Overview
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.
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.
Associated Conditions
- Chronic Immune thrombocytopenic purpura
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|
No clinical trials found
No clinical trials found for this drug
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Kamada Ltd. | 49591-330 | INTRAVENOUS, INTRAMUSCULAR | 1500 [iU] in 1.3 mL | 6/9/2025 | |
| Saol Therapeutics Inc. | 70257-300 | INTRAVENOUS, INTRAMUSCULAR | 15000 [iU] in 1 1 | 4/10/2020 | |
| Saol Therapeutics Inc. | 70257-350 | INTRAVENOUS, INTRAMUSCULAR | 2500 [iU] in 1 1 | 4/10/2020 | |
| Kamada Ltd. | 49591-350 | INTRAVENOUS, INTRAMUSCULAR | 2500 [iU] in 2.2 mL | 6/9/2025 | |
| Kamada Ltd. | 49591-310 | INTRAVENOUS, INTRAMUSCULAR | 5000 [iU] in 4.4 mL | 6/9/2025 | |
| Saol Therapeutics Inc. | 70257-310 | INTRAVENOUS, INTRAMUSCULAR | 5000 [iU] in 1 1 | 4/10/2020 | |
| GRIFOLS USA, LLC | 13533-631 | INTRAMUSCULAR | 1500 [iU] in 1 1 | 5/16/2025 | |
| Saol Therapeutics Inc. | 70257-330 | INTRAVENOUS, INTRAMUSCULAR | 1500 [iU] in 1 1 | 4/10/2020 | |
| Kamada Ltd. | 49591-300 | INTRAMUSCULAR, INTRAVENOUS | 15000 [iU] in 13 mL | 6/9/2025 | |
| GRIFOLS USA, LLC | 13533-661 | INTRAMUSCULAR | 250 [iU] in 1 1 | 5/16/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| HyperRHO S/D Injection | SIN09660P | INJECTION | at least 1500 IU/dose | 3/3/1998 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| WINRHO SDF | ki biopharma llc | 02302578 | Solution - Intramuscular
,
Intravenous | 1500 UNIT / VIAL | 6/16/2008 |
| WINRHO SD KIT INJ | rh pharmaceuticals inc. | 02022842 | Kit - Intramuscular
,
Intravenous | 120 MCG / KIT | 12/31/1993 |
| WINRHO SD KIT INJ. | rh pharmaceuticals inc. | 02022834 | Kit - Intravenous
,
Intramuscular | 300 MCG / KIT | 12/31/1993 |
| WINRHO SDF | 02230397 | Kit - Intravenous
,
Intramuscular | 5000 UNIT / KIT | 1/28/1998 | |
| WINRHO SDF | ki biopharma llc | 02302608 | Solution - Intravenous
,
Intramuscular | 15000 UNIT / VIAL | N/A |
| HYPERRHO S/D FULL DOSE | 02379457 | Solution - Intramuscular | 1500 UNIT / DOSE | N/A | |
| WINRHO SDF | ki biopharma llc | 02302551 | Solution - Intravenous
,
Intramuscular | 600 UNIT / VIAL | 6/16/2008 |
| WINRHO SDF | 02217430 | Kit - Intravenous
,
Intramuscular | 600 UNIT / KIT | 1/10/1997 | |
| WINRHO SDF | ki biopharma llc | 02302586 | Solution - Intramuscular
,
Intravenous | 2500 UNIT / VIAL | N/A |
| WINRHO SDF | ki biopharma llc | 02302594 | Solution - Intravenous
,
Intramuscular | 5000 UNIT / VIAL | 6/16/2008 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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