Visipaque

VISIPAQUE is indicated in for:

• Individualize the combination of volume and concentration of VISIPAQUE Injection considering age, body weight, size of the vessel, rate of blood flow within the vessel, and other applicable factors. (
  2.1 Important Dosage and Administration Instructions

  • VISIPAQUE is for intravascular use only
    [see Boxed Warning, Contraindications (4), and Warnings and Precautions (5.1)]
  • Use sterile technique for all handling and administration of VISIPAQUE.
  • Do not use if tamper-evident ring is broken or missing.
  • Warm VISIPAQUE and administer at body or room temperature.
  • Inspect VISIPAQUE for particulate matter or discoloration before administration, whenever solution and container permit. Do not administer if VISIPAQUE contains particulate matter or is discolored.
  • Do not mix VISIPAQUE with, or inject in intravenous lines containing, other drugs or total nutritional admixtures.
  • Use the lowest dose necessary to obtain adequate visualization.
  • Individualize the volume, strength, and rate of administration of VISIPAQUE. Consider factors such as age, bodyweight, vessel size, blood flow rate within the vessel, anticipated pathology, degree and extent of opacification required, structures or area to be examined, disease processes affecting the patient, and equipment and technique to be employed.
  • The maximum recommended total dose of iodine for adults is 80 grams.
  • Avoid extravasation when injecting VISIPAQUE; especially in patients with severe arterial or venous disease
    [see Warnings and Precautions (5.6)].
  • Hydrate patients before and after VISIPAQUE administration
    [see Warnings and Precautions (5.3)].
  ,
  2.2 Intra-Arterial Dosage and Administration

  • Intra-arterial digital subtraction angiography
    (IA-DSA) (270 and 320 mg Iodine/mL)
  • Angiocardiography (left ventriculography and selective coronary arteriography), peripheral arteriography, visceral arteriography, and cerebral arteriography
    (320 mg Iodine/mL)

  Use Injection rates approximately equal to the flow rate in the vessel being injected. The usual single injection volumes or total dose per patient (mL/kg) for adults and adolescents over 12 years of age are listed in Table 1.

  TABLE 1 ADULTS and PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER VISIPAQUE SINGLE DOSE RECOMMENDATIONS FOR INJECTION INTO SELECTED ARTERIES

  	ARTERIOGRAPHY	IA-DSAIA-DSA = Intra-Arterial Digital Subtraction Angiography		Maximum Total Dose
  Intra-Arterial Injection Sites	320 mg Iodine/mL	270 mg Iodine/mL	320 mg Iodine/mL
  Carotid Arteries	10 to 14 mL		5 to 8 mL	Usually Not to Exceed 175 mL
  Vertebral Arteries	10 to 12 mL		5 to 8 mL
  Right Coronary Artery	3 to 8 mL			Usually Not to Exceed 200 mL
  Left Coronary Artery	3 to 10 mL
  Left Ventricle	20 to 45 mL
  Renal Arteries	8 to 18 mL	10 to 25 mL	--	Usually Not to Exceed 250 mL
  Aortography	30 to 70 mL	20 to 50 mL	10 to 50 mL
  Major Branches of Aorta	10 to 70 mL	5 to 30 mL	2 to 10 mL
  Aortofemoral Runoffs	20 to 90 mL	--	6 to 15 mL
  Peripheral Arteries	15 to 30 mL	--	3 to 15 mL
  ,
  2.3 Intravenous Dosage and Administration

  • Computed Tomography of the Head or Body
    (270 mg Iodine/mL and 320 mg Iodine/mL)
  • Excretory Urography
    (270 mg Iodine/mL and 320 mg Iodine/mL)
  • Peripheral Venography
    (270 mg Iodine/mL)
  • Coronary Computed Tomography Angiography (CCTA)
    (320 mg Iodine/mL)

  Recommended dosage of VISIPAQUE is dependent on: the administration procedure, patient weight, and CT device factors, as detailed in Table 2. Calibrate the intravenous injection rate so that image acquisition coincides with peak arterial concentration. The time between VISIPAQUE injection and peak arterial concentration varies between patients. Selected dosing for different indications in adults and pediatric patients over 12 years of age are shown in Table 2.

  TABLE 2 ADULTS and PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER VISIPAQUE DOSING RECOMMENDATIONS FOR INTRAVENOUS CONTRAST ADMINISTRATION

  Study Type	Comment	270 mg Iodine/mL	320 mg Iodine/mL	Maximum Total Volume
  CT of Head or BodyFor CT of the head and body, VISIPAQUE may be used with an automated contrast injection system or contrast media management system cleared for use with VISIPAQUE.	Bolus Infusion	75 to 150 mL 100 to 150 mL	75 to 150 mL 100 to 150 mL	150 mL
  Excretory Urography	Normal Renal Function	1 mL/kg	1 mL/kg	100 mL
  Venography	Per lower extremity	50 to 150 mL		250 mL
  CCTA ,For pediatric patients aged 12 to 17, recommended dose is 1 to 2 mL/kg.	Bolus injection with test bolusThe main VISIPAQUE volume may be preceded by a test bolus consisting of 20 mL VISIPAQUE, immediately followed by a 20 mL saline flush, both injected at rate of 4 to 7 mL/sec.or bolus tracking		50 to 150 mLInjection of VISIPAQUE with saline can be either biphasic (without dilution phase) or triphasic (with dilution phase). Alternatively, a dose of 1 mL/kg may be used to calculate total VISIPAQUE dose (excluding any test bolus). For CCTA acquired at < 120 kVp, the dose of VISIPAQUE may be reduced by up to 15% in patients < 85 kg and BMI < 30 kg/m2. For CCTA acquired on a scanner with more than 64 detector rows, the dose of VISIPAQUE may be reduced in proportion to the scan duration. (4 to 7 mL per second)	150 mL
  ,
  2.4 Dosage in Pediatric Patients Less Than 12 Years of Age

  Intra-arterial Dosage and Administration

  Angiocardiography, cerebral arteriography, or visceral arteriography

  (320 mg Iodine/mL)

  :

  The recommended dosage is 1 to 2 mL/kg. The maximum dose should not exceed 4 mL/kg.

  Intravenous Dosage and Administration

  Computerized Tomography or Excretory Urography

  (270 mg Iodine/mL)

  :

  The recommended dosage is 1 to 2 mL/kg. The maximum dose should not exceed 2 mL/kg.
  )
• For CT of the head and body, VISIPAQUE may be used with an automated contrast injection system or contrast media management system cleared for use with VISIPAQUE. (
  2.5 Instructions for Use with an Automated Contrast Injection System or Contrast Management System for CT of the Head and Body

  • VISIPAQUE may be used with an automated contrast injection system cleared for use with contrast media.
    • See above Important Dosage and Administration Instructions for VISIPAQUE (2.1).
    • See device labeling for information on device indications, instructions for use, and techniques to help assure safe use.
  • VISIPAQUE 320 mg Iodine/mL in 100 mL and 150 mL bottles may be used with a contrast media management system cleared for use with VISIPAQUE 320 in 100 mL and 150 mL bottles.
    • See device labeling for information on device indications, instructions for use, and techniques to help assure safe use.
    • Use sterile technique for penetrating the container closure of VISIPAQUE 320 and transferring VISIPAQUE solution. Clean the stopper with a pad soaked in sporicidal solution followed by a pad soaked in alcohol, then puncture the stopper. The container closure may be penetrated only one time with a suitable sterile component of the contrast media management system cleared for use with VISIPAQUE 320 in 100 mL and 150 mL bottles.
    • Once the VISIPAQUE 320 Injection is punctured do not remove the bottle from the work area during the entire period of use.
    • Maximum use time is 4 hours after initial puncture.
    • Each bottle is for one procedure only. Discard unused portion.
  )
• For the adult patients, the maximum recommended total dose of iodine is 80 grams. (
  2.1 Important Dosage and Administration Instructions

  • VISIPAQUE is for intravascular use only
    [see Boxed Warning, Contraindications (4), and Warnings and Precautions (5.1)]
  • Use sterile technique for all handling and administration of VISIPAQUE.
  • Do not use if tamper-evident ring is broken or missing.
  • Warm VISIPAQUE and administer at body or room temperature.
  • Inspect VISIPAQUE for particulate matter or discoloration before administration, whenever solution and container permit. Do not administer if VISIPAQUE contains particulate matter or is discolored.
  • Do not mix VISIPAQUE with, or inject in intravenous lines containing, other drugs or total nutritional admixtures.
  • Use the lowest dose necessary to obtain adequate visualization.
  • Individualize the volume, strength, and rate of administration of VISIPAQUE. Consider factors such as age, bodyweight, vessel size, blood flow rate within the vessel, anticipated pathology, degree and extent of opacification required, structures or area to be examined, disease processes affecting the patient, and equipment and technique to be employed.
  • The maximum recommended total dose of iodine for adults is 80 grams.
  • Avoid extravasation when injecting VISIPAQUE; especially in patients with severe arterial or venous disease
    [see Warnings and Precautions (5.6)].
  • Hydrate patients before and after VISIPAQUE administration
    [see Warnings and Precautions (5.3)].
  )
• Patients should be adequately hydrated prior to and following the intravascular administration of iodinated contrast agents. (
  2.1 Important Dosage and Administration Instructions

  • VISIPAQUE is for intravascular use only
    [see Boxed Warning, Contraindications (4), and Warnings and Precautions (5.1)]
  • Use sterile technique for all handling and administration of VISIPAQUE.
  • Do not use if tamper-evident ring is broken or missing.
  • Warm VISIPAQUE and administer at body or room temperature.
  • Inspect VISIPAQUE for particulate matter or discoloration before administration, whenever solution and container permit. Do not administer if VISIPAQUE contains particulate matter or is discolored.
  • Do not mix VISIPAQUE with, or inject in intravenous lines containing, other drugs or total nutritional admixtures.
  • Use the lowest dose necessary to obtain adequate visualization.
  • Individualize the volume, strength, and rate of administration of VISIPAQUE. Consider factors such as age, bodyweight, vessel size, blood flow rate within the vessel, anticipated pathology, degree and extent of opacification required, structures or area to be examined, disease processes affecting the patient, and equipment and technique to be employed.
  • The maximum recommended total dose of iodine for adults is 80 grams.
  • Avoid extravasation when injecting VISIPAQUE; especially in patients with severe arterial or venous disease
    [see Warnings and Precautions (5.6)].
  • Hydrate patients before and after VISIPAQUE administration
    [see Warnings and Precautions (5.3)].
  ,
  5.3 Contrast-Induced Acute Kidney Injury

  Acute kidney injury, including renal failure, may occur after VISIPAQUE administration. Risk factors include: pre-existing renal impairment, dehydration, diabetes mellitus, congestive heart failure, advanced vascular disease, elderly age, concomitant use of nephrotoxic or diuretic medications, multiple myeloma / paraproteinaceous diseases, repetitive and/or large doses of an iodinated contrast agent.

  Use the lowest necessary dose of VISIPAQUE in patients with renal impairment. Adequately hydrate patients prior to and following VISIPAQUE administration. Do not use laxatives, diuretics, or preparatory dehydration prior to VISIPAQUE administration.
  )
• See full prescribing information for complete dosing and administration information. (
  2 DOSAGE AND ADMINISTRATION

  • Individualize the combination of volume and concentration of VISIPAQUE Injection considering age, body weight, size of the vessel, rate of blood flow within the vessel, and other applicable factors.
  • For CT of the head and body, VISIPAQUE may be used with an automated contrast injection system or contrast media management system cleared for use with VISIPAQUE.
  • For the adult patients, the maximum recommended total dose of iodine is 80 grams.
  • Patients should be adequately hydrated prior to and following the intravascular administration of iodinated contrast agents.
  • See full prescribing information for complete dosing and administration information.

  2.1 Important Dosage and Administration Instructions

  • VISIPAQUE is for intravascular use only
    [see Boxed Warning, Contraindications (4), and Warnings and Precautions (5.1)]
  • Use sterile technique for all handling and administration of VISIPAQUE.
  • Do not use if tamper-evident ring is broken or missing.
  • Warm VISIPAQUE and administer at body or room temperature.
  • Inspect VISIPAQUE for particulate matter or discoloration before administration, whenever solution and container permit. Do not administer if VISIPAQUE contains particulate matter or is discolored.
  • Do not mix VISIPAQUE with, or inject in intravenous lines containing, other drugs or total nutritional admixtures.
  • Use the lowest dose necessary to obtain adequate visualization.
  • Individualize the volume, strength, and rate of administration of VISIPAQUE. Consider factors such as age, bodyweight, vessel size, blood flow rate within the vessel, anticipated pathology, degree and extent of opacification required, structures or area to be examined, disease processes affecting the patient, and equipment and technique to be employed.
  • The maximum recommended total dose of iodine for adults is 80 grams.
  • Avoid extravasation when injecting VISIPAQUE; especially in patients with severe arterial or venous disease
    [see Warnings and Precautions (5.6)].
  • Hydrate patients before and after VISIPAQUE administration
    [see Warnings and Precautions (5.3)].

  2.2 Intra-Arterial Dosage and Administration

  • Intra-arterial digital subtraction angiography
    (IA-DSA) (270 and 320 mg Iodine/mL)
  • Angiocardiography (left ventriculography and selective coronary arteriography), peripheral arteriography, visceral arteriography, and cerebral arteriography
    (320 mg Iodine/mL)

  Use Injection rates approximately equal to the flow rate in the vessel being injected. The usual single injection volumes or total dose per patient (mL/kg) for adults and adolescents over 12 years of age are listed in Table 1.

  TABLE 1 ADULTS and PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER VISIPAQUE SINGLE DOSE RECOMMENDATIONS FOR INJECTION INTO SELECTED ARTERIES

  	ARTERIOGRAPHY	IA-DSAIA-DSA = Intra-Arterial Digital Subtraction Angiography		Maximum Total Dose
  Intra-Arterial Injection Sites	320 mg Iodine/mL	270 mg Iodine/mL	320 mg Iodine/mL
  Carotid Arteries	10 to 14 mL		5 to 8 mL	Usually Not to Exceed 175 mL
  Vertebral Arteries	10 to 12 mL		5 to 8 mL
  Right Coronary Artery	3 to 8 mL			Usually Not to Exceed 200 mL
  Left Coronary Artery	3 to 10 mL
  Left Ventricle	20 to 45 mL
  Renal Arteries	8 to 18 mL	10 to 25 mL	--	Usually Not to Exceed 250 mL
  Aortography	30 to 70 mL	20 to 50 mL	10 to 50 mL
  Major Branches of Aorta	10 to 70 mL	5 to 30 mL	2 to 10 mL
  Aortofemoral Runoffs	20 to 90 mL	--	6 to 15 mL
  Peripheral Arteries	15 to 30 mL	--	3 to 15 mL

  2.3 Intravenous Dosage and Administration

  • Computed Tomography of the Head or Body
    (270 mg Iodine/mL and 320 mg Iodine/mL)
  • Excretory Urography
    (270 mg Iodine/mL and 320 mg Iodine/mL)
  • Peripheral Venography
    (270 mg Iodine/mL)
  • Coronary Computed Tomography Angiography (CCTA)
    (320 mg Iodine/mL)

  Recommended dosage of VISIPAQUE is dependent on: the administration procedure, patient weight, and CT device factors, as detailed in Table 2. Calibrate the intravenous injection rate so that image acquisition coincides with peak arterial concentration. The time between VISIPAQUE injection and peak arterial concentration varies between patients. Selected dosing for different indications in adults and pediatric patients over 12 years of age are shown in Table 2.

  TABLE 2 ADULTS and PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER VISIPAQUE DOSING RECOMMENDATIONS FOR INTRAVENOUS CONTRAST ADMINISTRATION

  Study Type	Comment	270 mg Iodine/mL	320 mg Iodine/mL	Maximum Total Volume
  CT of Head or BodyFor CT of the head and body, VISIPAQUE may be used with an automated contrast injection system or contrast media management system cleared for use with VISIPAQUE.	Bolus Infusion	75 to 150 mL 100 to 150 mL	75 to 150 mL 100 to 150 mL	150 mL
  Excretory Urography	Normal Renal Function	1 mL/kg	1 mL/kg	100 mL
  Venography	Per lower extremity	50 to 150 mL		250 mL
  CCTA ,For pediatric patients aged 12 to 17, recommended dose is 1 to 2 mL/kg.	Bolus injection with test bolusThe main VISIPAQUE volume may be preceded by a test bolus consisting of 20 mL VISIPAQUE, immediately followed by a 20 mL saline flush, both injected at rate of 4 to 7 mL/sec.or bolus tracking		50 to 150 mLInjection of VISIPAQUE with saline can be either biphasic (without dilution phase) or triphasic (with dilution phase). Alternatively, a dose of 1 mL/kg may be used to calculate total VISIPAQUE dose (excluding any test bolus). For CCTA acquired at < 120 kVp, the dose of VISIPAQUE may be reduced by up to 15% in patients < 85 kg and BMI < 30 kg/m2. For CCTA acquired on a scanner with more than 64 detector rows, the dose of VISIPAQUE may be reduced in proportion to the scan duration. (4 to 7 mL per second)	150 mL

  2.4 Dosage in Pediatric Patients Less Than 12 Years of Age

  Intra-arterial Dosage and Administration

  Angiocardiography, cerebral arteriography, or visceral arteriography

  (320 mg Iodine/mL)

  :

  The recommended dosage is 1 to 2 mL/kg. The maximum dose should not exceed 4 mL/kg.

  Intravenous Dosage and Administration

  Computerized Tomography or Excretory Urography

  (270 mg Iodine/mL)

  :

  The recommended dosage is 1 to 2 mL/kg. The maximum dose should not exceed 2 mL/kg.

  2.5 Instructions for Use with an Automated Contrast Injection System or Contrast Management System for CT of the Head and Body

  • VISIPAQUE may be used with an automated contrast injection system cleared for use with contrast media.
    • See above Important Dosage and Administration Instructions for VISIPAQUE (2.1).
    • See device labeling for information on device indications, instructions for use, and techniques to help assure safe use.
  • VISIPAQUE 320 mg Iodine/mL in 100 mL and 150 mL bottles may be used with a contrast media management system cleared for use with VISIPAQUE 320 in 100 mL and 150 mL bottles.
    • See device labeling for information on device indications, instructions for use, and techniques to help assure safe use.
    • Use sterile technique for penetrating the container closure of VISIPAQUE 320 and transferring VISIPAQUE solution. Clean the stopper with a pad soaked in sporicidal solution followed by a pad soaked in alcohol, then puncture the stopper. The container closure may be penetrated only one time with a suitable sterile component of the contrast media management system cleared for use with VISIPAQUE 320 in 100 mL and 150 mL bottles.
    • Once the VISIPAQUE 320 Injection is punctured do not remove the bottle from the work area during the entire period of use.
    • Maximum use time is 4 hours after initial puncture.
    • Each bottle is for one procedure only. Discard unused portion.
  )

Injection: Non-ionic, isotonic, water-soluble, sterile, pyrogen-free, colorless to pale yellow solution in the following strengths:

• 270 mg of organically bound iodine per mL (550 mg Iodixanol per mL)
• 320 mg of organically bound iodine per mL (652 mg Iodixanol per mL)

Available in the following format: Single-dose polymer bottle (+

• Lactation: A lactating woman may pump and discard breast milk for 10 hours after VISIPAQUE administration. (
  8.2 Lactation

  Risk Summary

  There are no data on the presence of iodixanol in human milk, the effects on the breastfed infant or the effects on milk production. Iodinated contrast agents are poorly excreted into human milk and are poorly absorbed by the gastrointestinal tract of a breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for VISIPAQUE and any potential adverse effects on the breastfed infant from VISIPAQUE or from the underlying maternal condition.

  Clinical Considerations

  Interruption of breastfeeding after exposure to iodinated contrast agents is not necessary because the potential exposure of the breastfed infant to iodine is small. However, a lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk for 10 hours (approximately 5 elimination half-lives) after VISIPAQUE administration in order to minimize drug exposure to a breast fed infant.
  )
• Geriatrics: Exercise caution in dose selection for elderly patients. (
  8.5 Geriatric Use

  In clinical studies of VISIPAQUE, 254/757 (34%) of patients were 65 and over. No overall differences in safety or effectiveness were observed between these patients and younger patients. Other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. In general, dose selection for an elderly patient should be cautious usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
  )