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Plasma Source:
Committed to Safety

Kedrion Biopharma Takes Great Pride in Our Excellent Safety and Quality Record

Plasma for RhoGAM is collected from dedicated KEDPLASMA centers before being manufactured. Every step of the production process for RhoGAM is owned by Kedrion Biopharma and takes place in the U.S.1,2

RhoGAM is made from human plasma. Products made from human blood may carry a risk of transmitting infectious agents (eg, viruses, the variant Creutzfeldt-Jakob disease [vCJD] and, theoretically, the Creutzfeldt-Jakob disease [CJD] agent)1

The human plasma that makes up RhoGAM undergoes a rigorous safety protocol, including donor selection and fractionation processes, a viral filtration step, and a viral inactivation process.1

Circle graphic with text No documented cases of viral transmission in over 50 years

Plasma safety and COVID-19

COVID-19 is a highly contagious coronavirus infection spread by respiratory droplets. It is caused by SARS-CoV-2, a single-strand enveloped RNA virus.3

The viral filtration and viral inactivation processes remove and inactivate enveloped viruses similar to COVID-19.1

Steps to ensure plasma safety1

  • Red checkmark icon indicating a confirmed pointAll donors are screened via medical history and laboratory testing for blood-borne pathogens.
  • Red checkmark icon indicating a confirmed pointOnly plasma that has passed this screening is used for production. Each donation is screened for: Hepatitis B surface antigen (HBsAg), Hepatitis C antibodies (HCV), Human immunodeficiency virus (HIV) 1 and 2.
  • Red checkmark icon indicating a confirmed pointNucleic acid testing (NAT) is used to detect: Hepatitis B virus (HBV), Hepatitis C virus (HCV), HIV 1, Parvovirus B19.
  • Red checkmark icon indicating a confirmed pointPlasma then undergoes fractionation via a modification of the cold alcohol procedure.
  • Red checkmark icon indicating a confirmed pointNext, viral filtration and viral inactivation steps are performed to remove enveloped and non-enveloped viruses.

For more information on the donor process, please see the full Prescribing Information.

The RhoGAM Donor Story

Photo collage of RhIG plasma donor as young man and as adult donating

The RhoGAM story began with one generous donor

James Harrison was discovered by Australian scientists to have the anti-D antibodies needed for RhoGAM. Over his lifetime, he generously gave over 1,000 donations, a gift that has helped protect more than 2.4 million babies.6

RhoGAM owes its life-saving impact to the generosity of plasma donors. Discover more about their crucial contributions.

Blood donation arm with overlay text Coming Soon

Today, that spirit of generosity still lives on through donors for Kedrion.

RhoGAM is made with human plasma provided by generous donors. Plasma is collected at designated KEDPLASMA facilities. Once accepted in the program after careful screening, donors can make up to 8 donations a month.1,2

Watch to catch a glimpse of life at Somerset Laboratory, one of RhoGAM’s plasma collection centers.

Learn More About KEDPLASMA
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.

Book
Teal Columbia WiRhE logo for Rh education and research

Learn about global education initiatives

WIRhE is a non-profit organization dedicated to eliminating Rh disease worldwide.

Why RhoGAM
Plasma donation scene with staff supporting donor

Interested in becoming a donor?

If you or someone you know is Rh-negative, see how you could help others by becoming an anti-D donor.

Articles
References: 1. RhoGAM Ultra-filtered PLUS [prescribing information]. Kedrion Biopharma Inc. 2024. 2. Data on file. Kedrion Biopharma Inc. 3. Auwaerter PG. Johns Hopkins ABX Guide: Coronavirus COVID-19 (SARS-CoV-2). Johns Hopkins Medicine. Updated July 30, 2025. Accessed November 13, 2025. https://‌www.‌hopkinsguides.‌com/‌hopkins/‌view/‌Johns_Hopkins_ABX_Guide/‌540747/‌all/‌Coronavirus_COVID_19__SARS_CoV_2_ 4. Guthrie J. Good Blood. Abrams Press; 2020.

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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