About RhoGAM1

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

#1RhoGAM is the #1-selling anti-D brand in the US2

RhoGAM is typically administered twice to expectant mothers – once during pregnancy and once after delivery. RhoGAM is an intramuscular injection given by a healthcare professional to the mother.

Antepartum:

  • If the mother’s blood type is Rh-negative, the 1st injection of RhoGAM is delivered between 26-28 weeks of pregnancy

Postpartum:

  • If the baby is found to be Rh-positive at birth, administer within 72 hours of delivery
  • If the baby is determined to be Rh-negative at birth, an additional dose is not needed

Additional doses of RhoGAM are indicated when the patient has been exposed to more than 15 mL of Rh-positive red blood cells. This may be determined by use of qualitative or quantitative tests for fetal-maternal hemorrhage.

For complete dosing & administration information, click here for the RhoGAM Full Prescribing Information.


References1. RhoGAM Ultra-Filtered PLUS [prescribing Information]. Fort Lee, NJ. Kedrion Biopharma Inc. 2019. 2. The plasma proteins market in the United States, 2017. The Marketing Research Bureau. Orange, CT: 2018.

 

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.

 

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