Gadoteridol

Gadoteridol Brand Name– Prohance

What is Gadoteridol

Gadoteridol is a nonionic, paramagnetic contrast agent indicated for magnetic resonance imaging (MRI) of the central nervous system (CNS) to visualize lesions with abnormal vascularity in adults and pediatric patients 2 years and older. In adults, gadoteridol is also indicated for use during MRI to visualize lesions in the extracranial or extraspinal tissues of the head and neck.

Approval was based on the results of 2 clinical trials involving 133 adults with an indication for head and neck extracranial or extraspinal MRI, and 1 trial involving 103 pediatric patients with an indication for brain or spine MRI.

In adult trials, gadoteridol-enhanced MRI imaging was used in 75% to 82% of the scans and provided additional diagnostic information in 45% to 48% of the scans; diagnosis was changed in 8% to 25% of the scans.

In the pediatric trial, gadoteridol enhanced 60% of the MRI scans and provided additional diagnostic information in 30% to 95% of the scans. Like all gadolinium-based contrast agents (GBCAs), gadoteridol carries a black box warning for nephrogenic systemic fibrosis (NSF).

NSF is a serious condition that may result in fatal or debilitating fibrosis of the skin, muscle, and internal organs.

The propensity to cause NSF differs among available GBCAs; most unconfounded cases have been reported with gadodiamide, gadopentetate dimeglumine, and gadoversetamide

Indications

  • magnetic resonance imaging (MRI)

For use with magnetic resonance imaging (MRI) to enhance visualization of lesions with abnormal vascularity within the central nervous system (CNS) or extracranial/extraspinal tissues of the head and neck

for visualization of lesions within the CNS

Side Effects

  1. anaphylactoid reactions
  2. anxiety
  3. apnea
  4. bradycardia
  5. cardiac arrest
  6. chest pain (unspecified)
  7. cough
  8. cyanosis
  9. diaphoresis
  10. diarrhea
  11. dizziness
  12. dysgeusia
  13. dysphagia
  14. dyspnea
  15. edema
  16. fever
  17. flushing
  18. gingivitis
  19. headache
  20. hearing loss
  21. hypersalivation
  22. hypertension
  23. hypotension
  24. injection site reaction
  25. laryngeal edema
  26. maculopapular rash
  27. malaise
  28. nausea
  29. nephrogenic systemic fibrosis (nephrogenic fibrosing dermopathy)
  30. paresthesias
  31. PR prolongation
  32. pruritus
  33. rash
  34. renal failure (unspecified)
  35. rhinitis
  36. seizures
  37. sinus tachycardia
  38. syncope
  39. tinnitus
  40. tremor
  41. urinary incontinence
  42. urticaria
  43. vomiting
  44. wheezing
  45. xerostomia

Monitoring Parameters

  • serum creatinine/BUN

Contraindications

  • asthma
  • atopy
  • breast-feeding
  • diabetes mellitus
  • geriatric
  • hemolytic anemia
  • hypertension
  • magnetic resonance imaging (MRI)
  • nephrogenic systemic fibrosis (nephrogenic fibrosing dermopathy)
  • pregnancy
  • radiopaque contrast media hypersensitivity
  • renal disease
  • renal failure
  • renal impairment
  • seizure disorder
  • sickle cell disease

Interactions

There are no drug interactions associated with Gadoteridol products.