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10804 details
Primary information
ID10804
Therapeutic IDTh1187
Protein NameHuman Rho(D) immune globulin
SequenceNA
Molecular WeightNA
Chemical FormulaNA
Isoelectric PointNA
HydrophobicityNA
Melting pointNA
Half-lifeThe half life is 16 ± 4 days following IV administration and 18 ± 5 days following IM administration.
DescriptionHuman Rho(D) immune globulin is a medicine given by intramuscular injection that is used to prevent the immunological condition known as Rh disease (or hemolytic disease of newborn). Human Rho(D) immune globulin is produced by an ion-exchange chromatography isolation procedure, using pooled plasma obtained by plasmapheresis of immunized Rh0(D)-negative US donors.
Indication/DiseaseNA
PharmacodynamicsNA
Mechanism of ActionIt acts by suppressing the immune response of Rh-negative individuals to Rh-positive red blood cells. The mechanism of action is unknown. RhoGAM, MICRhoGAM and other Rho(D) Immune Globulin (Human) products are not effective in altering the course or consequences of Rh immunization once it has occurred.
ToxicityMost 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.
MetabolismRho (D) immune globulin is expected to undergo nonspecific catabolism.
AbsorptionIn 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%.
A single dose of 300ug Rho(D) Immune Globulin through intramuscular injection displays a Vd of 8.59L [L805].
ClearanceMean 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.
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetRhesus blood group D antigen
Brand NameRhogam Ultra-filtered Plus
CompanyKedrion Melville, Inc.
Brand DescriptionKedrion Melville, Inc.
Prescribed ForNA
Chemical NameNA
Formulation300 ug/1
Physical Appearance injection, solution
Route of AdministrationIntramuscular
Recommended DosageNA
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2NA
RemarksNA