Ultravist

•  Warning 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 medical 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 ]

  .
  ) 4/2023

ULTRAVIST^® Injection is an iodinated contrast agent indicated for:

• •ULTRAVIST PHARMACY BULK PACKAGE is not for direct infusion.
• •Visually inspect ULTRAVIST for particulate matter and/or discoloration, whenever solution and container permit. Do not administer ULTRAVIST if particulate matter (including crystals) and/or discoloration is observed or 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 taking into account 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 ]
  .

ULTRAVIST Injection is a nonionic, sterile, clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution of iopromide, containing 2.42 mg/mL tromethamine buffer and 0.1 mg/mL edetate calcium disodium stabilizer.

ULTRAVIST Injection PHARMACY BULK PACKAGE is available 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 have been established in the pediatric population over 2 years of age. (
  8.4 Pediatric Use

  The safety and efficacy of ULTRAVIST Injection have been established in the pediatric population over 2 years of age. 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%). These patients were evaluated in intra-arterial coronary angiographic (n=60), intravenous contrast computerized tomography (CT) (n=87), excretory urography (n=99) and 28 other procedures.

  In these pediatric patients, a concentration of 300 mg Iodine per mL was employed for intravenous contrast CT or excretory urography. A concentration of 370 mg Iodine per mL was employed for intra-arterial and intracardiac administration in the radiographic evaluation of the heart cavities and major arteries. 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.

  Safety and effectiveness in pediatric patients below the age of two have not been established.
  )