Experience Matters,
Trust in RhoGAM

  • RhoGAM was the first anti-D product available1
  • RhoGAM helped set the standards and clinical practice guidelines that are still followed today
  • Only RhoGAM has been consistently available across five decades with no interruptions in supply1

Year after year, RhoGAM is a reliable choice.

Below are a few of RhoGAM’s milestones over the last 50 years

1968 >
  • RhoGAM approved
1979 >
  • MICRhoGAM approved
1984 >
  • ACOG releases antepartum protocols
1985 >
  • Pre-filled, ready-to-use syringe available
1991 >

New indications approved for:

> PUBS

> CVS

1997 >
  • RhoGAM Ultra-Filtered approved
  • Viresolve 180 Ultrafiltration added to remove potential viruses present, including HAV
2001 >
  • Safety Shield added
  • Thimerosal removed
2007 >
  • RhoGAM Ultra-Filtered PLUS approved
  • West Nile virus removal capability validated
2012 >
  • Kedrion Biopharma acquired RhoGAM and MICRhoGAM
2013 >
  • Medicaid Drug Rebate Program enrollment
2018 >
  • RhoGAM 50 year anniversary 

 

Reference: 1. Data on File. Kedrion Biopharma Inc.

 

Indication

  • RhoGAM® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) and MICRhoGAM® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (50 μg) are immune globulins 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.
  • In the case of postpartum use, RhoGAM and MICRhoGAM are intended for maternal administration. Do not inject the newborn infant.

Important Safety Information

  • RhoGAM and MICRhoGAM are 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 or MICRhoGAM. RhoGAM and MICRhoGAM 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.
  • 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 adverse events of prescription drugs to the FDA. Visit www.fda.gov/Safety/MedWatch/ or
call 1-800-FDA-1088.

Click here for the RhoGAM and MicRhoGAM Full Prescribing Information
This site is intended for residents of the US only.

 

Back to top