Dosing & Uses

AdultPediatric

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

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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

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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
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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.

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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.

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Patient Handout

A Patient Handout is not currently available for this monograph.
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Formulary

FormularyPatient Discounts

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Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
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  • Compare formulary status to other drugs in the same class.
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.