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.

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.


  • 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
Home About Rhophylac ChromaPlus™

Important Safety Information

This warning does not apply to Rh (D)-negative patients treated for the suppression of Rh isoimmunization.
Intravascular hemolysis leading to death has been reported in Rh (D)-positive patients treated for immune thrombocytopenic purpura (ITP) with Rh (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); acute renal insufficiency, renal failure, and disseminated intravascular coagulation (DIC). Monitor patients for signs and symptoms of intravascular hemolysis in a healthcare setting for at least 8 hours after administration. See full prescribing information for complete boxed warning.

Rhophylac®, Rho(D), Immune Globulin Intravenous (Human), is indicated for suppression of rhesus (Rh) isoimmunization in:

  • Pregnancy and obstetric conditions in non-sensitized, Rh (D)-negative women with an Rh-incompatible pregnancy, including routine antepartum and postpartum Rh prophylaxis and Rh prophylaxis in cases of obstetric complications or invasive procedures.
  • Incompatible transfusions in Rh (D)-negative individuals transfused with blood components containing Rh (D)-positive red blood cells.

For suppression of Rh isoimmunization, Rhophylac can be administered IM or IV. Consider IV administration if reaching the muscle is of concern.

Rhophylac is indicated to raise platelet counts in Rh (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, and in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity to Rhophylac or any of its components. Do not administer Rhophylac to the newborn infant of a mother who received Rhophylac postpartum.

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: The most common adverse reactions in the suppression of Rh isoimmunization with Rhophylac (≥0.5% of patients) are nausea, dizziness, headache, injection-site pain, and malaise.

Immune Thrombocytopenic Purpura: The most serious adverse reactions in patients receiving Rh (D) immune globulin have been observed in the treatment of ITP. ITP patients being treated with Rhophylac should be alerted to and monitored for signs and symptoms of intravascular hemolysis, including back pain, shaking chills, fever, and hematuria. 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 (>14% of patients) are chills, pyrexia/increased body temperature, headache, and hemolysis. In patients with preexisting anemia, Rhophylac may increase the severity of 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 or call 1-800-FDA-1088.

Rhophylac is manufactured by CSL Behring AG and distributed by CSL Behring LLC.
Rhophylac® is a registered trademark of CSL Behring AG.
Other trademarks mentioned are the property of their respective owners.
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