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Millions of life stories
begin with RhoGAM

Protecting Rh-negative mothers
through delivery1-3

The Irreplaceable Anti-D Prophylaxis

Only RhoGAM can be administered as early as 26 weeks to prevent Rh sensitization in Rh-negative pregnant mothers1

RhoGAM prefilled syringe on light circular background

RhoGAM Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] is a prescription medicine given by intramuscular injection that is used to prevent Rh sensitization in Rh-negative expectant mothers.1

RhoGAM prefilled syringe on light circular background

RhoGAM may help protect your Rh-negative pregnant patients from Rh sensitization. During pregnancy, Rh sensitization of the mother may lead to hemolytic disease of the fetus and newborn (HDFN) in future pregnancies.1

Manufacturing Update

We've taken steps to bolster RhoGAM production capabilities4:

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Brought some manufacturing processes in-house to a Kedrion facility, expanding production capacity

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Increased number of KEDPLASMA donation centers contributing to RhoGAM supply


Stock the Irreplaceable RhoGAM

How to Order

RhoGAM Remains the Trusted Standard

Throughout its over 50-year history, RhoGAM has incorporated innovations to remain the trusted standard in anti-D care1,4,5

Mother holding toddler in a wildflower meadow, vintage style
1968
Approval of RhoGAM
Mother holding newborn baby in hospital bed, black and white
1985
Prefilled, ready-to-use syringe available
Black-and-white photo of mother standing with young child
1991
New indications
  • Percutaneous umbilical cord sampling (PUBS)
  • Chorionic villus sampling (CVS)
Close-up of mother embracing child, black and white
2001
Safety Shield

Designed to offer protection from needlesticks by completely encompassing the needle once engaged.

Mother holding young child in a flower field
2007
RhoGAM Ultra-Filtered PLUS approved
Mother lifting smiling baby in bright room, black and white
2018
RhoGAM 50-year anniversary
Collage of babies with text The RhoGAM story never gets old
2024
Increase in RhoGAM manufacturing capabilities

Completed RhoGAM tech-transfer from Ortho-Clinical Diagnostics, Inc. to Kedrion manufacturing facility and opened 2 specialty plasma donation centers

RhoGAM flipbook cover featuring prefilled syringe safety callouts

RhoGAM is the anti-D breakthrough that continues to make life-saving history4,6,7

The remarkable true story of one of the greatest medical breakthroughs of the 20th century.

Before the 1960s, there was no method available to prevent Rh immunization during Rh-incompatible pregnancies, which could result in hemolytic disease of the fetus and newborn (HDFN).3 At that time, HDFN affected 9%-10% of all pregnancies and contributed significantly to fetal deaths in the US.8 Innovators were needed for this complex problem.

“Before it’s a breakthrough, it’s a crazy idea.”

A team of scientists were convinced that the answer could be what was then an unconventional theory. Known as passive antibody immunosuppression, an active immune response is prevented by passive administration of antibodies directed to the stimulus.9-11 Based on this idea, it was theorized that administering passively administered anti-D immunoglobulin to Rh-negative mothers could help prevent Rh immunization.

“A story of heroism and triumph. Of brilliant science and generous empathy.”

Before the 1960s, employing passive antibody immunosuppression to garner an immune response was not well received. But the research team remained dedicated to this idea to reduce Rh-sensitivity. As a result, in 1968, the FDA approved the use of RhoGAM to help prevent Rh immunization.1 As the first anti-D product available, RhoGAM has given hope to Rh-negative mothers by protecting millions of Rh-positive babies for five decades.2,4,6,7

RhoGAM flipbook cover featuring prefilled syringe safety callouts
Woman boxing in front of large baby image on teal background

Life Stories Begin With RhoGAM

Learn about the life-saving science behind RhoGAM

Why RhoGAM
Teal-colored close-up illustration of red blood cells

The Anti-D Clinical Digest

Explore all things anti-D, Rh sensitization, HDFN, and other related topics.

Articles
Good Blood book cover about the breakthrough that saved millions of babies

Read About the Heroes of RhoGAM

Order “Good Blood” by Julian Guthrie to learn about the story of how RhoGAM was invented to save thousands of babies.

Book
References: 1. RhoGAM Ultra-filtered PLUS [prescribing information]. Kedrion Biopharma Inc. 2024. 2. Bowman JM, Pollock JM. Antenatal prophylaxis of Rh isoimmunization: 28-weeks’-gestation service program. Can Med Assoc J. 1978;118(6):627-630. 3. Aitken SL, Tichy EM. Rh(O)D immune globulin products for prevention of alloimmunization during pregnancy. Am J Health Syst Pharm. 2015;72(4):267-276. 4. Data on file. Kedrion Biopharma Inc. 5. The plasma proteins market in the United States 2023. Marketing Research Bureau. Accessed November 13, 2025. https://marketingresearchbureau.com/the-plasma-proteins-market-in-the-united-states-2023 6. Hartwell EA; American Society of Clinical Pathologists. Use of Rh immune globulin: ASCP practice parameter. Am J Clin Pathol. 1998;110(3):281-292. 7. Bowman JM. The prevention of Rh immunization. Transfus Med Rev. 1988;2(3):129-150. 8. Practice bulletin no. 181: prevention of Rh D alloimmunization. Obstet Gynecol. 2017;130(2):e57-e70. 9. Freda VJ, Gorman JG, Pollack W. Successful prevention of sensitization to Rh with experimental anti-Rh gamma-globulin antibody preparation. Fed Proc. 1963;22:374. 10. Finn R, Clarke CA, Donohoe WT, et al. Experimental studies on the prevention of Rh haemolytic disease. Br Med J. 1961;1(5238):1486-1490. 11. Uhr JW, Baumann JB. Antibody formation. I. The suppression of antibody formation by passively administered antibody. J Exp Med. 1961;113(5):935-957.

Indication

  • RhoGAM® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) is an immune globulin indicated for use in preventing Rh immunization for pregnancy and other obstetrical conditions in Rh-negative women unless the father or baby is conclusively Rh-negative, e.g., delivery of an Rh-positive baby irrespective of the ABO groups of the mother and baby, any antepartum fetal-maternal hemorrhage (suspected or proven), actual or threatened pregnancy loss at any stage of gestation and ectopic pregnancy.
  • Prevention of Rh immunization in any Rh-negative person after incompatible transfusion of Rh-positive blood or blood products.
  • In the case of postpartum use, RhoGAM is intended for maternal administration. Do not inject the newborn infant.

Important Safety Information

  • RhoGAM is contraindicated in Rh-positive individuals and in patients with a known history of anaphylactic or severe systemic reactions to the administration of human immune globulin products.
  • Severe hypersensitivity reactions may occur with the use of RhoGAM. RhoGAM should be administered in a setting where appropriate equipment, medications such as epinephrine, and personnel trained in the management of hypersensitivity, anaphylaxis, and shock are available.
  • RhoGAM contains a small quantity of IgA. There is a potential risk of hypersensitivity in IgA deficient individuals. Although high doses of intravenous immune globulin containing IgA at levels of 270-720 μg/mL have been given without incident during treatment of patients with high-titer antibodies to IgA, the attending physician must weigh the benefit against the potential risks of hypersensitivity reactions.
  • Products made from human blood may carry a risk of transmitting infectious agents (e.g., viruses, the variant Creutzfeldt-Jakob disease [vCJD] and, theoretically, the Creutzfeldt-Jakob disease [CJD] agent).
  • After administration of Rho(D) immune globulin, a transitory increase of various passively transferred antibodies in the patient’s blood may yield positive serological testing results.
  • The most frequently reported adverse reactions in patients receiving Rho(D) Immune Globulin (Human) products are 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 reactions include allergic reactions and hemolytic reactions.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please click here for full Prescribing Information.

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