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
- anaphylactoid reactions
- anxiety
- apnea
- bradycardia
- cardiac arrest
- chest pain (unspecified)
- cough
- cyanosis
- diaphoresis
- diarrhea
- dizziness
- dysgeusia
- dysphagia
- dyspnea
- edema
- fever
- flushing
- gingivitis
- headache
- hearing loss
- hypersalivation
- hypertension
- hypotension
- injection site reaction
- laryngeal edema
- maculopapular rash
- malaise
- nausea
- nephrogenic systemic fibrosis (nephrogenic fibrosing dermopathy)
- paresthesias
- PR prolongation
- pruritus
- rash
- renal failure (unspecified)
- rhinitis
- seizures
- sinus tachycardia
- syncope
- tinnitus
- tremor
- urinary incontinence
- urticaria
- vomiting
- wheezing
- 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.
