Radiographic Contrast Agent

Isovue-128

Approved 31 Dec 1985InjectionInjectable

Indications

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 )

Contraindications

None. None ( 4 )

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 )

5.1Hypersensitivity 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 develop shortly after the start of injection (e.g., within 1 to 3 minutes), but delayed reactions can also occur. There is increased risk of hypersensitivity reactions in patients with a history of previous reactions to contrast agents, and known allergic disorders (i.e., bronchial asthma, allergic rhinitis, and food allergies) or other hypersensitivities.

Premedication with antihistamines or corticosteroids does not prevent serious life-threatening reactions, but may reduce their incidence and severity. Obtain a history of allergy or hypersensitivity reactions to iodinated contrast agents and always have emergency resuscitation equipment and trained personnel available prior to ISOVUE-M administration. Monitor all patients for hypersensitivity reactions.

At a glance

Brand name: Isovue-128
Active substance: iopamidol
Pharmacologic class: Radiographic Contrast Agent
Route: Injection
Dosage form: Injectable
Applicant: Bracco
Status: Discontinued
FDA approval: 31 Dec 1985
Application: NDA018735-005

Indications

( 2.2 , 2.3 )

Warnings and precautions

( 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 )

5.1Hypersensitivity Reactions

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 .

6.1Clinical 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

6.2Postmarketing 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

Isovue-128

Indications

Contraindications

Warnings and precautions

5.1Hypersensitivity Reactions

At a glance

Two medicines in one question?

Isovue-128

Indications

Contraindications

Warnings and precautions

5.1Hypersensitivity Reactions

At a glance

Two medicines in one question?

5.2Acute Kidney Injury

5.3Increased Risk of Seizures Focal

5.4Cardiovascular Adverse Reactions

5.5Thyroid Storm in Patients with Hyperthyroidism

5.6Thyroid Dysfunction in Pediatric Patients 0 Years to 3 Years of Age

5.7Hypertensive Crisis in Patients with Pheochromocytoma

5.8Sickle Cell Crisis in Patients with Sickle Cell Disease

5.9Severe Cutaneous Adverse Reactions

5.10Interference with Laboratory Test

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Official product information