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RhoGAM Ultra-Filtered PLUS packaging with prefilled syringe

There Is No Substitute for Proven Protection1,2

Stock the Irreplaceable RhoGAM

Order RhoGAM Through Your Authorized Distributor
or Kedrion Biopharma Customer Service3

NDC Description Unit Measure Quantity Level
0562-7805-01 RhoGAM Ultra-Filtered PLUS EA 1 pack
0562-7805-05 RhoGAM Ultra-Filtered PLUS EA 5 pack
0562-7805-25 RhoGAM Ultra-Filtered PLUS EA 25 pack

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References: 1. Bowman JM. The prevention of Rh immunization. Transfus Med Rev. 1988;2(3):129-150. 2. Hartwell EA; American Society of Clinical Pathologists. Use of Rh immune globulin: ASCP practice parameter. Am J Clin Pathol. 1998;110(3):281-292. 3. RhoGAM Ultra-filtered PLUS [prescribing information]. Kedrion Biopharma Inc. 2024.

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.

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