gadodiamide (Omniscan)
Classes: Gadolinium-Containing Contrast Agents; Contrast Media, Nonionic/Low Osmolality
Dosing and uses of Omniscan (gadodiamide)
Adult dosage forms and strengths
injectable solution
- 287mg/mL
MRI Contrast Agent
0.2 mL/kg IV bolus, may give additional 0.4 mL/kg within 20 min of first dose
Glioma (Orphan)
Liposomal gadodiamide: Treatment of glioma
Orphan indication sponsor
- MedGenesis Therapeutix, Inc; 730-730 View Street; Victoria, BC V8W 3Y7, Canada
Pediatric dosage forms and strengths
injectable solution
- 287mg/mL
MRI Contrast Agent
0.2 mL/kg IV bolus
Omniscan (gadodiamide) adverse (side) effects
<1%
Application site disorders: Injection site reaction
Autonomic nervous system disorders: Vasodilation
Body as a whole-general disorders: Anaphylactoid reactions (characterized by cardiovascular, respiratory, and cutaneous symptoms), fever, hot flushes, rigors, fatigue, malaise, pain, syncope
Cardiovascular disorders: Cardiac failure, rare arrhythmia and myocardial infarction resulting in death in patients with ischemic heart disease, flushing, chest pain, deep thrombophlebitis
Central and peripheral nervous system disorders: Convulsions including grand mal, ataxia, abnormal coordination, paresthesia, tremor, aggravated multiple sclerosis (characterized by sensory and motor disturbances), aggravated migraine
Gastrointestinal system disorders: Abdominal pain, diarrhea, eructation, dry mouth/vomiting, melena
Hearing and vestibular disorders: Tinnitus
Liver and biliary system disorders: Abnormal hepatic function
Musculoskeletal system disorders: Arthralgia, myalgia
Respiratory system disorders: Rhinitis, dyspnea
Skin and appendage disorders: Pruritus, rash, erythematous rash, sweating increased, urticaria
Special senses, other disorders: Taste loss, taste perversion
Urinary system disorders: Acute reversible renal failure
Vision disorders: Abnormal vision
Warnings
Black box warnings
Not for intrathecal (IT) use; inadvertent IT administration has caused convulsions, coma, sensory and motor neurologic deficits
Risk for nephrogenic systemic fibrosis (NSF) with acute or chronic renal insufficiency (GFR <30 mL/min/1.73m²), 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
Acute kidney disease or chronic, severe kidney disease (ie, GFR <30 mL/min/1.73m²); use associated with increased risk for nephrogenic systemic fibrosis (NSF)
Hypersensitivity
Cautions
Not for intrathecal use (see Black box warnings)
Anemia, hepatic/renal impairment
Acute renal failure has occurred in patients with pre-existing renal insufficiency; use the lowest necessary dose and evaluate renal function
Nephrogenic systemic fibrosis (NSF) reported in patients with impaired elimination; higher than recommended dosing or repeat dosing appears to increase the risk
Anaphylactoid and anaphylactic reactions with cardiovascular, respiratory and/or cutaneous manifestations, resulting in death have occurred
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 whether 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.