Ultravist

•  Warnings and Precautions, Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age (
  5.6 Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age

  Thyroid dysfunction characterized by hypothyroidism or transient thyroid suppression has been reported after both single exposure and multiple exposures to iodinated contrast media (ICM) in pediatric patients 0 to 3 years of age.

  Younger age, very low birth weight, prematurity, underlying medial conditions affecting thyroid function, admission to neonatal or pediatric intensive care units, and congenital cardiac conditions are associated with an increased risk of hypothyroidism after ICM exposure. Pediatric patients with congenital cardiac conditions may be at the greatest risk given that they often require high doses of contrast during invasive cardiac procedures.

  An underactive thyroid during early life may be harmful for cognitive and neurological development and may require thyroid hormone replacement therapy. After exposure to ICM, individualize thyroid function monitoring based on underlying risk factors, especially in term and preterm neonates.

  The safety and effectiveness of ULTRAVIST in pediatric patients younger than 2 years of age have not been established, and ULTRAVIST is not approved for use in pediatric patients younger than 2 years of age

  [see Use in Specific Populations (

  8.4)].
  ) 4/2023

ULTRAVIST^® injection is an iodinated contrast agent indicated In

• •For Computed Tomography (CT) of the head and body (intrathoracic, intra-abdominal and retroperitoneal regions) for the evaluation of neoplastic and non-neoplastic lesions in adults.
• •The usefulness of contrast enhancement for the investigation of the retrobulbar space and of low grade or infiltrative glioma has not been demonstrated.

• •For Computed Tomography (CT) of the head and body

• •Individualize the volume and concentration of ULTRAVIST injection to be used for a vascular procedure, according to the specific dosing tables. Adjust the dose accounting for factors such as age, body weight, size of the vessel and the rate of blood flow within the vessel. (
  2.1 Important Administration Instructions

  • •ULTRAVIST IMAGING BULK PACKAGE is for intravenous use only not for direct infusion.
  • •Visually inspect ULTRAVIST injection for particulate matter and/or discoloration, whenever solution and container permit. Do not administer ULTRAVIST injection if particulate matter (including crystals) and/or discoloration is observed or if containers are defective. As ULTRAVIST injection is a highly concentrated solution, crystallization (milky-cloudy appearance and/or sediment at bottom, or floating crystals) may occur.
  • •Use sterile technique for all handling and administration of ULTRAVIST.
  • •Determine the volume and concentration of ULTRAVIST injection to be used considering factors such as age, body weight, size of the vessel and the rate of blood flow within the vessel; consider also extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed. Specific dose adjustments for age, gender, weight and renal function have not been studied for ULTRAVIST injection. As with all iodinated contrast agents, lower doses may have less risk. The efficacy of ULTRAVIST injection below doses recommended has not been established.
  • •Administer ULTRAVIST at or close to body temperature.

  Do not mix or inject ULTRAVIST injection in intravenous administration lines containing other drugs or total nutritional admixtures. ULTRAVIST can be mixed with saline when used in a power injector suitable for simultaneous injection of contrast and saline

  [see Dosage and Administration ]

  .

  • •The maximum recommended total dose of iodine in adults is 86 grams; a maximum recommended total dose of iodine has not been established for pediatric patients.
  • •Hydrate patients, as appropriate, prior to and following the administration of ULTRAVIST injection
    [see Warnings and Precautions ].
  ,
  2.2 Intravenous Procedures

  • •Computed Tomography (CT) (300 mg Iodine per mL and 370 mg Iodine per mL): see
    Table 1
    .

  Table 1: Suggested ULTRAVIST injection Dosing for Adult Intravenous Contrast Administration
  	Contrast Computed Tomography (300 mg Iodine per mL)	Contrast Computed Tomography (370 mg Iodine per mL)
  Head	50 ml to 200 mL	41 ml to 162 mL
  Body Single Contrast Phase
  Bolus Injection	50 ml to 200 mL	41 ml to 162 mL
  Rapid Infusion	100 ml to 200 mL	81 ml to 162 mL
  Body Multiple Phase Contrast	50 ml to 200 mL total volume Phase 1: 100% contrast Phase 2 : 20-60% contrast, using a power injector suitable for simultaneous injection of contrast and saline	41 ml to 162 mL total volume Phase 1: 100% contrast, Phase 2: 20-60% contrast, using a power injector suitable for simultaneous injection of contrast and saline
  Maximum Total Dose	200 mL (60 g iodine)	162 mL (60 g iodine)
  ,
  2.3 Pediatric Dosing

  The recommended dose in children over 2 years of age for Computerized Tomography of the head and body (300 mg Iodine per mL):

  • •1 to 2 milliliters per kilogram (mL/kg) injected intravenously.
  • •
    [see Use in Specific Populations and Clinical Pharmacology ]
    .

  Do not exceed the adult dose (200 mL)
  )
• •For Intravenous use, only (
  2.4 Imaging Bulk Package Preparation Instructions

  ULTRAVIST Imaging Bulk Package is for use only with an automated contrast injection system, contrast management system, or contrast media transfer set approved or cleared for use with this contrast agent in this Imaging Bulk Package. Please see drug and device labeling for information on devices indicated for use with this Imaging Bulk Package and techniques to help assure safe use.

  • 1.000000000000000e+00The ULTRAVIST Imaging Bulk Package is to be used only in a room designated for radiological procedures that involve intravascular administration of a contrast agent.
  • 2.000000000000000e+00Utilize aseptic technique for penetrating the container closure of the ULTRAVIST Imaging Bulk Package and transferring ULTRAVIST injection. The container closure may be penetrated only one time with a suitable sterile component of the automated contrast injection system, contrast management system, or contrast media transfer set approved or cleared for use with this contrast agent in this this Imaging Bulk Package.
  • 3.000000000000000e+00Once the ULTRAVIST Imaging Bulk Package is punctured, do not be remove it from the work area during the entire period of use. Maintain the bottle in an inverted position such that container contents are in continuous contact with the dispensing set.
  • 4.000000000000000e+00A maximum use time of 10 hours from initial puncture is permitted to complete fluid transfer. Discard any unused ULTRAVIST injection 10 hours after initial puncture of the Imaging Bulk Package.
  • 5.000000000000000e+00After the container closure is punctured, if the integrity of the Imaging Bulk Package and the delivery system cannot be assured through direct continuous supervision, the Imaging Bulk Package and all associated disposables for the automated contrast injection system, contrast management system, or contrast media transfer set should be discarded.
  • Storage temperature of Imaging Bulk Package after the closure has been entered should not exceed 25°C (77°F) excursions permitted to 15–30°C (59–86°F); however, it is desirable that the contents be warmed to body temperature prior to injection.
  )
• •Not for direct infusion (
  2.4 Imaging Bulk Package Preparation Instructions

  ULTRAVIST Imaging Bulk Package is for use only with an automated contrast injection system, contrast management system, or contrast media transfer set approved or cleared for use with this contrast agent in this Imaging Bulk Package. Please see drug and device labeling for information on devices indicated for use with this Imaging Bulk Package and techniques to help assure safe use.

  • 1.000000000000000e+00The ULTRAVIST Imaging Bulk Package is to be used only in a room designated for radiological procedures that involve intravascular administration of a contrast agent.
  • 2.000000000000000e+00Utilize aseptic technique for penetrating the container closure of the ULTRAVIST Imaging Bulk Package and transferring ULTRAVIST injection. The container closure may be penetrated only one time with a suitable sterile component of the automated contrast injection system, contrast management system, or contrast media transfer set approved or cleared for use with this contrast agent in this this Imaging Bulk Package.
  • 3.000000000000000e+00Once the ULTRAVIST Imaging Bulk Package is punctured, do not be remove it from the work area during the entire period of use. Maintain the bottle in an inverted position such that container contents are in continuous contact with the dispensing set.
  • 4.000000000000000e+00A maximum use time of 10 hours from initial puncture is permitted to complete fluid transfer. Discard any unused ULTRAVIST injection 10 hours after initial puncture of the Imaging Bulk Package.
  • 5.000000000000000e+00After the container closure is punctured, if the integrity of the Imaging Bulk Package and the delivery system cannot be assured through direct continuous supervision, the Imaging Bulk Package and all associated disposables for the automated contrast injection system, contrast management system, or contrast media transfer set should be discarded.
  • Storage temperature of Imaging Bulk Package after the closure has been entered should not exceed 25°C (77°F) excursions permitted to 15–30°C (59–86°F); however, it is desirable that the contents be warmed to body temperature prior to injection.
  )

ULTRAVIST injection is a nonionic, sterile, clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution of iopromide available as an Imaging Bulk Package in two strengths:

300 mg Iodine per mL provides 623.4 mg/mL iopromide

370 mg Iodine per mL provides 768.86 mg/mL iopromide

• •Lactation: Advise lactating women that interruption of breast feeding is not necessary, however, a lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk for 12 to 24 hours after ULTRAVIST Injection administration to minimize exposure to the breastfed infant (
  8.2 Lactation

  Risk Summary

  There are no data on the presence of iopromide 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 ULTRAVIST Injection and any potential adverse effects on the breastfed infant from ULTRAVIST Injection or from the underlying maternal condition (see Clinical Considerations).

  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 12 to 24 hours (approximately 5 elimination half-lives) after ULTRAVIST Injection administration in order to minimize drug exposure to a breast fed infant.
  )
• •The safety and efficacy of ULTRAVIST injection has been established in the pediatric population over 2 years of age. (
  8.4 Pediatric Use

  The safety and efficacy of ULTRAVIST injection 300 mg iodine per mL have been established in pediatric patients over 2 years of age for CT of the body and head. Use of ULTRAVIST injection in these age groups is supported by evidence from adequate and well controlled studies of ULTRAVIST injection in adults and additional safety data obtained in literature and other reports in a total of 274 pediatric patients. Of these, there were 131 children (2–12 years), 57 adolescents, and 86 children of unreported or other ages. There were 148 females, 94 males and 32 in whom gender was not reported. The racial distribution was: Caucasian 93 (33.9%), Black 1 (0.4%), Asian 6 (2.2%), and unknown 174 (63.5%). Eighty-seven of these patients were evaluated in intravenous contrast computerized tomography (CT) (n=87).

  In these pediatric patients, a concentration of 300 mg iodine per mL was employed for intravenous contrast CT. Most pediatric patients received initial volumes of 1–2 mL/kg.

  Optimal doses of ULTRAVIST injection have not been established because different injection volumes, concentrations and injection rates were not studied. The relationship of the volume of injection with respect to the size of the target vascular bed has not been established. The potential need for dose adjustment on the basis of immature renal function has not been established. In the pediatric population, the pharmacokinetic parameters have not been established.

  Pediatric patients at higher risk of experiencing an adverse reaction during and after administration of any contrast agent include those with asthma, a sensitivity to medication and/or allergens, cyanotic and acyanotic heart disease, congestive heart failure, or a serum creatinine greater than 1.5 mg/dL.

  Thyroid function tests indicative of thyroid dysfunction, characterized by hypothyroidism or transient thyroid suppression have been reported following iodinated contrast media administration in pediatric patients, including term and preterm neonates; some patients were treated for hypothyroidism. After exposure to iodinated contrast media, individualize thyroid function monitoring in pediatric patients 0 to 3 years of age based on underlying risk factors, especially in term and preterm neonates

  [see Warnings and Precautions (

  5.6) and Adverse Reactions ].

  The injection rates in small vascular beds, and the relationship of the dose by volume or concentration in small pediatric patients have not been established. Exercise caution in selecting the dose.

  The safety and effectiveness of ULTRAVIST injection 300 iodine per mL have not been established in pediatric patients below the age of two for CT of the body and head . The safety and effectiveness of ULTRAVIST injection 370 mg iodine per mL have not been established in pediatric patients of any age for CT of the body and head
  )