DRAXIMAGE MAA

5 WARNINGS AND PRECAUTIONS Patients with Pulmonary Hypertension: Administer the lowest number of particles possible and have emergency resuscitation equipment available. (5.1) Hypersensitivity Reactions: Have emergency resuscitation equipment and trained personnel available. Interrupt the administration if a reaction occurs during administration. Monitor patients. (5.2) Risk of Temporary Impediment to Blood Flow in Patients with Right-to-Left Heart Shunts: Administer the lowest possible number of particles. (5.3) Radiation Risks: Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. (5.4) 5.1 Patients with Pulmonary Hypertension Deaths have been reported in patients with severe pulmonary hypertension after the administration of technetium Tc 99m albumin aggregated products [see Adverse Reactions (6)]. Assess patients for history or signs of pulmonary hypertension. DRAXIMAGE MAA is contraindicated in patients with severe pulmonary hypertension [see Contraindications (4)]. Administer the lowest number of particles possible, have emergency resuscitation equipment available, and monitor patients for adverse reactions. 5.2 Hypersensitivity Reactions Serious hypersensitivity reactions including anaphylaxis have been reported in patients treated with products containing albumin human, including DRAXIMAGE MAA [see Adverse Reactions (6)]. Obtain a history of allergy or hypersensitivity reactions. DRAXIMAGE MAA is contraindicated in patients with a history of hypersensitivity to albumin human [see Contraindications (4)] . Have emergency resuscitation equipment and trained personnel available prior to administration of Technetium Tc 99m Albumin Aggregated Injection. Monitor all patients for signs or symptoms of hypersensitivity reactions. 5.3 Risk of Temporary Impediment to Blood Flow in Patients with Right-to-Left Heart Shunts In patients with right-to-left heart shunts, risk for temporary mechanical impediment to blood flow may exist due to the rapid entry of aggregated albumin into the systemic circulation. Administer the lowest possible number of particles of Technetium Tc 99m Albumin Aggregated Injection in these patients. 5.4 Radiation Risks Technetium Tc 99m albumin aggregated contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration [see Dosage and Administration (2.2)].

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Patients with Pulmonary hypertension [see Warnings and Precautions (5.1)]. Hypersensitivity Reactions [see Warnings and Precautions (5.2)]. The following adverse reactions associated with the use of technetium Tc 99m albumin aggregated products including DRAXIMAGE MAA were identified in clinical studies or postmarketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular Disorders : Deaths in patients with severe pulmonary hypertension Immune System Disorders : Hypersensitivity reactions such as anaphylaxis, impairment of cardiac and circulatory functions in the form of changes in respiration, pulse, and blood pressure, chest pain and syncope, urticaria, reddening of the face, sweating, and nausea Skin and Subcutaneous Tissue Disorders : Injection site reactions The following adverse reactions have been reported: Death in patients with severe pulmonary hypertension, anaphylaxis, impairment of cardiac and circulatory functions in the form of changes in respiration, pulse, and blood pressure, chest pain, and possible syncope, urticaria, reddening of the face, sweating, nausea, and injection site reaction. (6) To report SUSPECTED ADVERSE REACTIONS, contact Jubilant DraxImage Inc. at 1-888-633-5343 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .