FDA label 49141106-ddc5-4245-a688-bdac3d6d5361

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.

5 WARNINGS AND PRECAUTIONS Do not inject intravenously. ( 5.1 ) In the case of postpartum use, the product is intended for maternal use only. ( 5.1 ) Do not inject the newborn infant. ( 5.1 ) May carry a risk of transmitting infectious agents because it is made from human plasma. ( 5.2 ) Administer with caution to patients who have had prior severe systemic allergic reactions to human immune globulin. ( 5.1 ) Contains a small quantity of immunoglobulin A (IgA), there is a potential risk of hypersensitivity in IgA deficient individuals. ( 5.1 ) Patients treated for Rh-incompatible transfusion should be monitored by clinical and laboratory means for signs and symptoms of a hemolytic reaction. ( 5.1 ) 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. 5.2 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. 5.3 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

6 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. Most common are: Injection site reactions that include swelling, induration, redness and mild pain or warmth. ( 6 ) Systemic reactions that include skin rash, body aches or a slight elevation in temperature. Patients should be observed for at least 20 minutes after administration. Severe systemic allergic reactions are extremely rare. ( 6 ) Anti-D formation is rarely reported after proper administration of RhoGAM. ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact: Ortho-Clinical Diagnostics, Inc. at 1-800-421-3311 in the United States. Outside of the United States, the company distributing these products should be contacted. Voluntary reporting of adverse reactions may also be made to the FDA through MedWatch at 1-800-FDA-1088 or on the Internet at www.fda.gov/medwatch.