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Landmark Rh Immune Globulin Celebrates 40 Years of Saving Babies' Lives

RhoGAM(R) Brand Hailed as One of the Top Achievements in 50 Years of Women's Health

RARITAN, N.J., Feb. 9 /PRNewswire/ -- RhoGAM(R) Brand, the original Rh immune globulin product, celebrates its 40th year in the marketplace helping Rh-negative women in the prevention of Hemolytic Disease of the Newborn (HDN). In 1968, a new mother at Holy Name Hospital in Teaneck, N.J., helped make history as the initial recipient of the world's first injectable treatment to prevent the disease -- an event that marked the launch of one of the most significant medical breakthroughs of the 20th century. Prior to the introduction of RhoGAM(R) Brand, nearly 10,000 babies died each year in the U.S. alone from HDN.(1)

"Today, this condition has been substantially reduced due to the safe and effective use of Rh immune globulin products, saving hundreds of thousands of newborns from crippling birth defects and possible death," said Ronald T. Burkman, MD, attending physician at Wesson Women's Group, Baystate Medical Center and Professor of Obstetrics and Gynecology, Tufts University School of Medicine.

About HDN

HDN can develop when the Rh-negative blood of a pregnant woman comes in contact with the Rh-positive blood of her fetus. These Rh-negative women become sensitized and make antibodies that attack the blood of the Rh-positive fetus.(2) This reaction usually does not affect the first pregnancy, but once the mother has produced Rh antibodies, all future pregnancies are at risk.

"It is still important for women, as part of their prenatal care, to have a blood test and find out their blood type," continued Dr. Burkman.

About RhoGAM(R) Brand

Rh immune globulin products prevent the body from making antibodies that would destroy Rh-positive cells in future pregnancies and cause HDN to develop. RhoGAM(R) Brand has maintained a 40-year record of proven safety, efficacy and uninterrupted product supply, due in part to its unique donor program. Plasma for RhoGAM(R) Brand is sourced from a small collection site near Buffalo, N.Y. made up of approximately 300 participants. One third of the donors have been contributing to the program for more than 10 years, and some have personal reasons for doing so.

"My primary reason is simple -- I want to spare other Rh-negative expecting mothers from what I went through before RhoGAM(R) Brand was introduced," said Elizabeth Pascoe, a plasma donor for 30 years who has helped save potentially 115,000 babies' lives. "Sometimes I worry that people forget how dreadful this disease can be. I am truly grateful that my children and future generations have a way to protect against Hemolytic Disease of the Newborn."

The development of RhoGAM(R) Brand was the result of years of collaborative work by researchers at Columbia University in New York and the Ortho Research Foundation (now Ortho Clinical Diagnostics) in Raritan, N.J. When it was launched, RhoGAM(R) Brand was heralded as an obstetrical milestone. Charles Lockwood, MD, former chair of the American College of Obstetricians and Gynecologists' (ACOG) Committee on Obstetric Practice, has hailed RhoGAM(R) Brand as "one of the top achievements in 50 years of women's health."

Important Safety Information

RhoGAM(R) and MICRhoGAM(R) 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(R) and MICRhoGAM(R) 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(R) and MICRhoGAM(R) contain a small quantity of IgA and physicians must weigh the benefit against the potential risks of hypersensitivity reactions. Patients who receive RhoGAM(R) and MICRhoGAM(R) for Rh-incompatible transfusion should be monitored by clinical and laboratory means due to the risk of a hemolytic reaction.

For more detailed information regarding the safe and effective use of RhoGAM(R) Brand, please visit

About Ortho Clinical Diagnostics

Ortho-Clinical Diagnostics, Inc., a Johnson & Johnson company, delivers the high-quality in-vitro diagnostic products that give healthcare professionals around the world the knowledge they need to make better treatment decisions sooner. The company serves the global transfusion medicine community with donor screening and blood typing products to ensure every patient receives blood that's safe, the right type, and the right unit. Ortho Clinical Diagnostics also brings sophisticated information management, testing technologies, and automation and interpretation tools to clinical laboratories worldwide to help them run more efficiently and improve patient care. For more information, visit

(1) Zimmerman D.R. Rh: The Intimate History of a Disease and its Conquest. New York, NY: MacMillan Publishing Company, May 1973.


Rho(D) Immune Globulin (Human)

RhoGAM(R) Ultra-Filtered PLUS (300 micro grams) (1500 IU)

MICRhoGAM(R) Ultra-Filtered PLUS (50 micro grams) (250 IU)

Rx Only

For Intramuscular Injection Only

Prefilled syringes, preservative-free (thimerosal free), latex-free delivery system


Pregnancy and other obstetrical conditions

For administration to Rh-negative women not previously sensitized to the Rho(D) factor, unless the father or baby are conclusively Rh-negative.

  • Delivery of an Rh-positive baby irrespective of the ABO groups of the mother and baby
  • Antepartum prophylaxis at 26 to 28 weeks gestation
  • Antepartum fetal-maternal hemorrhage (suspected or proven) as a result of placenta previa, amniocentesis, chorionic villus sampling, percutaneous umbilical blood sampling, other obstetrical manipulative procedure (e.g., version) or abdominal trauma
  • Actual or threatened pregnancy loss at any stage of gestation
  • Ectopic pregnancy

To maintain an adequate level of anti-D, RhoGAM should be administered every 12 weeks. If delivery of the baby does not occur 12 weeks after the administration of the standard antepartum dose (at 26 to 28 weeks), a second dose is recommended to maximize protection antepartum.

Transfusion of Rh-incompatible blood or blood products

  • Prevention of Rh immunization in any Rh-negative person after incompatible transfusion of Rh-positive blood or blood products (e.g., red blood cells, platelet concentrates, granulocyte concentrates)


  • The use of RhoGAM and MICRhoGAM is contraindicated in Rh-positive individuals.


For intramuscular use only, do not administer intravenously.

Pregnancy and other obstetrical conditions

RhoGAM (300 micro grams) (1500 IU)

  • Postpartum - if the newborn is Rh-positive. Administer within 72 hours of delivery.
  • Antepartum -
    • Prophylaxis at 26-28 weeks gestation.
    • At or beyond thirteen weeks gestation: administer within 72 hours when suspected or proven exposure to Rh-positive red blood cells occurs resulting from invasive procedures, abdominal trauma or obstetrical manipulation, ectopic pregnancy, pregnancy termination or threatened termination.

Administer every 12 weeks starting from first injection to maintain a level of passively acquired anti-D. If delivery occurs within three weeks after the last antepartum dose, the postpartum dose may be withheld, but a test for fetal-maternal hemorrhage should be performed to determine if exposure to >15 mL of red blood cells has occurred.

MICRhoGAM (50 micro grams) (250 IU)

  • Administer within 72 hours of actual or threatened termination of pregnancy (spontaneous or induced) up to and including 12 weeks gestation.

Transfusion of Rh-incompatible blood or blood products

Administer within 72 hours.

RhoGAM (300 micro grams) (1500 IU)

  • 2.5 - 15.0 mL Rh-positive red blood cells
  • >15.0 mL Rh-positive red blood cells (multiple syringes)

MICRhoGAM (50 micro grams) (250 IU)

  • < 2.5 mL Rh-positive red blood cells



  • For intramuscular use only, do not inject intravenously.
  • In the case of postpartum use, the product is intended for maternal administration.
  • Do not inject the newborn infant.
  • Patients should be observed for at least 20 minutes after administration.
  • Administer with caution to patients who have had prior severe systemic allergic reactions to human immune globulin.
  • RhoGAM / MICRhoGAM contain a small quantity of IgA. There is a potential risk of hypersensitivity in IgA deficient individuals.
  • Patients treated for Rh-incompatible transfusion should be monitored by clinical and laboratory means for signs and symptoms of a hemolytic reaction.
  • Store at 2 to 8 degrees C. Do not store frozen.
  • Do not use after the expiration date printed on the syringe.

Parenteral drug products should be inspected visually for particulate matter, discoloration and syringe damage prior to administration. Do not use if particulate matter and / or discoloration are observed. The solution should appear clear or slightly opalescent.

Use of Plasma Derived Products

RhoGAM and MICRhoGAM are made from human plasma and may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically the Creutzfeldt-Jakob disease (CJD) agent. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing plasma for the presence of certain current virus infections and by using pathogen removal and inactivation techniques during the manufacturing process. All of the above steps are designed to increase product safety by reducing the risk of pathogen transmission.

Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. All infections thought by a physician possibly to have been transmitted by these products should be reported by the physician or other healthcare provider in the United States to Ortho-Clinical Diagnostics, Inc. at 1-800-421-3311. Outside the United States, the company distributing these products should be contacted. The physician should discuss the risks and benefits of these products with the patient.


Adverse events (AE) after administration of RhoGAM and MICRhoGAM are rare.

The most frequently reported AEs are anti-D formation and injection site reactions, such as swelling, induration, redness and mild pain or warmth. Possible systemic reactions are skin rash, body aches or a slight elevation in temperature. Severe systemic allergic reactions are extremely rare. Patients should be observed for at least 20 minutes after administration. There have been no reported fatalities due to anaphylaxis or any other cause related to RhoGAM or MICRhoGAM administration.

As with any Rho(D) Immune Globulin (Human), administration to patients who are Rh-positive or have received Rh-positive red blood cells may result in signs and symptoms of a hemolytic reaction, including fever, back pain, nausea and vomiting, hypo- or hypertension, hemoglobinuria/emia, elevated bilirubin and creatinine and decreased haptoglobin.

RhoGAM and MICRhoGAM contain a small quantity of IgA (less than 15 micro grams per dose). Although high doses of intravenous immune globulin containing IgA at levels of 270-720 micro grams/mL have been given without incident during treatment of patients with high-titered antibodies to IgA, the attending physician must weigh the benefit against the potential risks of hypersensitivity reactions.


Immune globulin preparations including Rho(D) Immune Globulin (Human) may impair the efficacy of live vaccines such as measles, mumps and varicella. Administration of live vaccines should generally be delayed until 12 weeks after the final dose of immune globulin. If an immune globulin is administered within 14 days after administration of a live vaccine, the immune response to the vaccination may be inhibited.

Because of the importance of rubella immunity among women of childbearing age, the postpartum vaccination of rubella-susceptible women with rubella or MMR vaccine should not be delayed because of the receipt of Rho(D) Immune Globulin (Human) during the last trimester of pregnancy or at delivery. Vaccination should occur immediately after delivery and if possible, testing should be performed after 3 or more months to ensure immunity to rubella and if necessary, to measles.


Pregnancy Category C

Animal reproduction studies have not been conducted with RhoGAM or MICRhoGAM. The available evidence suggests that Rho(D) Immune Globulin (Human) does not harm the fetus or affect future pregnancies or the reproduction capacity of the maternal recipient.

Rh Blood Type

RhoGAM or MICRhoGAM Rho(D) Immune Globulin (Human) should only be administered to Rh-negative patients exposed or potentially exposed to Rh-positive red blood cells to prevent Rh immunization.


Repeated administration or increased dosage in Rh-negative individuals should not cause more severe or more frequent adverse reactions than the normal dose. Patients who receive RhoGAM or MICRhoGAM for Rh-incompatible transfusion should be monitored by clinical and laboratory means due to the risk of a hemolytic reaction.


RhoGAM and MICRhoGAM Rho(D) Immune Globulin (Human) are sterile solutions containing immunoglobulin G (IgG) anti-D (anti-Rh) for use in preventing Rh immunization. They are manufactured from human plasma containing anti-D. A single dose of RhoGAM contains sufficient anti-D (300 micro grams or 1500 IU) to suppress the immune response to up to 15 mL of Rh-positive red blood cells. A single dose of MICRhoGAM contains sufficient anti-D (50 micro grams or 250 IU) to suppress the immune response to up to 2.5 mL of Rh-positive red blood cells.

The final product contains 5 +/- 1% IgG, 2.9 mg/mL sodium chloride, 0.01% Polysorbate 80 (non-animal derived) and 15 mg/mL glycine. Small amounts of IgA, typically less than 15 micro grams per dose, are present. The pH range is 6.20-6.55 and IgG purity is greater than or equal to 98%. The product contains no added human serum albumin (HSA), no thimerosal or other preservatives and utilizes a latex-free delivery system.


RhoGAM and MICRhoGAM act by suppressing the immune response of Rh-negative individuals to Rh-positive red blood cells. The mechanism of action is unknown. RhoGAM, MICRhoGAM and other Rho(D) Immune Globulin (Human) products are not effective in altering the course or consequences of Rh immunization once it has occurred.

NOTE: For complete prescribing information, see package insert.

SOURCE Ortho-Clinical Diagnostics, Inc.
Copyright©2009 PR Newswire.
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