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Safety & Tolerability
Rhophylac Safety and Tolerability Assurance of Safety

The Rhophylac® Assurance of Safety is characterized by a staunch focus on viral safety during two fundamental steps: plasma collection and manufacturing.

The safety process begins with careful screening of donors and testing of donor plasma, while our patented 3-step ChromaPlus™ manufacturing process includes virus removal and inactivation steps to further safeguard against virus transmission.

Rhophylac® contains no thimerosal (mercury) and is latex free.
Plasma Collection

Plasma donations are taken from RhO(D)-negative healthy donors who have been immunized with RhO(D)-positive red blood cells. Donors are carefully screened to minimize the risk of donations containing blood-borne pathogens.

Further, each plasma donation to be used for the manufacture of Rhophylac® is first tested for the presence of HAV, HBV, HCV, HIV, and parvovirus B19 antibodies, as well as elevated alanine aminotransferase (ALT) activity.

All plasma is collected at US-based FDA-certified centers.

ChromaPlus™ Manufacturing

Following careful donor screening and donation testing, the ChromaPlus™ process further reduces the risk of disease transmission. Three complementary processes, including two viral inactivation steps, enhance product safety:

  1. Patented ion-exchange chromatography separates unwanted proteins from anti-D immunoglobulin
  2. Solvent detergent treatment rapidly inactivates enveloped viruses (HBV, HCV, HIV)
  3. Nanofiltration (15 nm) eliminates both enveloped and non-enveloped viruses
Vital Inactivation and Removal
Virus
HIV
BVDV
PRV
MVM
GenomeRNARNADNADNA
EnvelopeYesYesYesNo
Size 80-100 nm40-70nm120-200nm18-24nm
S/D Treatment ≥ 6.0≥5.4≥ 5.6 Not Tested
Chromatographic Process Steps 4.51.6≥ 3.9 ≥ 2.6
Nanofiltration≥ 6.3 ≥ 5.5≥ 5.6 3.4
Overall reduction (log units) ≥ 16.8 ≥ 12.5 ≥ 15.1 ≥ 6.0

HIV: Model for HIV 1 and HIV 2
BVDV: Bovine viral diarrhea virus, as a model for HCV
PRV: Pseudorabies virus, as a model for large, enveloped DNA viruses (eg. herpes virus)
MVM: Minute virus of mice, as a model for parvovirus B19 and other small, non-enveloped DVA viruses.

Tolerability

The most commonly reported adverse events with Rhophylac® administration were chills (35%), fever (31%), and headache (11%). Mild extravascular hemolysis was observed, as expected when any anti-D is given to an Rh-positive patient.

Premedication was not given at the time of treatment, except in one patient.

Adverse events were mild to moderate in intensity with the exception of one case of severe headache; of the 10 patients reporting serious adverse events, only 4 were considered to be drug-related and all patients recovered completely.

No deaths, renal failure, or DIC were reported in the clinical trial.

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.