RhoGAM > Professional > About RhoGAM Brand

 

About RhoGAM® Brand

Trusted for more than a generation …

Proven Record of Safety and Quality

  • Typically produced from plasma obtained from small pools of carefully selected, healthy donors.

  • Every plasma pool is screened using the sensitive polymerase chain reaction technique to reduce the risk of viral contamination.

  • Viresolve™ 180 ultrafiltration process is effective in removing both enveloped (HIV, hepatitis B, hepatitis C) and nonenveloped (hepatitis A, Parvovirus B-19) viruses.

  • Viral Inactivation process which utilizes solvent/detergent treatment effective at inactivating lipid enveloped viruses

  • Produced according to strict standards of U.S. Food and Drug Administration (FDA).

  • More than 39 years of reliability – with no confirmed cases of virus transmission.

The Right Application for Every Indication

Administer RhoGAM® Ultra-Filtered PLUS

  • At 28 weeks’ gestation 2-5

  • Within 72 hours postpartum 6,7

  • Following spontaneous or induced termination 8

  • Following any event that could lead to transplacental hemorrhage (such as amniocentesis, cvs, pubs, abdominal trauma) 9

  • RhoGAM® should be administered in 12 week intervals

Available in two dosage strengths for the right treatment

  • 300 µg, a single dose, contains sufficient human anti-D immunoglobulin to suppress the immune response to 15 mL (or less) of Rh(D)-positive red blood cells for antenatal and postpartum use, second- and third-trimester pregnancy terminations, or transplacental hemorrhage 6,9,10

  • 50 µg, a single dose, contains sufficient human anti-D immunoglobulin to suppress the immune response to 2.5 mL (or less) of Rh(D)-positive red blood cells for use immediately after first-trimester pregnancy termination 8,10

Systemic reactions associated with administration of RhoGAM® Ultra-Filtered PLUS are extremely rare.10

The Ultimate in Convenience for Easier Patient Care

  • Simple to use – no need to reconstitute; supplied in single-dose, prefilled, latex- and thimerosal-free, disposable syringes with safety shields

  • Easy to explain – educational materials available to help you teach your patients about sensitization and the benefits of RhoGAM® Ultra-Filtered PLUS

There is Only ONE RhoGAM®

  • More than a generation of proven safety and efficacy

  • The only Rh immune globulin product with Viresolve™ ultrafiltration, proven to remove both enveloped and nonenveloped viruses

  • All prefilled syringes are supplied, thimerosal-free, with safety shields and a latex-free delivery system

References:

  1. RhoGAM® Ultra-Filtered Product Monograph, 2003. Ortho-Clinical Diagnostics, Inc., Raritan, NJ.

  2. Bowman JM, Chown B, Lewis M, Pollock JM. Rh isoimmunization during pregnancy: antenatal prophylaxis. Can Med Assoc J. 1978; 118:627

  3. Bowman JM, Chown B, Lewis M, Pollock JM. Antenatal prophylaxis of Rh isoimmunization: 28-weeks’ gestation service program. Can Med Assoc J. 1978;118:627

  4. Baskett TF, Parsons ML. Prevention of Rh(D) alloimmunization: a cost-benefit analysis. Can Med Assoc J. 1990;14;337-339

  5. Bowman JM. Antenatal suppression of Rh alloimmunization. Clin Obst Cyn. 1991;34:296-303.

  6. RhoGAM® Ultra-Filtered Package Insert.

  7. Freda VJ, Gorman JG, Pollack W, Bowe E. Prevention of Rh hemolytic disease – ten years’ clinical experience with Rh immune globulin. N. Engl. J Med. 1975;292:1014-1016.

  8. Frigolette FD Jr., ed. Antepartum Administration of Rh immune globulin: a guide to office procedure. Raritan, NJ: Ortho-Diagnostic Systems, Inc. 1983.

  9. RhoGAM®® Ultra-Filtered Marketing Authorization Application: Part IB1. Summary of Product Characteristics. Ortho-Clinical Diagnostics. November 2000.

  10. Pollack W., Ascari WQ, Kochesky RJ, O’Connor RR, Ho TY, Tripodi D. Studies on Rh prophylaxis. I. Relationship between doses of anti-Rh and size of antigenic stimulus. Transfusion. 1971;11:333-339.

Complete Prescribing Information for RhoGAM® Ultra-Filtered PLUS