pharmaceuticals [2.5:15.0 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. RhoGAM Administration Each single dose prefilled syringe of RhoGAM contains 300 μg (1500 IU) of Rh o (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. MICRhoGAM Administration Each single dose prefilled syringe of MICRhoGAM contains 50 μg (250 IU) of Rh o (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. Multiple Dosage Multiple 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 Dosage Frequency To 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 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. Dosage Forms and Strengths RhoGAM Ultra-Filtered PLUS - 300 μg (1500 IU) 1 Prefilled Syringes MICRhoGAM Ultra-Filtered PLUS - 50 μg (250 IU) 1 Prefilled Syringes 1 The anti-D content of RhoGAM / MICRhoGAM is expressed as μg per dose or as International Units (IU) per dose. The conversion factor is 1 μg = 5 IU. 8 Contraindications The use of RhoGAM and MICRhoGAM is contraindicated in Rh-positive individuals. Warnings and Precautions 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. Use of Plasma Derived Products RhoGAM and MICRhoGAM are made from human plasma and may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically the Creutzfeldt-Jakob disease (CJD) agent. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing plasma for the presence of certain current virus infections and by using pathogen removal and inactivation techniques during the manufacturing process. All of the above steps are designed to increase product safety by reducing the risk of pathogen transmission. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. All infections thought by a physician possibly to have been transmitted by these products should be reported by the physician or other healthcare provider in the United States to Ortho-Clinical Diagnostics, Inc. at 1-800-421-3311. Outside the United States, the company distributing these products should be contacted. The physician should discuss the risks and benefits of these products with the patient. Laboratory Tests Recovery of anti-D in plasma or serum after injection of RhoGAM or other Rh o (D) Immune Globulin (Human) products is highly variable among individuals. Anti-D detection in a patient's plasma is dependent on assay sensitivity and time of sample collection post-injection. Currently there are no requirements or practice standards to test for the presence of anti-D in order to determine adequacy or efficacy of dose following an injection of RhoGAM. The presence of passively acquired anti-D in the maternal serum may cause a positive antibody screening test. This does not preclude further antepartum or postpartum prophylaxis. Some babies born to women given Rh o (D) Immune Globulin (Human) antepartum have weakly positive direct antiglobulin (Coombs) tests at birth. Fetal-maternal hemorrhage may cause false blood typing results in the mother. Late in pregnancy or following delivery, there may be sufficient fetal Rh-positive red blood cells in the circulation of the Rh-negative mother to cause a positive antiglobulin test for weak D (Du). In this instance if there is any doubt as to the patient's Rh type, RhoGAM or MICRhoGAM should be administered. 9 Adverse Reactions Adverse events (AE) after administration of RhoGAM and MICRhoGAM are rare. The most frequently reported AEs are anti-D formation and injection site reactions, such as swelling, induration, redness and mild pain or warmth. Possible systemic reactions are skin rash, body aches or a slight elevation in temperature. Severe systemic allergic reactions are extremely rare. Patients should be observed for at least 20 minutes after administration. There have been no reported fatalities due to anaphylaxis or any other cause related to RhoGAM or MICRhoGAM administration. As with any Rh o (D) Immune Globulin (Human), administration to patients who are Rh-positive or have received Rh-positive red blood cells may result in signs and symptoms of a hemolytic reaction, including fever, back pain, nausea and vomiting, hypo- or hypertension, hemoglobinuria/emia, elevated bilirubin and creatinine and decreased haptoglobin. RhoGAM and MICRhoGAM contain a small quantity of IgA (less than 15 μg per dose). 10 Although high doses of intravenous immune globulin containing IgA at levels of 270-720 μg/mL have been given without incident during treatment of patients with high-titered antibodies to IgA, 11 the attending physician must weigh the benefit against the potential risks of hypersensitivity reactions. Drug Interactions Immune globulin preparations including Rh o (D) Immune Globulin (Human) may impair the efficacy of live vaccines such as measles, mumps and varicella. Administration of live vaccines should generally be delayed until 12 weeks after the final dose of immune globulin. If an immune globulin is administered within 14 days after administration of a live vaccine, the immune response to the vaccination may be inhibited. 12 Because of the importance of rubella immunity among women of childbearing age, the postpartum vaccination of rubella-susceptible women with rubella or MMR vaccine should not be delayed because of the receipt of Rh o (D) Immune Globulin (Human) during the last trimester of pregnancy or at delivery. Vaccination should occur immediately after delivery and if possible, testing should be performed after 3 or more months to ensure immunity to rubella and if necessary, to measles. 12 USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with RhoGAM or MICRhoGAM. The available evidence suggests that Rh o (D) Immune Globulin (Human) does not harm the fetus or affect future pregnancies or the reproduction capacity of the maternal recipient. 13,14 Rh Blood Type RhoGAM or MICRhoGAM Rh o (D) Immune Globulin (Human) should only be administered to Rh-negative patients exposed or potentially exposed to Rh-positive red blood cells to prevent Rh immunization. Overdosage Repeated administration or increased dosage in Rh-negative individuals should not cause more severe or more frequent adverse reactions than the normal dose. Patients who receive RhoGAM or MICRhoGAM for Rh-incompatible transfusion should be monitored by clinical and laboratory means due to the risk of a hemolytic reaction. RhoGAM Ultra-Filtered PLUS Description RhoGAM and MICRhoGAM Rh o (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 Rh o (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 10 4 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 (Patent Pending). 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. Rh o (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 studies 10,20 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 = log 10 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 Rh o (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 Rh o (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 Rh o (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 - 6.55 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. RhoGAM Ultra-Filtered PLUS - Clinical Pharmacology Mechanism of Action RhoGAM and MICRhoGAM act 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 Rh o (D) Immune Globulin (Human) products are not effective in altering the course or consequences of Rh immunization once it has occurred. Pharmacokinetic Properties Pharmacokinetic studies after intramuscular injection were performed on sixteen Rh-negative subjects receiving a single dose of (368 μg or 1840 IU) RhoGAM. 10 Plasma anti-D levels were monitored for thirteen weeks using a validated Automated Quantitative Hemagglutination method with sensitivity of approximately 1 ng/mL. The following mean pharmacokinetic parameters were obtained from data collected over the first ten weeks of a thirteen-week study: Parameter Mean SD Units Maximum plasma concentration obtained (Cmax) 54.0 13.0 ng/mL Time to attain Cmax (Tmax) 4 days Elimination half-life (T1/2) 30.9 13.8 days Volume of distribution (Vd) 7.3 1.5 liters Clearance (CL) 150.4 53.3 mL/day Obstetrical Use The Rh-negative obstetrical patient may be exposed to red blood cells from her Rh-positive fetus during the normal course of pregnancy or after obstetrical procedures or abdominal trauma. Use after Rh-Incompatible Transfusion An Rh-negative individual transfused with one unit of Rh-positive red blood cells has about an 80% likelihood of producing anti-D. 4 However, Rh immunization can occur after exposure to]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Manufacturer Kedrion Biopharma, Inc. Drug Class Immune globulins Related Drugs immune globulins Gammagard , RhoGAM , Hizentra , Synagis , Gamunex , Privigen Idiopathic Thrombocytopenic Purpura prednisone , triamcinolone , dexamethasone , Decadron , Deltasone , cortisone , Promacta , Kenalog-40 , Gammagard , RhoGAM , Privigen , More... Rh-Isoimmunization RhoGAM , MICRhoGAM , WinRho SDF , Rhophylac , More... RhoGAM Ultra-Filtered Plus Rating No Reviews - Be the first! No Reviews - Be the first! 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