isosulfanblue.mylan.comlsosulfan Blue Injection 1%| Mylan

PRESCRIBING INFORMATION IMPORTANT SAFETY INFORMATION ORDERING INFORMATION US HEALTHCARE PROFESSIONALS US HEALTHCARE PROFESSIONALS PRESCRIBING INFORMATION IMPORTANT SAFETY INFORMATION Why consider Isosulfan Blue? ADMINISTRATION ORDERING INFORMATION US HEALTHCARE PROFESSIONALS US HEALTHCARE PROFESSIONALS Why consider Isosulfan Blue? ADMINISTRATIONWhen you trust the only commercially available FDA-approved blue dye indicated for sentinel lymph node mapping, the results are illuminating! 1,2When you trust the only commercially available FDA-approved blue dye indicated for sentinel lymph node mapping, the results are illuminating! 1,2 Isosulfan Blue injection 1% has been used in sentinel lymph node mapping for more than 30 years. * Isosulfan Blue injection has exceptionally high purity of at least 99%. † INDICATION: lsosulfan Blue Injection 1% upon subcutaneous administration, delineates lymphatic vessels draining the region of injection. It is an adjunct to lymphography in: primary and secondary lymphedema of the extremities; chyluria, chylous ascites or chylothorax; lymph node involvement by primary or secondary neoplasm; and lymph node response to therapeutic modalities.Efficacy profile highlights Isosulfan Blue Injection 1% offers clinicians a ready-to-inject blue dye, with no reconstitution or dilution required prior to administration. For Subcutaneous Use Only.Administration highlights Isosulfan blue injection 1% is to be administered subcutaneously, one-half (1/2) mL into three (3) interdigital spaces of each extremity per study. A maximum dose of 3 mL (30 mg) isosulfan blue is, therefore, injected. Overall incidence of hypersensitivity reaction in approximately 2% of patients, including life-threatening anaphylactic reactions. In a study of 543 patients, 1% receiving Isosulfan Blue experienced an allergic reaction, all of whom recovered within 1 hour with no or minimal symptomatic therapy. 3 Trained personnel should be available to carry out emergency care, including resuscitation, for at least 60 minutes after administration. Adverse skin reactions include transient or long-term (tattooing) blue coloration. No drug interactions have been reported in the full Prescribing Information. Postmarketing cases report drug interactions with chronic preoperative use of angiotensin-converting enzyme inhibitors and angiotensin receptor blocking agents. πPlease see Indications and Important Safety Information * Lymphazurin is a registered trademark of Covidien LP, but this product is not currently commercially available. † Purity of the active pharmaceutical ingredient as determined by high-performance liquid chromatography (HPLC). ‡ In the study by Hirsch and colleagues, the 543 patients who received Isosulfan Blue (Lymphazurin ® ) were divided into 3 groups according to the clinical indication for the lymphangiogram. Group 1 (n=508) included patients with possible lymph node involvement by primary or secondary malignancy; group 2 (n=28) included patients with possible primary lymphatic disease; and group 3 (n=7) included patients with chyluria, chylous ascites or chylothorax. Inadequate identification of lymphatics occurred in 5, 9 and 0 patients in groups 1, 2 and 3, respectively. References x † Lymphazurin is a registered trademark of Covidien LP, but this product is not currently commercially available.‡ IMS Health Procedure Data (December 2015).§ In the study by Hirsch and colleagues, the 543 patients who received Isosulfan Blue (Lymphazurin ® ) were divided into 3 groups according to the clinical indication for the lymphangiogram. Group 1 (n=508) included patients with possible lymph node involvement by primary or secondary malignancy; group 2 (n=28) included patients with possible primary lymphatic disease; and group 3 (n=7) included patients with chyluria, chylous ascites or chylothorax. Inadequate identification of lymphatics occurred in 5, 9 and 0 patients in groups 1, 2 and 3, respectively. (Hirsch JI, Tisnado J, Cho SR, Beachley MC. Use of isosulfan blue for identification of lymphatic vessels: experimental and clinical evaluation. AJR Am J Roentgenol. 1982;139(6):1061-1064). ¥ Purity of the active pharmaceutical ingredient as determined by high-performance liquid chromatography (HPLC). π ISOSULPHAN BLUE 1% Injection package insert. Morgantown, WV: Mylan Institutional LLC; 9/2020.1) Data on File. IMS DATA. July 2021. 2) Isosulfan Blue Injection, Prescribing Information, 2022. Mylan Pharmaceuticals Inc., Morgantown, WV. 3) Hirsch JI, Tisnado J, Cho SR, Beachley MC. Use of isosulfan blue for identification of lymphatic vessels: experimental and clinical evaluation. AJR Am J Roentgenol. 1982;139(6):1061-1064. Mylan.comVIATRIS and the Viatris Logo are trademarks of Mylan Inc., a Viatris Company. © 2022 Viatris Inc. All Rights Reserved. ISB-2021-0001 V2 TERMS OF USE PRIVACY NOTICE CONTACT US CALIFORNIA SUPPLEMENTAL DISCLOSURE STATEMENT COOKIE NOTICE MORE LESS IMPORTANT SAFETY INFORMATION INDICATION lsosulfan Blue Injection 1% upon subcutaneous administration, delineates lymphatic vessels draining the region of injection. It is an adjunct to lymphography in: primary and secondary lymph edema of the extremities; chyluria, chylous ascites or chylothorax; lymph node involvement by primary or secondary neoplasm; and lymph node response to therapeutic modalities.Isosulfan blue injection 1% is contraindicated in those individuals with known hypersensitivity to triphenylmethane or related compounds. Life-threatening anaphylactic reactions have occurred after isosulfan blue injection 1% administration. Reactions are more likely to occur in patients with a history of bronchial asthma, allergies, drug reactions or previous reactions to triphenylmethane dyes or related compounds. Monitor patients closely for at least 60 minutes after administration and have trained personnel available to administer emergency care including resuscitation. lsosulfan blue interferes with measurements of oxygen saturation in peripheral blood by pulse oximetry and can cause falsely low readings. The interference effect is maximal at 30 minutes and minimal generally by 4 hours after administration. Arterial blood gas analysis may be needed to verify decreased arterial partial pressure of oxygen.Isosulfan blue interferes with measurements of oxygen saturation in peripheral blood by pulse oximetry and can cause falsely low readings. The interference effect is maximal at 30 minutes and minimal generally by 4 hours after administration. Arterial blood gas analysis may be needed to verify decreased arterial partial pressure of oxygen. Do not mix isosulfan blue with local anesthetics in the same syringe as this results in immediate precipitation. Isosulfan blue injection 1% may also cause falsely elevated readings of methemoglobin by arterial blood gas analyzer. Therefore, cooximetry may be needed to verify methemoglobin level. In post-marketing experience, hypersensitivity reactions have occurred in approximately 2% of patients. Transient or long-term (tattooing) blue coloration has been reported. Click here for Full Prescribing Information . INDICATION Isosulfan Blue Injection 1% upon subcutaneous administration, delineates lymphatic vessels draining the region of injection. It is an adjunct to lymphography in: primary and secondary lymphedema of the extremities; chyluria, chylous ascites or chylothorax; lymph node involvement by primary or secondary neoplasm; and lymph node response to therapeutic...