ISOVUE-M

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE ISOVUE-M is indicated for: Lumbar and thoracic myelography, and computed tomography (CT) myelography in adults and pediatric patients aged 2 years and older Cervical and total columnar myelography and CT myelography in adults CT cisternography in adults Specific concentrations of ISOVUE-M are recommended for each type of imaging procedure [see Dosage and Administration ( 2.2 , 2.3 )]. ISOVUE-M is a radiographic contrast agent indicated for: Lumbar and thoracic myelography and computed tomography (CT) myelography in adults and pediatric patients aged 2 years and older Cervical and total columnar myelography in adults CT cisternography in adults ( 1 ) Specific concentrations of ISOVUE-M are recommended for each type of imaging procedure. ( 2.2 , 2.3 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION Individualize the volume and concentration of ISOVUE-M according to the specific dosing tables based on patient age, body weight, and study to be performed. ( 2.2 , 2.3 ) See full prescribing information for important dosage and administration information. ( 2.1 ) 2.1 Important Dosage and Administration Information ISOVUE-M is for intrathecal use only. Specific concentrations of ISOVUE-M are recommended for each type of imaging procedure [see Dosage and Administration ( 2.2 , 2.3 )]. Individualize the volume, concentration, and injection rate of ISOVUE-M according to the dosing tables [see Dosage and Administration ( 2.2 , 2.3 )]. Consider factors such as age, body weight, anticipated pathology and degree and extent of opacification required, structure(s) or area to be examined, concomitant medical conditions, and imaging equipment and technique to be employed. Hydrate patients prior to and following ISOVUE-M administration [see Warnings and Precautions ( 5.2) ] . Use aseptic technique for all handling and administration of ISOVUE-M. ISOVUE-M may be administered at either body temperature (37°C, 98.6°F) or room temperature (20°C to 25°C, 68°F to 77°F). Visually inspect ISOVUE-M for particulate matter and discoloration prior to administration whenever the solution and container permit. Do not administer ISOVUE-M if particulate matter or discoloration are observed. Do not mix ISOVUE-M with other drugs. ISOVUE-M is packaged in a single-dose vial and intended for one procedure only. Discard any unused portion. 2.2 Recommended Dosage for Intrathecal Procedures in Adults The recommended doses in adults are shown in Table 1 . Administer over 1 minute to 2 minutes. Allow at least 48 hours before repeat administration to avoid overdose; however, whenever possible, 5 days to 7 days is recommended. If CT myelography is performed, delay imaging by at least 4 hours to reduce the degree of contrast. Table 1: Recommended Concentrations and Volumes of ISOVUE-M for Intrathecal Procedures in Adults Imaging Procedure Concentration (mg Iodine/mL) Volume to Administer Injection Type Lumbar and thoracic myelography 200 10 mL to 15 mL Lumbar Cervical myelography 200 10 mL to 15 mL Lumbar 10 mL Lateral cervical 300 10 mL Lumbar Total columnar myelography 300 10 mL Lumbar CT cisternography 200 4 mL to 6 mL Lumbar 2.3 Recommended Dosage for Intrathecal Procedures in Pediatric Patients Aged 2 Years and Older The recommended doses based on age for pediatric patients aged 2 years and older are shown in Table 2. Administer over 1 minute to 2 minutes. Allow at least 48 hours before repeat administration to avoid overdose; however, whenever possible, 5 days to 7 days is recommended. If CT myelography is performed, delay imaging by at least 4 hours to reduce the degree of contrast. Table 2: Recommended Concentrations and Volumes of ISOVUE-M Based on Age for Intrathecal Procedures in Pediatric Patients Aged 2 Years and Older Imaging Procedure Age Concentration (mg Iodine/mL) Volume to Administer Injection Type Lumbar and thoracic myelography 2 years to 7 years 200 7 mL to 9 mL Lumbar 8 years to 12 years 8 mL to 11 mL Lumbar 13 years and older 10 mL to 12 mL Lumbar Warnings and cautions 5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Life-threatening or fatal reactions can occur. Always have emergency resuscitation equipment and trained personnel available. ( 5.1 ) Acute Kidney Injury: Acute injury including renal failure can occur. Use the lowest dose and maintain adequate hydration to minimize risk. ( 5.2 ) Cardiovascular Adverse Reactions: Hemodynamic disturbances including shock and cardiac arrest may occur during or after ISOVUE-M administration. ( 5.4 ) Thyroid Dysfunction in Pediatric Patients 0 Years to 3 Years of Age: Individualize thyroid function monitoring based on risk factors such as prematurity. ( 5.6 ) 5.1 Hypersensitivity Reactions ISOVUE-M can cause life-threatening or fatal hypersensitivity reactions including anaphylaxis. Manifestations include respiratory arrest, laryngospasm, bronchospasm, angioedema, and shock [see Adverse Reactions ( 6.2 )] . Most severe reactions d