Dosing and uses of Ablavar (gadofosveset)
Adult dosage forms and strengths
injectable solution
- 244mg/mL
MRI Contrast
MRI contrast agent for visualisation of abdominal or limb vessels
0.12 mL/kg (0.03 mmoL/kg) IV bolus
Administer over period up to 30 sec; follow by 25-30 mL NS flush; infusion rate not to exceed 1.5 mL/seconds
Pediatric dosage forms and strengths
Safety and efficacy not established
Ablavar (gadofosveset) adverse (side) effects
1-10%
Pruritus (5%)
Headache (4%)
Nausea (4%)
Paresthesia (3%)
Vasodilation (3%)
Anaphylaxis (2%)
Dysgeusia
Burning sensation
<1%
Coronary artery disease
Prolonged QT intervaL
Nephrogenic systemic fibrosis
Hyperglycemia
Gangrene
Chest pain
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 to product or component of the formulation
Cautions
Renal insufficiency
Asthma, allergic disorder, hypersensitivity; trained personnel and emergency resuscitative equipment must be available prior to and during administration
Risk of nephrogenic systemic fibrosis (NSF) with severe renal impairment
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
Mild QT prolongation w/ elevated levels of gadofosveset (repeated use or overdose >0.05 mmoL/kg)
QTc prolongation reported (rare)
Elimination may occur faster in patients with hypoalbuminemia
Use in patients with sickle cell anemia not studied
Use caution in patients that have received iodine containing agents within 24 hr prior to gadofosveset
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: Excretion in milk unknown; use with 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.
