About RhoGAM® Brand
RhoGAM® Brand was the first, and is still the leading prescribed Rho(D) Immune Globulin Brand for the prevention of Rh hemolytic disease of the fetus and newborn (HDFN).1 Prior to the introduction of RhoGAM® Brand in 1968, HDFN was a major cause of infant mortality, responsible for an average of 10,000 deaths annually in the United States.2 Since the introduction of Rh immune globulin products, like RhoGAM® Brand, the incidence of HDFN has been virtually eliminated in most developed countries. RhoGAM® Brand is manufactured by Ortho-Clinical Diagnostics for Kedrion Biopharma.
RhoGAM® BRAND OFFERS ALL OF THESE BENEFITS:
- Over 40-year history of safety and reliability
- No documented cases of viral transmission
- No interruptions in product supply
- Somerset Labs- single plasma collection site located in Buffalo, NY with approximately 400 dedicated, carefully-screened plasma donors
- Robust viral inactivation (including West Nile virus) and removal processes (including hepatitis A) to minimize risk of viral transmission
- Dosing guidelines that align with ACOG and AABB standards
- A product free human serum albumin
Heritage of Leadership
A BREAKTHROUGH FOR Rh-NEGATIVE MOTHERS, A FUTURE FOR Rh-POSITIVE INFANTS
"One of the greatest accomplishments in obstetrics and gynecology in the past 50 years.” Charles Lockwood, MD, American College of Obstetricians and Gynecologists (ACOG)
Prior to the development of RhoGAM® Brand, about 10,000 infants died each year in the U.S. from HDFN, and many more suffered from crippling birth defects.2 But all that changed with the very first dose of RhoGAM® Brand—the original Rho(D) immune globulin—from Ortho-Clinical Diagnostics and Johnson & Johnson (now manufactured for Kedrion Biopharma). If administered properly, Rh-negative women may be protected from the ravages of Rh disease.
Since the introduction of RhoGAM® Brand, other anti-D products have entered the market. But it's important to remember that all Rho(D) immune globulin products are not the same, and there is only one RhoGAM® Brand.
TRUSTED BY DOCTORS AND MOTHERS FOR OVER 40 YEARS
Only RhoGAM® Brand has been consistently available for doctors and mothers across four decades with millions of doses administered. Since RhoGAM® Brand was introduced, there has never been an interruption in product supply or any documented cases of viral transmission.1 During the mid 1990s, when other manufacturers had supply issues, RhoGAM® Brand was the sole Rh immune globulin product available in the United States.
THERE IS STILL ONLY ONE RhoGAM® BRAND
Safe, effective, reliable, protective—there is only one RhoGAM® Brand. If you’re writing a prescription for RhoGAM® Brand, be sure to indicate dispense as written and then follow up with the blood bank lab, hospital pharmacy or retail pharmacy to make sure your patient is actually getting RhoGAM® Brand and not another anti-D product.
For your convenience, we’ve created a customizable letter to make it easy for you to ask the question: IS SHE REALLY GETTING RhoGAM® BRAND?
- Data on file, Ortho-Clinical Diagnostics, Inc.
- Zimmerman DA.Rh: The Intimate History of a Disease and its Conquest. New York, NJ: MacMilan Publishing Company. May 1973
Important Safety Information
RhoGAM® Brand is indicated for the prevention of Rh immunization, including during and after pregnancy and other obstetrical conditions or incompatible transfusion of Rh-positive blood.
RhoGAM® and MICRhoGAM® Ultra-Filtered PLUS Rho(D) Immune Globulin (Human) are made from human plasma. Since all plasma-derived products are made from human blood, they may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically the Creutzfeldt-Jakob disease (CJD) agent.
RhoGAM® and MICRhoGAM® are intended for maternal administration. Do not inject the newborn infant. Local adverse reactions may include redness, swelling, and mild pain at the site of injection and a small number of patients have noted a slight elevation in temperature. Patients should be observed for at least 20 minutes after administration. Hypersensitivity reactions include hives, generalized urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.
RhoGAM® and MICRhoGAM® contain a small quantity of IgA and physicians must weigh the benefit against the potential risks of hypersensitivity reactions. Patients who receive RhoGAM® and MICRhoGAM® for Rh-incompatible transfusion should be monitored by clinical and laboratory means due to the risk of a hemolytic reaction.