ChromaPlus Manufacturing Process

ChromaPlus is a patented, FDA-approved process used to manufacture Rhophylac®. This highly sophisticated process ensures a product with high quality, safety, and purity. The risk of transmission of infectious agents cannot be completely eliminated.

View a video showing the ChromaPlus™ process in detail.

Individuals with selective IgA deficiency can develop antibodies to IgA and may develop severe hypersensitivity and anaphylactic reactions.

How ChromaPlus Works

The ChromaPlus process involves carefully calibrated phases that work cohesively to inactivate and remove enveloped and non-enveloped viruses. ChromaPlus has three complementary phases:

  1. Solvent/detergent (S/D) treatment: Inactivates enveloped viruses (HBV, HCV, HIV)
  2. Ion exchange chromatography: Fractionates RhIgG while removing contaminants and unwanted components, providing the purity that allows for IM and IV administration.
  3. Nanofiltration: Removes enveloped and non-enveloped viruses (HAV, parvovirus B19) through 15 nm filterpores

Most anti-D products are manufactured by a form of Cohn cold ethanol fractionation method developed in the 1950s, which may not completely remove aggregates from immunoglobulin preparations. Aggregates have the potential to be problematic for patients if administered intravenously, which is why most anti-Ds are only administered intramuscularly. Because of the ChromaPlus manufacturing process, Rhophylac® is aggregate-free, providing the convenience and safety for IM or IV administration.

ChromaPlus:

  • Allows for a highly pure product, allowing Rhophylac to be administered IV or IM
  • Produces excellent IgG yields, maximizing donor plasma utilization
  • Removes contaminants, such as protein aggregates

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 for Rhophylac.

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.