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 )

6 ADVERSE REACTIONS The following adverse reactions are described in greater detail in other sections: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Acute Kidney Injury [see Warnings and Precautions ( 5.2 )] Increased Risk of Seizures [see Warnings and Precautions ( 5.3 )] Cardiovascular Adverse Reactions [see Warnings and Precautions ( 5.4 )] Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age [see Warnings and Precautions ( 5.6 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.9 )] Most common adverse reactions (incidence > 1%) are headache, nausea, vomiting, back pain, leg pain, neck pain, and hypotension.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bracco Diagnostics Inc.

at 1-800-257-5181 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.

The safety of ISOVUE-M was evaluated in 686 adult patients receiving ISOVUE-M intrathecally in clinical studies.

Table 3 shows the common adverse reactions (>1%).

These reactions usually occur 1 to 10 hours after injection, almost all occurring within 24 hours.

Table 3: Adverse Reactions Reported in >1% of Patients Receiving Intrathecal Injection of ISOVUE-M in Clinical Studies Adverse Reaction ISOVUE-M (N=686) % Headache 16.4 Nausea 7.3 Vomiting 3.6 Back pain 2.2 Leg Pain 1.4 Neck Pain 1.1 Hypotension 1.1 The following additional adverse reactions occurred in ≤ 1% of patients receiving intrathecal injection of ISOVUE-M: Cardiovascular disorder: tachycardia, hypertension, chest pain Gastrointestinal: diarrhea, heartburn General disorders and administration site conditions: pyrexia, muscle weakness, hot flashes, malaise, fatigue, weakness, injection site pain Musculoskeletal: leg cramps, sciatica, cervicobrachial irritation, meningeal irritation, radicular irritation lumbosacral, other musculoskeletal pain, involuntary movement, burning sensation Nervous system: dizziness, paresthesia, confusion, hallucinations, lightheadedness, syncope, numbness, cold extremities, ataxia, irritability Urogenital: urinary retention Respiratory: dyspnea Skin and subcutaneous tissues : rash 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of ISOVUE-M and other iopamidol products.

Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure.

Blood and lymphatic system disorders: thrombocytopenia Cardiovascular disorders: cardiopulmonary arrest, cardiac decompensation, arrhythmias, myocardial infarction, shock, electrocardiographic changes (e.g., increased QTc, increased R-R, increased T-wave amplitude), decreased systolic pressure, deep vein thrombosis, arterial spasms, transient ischemic attack, flushing, vasodilation, chest pain, pallor Endocrine disorders: hyperthyroidism, hypothyroidism Eye disorders: lacrimation increased, conjunctivitis, eye pruritus, transient blindness, visual disturbance, photophobia Gastrointestinal disorders: retching, abdominal pain, salivary hypersecretion, salivary gland enlargement General disorders and administration site conditions: chills, malaise Immune system disorders: anaphylaxis characterized by cardiovascular, respiratory, and cutaneous manifestations (e.g., chest tightness, laryngeal edema, periorbital edema, facial edema); delayed hypersensitivity reactions including generalized maculopapular rash, erythema, pruritus, localized blistering, skin peeling Infections and infestations: meningitis aseptic, meningitis bacterial as consequence of the procedural hazard Musculoskeletal disorders: muscle spasm, musculoskeletal pain, muscular weakness Nervous system: coma, seizure, tremors, syncope, cerebral edema, paralysis, depressed level of consciousness or loss of consciousness, meningism, encephalopathy Psychiatric disorders: disorientation, agitation, restlessness, confusional state Respiratory system disorders: respiratory arrest, respiratory failure, acute respiratory distress syndrome, respiratory distress, apnea, asthma, sneezing, choking, laryngeal edema, bronchospasm, rhinitis Skin and subcutaneous tissue disorders : Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP), erythema multiforme and drug reaction with eosinophilia and systemic symptoms (DRESS), skin necrosis, face edema