"The U.S. Food and Drug Administration today approved Tretten, Coagulation Factor XIII A-Subunit (Recombinant), the first recombinant product for use in the routine prevention of bleeding in adults and children who have a rare clotting disorder, k"...
Rhophylac® (immune globulin intravenous human solution)
(Rh0(D) Immune Globulin Intravenous (Human))
For Intravenous or Intramuscular Injection Preservative-free, Latex-free, Ready-to-use Prefilled Syringe
Rhophylac® (immune globulin intravenous human solution) is a sterile Rh0(D) Immune Globulin Intravenous (Human) solution in a ready-to-use prefilled syringe for intravenous or intramuscular injection. One syringe contains at least 1500 IU (300 mcg) of IgG antibodies to Rh0(D) in a 2 mL solution, sufficient to suppress the immune response to at least 15 mL of Rh-positive RBCs.1 The product potency is expressed in IUs by comparison to the World Health Organization (WHO) standard, which is also the US and the European Pharmacopoeia standard.
Plasma is obtained from healthy Rh0(D)-negative donors who have been immunized with Rh0(D)-positive RBCs. The donors are screened carefully to reduce the risk of receiving donations containing blood-borne pathogens. Each plasma donation used in the manufacture of Rhophylac® (immune globulin intravenous human solution) is tested for the presence of HBV surface antigen (HBsAg), HIV-1/2, and HCV antibodies. In addition, plasma used in the manufacture of Rhophylac® (immune globulin intravenous human solution) is tested by FDA-licensed Nucleic Acid Testing (NAT) for HIV and HCV and found to be negative. An investigational NAT for HBV is also performed on all source plasma used and found to be negative; however, the significance of a negative result has not been established. The source plasma is also tested by NAT for hepatitis A virus (HAV) and B19 virus (B19V).
Rhophylac® (immune globulin intravenous human solution) is produced by an ion-exchange chromatography isolation procedure7, using pooled plasma obtained by plasmapheresis of immunized Rh0(D)-negative US donors. The manufacturing process includes a solvent/detergent treatment step (using tri-n-butyl phosphate and Triton™ X-100) that is effective in inactivating enveloped viruses such as HIV, HCV, and HBV.8,9 Rhophylac® (immune globulin intravenous human solution) is filtered using a Planova® 15 nanometer (nm) virus filter that has been validated to be effective in removing both enveloped and non-enveloped viruses. Table 3 presents viral clearance and inactivation data from validation studies, expressed as the mean log10 reduction factor.
Table 3: Virus Inactivation and Removal in Rhophylac® (immune globulin intravenous human solution)
|Virus||HIV 1||PRV 1||BVDV 1||MVM|
|Size||80-100 nm||120-200 nm||40-70 nm||18-24 nm|
|Solvent/detergent treatment||≥ 6.0||≥ 5.6||≥ 5.4||Not tested|
|Chromatographic process steps||4.5||≥ 3.9||1.6||≥ 2.6|
|Virus filtration||≥ 6.3||≥ 5.6||≥ 5.5||3.4|
|Overall reduction (log10 units)||≥ 16.8||≥ 15.1||≥ 12.5||≥ 6.0|
|HIV, a model for HIV-1 and HIV-2; PRV, pseudorabies virus, a model for large, enveloped DNA viruses (e.g., herpes virus); BVDV, bovine viral diarrhea virus, a model for HCV; MVM, minute virus of mice, a model for B19V and other small, non-enveloped DNA viruses.|
Rhophylac® (immune globulin intravenous human solution) contains a maximum of 30 mg/mL of human plasma proteins, 10 mg/mL of which is human albumin added as a stabilizer. Prior to the addition of the stabilizer, Rhophylac® (immune globulin intravenous human solution) has a purity greater than 95% IgG. Rhophylac® (immune globulin intravenous human solution) contains less than 5 mcg/mL of IgA, which is the limit of detection. Additional excipients are approximately 20 mg/mL of glycine and up to 0.25 M of sodium chloride. Rhophylac® (immune globulin intravenous human solution) contains no preservative. Human albumin is manufactured from pooled plasma of US donors by cold ethanol fractionation, followed by pasteurization.
What are the possible side effects of RHo (D) immune globulin?
Get emergency medical help if you have any of these signs of an allergic reaction: rash or hives; feeling light-headed, chest tightness, difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- fever, chills, shaking, back pain, dark colored urine;
- rapid breathing, feeling short of breath.
- urinating less than usual or not at all, swelling, rapid weight gain; or
- pale skin, easy bruising or bleeding, rapid heart rate, trouble concentrating, feeling...
Last reviewed on RxList: 5/18/2007
This monograph has been modified to include the generic and brand name in many instances.
Additional Rhophylac Information
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