Rho(D) Immune Globulin

Table of contents

  • Brand Names
  • Chemistry
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic Use
  • Pregnancy and Lactation Implications
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Caution and personalized dose adjustment in patients with the following genotypes
  • Other genes that may be involved
  • Drug Interactions
  • Dosage
  • Pharmacokinetics and Pharmacodynamics
  • Special Considerations

Brand Names

Europe

Austria: Partobulin, Rhophylac; Belgium: Rhogam; Bulgaria: Anti-D(Rh~o~)-immunoglobulin-NCHT, Hyper Rh~o~ S/D, Rhesonativ; Cyprus: Rhesonativ, WinRh~o~ SDF; Czech Republic: Igamad, Partobulin, Rhesonativ, Rhophylac; Denmark: Rhesonativ, Rhophylac; Estonia: Rhesonativ; Finland: Rhophylac; France: Rhophylac; Germany: Rhesogam, Rhesonativ; Hungary: Rhesonativ; Ireland: Rhesonativ, Rhophylac; Italy: Igamad, ImmunoRh~o~, Partobulin, Rhophylac; Latvia: Rhesonativ; Lithuania: Rhesonativ; Luxembourg: Rhophylac; Netherlands: RheDQuin, Rhesonativ, Rhophylac; Poland: Rhesonativ; Portugal: Igantid, Rhesonativ, Rhophylac; Romania: Rhesonativ, Rhogam; Slovakia: Igamad, Partobulin, Rhesonativ, Rhophylac; Slovenia: Rhesonativ, Rhophylac; Spain: Rhophylac; Sweden: Rhesonativ, Rhophylac; UK: Rhophylac.

North America

Canada: WinRho SDF; USA: Rhophylac, WinRho SDF.

Latin America

Argentina: Gamma Anti-Rh~o~ Unc, Igantid, ImmunoRh~o~, Kam-Rh~o~, Partoben, Partogamma SDF, Rhesogamma-P, Rhophylac; Mexico: Octaglob-D, Rhesogamma-P, Rhophylac.

Asia

Japan: Anti-D Globulin-Nichiyaku, Human Immunoglobulin Anti-D.

Drug combinations

Chemistry

Rh~o~(D) Immune Globulin: Immunizing agent (passive).

Pharmacologic Category

Serums, Toxoids, and Vaccines; Serums. Immune Globulin. (ATC-Code: J06BB01).

Mechanism of action

Rh suppression: Prevents isoimmunization by suppressing immune response and antibody formation by Rh~o~(D) negative individuals to Rh~o~(D) positive red blood cells.

ITP (Idiopathic Thrombocytopenic Purpura): Not completely characterized. Rh~o~(D) immune globulin thought to form anti-D-coated red blood cell complexes which bind to macrophage Fc receptors within spleen; blocking or saturating spleen’s ability to clear antibody-coated cells, including platelets. In this manner, platelets spared from destruction.

Therapeutic use

Suppression of Rh isoimmunization. Treatment of idiopathic thrombocytopenic purpura (ITP).

Pregnancy and lactiation implications

Animal studies not conducted. Available evidence suggests that Rh~o~(D) immune globulin administration during pregnancy does not harm fetus or affect future pregnancies. Does not enter breast milk.

Unlabeled use

Contraindications

Hypersensitivity to immune globulins or any component of the formulation. Prior sensitization to Rh~o~(D).

Warnings and precautions

Use with caution in IgA deficiency (may contain trace amounts of IgA). IgA-deficient patients may have potential for developing IgA antibodies (anaphylactic reactions may occur). Rare but serious signs and symptoms (e.g. back pain, shaking, chills, fever, discolored urine) of intravascular hemolysis reported. Clinically-compromising anemia, acute renal insufficiency and disseminated intravascular coagulation also reported. Use with caution in thrombocytopenia or coagulation disorders (bleeding/hematoma may occur from I.M. administration). Not for replacement therapy in immune globulin deficiency syndromes. Use with caution in renal impairment. For use in mother (do not administer to neonate). Product of human plasma (may potentially contain infectious agents).

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