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| Primary information |
|---|
| ID | 10806 |
| Therapeutic ID | Th1187 |
| Protein Name | Human Rho(D) immune globulin |
| Sequence | NA
|
| Molecular Weight | NA |
| Chemical Formula | NA |
| Isoelectric Point | NA |
| Hydrophobicity | NA |
| Melting point | NA |
| Half-life | The half life is 16 ± 4 days following IV administration and 18 ± 5 days following IM administration. |
| Description | Human 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/Disease | NA |
| Pharmacodynamics | NA |
| Mechanism of Action | It 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. |
| 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. |
| Metabolism | Rho (D) immune globulin is expected to undergo nonspecific catabolism. |
| 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%. |
| A single dose of 300ug Rho(D) Immune Globulin through intramuscular injection displays a Vd of 8.59L [L805]. |
| 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. |
| Categories | NA |
| Patents Number | NA |
| Date of Issue | NA |
| Date of Expiry | NA |
| Drug Interaction | NA |
| Target | Rhesus blood group D antigen |
| Brand Name | Winrho Sdf |
| Company | Aptevo Biotherapeutics Llc |
| Brand Description | Aptevo Biotherapeutics Llc |
| Prescribed For | NA |
| Chemical Name | NA |
| Formulation | 5000 unit; 1500 unit; 600 unit |
| Physical Appearance | kit |
| Route of Administration | intramuscular; intravenous |
| Recommended Dosage | NA |
| Contraindication | NA |
| Side Effects | NA |
| Useful Link 1 | Link |
| Useful Link 2 | NA |
| Remarks | NA |