gadodiamide (Omniscan)

Dosing and uses of Omniscan (gadodiamide)

• Adult
• Pediatric

 

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.