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Gadodiamide: Drug information

Gadodiamide: Drug information
(For additional information see "Gadodiamide: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Intrathecal use:

Gadodiamide is not for intrathecal use. Inadvertent intrathecal use of gadodiamide has caused convulsions, coma, and sensory and motor neurologic deficits.

Nephrogenic systemic fibrosis:

Gadolinium-based contrast agents (GBCAs) increase the risk of nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. In these patients, avoid the use of GBCAs unless the diagnostic information is essential and not available with non–contrast-enhanced magnetic resonance imaging (MRI) or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs.

Do not administer gadodiamide to patients with chronic, severe kidney disease (glomerular filtration rate [GFR] <30 mL/minute/1.73 m2) or acute kidney injury.

Screen all patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (eg, >60 years, hypertension, diabetes), estimate the GFR through laboratory testing. Do not exceed the recommended dose of gadodiamide. Allow a sufficient period of time for elimination of the drug from the body prior to any readministration.

Brand Names: US
  • Omniscan
Brand Names: Canada
  • Omniscan
Pharmacologic Category
  • Diagnostic Agent;
  • Gadolinium-Containing Contrast Agent;
  • Linear Gadolinium-Based Contrast Agent;
  • Radiological/Contrast Media (Nonionic, Low Osmolality);
  • Radiological/Contrast Media, Paramagnetic Agent
Dosing: Adult

Note: Dosing for patients >130 kg (286 pounds) has not been studied.

Body imaging

Body imaging: IV:

Kidney: 0.05 mmol/kg (0.1 mL/kg).

Intrathoracic (noncardiac), intra-abdominal, pelvic cavities: 0.1 mmol/kg (0.2 mL/kg).

CNS imaging

CNS imaging: IV: 0.1 mmol/kg (0.2 mL/kg); a repeat dose of 0.2 mmol/kg (0.4 mL/kg) given 20 minutes after the initial dose has been studied in a clinical trial with some diagnostic benefit.

Magnetic resonance angiography

Magnetic resonance angiography (MRA) (unlabeled use in US): IV: 0.1 mmol/kg (0.2 mL/kg) (Omniscan Canadian product monograph).

Musculoskeletal imaging

Musculoskeletal imaging (off-label): IV: 0.3 mmol/kg (0.6 mL/kg) (Verstraete 1995).

Dosing: Kidney Impairment: Adult

GFR ≥30 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); use with caution. Risk for NSF development increases as renal function decreases.

GFR <30 mL/minute/1.73 m2: Use is contraindicated

Hemodialysis: If administered to patients already receiving hemodialysis, consider prompt hemodialysis following exposure (eg, within 3 hours) (Kuo 2007). Data has shown hemodialysis enhances gadolinium elimination with average gadolinium excretory rates of 78%, 96%, and 99% in the first to third hemodialysis sessions, respectively (Kuo 2007; Okada 2001).

Peritoneal dialysis: Likely to be less efficient at clearing gadolinium (Joffe 1998; Kuo 2007).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

Note: Dosing for patients >130 kg (286 pounds) has not been studied.

Body imaging

Body imaging: Children ≥2 years and Adolescents: IV: Refer to adult dosing.

CNS imaging

CNS imaging: Children ≥2 years and Adolescents ≤16 years: IV: 0.1 mmol/kg (0.2 mL/kg).

Musculoskeletal imaging

Musculoskeletal imaging (off-label): Adolescents ≥13 years: IV: Refer to adult dosing.

Dosing: Kidney Impairment: Pediatric

Children ≥2 years and Adolescents:

GFR ≥30 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); use with caution. Risk for nephrogenic systemic fibrosis (NSF) development increases as renal function decreases.

GFR <30 mL/minute/1.73 m2: Use is contraindicated

Dialysis: There are no pediatric specific recommendations; based on experience in adult patients the following has been observed:

Hemodialysis: If administered to patients already receiving hemodialysis, consider prompt hemodialysis following exposure (eg, within 3 hours) (Kuo 2007). Data has shown hemodialysis enhances gadolinium elimination with average gadolinium excretory rates of 78%, 96%, and 99% in the first to third hemodialysis sessions, respectively (Kuo 2007; Okada 2001).

Peritoneal dialysis: Likely to be less efficient at clearing gadolinium (Joffe 1998; Kuo 2007).

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Central nervous system: Dizziness (≤3%), headache (≤3%)

Gastrointestinal: Nausea (≤3%)

<1%, postmarketing, and/or case reports: Abdominal pain, acute exacerbations of multiple sclerosis, acute renal failure, ageusia, anaphylactoid shock, arthralgia, asthenia, ataxia, cardiac arrhythmia, cardiac failure, chest pain, decreased serum iron (asymptomatic, transitory), diaphoresis, diarrhea, dysgeusia, dyspnea, eructation, erythematous rash, fatigue, fever, flushing, hepatic insufficiency, increased serum creatinine, increased serum iron (asymptomatic, transitory), injection site reaction, malaise, melena, migraine, myalgia, myocardial infarction, nephrogenic systemic fibrosis, pain, paresthesia, pruritus, renal insufficiency, rhinitis, rigors, seizure, skin changes (plaques), skin rash, syncope, thrombophlebitis, tinnitus, tremor, urticaria, vasodilation, visual disturbance, vomiting, xerostomia

Contraindications

Chronic severe kidney disease (GFR <30 mL/minute/1.73 m2); acute kidney injury; hypersensitivity to gadodiamide or any component of the formulation

Canadian labeling: Additional contraindications (not in US labeling): Neonates up to 4 weeks of age (due to their immature renal function)

Warnings/Precautions

Concerns related to adverse effects:

• Gadolinium retention: Gadolinium is retained for months or years in brain, bone, skin, and other organs (kidney, liver, spleen); the highest concentration and longest duration have been found in the bone. Linear GBCAs (gadodiamide and gadoversetamide > gadoxetate disodium, gadopentetate dimeglumine, and gadobenate dimeglumine) result in more retention than macrocyclic GBCAs (gadoterate meglumine, gadobutrol, and gadoteridol). Pathologic and clinical consequences of gadolinium retention in skin and other organs have been established in patients with impaired renal function; there also have been rare reports of pathologic skin changes in patients with normal renal function. Consequences of gadolinium retention in the brain or in patients with normal renal function have not been established. Patients with normal renal function that may be at higher risk for gadolinium retention include: patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions; take GBCA retention characteristics into consideration for these patients. Minimize repetitive GBCA imaging studies.

• Hypersensitivity reactions: Hypersensitivity, including anaphylactic reactions (rare), may occur; appropriate equipment (eg, ventilator) and emergency medications (eg, epinephrine) should be available during use. Delayed reactions may also occur (within several hours of administration). Patients with a history of allergic reactions and/or bronchial asthma may be at an increased risk for developing hypersensitivity reactions; use caution in these patients.

• Nephrogenic systemic fibrosis: [US Boxed Warning]: Gadolinium-based contrast agents (GBCAs) exposure may increase the risk for nephrogenic systemic fibrosis (NSF) in patients with renal impairment; avoid use unless GBCA enhanced imaging is essential for diagnostic purposes. Use is contraindicated in patients with acute kidney injury or chronic, severe renal disease (GFR <30 mL/minute/1.73 m2). The risk appears lower in patients with moderate, chronic renal disease (GFR 30 to 59 mL/minute/1.73 m2) and little, if any, in patients with mild, chronic renal disease (GFR 60 to 89 mL/minute/1.73 m2). NSF, a potentially fatal disease, affects the skin, muscle, and internal organs. All patients should be screened for renal dysfunction prior to administration; estimate GFR in patients at risk for chronic renal disease (diabetes, chronic hypertension, age >60 years). In patients at risk of NSF, do not exceed the recommended dosage and allow sufficient time (ie, several half-lives) for elimination prior to readministration (avoidance of readministration is preferred). In patients receiving hemodialysis, consider prompt initiation of hemodialysis following administration.

Disease-related concerns:

• Renal impairment: Use with caution in patients with renal impairment; contraindicated in patients with acute kidney injury or chronic, severe renal impairment (GFR <30 mL/minute/1.73 m2). Dose-dependent worsening of renal function or acute renal failure has occurred in patients with renal insufficiency, generally within 48 hours following administration. Evaluate renal function in patients with renal impairment prior to use; consider follow-up monitoring.

Other warnings/precautions:

• Appropriate administration: [US Boxed Warning]: Not for intrathecal use. Convulsions, coma, and sensory/motor neurologic deficits have occurred with inadvertent intrathecal administration.

• Repeat dosing: Safety of repeat dosing has only been studied in adults for CNS studies.

• Scan interpretation: Use caution when interpreting a contrast-enhanced scan in the absence of a companion unenhanced noncontrast MRI.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Injectable, Injection:

Omniscan: 287 mg/mL (10 mL [DSC], 15 mL [DSC], 20 mL [DSC])

Solution, Intravenous:

Omniscan: 287 mg/mL (5 mL [DSC], 10 mL, 15 mL, 20 mL, 100 mL [DSC])

Generic Equivalent Available: US

No

Pricing: US

Solution (Omniscan Intravenous)

287 mg/mL (per mL): $6.67

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous:

Omniscan: 287 mg/mL (5 mL, 10 mL, 15 mL, 20 mL)

Administration: Adult

IV: For IV use only; not for intrathecal use. Administer as bolus injection. Flush line with NS 5 mL to ensure complete injection of medium. Imaging should be completed within 60 minutes of injection. Following administration in musculoskeletal imaging (off-label use), injection site was flushed with 40 mL NS (Verstraete 1995).

Administration: Pediatric

IV: For IV use only; not for intrathecal use. Administer as bolus injection. Flush line with 5 mL NS to ensure complete injection of medium. Imaging should be completed within 60 minutes of injection. Following administration in musculoskeletal imaging, injection site was flushed with 40 mL NS (Verstraete 1995).

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication;

Omniscan: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020123s046lbl.pdf#page=1

Use: Labeled Indications

Body imaging: Contrast medium for magnetic resonance imaging (MRI) to visualize lesions with abnormal vascularity within the thoracic (noncardiac), abdominal, pelvic cavities, and retroperitoneal space

CNS imaging: Contrast medium for magnetic resonance imaging (MRI) to visualize lesions with abnormal vascularity in the brain, spine, and associated tissues

Canadian labeling: Additional indications (not in U.S. labeling): Contrast medium for MRI to visualize breast or musculoskeletal lesions with abnormal vascularity and for magnetic resonance angiography (MRA) to visualize and detect stenosis of the renal and aortoiliac arteries

Use: Off-Label: Adult

Magnetic resonance angiography (MRA); Musculoskeletal imaging

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Gadolinium-based contrast agents may cross the placenta (ACOG 723 2017; ACR 2018).

Pregnant patients may be at increased risk for gadolinium retention. Use of gadolinium-based contrast agents in pregnancy is controversial and should be limited. A gadolinium-based contrast agent with MRI may be considered for use in pregnancy if it will significantly improve diagnostic performance and is expected to improve fetal or maternal outcome (ACOG 723 2017). In addition, use should only be considered if information needed from the MRI study cannot be acquired without using a contrast agent and cannot be deferred until after delivery. Agents with a low risk for development of nephrogenic systemic fibrosis should be used at the lowest effective dose (ACR 2018).

Breastfeeding Considerations

Gadolinium-based contrast agents may be present in breast milk (ACOG 723 2017; ACR 2018).

Because of the low expected excretion into breast milk and the low absorption from an infant's GI tract, breastfeeding may be continued without interruption after use (ACOG 723 2017; ACR 2018). Theoretically, the taste of milk could be altered if it contains contrast media. Women who prefer to temporarily withhold breastfeeding may express and discard milk from both breasts during a period of 12 to 24 hours after the administration of contrast media. They can pump and store milk prior to the procedure then bottle feed using the stored milk during this time (ACR 2018). The manufacturer recommends that caution be used if administered to breastfeeding women.

Monitoring Parameters

Signs of hypersensitivity (during and for several hours after procedure); renal function (prior to administration); short- and long-term monitoring of signs and symptoms of NSF (eg, burning, itching, swelling, hardening and/or tightening of skin, joint stiffness, deep hip or rib bone pain, muscle weakness, limited range of motion, and/or yellowed/raised spots on whites of eye)

Mechanism of Action

Gadodiamide is a gadolinium-containing paramagnetic agent. Exposure to an external magnetic field induces a large local magnetic field in exposed tissues. This local magnetism disrupts water protons in the vicinity, resulting in a change in proton density and spin characteristics, which can be detected by the imaging device.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Vd: 200 ± 61 mL/kg; does not cross intact blood-brain barrier; distribution half-life: 3.7 ± 2.7 minutes

Half-life elimination: 77.8 ± 16 minutes

Excretion: Urine (~95% within 24 hours)

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AR) Argentina: Omniscan;
  • (AT) Austria: Omniscan;
  • (AU) Australia: Omniscan;
  • (BE) Belgium: Omniscan;
  • (CH) Switzerland: Omniscan;
  • (CI) Côte d'Ivoire: Omniscan;
  • (CN) China: Omniscan;
  • (CO) Colombia: Omniscan;
  • (CZ) Czech Republic: Omniscan;
  • (EE) Estonia: Omniscan;
  • (ET) Ethiopia: Omniscan;
  • (FI) Finland: Omniscan;
  • (FR) France: Omniscan;
  • (GB) United Kingdom: Omniscan;
  • (GR) Greece: Omniscan;
  • (HK) Hong Kong: Omniscan;
  • (HU) Hungary: Omniscan;
  • (IE) Ireland: Omniscan;
  • (IT) Italy: Omniscan;
  • (JO) Jordan: Omniscan;
  • (JP) Japan: Omniscan;
  • (KE) Kenya: Omniscan;
  • (KR) Korea, Republic of: Omniscan;
  • (KW) Kuwait: Omniscan;
  • (LT) Lithuania: Omniscan;
  • (LV) Latvia: Omniscan;
  • (MY) Malaysia: Omniscan;
  • (NG) Nigeria: Omniscan;
  • (NL) Netherlands: Omniscan;
  • (NZ) New Zealand: Omniscan;
  • (PH) Philippines: Omniscan;
  • (PL) Poland: Omniscan;
  • (PT) Portugal: Omniscan;
  • (PY) Paraguay: Omniscan;
  • (QA) Qatar: Omniscan (0.5 mmol/ml);
  • (RO) Romania: Omniscan;
  • (RU) Russian Federation: Gadodiamide tl | Omniscan;
  • (SA) Saudi Arabia: Omniscan;
  • (SE) Sweden: Omniscan;
  • (SG) Singapore: Omniscan;
  • (SK) Slovakia: Omniscan;
  • (TH) Thailand: Omniscan;
  • (TN) Tunisia: Omniscan;
  • (TR) Turkey: Gadodiem | Gadotu | Omniscan
  1. American College of Obstetricians and Gynecologists (ACOG) Committee on Obstetric Practice. Committee opinion no. 723: guidelines for diagnostic imaging during pregnancy and lactation. Obstet Gynecol. 2017;130(4):e210-e216. Erratum in: Obstet Gynecol. 2018;132(3):786. [PubMed 28937575]
  2. American College of Radiology (ACR) Committee of Drugs and Contrast Media. ACR manual on contrast media. 2018. Available at https://www.acr.org
  3. Centers for Disease Control, “Nephrogenic Fibrosing Dermopathy Associated with Exposure to Gadolinium-Containing Contrast Agents: St. Louis, Missouri,” MMWR Weekly Rep, 2007, 56(07):137-141.
  4. Emerson J and Kost G, “Spurious Hypocalcemia After Omniscan- or Optimark-Enhanced Magnetic Resonance Imaging: An Algorithm for Minimizing a False-Positive Laboratory Value,” Arch Pathol Lab Med , 2004, 128(10):1151-6. [PubMed 15387706]
  5. Expert Panel on MR Safety, "ACR Guidance Document on MR Safe Practices: 2013," J Magn Reson Imaging, 2013, 37(3):501-30. [PubMed 23345200]
  6. Grobner T, “Gadolinium - A Specific Trigger for the Development of Nephrogenic Fibrosing Dermopathy and Nephrogenic Systemic Fibrosis,” Nephrol Dial Transplant, 2006, 21(4):1104-8. [PubMed 16431890]
  7. Joffe P, Thomsen HS, and Meusel M, "Pharmacokinetics of Gadodiamide Injection in Patients with Severe Renal Insufficiency and Patients Undergoing Hemodialysis or Continuous Ambulatory Peritoneal Dialysis," Acad Radiol, 1998, 5(7):491-502. [PubMed 9653466]
  8. Kuo PH, Kanal E, Abu-Alfa AK, et al, "Gadolinium-Based MR Contrast Agents and Nephrogenic Systemic Fibrosis," Radiology, 2007, 242(3):647-9. [PubMed 17213364]
  9. Okada S, Katagiri K, Kumazaki T, et al, “Safety of Gadolinium Contrast Agent in Hemodialysis Patients,” Acta Radiol, 2001, 42(3):339-41. [PubMed 11350296]
  10. Omniscan (gadodiamide) [prescribing information]. Marlborough, MA: GE Healthcare Inc; October 2019.
  11. Omniscan (gadodiamide) [product monograph]. Mississauga, Ontario, Canada: GE Healthcare Canada Inc; May 2019.
  12. Verstraete KL, Vanzieleghem B, De Deene Y, et al. Static, dynamic and first-pass MR imaging of musculoskeletal lesions using gadodiamide injection. Acta Radiol. 1995;36(1):27-36. [PubMed 7833165]
  13. Widmark JM, “Imaging-related Medications: A Class Overview,” Proc (Bayl Univ Med Cent), 2007, 20(4):408-17.
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