Rhogam Ultra-filtered Plus
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Questions & Answers
Side Effects & Adverse Reactions
5.1 Warnings
- For intramuscular use only, do not inject intravenously.
- In the case of postpartum use, the product is intended for maternal administration.
- Do not inject the newborn infant.
- Patients should be observed for at least 20 minutes after administration.
- Administer with caution to patients who have had prior severe systemic allergic reactions to human immune globulin.
- RhoGAM / MICRhoGAM contain a small quantity og IgA. There is a potential risk of hypersensitivity in IgA deficient individuals.
- Patients treated for Rh-incompatible transfusion should be monitored by clinical and laboratory means for signs and symptoms of a hemolytic reaction.
- Store at 2 to 8°C. Do not store frozen.
- Do not use after the expiration date printed on the syringe.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
For administration to Rh-negative women not previously sensitized to the Rho(D) factor, unless the father or baby are conclusively Rh-negative.
- Delivery of an Rh-positive baby irrespective of the ABO groups of the mother and baby
- Antepartum prophylaxis at 26 to 28 weeks gestation
- Antepartum fetal-maternal hemorrhage (suspected or proven) as a result of placenta previa, amniocentesis, chorionic villus sampling, percutaneous umbilical blood sampling, other obstetrical manipulative procedure (e.g., version) or abdominal trauma
- Actual or threatened pregnancy loss at any stage of gestation
- Ectopic pregnancy
- Prevention of Rh immunization in any Rh-negative person after incompatible transfusion of Rh-positive blood or blood products (e.g., red blood cells, platelet concentrates, granulocyte concentrates)
History
There is currently no drug history available for this drug.
Other Information
RhoGAM and MICRhoGAM Rho(D) Immune Globulin (Human) are sterile solutions containing immunoglobulin G (IgG) anti-D (anti-Rh) for use in preventing Rh immunization. They are manufactured from human plasma containing anti-D. A single dose of RhoGAM contains sufficient anti-D (300 μg or 1500 IU) to suppress the immune response to up to 15 mL of Rh-positive red blood cells.4,15 A single dose of MICRhoGAM contains sufficient anti-D (50 μg or 250 IU) to suppress the immune response to up to 2.5 mL of Rh-positive red blood cells. The anti-D dose is measured by comparison to the RhoGAM in-house reference standard, the potency of which is established relative to the U.S./World Health Organization/European Pharmacopoeia Standard Anti-D Immunoglobulin Rho(D) Immune Globulin (Human) CBER Lot 4: NIBSC Lot 01/572 (285 IU/ampoule).16
Plasma for RhoGAM is typically sourced from a donor center owned and operated by Ortho-Clinical Diagnostics. All donors are carefully screened by history and laboratory testing to reduce the risk of transmitting blood-borne pathogens from infected donors. Each plasma donation is tested and found to be non-reactive for the presence of hepatitis B surface antigen (HBsAg) and antibodies to hepatitis C (HCV) and human immunodeficiency viruses (HIV) 1 and 2. Additionally, plasma is tested by FDA licensed Nucleic Acid Testing (NAT) for HCV and HIV-1 and the results must be negative. Plasma is also tested by investigational NAT for hepatitis B (HBV) and must be non-reactive. However, the significance of a negative result has not been established. Plasma is tested by in-process NAT procedures for hepatitis A virus (HAV) and parvovirus B19 (B19) in a minipool format. Only plasma that has passed virus screening is used for production. The procedure for B19 detects all three genotypes based upon sequence alignment of known virus isolates. The limit of B19 DNA in the manufacturing pool is set not to exceed 104 IU per mL.
Fractionation of the plasma is performed by a modification of the cold alcohol procedure that has been shown to significantly lower viral titers.10 Following plasma fractionation, a viral clearance filtration step and a viral inactivation step are performed. The viral filtration step removes viruses via a size-exclusion mechanism utilizing a patented Viresolve 180 ultrafiltration membrane with defined pore-size distribution of 12-18 nanometers to remove enveloped and non-enveloped viruses. Following viral filtration, quality control tests (CorrTest and diffusion test) are performed on the Viresolve 180 ultrafiltration membrane to insure filter integrity.17 The viral inactivation step utilizes Triton X-100 and tri-n-butyl phosphate (TNBP) to inactivate enveloped viruses such as HCV, HIV and West Nile Virus (WNV)10,18.
The donor selection process, the fractionation process, the viral filtration step and the viral inactivation process increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses. Rho(D) Immune Globulin (Human) intended for intramuscular use and prepared by cold alcohol fractionation has not been shown to transmit hepatitis or other infectious diseases.19 There have been no documented cases of infectious disease transmission by RhoGAM or MICRhoGAM.
Laboratory spiking studies10,20 have shown that the cumulative viral removal and inactivation capability of the RhoGAM / MICRhoGAM manufacturing process is as follows:
| Virus | HIV | BVDV | PRV | PPV | EMC | WNV | HAV |
|---|---|---|---|---|---|---|---|
| Units = log10 reduction HIV Human Immunodeficiency Virus, Model for HIV-1 and 2 and Human T-cell Lymphotropic Virus (HTLV) 1 and 2 BVDV Bovine Viral Diarrhea Virus, Model for Hepatitis C Virus PRV Pseudorabies Virus, Model for Herpes Viruses PPV Porcine Parvovirus, Model for Parvovirus B19 EMC Encephalomyocarditis Virus, Model for Hepatitis A Virus WNV West Nile Virus HAV Hepatitis A Virus ND Not Determined N/A Not Applicable |
|||||||
| Lipid Enveloped | Yes | Yes | Yes | No | No | Yes | No |
| Size (nm) | 80-120 | 40-70 | 120-200 | 18-24 | 25-30 | 40-60 | 27-32 |
| Genome | SS-RNA | SS-RNA | DS-DNA | SS-DNA | SS-RNA | SS-RNA | SS-RNA |
| Fractionation | ≥ 7.98 | 7.29 | ≥ 11.74 | 8.30 | ND | ND | ND |
| Viral Filtration | ≥ 5.60 | 5.40 | ≥ 6.20 | 3.30 | 4.16 | ND | ≥ 5.07 |
| Viral Inactivation | ≥ 4.28 | ≥ 4.90 | ≥ 5.58 | N/A | N/A | ≥ 7.05 | N/A |
| Total Viral Reduction | ≥ 17.86 | ≥ 17.59 | ≥ 23.52 | 11.60 | 4.16 | ≥ 7.05 | ≥ 5.07 |
The safety of Rho(D) Immune Globulin (Human) has been further shown in an empirical study of viral marker rates in female blood donors in the United States.21 This study revealed that Rh-negative donors, of whom an estimated 55-60% had received Rho(D) Immune Globulin (Human) for pregnancy-related indications, had prevalence and incidence viral marker rates similar to those of Rh-positive female donors who had not received Rho(D) Immune Globulin (Human).
The final product contains 5 ± 1% IgG, 2.9 mg/mL sodium chloride, 0.01% Polysorbate 80 (non-animal derived) and 15 mg/mL glycine. Small amounts of IgA, typically less than 15 μg per dose, are present.10 The pH range is 6.20 - 7.00 and IgG purity is ≥ 98%. The product contains no added human serum albumin (HSA), no thimerosal or other preservatives and utilizes a latex-free delivery system.
RhoGAM Ultra-Filtered PLUS and MICRhoGAM Ultra-Filtered PLUS are manufactured and distributed by Ortho-Clinical Diagnostics, Inc., Raritan, NJ 08869.
Sources
Rhogam Ultra-filtered Plus Manufacturers
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Kedrion Melville, Inc.
![Rhogam Ultra-filtered Plus (Human Rho(D) Immune Globulin) Injection, Solution Micrhogam Ultra-filtered Plus (Human Rho(D) Immune Globulin) Injection, Solution [Kedrion Melville, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Rhogam Ultra-filtered Plus | Kedrion Melville, Inc.
For intramuscular use only. Do not inject RhoGAM Ultra-Filtered PLUS (RhoGAM) or MICRhoGAM Ultra-Filtered PLUS (MICRhoGAM) intravenously. In the case of postpartum use, the product is intended for maternal administration. Do not inject the newborn infant. Inject the entire contents of the syringe(s). For single use only. (See WARNINGS AND PRECAUTIONS)
RhoGAM or MICRhoGAM should be administered within 72 hours of delivery or known or suspected exposure to Rh-positive red blood cells. There is little information concerning the effectiveness of Rho(D) Immune Globulin (Human) when given beyond this 72 hour period. In one study, Rho(D) Immune Globulin (Human) provided protection against Rh immunization in about 50% of subjects when given 13 days after exposure to Rh-positive red blood cells.1 Administer every 12 weeks starting from first injection to maintain a level of passively acquired anti-D. If delivery occurs within three weeks after the last antepartum dose, the postpartum dose may be withheld, but a test for fetal-maternal hemorrhage should be performed to determine if exposure to > 15 mL of red blood cells has occurred.2
Parenteral drug products should be inspected visually for particulate matter, discoloration and syringe damage prior to administration. Do not use if particulate matter and / or discoloration are observed. The solution should appear clear or slightly opalescent.
2.1 Indications and Recommended Dosage Indication Dose Notes Postpartum (if the newborn is Rh-positive) RhoGAM
(300 μg)
(1500 IU) Additional doses of RhoGAM are indicated when the patient has been exposed to > 15 mL of Rh-positive red blood cells. This may be determined by use of qualitative or quantitative tests for fetal-maternal hemorrhage. Administer within 72 hours of delivery. Antepartum: Prophylaxis at 26 to 28 weeks gestation Administer within 72 hours of suspected or proven exposure to Rh-positive red blood cells resulting from: Amniocentesis, chorionic villus sampling (CVS) and percutaneous umbilical blood sampling (PUBS) Abdominal trauma or obstetrical manipulation Ectopic pregnancy Threatened pregnancy loss after 12 weeks gestation with continuation of pregnancy Pregnancy termination (spontaneous or induced) beyond 12 weeks gestation If antepartum prophylaxis is indicated, it is essential that the mother receive a postpartum dose if the infant is Rh-positive. If RhoGAM is administered early in pregnancy (before 26 to 28 weeks), there is an obligation to maintain a level of passively acquired anti-D by administration of RhoGAM at 12-week intervals. Actual or threatened termination of pregnancy (spontaneous or induced) up to and including 12 weeks gestation
Administer within 72 hours MICRhoGAM
(50 μg)
(250 IU) RhoGAM may be administered if MICRhoGAM is not available. Transfusion of Rh-incompatible blood or blood products Administer within 72 hours of suspected or proven exposure to Rh-positive red blood cells. < 2.5 mL Rh-positive red blood cells MICRhoGAM
(50 μg)
(250 IU) RhoGAM may be administered if MICRhoGAM is not available. 2.5 - 15.0 mL Rh-positive red blood cells RhoGAM
(300 μg)
(1500 IU) > 15.0 mL Rh-positive red blood cells RhoGAM
(300 μg)
(1500 IU)
(multiple syringes) Additional doses of RhoGAM are indicated when the patient has been exposed to > 15 mL of Rh-positive red blood cells.
Administer 20 μg of RhoGAM per mL of Rh-positive red blood cell exposure.
Multiple doses may be administered at the same time or at spaced intervals, as long as the total dose is administered within three days of exposure. 2.2 RhoGAM AdministrationEach single dose prefilled syringe of RhoGAM contains 300 μg (1500 IU) of Rho(D) Immune Globulin (Human). This is the dose for the indications associated with pregnancy at or beyond 13 weeks unless there is clinical or laboratory evidence of a fetal-maternal hemorrhage (FMH) in excess of 15 mL of Rh-positive red blood cells.
2.3 MICRhoGAM AdministrationEach single dose prefilled syringe of MICRhoGAM contains 50 μg (250 IU) of Rho(D) Immune Globulin (Human). This dose will suppress the immune response to up to 2.5 mL of Rh-positive red blood cells. MICRhoGAM is indicated within 72 hours after termination of pregnancy up to and including 12 weeks gestation. At or beyond 13 weeks gestation, RhoGAM should be administered instead of MICRhoGAM.
2.4 Multiple DosageMultiple doses of RhoGAM are required if a FMH exceeds 15 mL, an event that is possible but unlikely prior to the third trimester of pregnancy and is most likely at delivery. Patients known or suspected to be at increased risk of FMH should be tested for FMH by qualitative or quantitative methods.3 In efficacy studies, RhoGAM was shown to suppress Rh immunization in all subjects when given at a dose of ≥ 20 μg per mL of Rh-positive red blood cells.4 Thus, a single dose of RhoGAM will suppress the immune response after exposure to≤ 15 mL of Rh-positive red blood cells. However, in clinical practice, laboratory methods used to determine the amount of exposure (volume of transfusion or FMH) to Rh-positive red blood cells are imprecise.5,6 Therefore, administration of more than 20 μg of RhoGAM per mL of Rh-positive red blood cells should be considered whenever a large FMH or red blood cell exposure is suspected or documented.6 Multiple doses may be administered at the same time or at spaced intervals, as long as the total dose is administered within three days of exposure.7
2.5 Dosage FrequencyTo maintain an adequate level of anti-D, RhoGAM should be administered every 12 weeks. The exact timing for the injection is based on 12 week intervals starting from the administration of the first injection. If delivery of the baby does not occur 12 weeks after the administration of the standard antepartum dose (at 26 to 28 weeks), a second dose is recommended to maximize protection antepartum. If delivery occurs within three weeks after the last antepartum dose, the postpartum dose may be withheld, but a test for FMH should be performed to determine if exposure to > 15 mL of red blood cells has occurred.2
2.6 Administration Administer injection per standard protocol. Note: When administering an intramuscular injection, place fingers in contact with syringe barrel through windows in shield to prevent possible premature activation of safety guard. Slide safety guard over needle. After injection, use free hand to slide safety guard over needle. An audible "click" indicates proper activation. Keep hands behind needle at all times. Dispose of the syringe in accordance with local regulations.
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