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ChromaPlus™ Manufacturing Process

ChromaPlus™ is a patented, FDA-approved process used to manufacture Rhophylac®. This highly sophisticated process ensures the highest quality, safety, and purity.

View a video showing the ChromaPlus™ process in detail.

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: Isolates RhIgG and removes 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 clear aggregates of immunoglobulins. Those aggregates could cause problems for patients if administered intravenously, which is why most anti-Ds are for IM use only. Because of the ChromaPlus™ manufacturing process, Rhophylac® is aggregate-free, meaning it can be safely administered via IM or IV route.

Another key difference between ChromaPlus™ and Cohn fractionation—the process used to produce other anti-D products—is that chromatography maximizes donor plasma utilization by increasing the RhIgG yield.

ChromaPlus™:

  • Results in high purity, allowing Rhophylac® to be administered IV or IM
  • Produces excellent yields, maximizing donor plasma utilization
  • Removes protein aggregates that can cause anaphylactic reactions in susceptible individuals

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 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.

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. 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.

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.