FDA label fb625515-a4a0-4d3b-8f4a-5de7705be9aa

5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions: Hypersensitivity reactions including anaphylaxis and urticaria have occurred. Always have cardiopulmonary resuscitation personnel and equipment readily available and monitor patients. ( 5.1 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions including anaphylaxis, urticaria and deaths due to anaphylaxis have been reported following intravenous administration of indocyanine green [see Adverse Reactions ( 6.2 )] . SPY AGENT GREEN is contraindicated in patients with a history of hypersensitivity to indocyanine green [see Contraindications ( 4 )] . Always have cardiopulmonary resuscitation personnel and equipment readily available and monitor all patients for hypersensitivity reactions. 5.2 Interference with Thyroid Radioactive Iodine Uptake Studies Because SPY AGENT GREEN contains iodine, the iodine-binding capacity of thyroid tissue may be reduced for at least one week following administration [see Drug Interactions ( 7 )] .

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] . Lymphatic mapping of breast cancers: Most common adverse reactions were skin and injection site discoloration in two patients (1.4%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Stryker Corp. at 1-800-624-4422 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials 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. Lymphatic Mapping of Breast Cancer In an open-label, single arm, clinical trial, 151 patients with breast cancer received a single dose of 0.25 mg SPY AGENT GREEN intradermally into the peri-areolar area. Five patients received a subsequent peri-tumoral injection of 0.375 mg intradermally in addition to the peri-areolar dose of 0.25 mg [see Clinical Studies ( 14.2 )]. Skin discoloration including injection site discoloration were reported in two patients (1.4%). 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of indocyanine green products including SPY AGENT GREEN. 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. Immune System Disorders: Anaphylaxis, urticaria.