People with PNH may have different symptoms that can unpredictably get worse (such as during times of stress) or better from time to time. However, all people with PNH experience chronic hemolysis.

People with PNH may have other medical conditions that affect the function of their bone marrow such as aplastic anemia (AA) or myelodysplastic syndromes (MDS). Unlike PNH, which destroys RBCs, these diseases may reduce the production of blood cells and further complicate PNH.5 If you have PNH in combination with AA or MDS, talk to your doctor — it’s important to effectively treat all the conditions you may have.

If you have PNH and are considering pregnancy, there are risks involved to both mother and child that should be discussed with your physician — and your partner. If you do choose to become pregnant, you will likely be referred to a high-risk pregnancy specialist and monitored closely for the duration of the pregnancy. But don’t worry, PNH cannot be inherited from parents, nor can it be passed on to children.

How PNH got its name

When PNH was first named, not much was known about it. The name literally means episodic hemoglobin (a component of blood) in the urine, which occurs at night. But actually, less than one-third of people with PNH experience hemoglobin in their urine at diagnosis.6 In fact, PNH is a complex disease that affects many parts of the body and hemolysis (the destruction of red blood cells) does not only happen at night — it happens all the time.

PNH is a rare disease

PNH affects approximately 8,000 to 10,000 people in North America and Western Europe.7 It can affect men and women of all races and ages but most commonly affects people between the ages of 20 to 40 years old.

Although PNH is rare, the medical community understands a lot about the way the disease works — and there are doctors who are experienced in treating it.





IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

Soliris increases the risk of meningococcal infections. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early

  • Vaccinate patients with a meningococcal vaccine at least 2 weeks prior to receiving the first dose of Soliris; revaccinate according to current medical 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 anticoagulant withdrawal during Soliris treatment has not been studied. Therefore, treatment with Soliris should not alter anticoagulant management.

Soliris is generally well tolerated. The most frequent adverse events observed in clinical studies were headache, a runny nose (nasopharyngitis), back pain, nausea, and tiredness (fatigue).

Please see full prescribing information for SOLIRIS, including boxed WARNING regarding serious meningitis.


References: 1. Socié G, Mary J-Y, de Gramont A, et al, for the French Society of Haematology. Paroxysmal nocturnal haemoglobinuria: long-term follow-up and prognostic factors. Lancet. 1996;348:573-577. 2. Hillmen P, Lewis SM, Bessler M, Luzzatto L, Dacie JV. Natural history of paroxysmal nocturnal hemoglobinuria. N Engl J Med. 1995;333:1253-1258. 3. Nishimura J-I, Kanakura Y, Ware RE, et al. Clinical course and flow cytometric analysis of paroxysmal nocturnal hemoglobinuria in the United States and Japan. Medicine. 2004;83:193-207. 4. Hillmen P, Young NS, Schubert J, et al. The complement inhibitor eculizumab in paroxysmal nocturnal hemoglobinuria. N Engl J Med. 2006;355:1233-1243. 5. Parker C, Omine M, Richards S, et al, for the International PNH Interest Group. Diagnosis and management of paroxysmal nocturnal hemoglobinuria. Blood. 2005;106:3699-3709. 6. Dacie JV, Lewis SM. Paroxysmal nocturnal haemoglobinuria: clinical manifestations, haematology, and nature of the disease. Ser Haematol. 1972;5:3-23. 7. Richards SJ, Cullen MJ, Dickinson AJ, et al. The effect of eculizumab therapy on red cell response kinetics in patients with paroxysmal nocturnal hemoglobinuria [ASH abstract]. Blood. 2005;106: Abstract 1047.