Safety & 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 Rh
O(D)-negative healthy donors who have been immunized with Rh
O(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
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Learn more about the ChromaPlus™ process. |
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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:
- Patented ion-exchange chromatography separates unwanted proteins from anti-D immunoglobulin
- Solvent detergent treatment rapidly inactivates enveloped viruses (HBV, HCV, HIV)
- Nanofiltration (15 nm) eliminates both enveloped and non-enveloped viruses
Vital Inactivation and Removal
Virus | HIV | BVDV | PRV | MVM |
|---|
| Genome | RNA | RNA | DNA | DNA |
| Envelope | Yes | Yes | Yes | No |
| Size | 80-100 nm | 40-70nm | 120-200nm | 18-24nm |
| S/D Treatment | ≥ 6.0 | ≥5.4 | ≥ 5.6 | Not Tested |
| Chromatographic Process Steps | 4.5 | 1.6 | ≥ 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® is indicated to raise platelet counts in Rh0(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. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.
The most serious adverse reactions in patients receiving Rh0(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.