Micro-dose for use only after spontaneous or induced abortion or termination of ectopic pregnancy up to and including 12 weeks' gestation.
Rx Only
For Intramuscular Injection Only
MICRhoGAM Rh o (D) Immune Globulin (Human) is a sterile solution containing IgG anti-D(RH1) for use in preventing Rh immunization. A single dose of MICRhoGAM contains sufficient anti-D(RH1) (approximately 50 µg) ** to suppress the immune response to 2.5 mL (or less) of Rh positive red blood cells.
All donors are carefully screened to reduce the risk of transmitting disease from individuals in high-risk groups. Fractionation of the plasma is performed by a modification of the cold alcohol procedure. Following fractionation, a viral-clearance filtration step is incorporated into the manufacturing process. This filtration step removes viruses via a size-exclusion mechanism utilizing a patented Viresolve * 180 ultrafiltration membrane with defined pore-size distribution. The filter is inert to the product. This virus removal process has been shown in laboratory spiking studies to reduce the levels of some viruses ranging from 18 to 200 nm in size, including enveloped viruses as well as non-enveloped viruses. Non-enveloped viruses are known to be resistant to chemical and physical inactivation.
The final product contains approximately 5±1% gamma globulin, 2.9 mg/mL sodium chloride, 0.01% polysorbate 80 and 0.003% thimerosal (mercury derivative), with glycine (15 mg/mL) as a stabilizer.
This product is for intramuscular injection only.
** A full dose of Rh o (D) Immune Globulin (Human) has traditionally been referred to as a "300 µg" dose and this usage is employed here for convenience in terminology. It should not be construed as the actual anti-D content. Each full dose of Rh o (D) Immune Globulin (Human) must contain at least as much anti-D as 1 milliliter of the U.S. Reference Rh o (D) Immune Globulin (Human). Studies performed at the Food and Drug Administration have shown that the U.S. Reference contains 820 international units (IU) of anti-D per milliliter. When the conversion factor determined for the International (WHO) Reference Preparation is used, 820 IU per milliliter is equivalent to 164 µg per milliliter of anti-D. MICRhoGAM contains approximately one-sixth the amount of anti-D contained in the full dose.
*Viresolve is a trademark of Millipore Corporation.
Intramuscular Rh o (D) human immune globulins prepared by cold alcohol fractionation have not been reported to transmit hepatitis or other infectious diseases.
MICRhoGAM acts by suppressing the immune response of Rh negative individuals to Rh positive red blood cells. The risk of immunization is related to the number of D positive red blood cells received. The risk was found to be 3% when 0.1 mL of fetal red blood cells is present in the mother and 65% when 5 mL is present. In the first 12 weeks of gestation, the total volume of red blood cells in the fetus is estimated at less than 2.5 mL.
Clinical studies demonstrated that administration of MICRhoGAM within three (3) hours following abortion was 100% effective in preventing Rh immunization. Studies showed MICRhoGAM to be effective when given as long as 72 hours after the infusion of Rh positive red cells. A lesser degree of protection is afforded if the antibody is administered beyond this time period.
MICRhoGAM is indicated for an Rh negative woman following spontaneous or induced abortion or termination of ectopic pregnancy up to and including 12 weeks' gestation, unless the father can be shown conclusively to be Rh negative.
MICRhoGAM must not be used for any indication with continuation of pregnancy. RhoGAM® Rh o (D) Immune Globulin (Human) is recommended for any indication beyond 12 weeks' gestation.
Individuals known to have had an anaphylactic or severe systemic reaction to human globulin should not receive MICRhoGAM or any other Rh o (D) Immune Globulin (Human).
Do not inject intravenously.
MICRhoGAM is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, and theoretically the Creutzfeldt-Jakob disease (CJD) agent, that can cause disease. 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 for the presence of certain current viral infections and by removing certain viruses during the manufacturing process. Following fractionation, a viral-clearance filtration step is incorporated into the manufacturing process. This filtration step removes viruses via a size-exclusion mechanism utilizing a patented Viresolve 180 ultrafiltration membrane with defined pore-size distribution. The filter is inert to the product. This virus removal process has been shown in laboratory spiking studies to reduce the levels of some viruses ranging from 18 to 200 nm in size, including enveloped viruses as well as non-enveloped viruses. 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 this product should be reported by the physician or other healthcare provider in the U.S. to Ortho-Clinical Diagnostics, Inc. at 1-800-322-6374. Outside of the U.S., the company distributing this product should be contacted. The physician should discuss the risks and benefits of this product with the patient.
Animal reproduction studies have not been conducted with MICRhoGAM. It is also not known whether Rh o (D) Immune Globulin (Human) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Rh o (D) Immune Globulin (Human) should be given to a pregnant woman only if clearly needed.
Systemic reactions associated with administration of MICRhoGAM are extremely rare. Discomfort at the site of injection has been reported and a small number of women have noted a slight elevation in temperature.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
A single dose (approximately 50 µg) *** is contained in each prefilled syringe of MICRhoGAM. This will completely suppress the immune response to 2.5 mL of Rh positive red blood cells (packed cells, not whole blood).
Administer MICRhoGAM intramuscularly as soon as possible after termination of a pregnancy up to and including 12 weeks' gestation. At or beyond 13 weeks' gestation, it is recommended that a single dose of RhoGAM be given instead of MICRhoGAM. Do not inject intravenously.
MICRhoGAM is available in packages containing:
5 prefilled single-dose syringes of MICRhoGAM
(Product Code 780805) NDC 0562-7808-05
5 package inserts
5 control forms
5 patient identification cards
and
25 prefilled single-dose syringes of MICRhoGAM
(Product Code 780825) NDC 0562-7808-25
25 package inserts
25 control forms
25 patient identification cards
Store at 2 to 8°C. Do not store frozen.