Dosing & Uses
Dosage Forms & Strengths
injectable solution
- 287mg/mL
CNS Imaging
Indicated for MRI of the CNS to visualize lesions with abnormal blood brain barrier or abnormal vascularity of the brain, spine, and associated tissue
0.2 mL/kg (0.1 mmol/kg) administered as a bolus IV injection, then flush IV line with 5 mL 0.9% NaCl to ensure dose is completely administered
Complete the imaging procedure within 1 hour of administration
Vascular Imaging
Indicated for IV use in MRI to facilitate the visualization of lesions with abnormal vascularity within the thoracic (noncardiac), abdominal, pelvic cavities, and the retroperitoneal space
Imaging of kidney: 0.1 mL/kg (0.05 mmol/kg) administered as an IV bolus injection
Imaging of intrathoracic (noncardiac), intra-abdominal, an pelvic cavites: 0.2 mL/kg (0.1 mmol/kg) administered as a bolus IV injection
Flush IV line with 5 mL 0.9% NaCl to ensure dose is completely administered Complete the imaging procedure within 1 hour of administration
Glioma (Orphan)
Orphan designation of liposomal gadodiamide for treatment of glioma
Sponsor
- MedGenesis Therapeutix, Inc; 730-730 View Street; Victoria, BC V8W 3Y7, Canada
Dosage Forms & Strengths
injectable solution
- 287mg/mL
CNS Imaging
Indicated for MRI of the CNS to visualize lesions with abnormal blood brain barrier or abnormal vascularity of the brain, spine, and associated tissue
<2 years: Safety and efficacy not established
2-16 years: 0.2 mL/kg (0.1 mmol/kg) administered as a bolus IV injection, then flush IV line with 5 mL 0.9% NaCl to ensure dose is completely administered
Complete the imaging procedure within 1 hour of administration
Vascular Imaging
Indicated for IV use in MRI to facilitate the visualization of lesions with abnormal vascularity within the thoracic (noncardiac), abdominal, pelvic cavities, and the retroperitoneal space
<2 years: Safety and efficacy not established
Imaging of kidney (2-16 years): 0.1 mL/kg (0.05 mmol/kg) administered as an IV bolus injection
Imaging of intrathoracic (noncardiac), intra-abdominal, an pelvic cavites (2-16 years:: 0.2 mL/kg (0.1 mmol/kg) administered as a bolus IV injection
Flush IV line with 5 mL 0.9% NaCl to ensure dose is completely administered
Complete the imaging procedure within 1 hour of administration
Adverse 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
Nephrogenic systemic fibrosis
- Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs
- Avoid use of GBCAs in these patients unless diagnostic information is essential and not available with noncontrasted MRI or other modalities
- NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs
- Highest risk for NSF is among patients with chronic, severe kidney disease (GFR <30 mL/min/1.73²) OR acute kidney injury
- Screen patients for acute kidney injury and other conditions that may reduce renal function
- For patients at risk for chronically reduced renal function (eg, age >60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing
- For patients at highest risk for NSF, do not exceed recommended dose and allow a sufficient period of time for elimination of the drug from the body prior to readministration
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
Gadolinium retention
- Gadolinium is retained for months or years in several organs
- Highest concentrations (nanomoles per gram of tissue) have been identified in the bone, followed by other organs (eg, brain, skin, kidney, liver, and spleen)
- Duration of retention also varies by tissue and is longest in bone
- Patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions are at higher risk of gadolinium retention
Brain deposits
- FDA investigated the risk of brain deposits following repeated use of GBCAs for MRI in 2015
- 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
- As of 2017, the FDA review had not identified adverse health effects from gadolinium retained in the brain after the use of GBCAs MRI; all GBCAs may be associated with some gadolinium retention in the brain and other body tissues
- 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 & Lactation
Pregnancy
GBCAs cross the placenta and result in fetal exposure and gadolinium retention
Human data on the association between GBCAs and adverse fetal outcomes are limited and inconclusive
Estimated background risk of major birth defects and miscarriage for the indicated population is unknown; because of potential risks of drug to fetus, use drug only if imaging is essential during pregnancy and cannot be delayed
Animal data
- Drug has been shown to have adverse effect on embryo-fetal development in rabbits at dosages as low as 0.5 mmol/ kg/ day for 13 days during gestation (approximately 0.6 times human dose based on a body surface area comparison); these adverse effects are observed as an increased incidence of flexed appendages and skeletal malformations which may be due to maternal toxicity since body weight of dams was reduced in response to gadodiamide administration during pregnancy
Lactation
There are no data on presence of drug in human milk, effects on breastfed infant or on milk production; estimated infant exposure is 0.001%-0.04% of the maternal dose
Unknown whether the effects of the drug on the breastfed infant or the effects of the drug on milk production
Developmental and health benefits of breastfeeding should be considered together with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant or from underlying maternal condition
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.Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Omniscan intravenous - | 10 mmol/20 mL (287 mg/mL) vial |  | |
| Omniscan intravenous - | 7.5 mmol/15 mL (287 mg/mL) vial |  | |
| Omniscan intravenous - | 5 mmol/10 mL (287 mg/mL) vial |  |
Copyright © 2010 First DataBank, Inc.
Formulary
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