Dosing and uses of ProHance (gadoteridol)
Adult dosage forms and strengths
injectable solution
- 279.3mg/mL
CNS MRI
0.2 mL/kg (0.1 mmol/kg) IV; may administer as second dose of 0.4 mL/kg (0.2 mmol/kg); may be repeated once within 30 min of the first dose
Extrascranial/Extraspinal Tissue
Usually 0.2 mL/kg (0.1 mmol/kg) IV bolus or rapid infusion (10-60 mL/min)
Pediatric dosage forms and strengths
injectable solution
- 279.3mg/mL
CNS MRI
<2 years: Safety and efficacy not established
>2 years: As adults; 0.2 mL/kg IV bolus or rapid infusion (10-60 mL/min)
Warnings
Black box warnings
Risk for nephrogenic systemic fibrosis (NSF) with acute or chronic renal insufficiency (GFR <30 mL/min/1.73 sq.m, hepatorenal syndrome, or acute renal insufficiency resulting from perioperative liver transplant
NSF affects internal organs, skin, and muscle and can be fataL
Only use if essential and MRI cannot not provide appropriate diagnostic image
Screen for renal dysfunction, do not exceed recommended dosage, and allow for drug elimination before giving subsequent doses
Contraindications
Hypersensitivity
Cautions
Caution in hyperthyroidism, pheochromocytoma, renal/hepatic impairment
Therapy in patients with sickle cell anemia not studied
Screen patients for kidney disease before use and monitor renal function afterward; nephrogenic systemic fibrosis (NSF) associated with use of gadolinium contrast media in patients with kidney disease; do not exceed recommended dose
Brain deposits
- 7/28/2015: FDA is investigating the risk of brain deposits following repeated use of gadolinium-based contrast agents (GBCAs) for MRI
- Recent publications in the medical literature have reported that deposits of GBCAs remain in the brains of some patients who undergo ≥4 contrast MRI scans, long after the last administration
- It is unknown whether these gadolinium deposits are harmful or can lead to adverse health effects
- Early data in rat studies show that linear GBCAs are more prone to dissociation into free gadolinium and demonstrate greater brain deposition than macrocyclic GBCAs, which are less prone to dissociation
Pregnancy and lactation
Pregnancy category: C
Lactation: not known if excreted in breast milk, use caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of ProHance (gadoteridol)
Mechanism of action
Paramagnetic agent; exposure to external magnetic field in gadopentetate may induce a large magnetic field. The local magnetism may change proton density and spin characteristics, which it is then detected by the imaging device
Pharmacokinetics
Half-Life: 1.5 hr
Vd: 204 mL/kg
Excretion: Urine (~94%)
