Human Rho(D) immune globulin
Identification
- Summary
Human Rho(D) immune globulin is a solution of antibodies used to prevent isoimmunization of Rho(D) negative patients exposed to Rho(D) positive blood in pregnancy or transfusion.
- Brand Names
- Hyperrho, Micrhogam, Rhogam, Rhophylac, Winrho
- Generic Name
- Human Rho(D) immune globulin
- DrugBank Accession Number
- DB11597
- Background
Human Rho(D) immune globulin is a medicine given by intramuscular or intravenous injection that is used to prevent the immunological condition known as Rh disease (or hemolytic disease of newborn). Rho (D) immune globulin is available as a sterile, lyophilized or liquid gamma globulin (IgG) fraction containing antibodies to the Rh0 (D) antigen (D antigen) under the name Rhophylac (IM/IV). Immune globullin was purified via ion-exchange chromatography method and prepared from pools of human plasma, where the donors are Rho (D)-negative donors who have been immunized with Rho(D)-positive RBCs. It was approved by FDA as treatment for suppression of rhesus (Rh) isoimmunization or chronic immune thrombocytopenic purpura (ITP) in adults.
- Type
- Biotech
- Groups
- Approved, Investigational
- Biologic Classification
- Protein Based Therapies
Polyclonal antibody (pAb) - Protein Chemical Formula
- Not Available
- Protein Average Weight
- Not Available
- Sequences
- Not Available
- Synonyms
- Anti-D (RH) immunoglobulin (human)
- Anti-D immunoglobulin
- Anti-D immunoglobulins
- Human anti-D immunoglobulin
- IGG, Rho (D)
- Immunoglobulin human anti-RH
- Rh0(D) Immune Globulin Intravenous (Human)
- Rho (D) immune globulin,human
- Rho D immune globulin human
- Rho(D) immune globulin (human)
- Rho(D) immune globulin human
- Rho(D) immune globulin IM human
Pharmacology
- Indication
Indicated for suppression of rhesus (Rh) isoimmunization in nonsensitized Rho (D)-negative women with an Rh-incompatible pregnancy, or in Rho (D)-negative individuals transfused with Rh0(D)-positive red blood cells (RBCs) or blood components containing Rh0(D)-positive RBCs. Also indicated in Rh0(D)-positive, non-splenectomized adult patients with chronic immune thrombocytopenic purpura (ITP) to raise platelet counts.
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- Associated Therapies
- Contraindications & Blackbox Warnings
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- Pharmacodynamics
15000 international unit (IU) contains sufficient anti-Rho (D) to effectively suppress the immunizing potential of approximately 17mL of Rho (D) (D-positive) red blood cells 12. Human Rho(D) immune globulin therapy prevents immunization to Rho (D)-positive red blood cells (RBC) by inducing antibody-mediated immunosuppression (AMIS) effectively clearing Rho-positive RBCs by rapidly binding to them. This prevents Rho-negative mothers to produce alloantibodies to paternally inherited RhD antigen expressed on fetal erythrocytes and cause haemolytic diseases of the newborn. Rho immune globulin increase platelet counts and reduce bleeding in Rho-positive patients with ITP by inhibiting autoantibody-mediated platelet clearance.
- Mechanism of action
The mechanism of action of Rho(D) immune globulin therapy is unclear. It is suggested that Rho immune globulin predominantly prevents the antibody response during incompatible pregnancy by accelerating the phagocytosis of RBC's and clearance from the circulation before the recognition by the immune system. IgG-opsonized RBCs may interact with activating IgG receptors (FcγRs) on effector cells and elicit phagocytosis via mononuclear phagocytic system, primarily by macrophages. IgG may also stimulate complement activation on the RBC surface, followed by RBC lysis or complement receptor-mediated phagocytosis but to smaller extent 4. Rho-specific IgG may inhibit the late stages of B cell activation by being internalized with Rho antigen by B cells, which alters the antigen processing and presentation. In response to the IgG-antigen complex formation, the immune globulin enhances the presentation of specific peptides and proliferation of epitope-specific T cells 4. Therapeutic efficacy of Rho (D) immune globulin in chronic immune thrombocytopenic purpura (ITP) may be explained by FcR blockade as well as the increase in the platelet count by substituting antibody-coated RBCs for antibodycoated platelets 2. In vitro studies of cytokine expression in human monocytes and granulocytes exposed to anti-D coated red blood cells have demonstrated enhanced secretion of interleukin 1 receptor antagonist resulting in down-regulation of FcγR mediated phagocytosis. Murine models show that RBC-specific antibodies can increase platelet counts by down-regulating FcγRIIIa on splenic macrophage, which is an opposing effect as predicted in intravenous Rho IgG 3.
Target Actions Organism ARhesus blood group D antigen antibodyHumans - Absorption
In patients undergoing therapy for Rh isoimmunization suppression, Rho(D) immune globulin titers were detected in all women up to at least 9 weeks following either intravenous or intramuscular administration. Following intravenous administration of a single 1500 IU (300 mcg) dose, peak serum levels of Rh0(D) immune globulin ranged from 62 to 84 ng/mL after first day. The levels ranged from 7 to 46 ng/mL and were achieved between 2 and 7 days following intramuscular injection. The absolute bioavailability achieved following IM administration is 69%.
- Volume of distribution
A single dose of 300ug Rho(D) Immune Globulin through intramuscular injection displays a Vd of 8.59L 13.
- Protein binding
Not Available
- Metabolism
Rho (D) immune globulin is expected to undergo nonspecific catabolism.
- Route of elimination
Human immune globulin and the fragments can be detected in feces and urine.
- Half-life
The half life is 16 ± 4 days following IV administration and 18 ± 5 days following IM administration.
- Clearance
Mean systemic clearance following IV administration is 0.20 ±0.03 mL/min. Mean apparent clearance following IM administration is 0.29 ± 0.12 mL/min.
- Adverse Effects
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- Toxicity
Most serious adverse reactions in patients with ITP include intravascular hemolysis, anemia, acute renal insufficiency, and death. In patients treated for Rh isoimmunization suppression, common adverse effects include nausea, dizziness, headache, pain at injection site and malaise. Common adverse effects in patients with ITP include chills, pyrexia, mild extravascular hemolysis and headache.
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Drug Interaction Integrate drug-drug
interactions in your softwareAbciximab The risk or severity of adverse effects can be increased when Abciximab is combined with Human Rho(D) immune globulin. Adalimumab The risk or severity of adverse effects can be increased when Adalimumab is combined with Human Rho(D) immune globulin. Aducanumab The risk or severity of adverse effects can be increased when Human Rho(D) immune globulin is combined with Aducanumab. Alemtuzumab The risk or severity of adverse effects can be increased when Alemtuzumab is combined with Human Rho(D) immune globulin. Alirocumab The risk or severity of adverse effects can be increased when Alirocumab is combined with Human Rho(D) immune globulin. Amivantamab The risk or severity of adverse effects can be increased when Human Rho(D) immune globulin is combined with Amivantamab. Anifrolumab The risk or severity of adverse effects can be increased when Human Rho(D) immune globulin is combined with Anifrolumab. Ansuvimab The risk or severity of adverse effects can be increased when Human Rho(D) immune globulin is combined with Ansuvimab. Anthrax immune globulin human The risk or severity of adverse effects can be increased when Anthrax immune globulin human is combined with Human Rho(D) immune globulin. Antilymphocyte immunoglobulin (horse) The risk or severity of adverse effects can be increased when Antilymphocyte immunoglobulin (horse) is combined with Human Rho(D) immune globulin. Identify potential medication risksEasily compare up to 40 drugs with our drug interaction checker.Get severity rating, description, and management advice.Learn more - Food Interactions
- No interactions found.
Products
- Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.
- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Hyp Rho D Inj 16.5% Liquid 16.5 % Intramuscular Cutter Med & Biol, Division Of Miles Canada Ltd. 1979-12-31 1998-09-25 Canada Hyperrho S/d Full Dose Solution 1500 unit / dose Intramuscular Grifols Therapeutics Llc Not applicable Not applicable Canada Hyperrho S/d Full Dose Solution 1500 unit / dose Intramuscular Grifols Therapeutics Llc Not applicable Not applicable Canada Hyperrho S/d Full Dose Solution 1500 [iU]/1 Intramuscular GRIFOLS USA, LLC 1996-08-14 Not applicable US Hyperrho S/d Mini-dose Solution 250 [iU]/1 Intramuscular GRIFOLS USA, LLC 1996-08-14 Not applicable US MICRhoGAM Ultra-Filtered PLUS Injection, solution 50 ug/1 Intramuscular Kedrion Biopharma Inc 2007-03-09 Not applicable US RhoGAM Ultra-Filtered PLUS Injection, solution 300 ug/1 Intramuscular Kedrion Biopharma Inc 2007-03-09 Not applicable US Rhophylac Solution 1500 [iU]/2mL Intramuscular; Intravenous Csl Behring Ag 2009-01-06 Not applicable US Winrho Liquid 1500 [iU]/1mL Intramuscular; Intravenous Aptevo Biotherapeutics Llc 2016-07-01 Not applicable US Winrho Liquid 5000 [iU]/1mL Intramuscular; Intravenous Aptevo Biotherapeutics Llc 2016-07-01 Not applicable US - Mixture Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Winrho Sd Kit Inj Human Rho(D) immune globulin (120 mcg / kit) + Sodium chloride (0.9 % / kit) Kit Intramuscular; Intravenous Rh Pharmaceuticals Inc. 1993-12-31 1997-07-22 Canada Winrho Sd Kit Inj. Human Rho(D) immune globulin (300 mcg / kit) + Sodium chloride (.9 % / kit) Kit Intramuscular; Intravenous Rh Pharmaceuticals Inc. 1993-12-31 1997-07-22 Canada - Unapproved/Other Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image WIN RHO SDF 300 MCG FLAKON, 1 ADET Human Rho(D) immune globulin (300 mcg) Injection, solution Intramuscular; Intravenous RA İLAÇ SAN.VE TİC. A.Ş. 2020-08-14 Not applicable Turkey
Categories
- ATC Codes
- J06BB01 — Anti-d (rh) immunoglobulin
- Drug Categories
- Chemical TaxonomyProvided by Classyfire
- Description
- Not Available
- Kingdom
- Organic Compounds
- Super Class
- Organic Acids
- Class
- Carboxylic Acids and Derivatives
- Sub Class
- Amino Acids, Peptides, and Analogues
- Direct Parent
- Peptides
- Alternative Parents
- Not Available
- Substituents
- Not Available
- Molecular Framework
- Not Available
- External Descriptors
- Not Available
- Affected organisms
- Not Available
Chemical Identifiers
- UNII
- 48W7181FLP
- CAS number
- Not Available
References
- General References
- Cheung E, Liebman HA: Anti-RhD immunoglobulin in the treatment of immune thrombocytopenia. Biologics. 2009;3:57-62. Epub 2009 Jul 13. [Article]
- Bussel JB, Graziano JN, Kimberly RP, Pahwa S, Aledort LM: Intravenous anti-D treatment of immune thrombocytopenic purpura: analysis of efficacy, toxicity, and mechanism of effect. Blood. 1991 May 1;77(9):1884-93. [Article]
- Crowther CA, Keirse MJ: Anti-D administration in pregnancy for preventing rhesus alloimmunisation. Cochrane Database Syst Rev. 2000;(2):CD000020. [Article]
- Brinc D, Lazarus AH: Mechanisms of anti-D action in the prevention of hemolytic disease of the fetus and newborn. Hematology Am Soc Hematol Educ Program. 2009:185-91. doi: 10.1182/asheducation-2009.1.185. [Article]
- Brinc D, Le-Tien H, Crow AR, Freedman J, Lazarus AH: IgG-mediated immunosuppression is not dependent on erythrocyte clearance or immunological evasion: implications for the mechanism of action of anti-D in the prevention of haemolytic disease of the newborn? Br J Haematol. 2007 Oct;139(2):275-9. [Article]
- Bichler J, Schondorfer G, Pabst G, Andresen I: Pharmacokinetics of anti-D IgG in pregnant RhD-negative women. BJOG. 2003 Jan;110(1):39-45. [Article]
- Poortmans JR, Jeanloz RW: Urinary excretion of immunoglobulins and their subunits in human subjects before and after exercise. Med Sci Sports Exerc. 1993 Feb;25(2):171-8. [Article]
- Haneberg B, Endresen C: Fragments of immunoglobulins in human faeces. Acta Pathol Microbiol Scand C. 1976 Feb;84(1):31-6. [Article]
- Haneberg B, Aarskog D: Human faecal immunoglobulins in healthy infants and children, and in some with diseases affecting the intestinal tract or the immune system. Clin Exp Immunol. 1975 Nov;22(2):210-22. [Article]
- Arend WP, Silverblatt FJ: Serum disappearance and catabolism of homologous immunoglobulin fragments in rats. Clin Exp Immunol. 1975 Dec;22(3):502-13. [Article]
- Rhophylac Summary of Basis for Approval [Link]
- WinRho Product information [Link]
- RhoGam (Rho(D) Immune Globulin intramuscular injection) product information [Link]
- External Links
- PubChem Substance
- 347911208
- 1789837
- Wikipedia
- Rho(D)_immune_globulin
- FDA label
- Download (513 KB)
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Recruiting Prevention Pregnancy Related 1 4 Terminated Treatment Hepatitis C Virus (HCV) Infection / Human Immunodeficiency Virus (HIV) Infections / Thrombocytopenia 1 3 Completed Treatment Localized, resectable Neuroblastoma (NB) / Localized, unresectable Neuroblastoma (NB) / Regional Neuroblastoma / Stage 4 Neuroblastoma / Stage 4S Neuroblastoma 1 2 Completed Not Available Healthy Subjects (HS) 1 1 Completed Treatment Healthy Subjects (HS) 1 Not Available Completed Treatment Dengue Fever 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection, solution Intramuscular 1500 IU/2ml Powder, for solution Intravenous Liquid Intramuscular 16.5 % Injection Intramuscular; Intravenous Solution Intramuscular 1500 [iU]/1 Solution Intramuscular 1500 unit / dose Injection Intramuscular 1500 IU/dose Solution Intramuscular 250 [iU]/1 Injection, solution Intramuscular 1500 iu Injection, powder, for solution Intramuscular 1250 U.I./2ML Injection, solution Intramuscular 1500 UI/2ML Solution Parenteral 300.000 mcg Injection, powder, for solution Intramuscular 200 MCG Injection, solution Intramuscular 100 mcg/2ml Injection, solution Intramuscular 300 MCG/2ML Injection, powder, for solution Intramuscular 300 mcg Injection, powder, lyophilized, for solution Intramuscular 300 mcg Solution Parenteral 1500 UI Injection, solution Intramuscular 50 ug/1 Injection, powder, for solution Intramuscular Injection, solution Intramuscular Injection, solution Parenteral 625 IU/ml Injection, solution Intramuscular 625 IU/ml Solution Parenteral 300 mcg Injection, solution Intramuscular 300 mcg Injection, solution Intramuscular 300 ug/1 Injection, solution Solution Intramuscular; Intravenous 1500 [iU]/2mL Solution Intravenous 300.00 mcg Injection Intramuscular; Intravenous 300 mcg/2ml Injection, solution Intramuscular; Intravenous Solution Intramuscular; Intravenous 300 mcg Solution Intramuscular 1500 UI Injection, solution Intramuscular; Intravenous 300 mcg Liquid Intramuscular; Intravenous 1500 [iU]/1mL Liquid Intramuscular; Intravenous 15000 [iU]/1mL Liquid Intramuscular; Intravenous 2500 [iU]/1mL Liquid Intramuscular; Intravenous 5000 [iU]/1mL Kit Intramuscular; Intravenous Injection Intramuscular; Intravenous 1500 [iU]/1 Injection Intramuscular; Intravenous 15000 [iU]/1 Injection Intramuscular; Intravenous 2500 [iU]/1 Injection Intramuscular; Intravenous 5000 [iU]/1 Injection, solution Intramuscular; Intravenous 1500 [iU]/1.3mL Injection, solution Intramuscular; Intravenous 15000 [iU]/13mL Injection, solution Intramuscular; Intravenous 2500 [iU]/2.2mL Injection, solution Intramuscular; Intravenous 5000 [iU]/4.4mL Kit Intramuscular; Intravenous 1500 unit / kit Kit Intramuscular; Intravenous 5000 unit / kit Kit Intramuscular; Intravenous 600 unit / kit Solution Intramuscular; Intravenous 1500 unit / vial Solution Intramuscular; Intravenous 15000 unit / vial Solution Intramuscular; Intravenous 2500 unit / vial Solution Intramuscular; Intravenous 5000 unit / vial Solution Intramuscular; Intravenous 600 unit / vial - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Liquid
- Experimental Properties
- Not Available
Targets

- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Yes
- Actions
- Antibody
- General Function
- Ammonium transmembrane transporter activity
- Specific Function
- Not Available
- Gene Name
- RHD
- Uniprot ID
- A6PZ59
- Uniprot Name
- Rhesus blood group D antigen
- Molecular Weight
- 45275.06 Da
Drug created at May 20, 2016 19:42 / Updated at September 25, 2023 04:25