Experience
Rhophylac® Experience
Now approved for use in adult patients with chronic ITP, Rhophylac® has been used for more than 11 years in the worldwide market to prevent Hemolytic Disease of the Newborn (HDN)—a condition that can affect a newborn from an Rh-incompatible pregnancy—and to treat Rh-negative individuals in the event of an incompatible blood transfusion.
To date, more than 2 million doses of Rhophylac® have been administered worldwide. Learn more about Rhophylac® for HDN.
CSL Behring: A Legacy of Innovation
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View an interactive timeline of CSL Behring's history. |
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CSL Behring and our parent company, CSL Limited, continue to build on an extensive legacy of innovation in patient care. CSL Behring traces our beginnings to the 1904 founding of Behringwerke, a company established by the first winner of the Nobel Prize in Medicine, Emil von Behring. In 1916, CSL Limited was founded to supply vaccines to the people of Australia. During the 20th century and into the 21st, leading companies came together, ultimately forming CSL Behring.
For more than 100 years, CSL Behring has specialized in plasma therapies to improve the quality of life of patients with bleeding disorders, immune deficiencies, inherited emphysema, and other conditions.
Our products are produced in accordance with international safety and quality standards at facilities in Bern, Switzerland; Marburg, Germany; and Kankakee, Illinois. CSL Behring also operates ZLB Plasma, one of the world’s largest plasma collection networks throughout the United States and Germany. The company employs more than 7,000 people in 18 countries.
We are passionate about safety, quality, and the customers we serve. Our extensive research and development and range of support services demonstrate our ongoing commitment to all who count on our products.
CSL Behring—Providing biotherapies for life for more than a century.
IMPORTANT SAFETY INFORMATION
Rhophylac® is indicated for suppression of rhesus (Rh) isoimmunization in:
- Pregnancy and obstetric conditions in non-sensitized, Rho(D)-negative women with an Rh-incompatible pregnancy, including routine antepartum and postpartum Rh prophylaxis and Rh prophylaxis in cases of obstetric complications, invasive procedures during pregnancy, or obstetric manipulative procedures.
- Incompatible transfusions in Rho(D)-negative individuals transfused with blood components containing Rho(D)-positive red blood cells.
For suppression of Rh isommunization, Rhophylac® can be administered IM or IV.
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.
Suppression of Rh Isoimmunization: For postpartum use following an Rh-incompatible pregnancy, Rhophylac® should not be given to the newborn infant.
The most common adverse reactions in the suppression of Rh isoimmunization with Rhophylac® are nausea, dizziness, headache, injection-site pain, and malaise.
Immune Thrombocytopenic Purpura: 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.
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full prescribing information.