Rhophylac for ITP
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About ITP

• About 200,000 people in the US currently have ITP

• ITP affects all age groups

• Women are three times more likely than men to have ITP

• Every year, roughly 30,000 new cases will occur in the United States: about half of those will be adults.

For more information about ITP, see FAQ's

ITP (immune thrombocytopenic purpura or idiopathic thrombocytopenic purpura) is an autoimmune disease in which the immune system attacks blood platelets in the spleen. Because platelets are essential for blood clotting, having a low platelet count can lead to a range of complications, including:

  • Red or purple marks on the skin (purpura)
  • Easy bruising
  • Bleeding gums
  • Fatigue
  • Depression
  • Heavier than normal menstruation
  • Cerebral hemorrhage (in rare cases)

ITP can be difficult to diagnose because other diseases can lower the platelet count. A hematologist or oncologist can help to make the correct diagnosis, which may involve bone-marrow testing.

ITP can be acute (lasting more than 6 months) or chronic. ITP in children does not usually become chronic (i.e., lasting more than 6 months). ITP in adults tends to become chronic and often requires treatment.

For more information about ITP, see FAQ's .

 

IMPORTANT SAFETY INFORMATION

Rhophylac® is indicated to raise platelet counts in Rh0(D)-positive, non-splenectomized adult patients with chronic immune thrombocytopenic purpura (ITP). For the treatment of ITP, Rhophylac® must be administered IV.

Rhophylac® is contraindicated in individuals with known anaphylactic or severe systemic reaction to human immune globulin products.

Allergic or hypersensitivity reactions may occur with Rhophylac®; early signs of hypersensitivity include generalized urticaria, chest tightness, wheezing, hypotension, and anaphylaxis. Individuals with selective IgA deficiency can develop antibodies to IgA and may develop severe hypersensitivity and anaphylactic reactions. For these individuals, weigh the expected benefits of treatment against the potential risks.

Rhophylac® is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

The most serious adverse reactions in patients receiving Rh0(D) immune globulin have been observed in the treatment of ITP. ITP patients being treated with Rhophylac® should be monitored for signs and symptoms of intravascular hemolysis, including back pain, shaking chills, fever, and hemoglobinuria. Potentially serious complications of intravascular hemolysis include clinically compromising anemia, acute renal insufficiency, and, very rarely, disseminated intravascular coagulation, and death.

The most common adverse reactions observed in the treatment of ITP are chills, pyrexia/increased body temperature, and headache. Mild extravascular hemolysis has also been observed. In patients with preexisting anemia, weigh the benefits of Rhophylac® against the potential risk of increasing the severity of the anemia.

Please see full prescribing information.

 

© 2008 CSL Behring
The product information presented on this site is intended for US residents only.