Ga-68-DOTATOC

5 WARNINGS AND PRECAUTIONS Radiation Risk: Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure Advise patients to hydrate before and after administration and to void frequently after administration ( 2.1 , 2.3 , 5.1 ) Hypersensitivity Reactions: Most reported reactions were rash and pruritus and reversible either spontaneously or with routine symptomatic management. ( 5.2 ) Risk for Image Misinterpretation: Uptake of Ga 68 DOTATOC injection can be seen in a variety of tumor types that contain somatostatin receptors, and in other pathologic conditions, and as a normal physiologic variant (e.g. uncinate process of the pancreas) ( 5.3 ) 5.1 Radiation Risk Ga 68 DOTATOC Injection contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration [see Dosage and Administration (2.1 , 2.3 )] . 5.2 Hypersensitivity Reactions Hypersensitivity reactions following administration of somatostatin receptor imaging agents predominantly consisted of cutaneous reactions such as rash and pruritus. Reactions reversed either spontaneously or with routine symptomatic management. Less frequently hypersensitivity reactions included angioedema or cases with features of anaphylaxis. 5.3 Risk for Image Misinterpretation The uptake of Ga 68 DOTATOC Injection reflects the level of somatostatin receptor density in NETs, however, uptake can also be seen in a variety of other tumors that also express somatostatin receptors. Increased uptake might also be seen in other non-cancerous pathologic conditions that express somatostatin receptors including thyroid disease or in subacute inflammation, or might occur as a normal physiologic variant (e.g. uncinate process of the pancreas) [see Dosage and Administration (2.5) ] . A negative scan after the administration of Ga 68 DOTATOC Injection in patients who do not have a history of NET disease does not rule out disease [see Clinical Studies (14) ] .

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity reactions Reported adverse reactions include: Nausea, pruritis, and flushing. To report SUSPECTED ADVERSE REACTIONS, contact the UIHC – P E T Imaging Center at 1-319-356-1092 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch ( 6 ) 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Ga-68 DOTATOC injection was evaluated in 334 patients in clinical trials of patients receiving a single dose of Ga-68 DOTATOC injection for imaging known or suspected NET. The following adverse reactions occurred at a rate of < 2%: Gastrointestinal Disorders : nausea The following adverse reactions occurred at a rate of a < 1% Skin and Subcutaneous Tissue Disorders: pruritus Vascular Disorders : flushing 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of other somatostatin receptor imaging agents. 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 the drug. Immune System Disorders : Hypersensitivity reactions , predominantly rash, pruritus, less frequently angioedema or features of anaphylaxis