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Rhophylac Experience Rhophylac® Experience

Before being approved for use in adult patients with chronic ITP, Rhophylac® had 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

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®, Rho(D), Immune Globulin Intravenous (Human), 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 isoimmunization, Rhophylac can be administered IM or IV.

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

WARNING: INTRAVASCULAR HEMOLYSIS IN ITP
This warning does not apply to Rh0(D)-negative patients treated for the suppression of Rh isoimmunization.
Intravascular hemolysis leading to death has been reported in Rho(D)-positive patients treated for immune thrombocytopenic purpura (ITP) with Rho(D) Immune Globulin Intravenous (Human) products. Intravascular hemolysis can lead to clinically compromising anemia and multi-system organ failure, including acute respiratory distress syndrome (ARDS). Serious complications, including severe anemia, acute renal insufficiency, renal failure, and disseminated intravascular coagulation (DIC), have also been reported. Closely monitor patients treated for ITP with Rhophylac in a healthcare setting for at least 8 hours after administration. See full prescribing information for complete boxed warning.

Rhophylac is contraindicated in individuals with known anaphylactic or severe systemic reaction to human immune globulin products. Rhophylac is contraindicated in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity.

Allergic or hypersensitivity reactions may occur with Rhophylac; early signs of hypersensitivity include generalized urticaria, chest tightness, wheezing, hypotension, and anaphylaxis.

Rhophylac is derived from human plasma. 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 Rho(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.

Immunoglobulin administration may transiently interfere with the immune response to live virus vaccines, such as measles, mumps and rubella

Please see full prescribing information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.