Gallium Ga-68 Edotreotide: uses, dosing, side effects & brands

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…

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Non-radioactive somatostatin analogs bind to the same somatostatin receptors as Ga 68 DOTATOC Injection. Image patients with Ga 68 DOTATOC Injection just prior to dosing with long-acting analogs of somatostatin. Short-acting analogs of somatostatin can be used up to 24 hours before imaging with Ga 68 DOTATOC Injection [see Dosage and Administration (2.3) ] . Somatostatin Analogs: Somatostatin analogs competitively bind to the same somatostatin receptors as Ga 68 DOTATOC Injection and may affect imaging –Discontinue short-acting somatostatin analogs 24 hours before imaging with Ga 68 DOTATOC and image just prior to dosing with long-acting somatostatin analogs ( 2.3 , 7 )