Gadodiamide

Gadodiamide is a gadolinium-containing contrast agent used for Magnetic Resonance Imaging (MRI) of the brain, spine and associated tissue as well as Vascular Imaging.

• Gadodiamide is available under the following different brand names: Omniscan

Common side effects of Gadodiamide include:

• headache,
• dizziness, and
• nausea

Serious side effects of Gadodiamide include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• burning, itching, swelling, scaling, tightening, or hardening of the skin,
• tiredness,
• muscle weakness,
• joint pain and stiffness,
• bone pain in the ribs or hips,
• difficulty moving,
• redness of the skin or dark discolorations,
• little or no urination,
• swelling in the feet or ankles,
• shortness of breath,
• chest pain or pressure, and
• pain spreading to the jaw or shoulder

Rare side effects of Gadodiamide include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injectable solution

• 287 mg/mL

CNS Imaging

Adult dosage

• 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 the dose is completely administered

Pediatric dosage

• Aged below 2 years: Safety and efficacy not established
• Aged between 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 the dose is completely administered

Vascular Imaging

Adult dosage

• Imaging of kidney: 0.1 mL/kg (0.05 mmol/kg) administered as an IV bolus injection
• Imaging of intrathoracic (noncardiac), intra-abdominal, and pelvic cavities: 0.2 mL/kg (0.1 mmol/kg) administered as a bolus IV injection
• Flush the IV line with 5 mL 0.9% NaCl to ensure the dose is completely administered Complete the imaging procedure within 1 hour of administration

Pediatric dosage

• Aged below 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, and pelvic cavities (2-16 years:: 0.2 mL/kg (0.1 mmol/kg) administered as a bolus IV injection
• Flush the IV line with 5 mL 0.9% NaCl to ensure the dose is completely administered

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Gadodiamide has no noted severe interactions with any other drugs.
• Gadodiamide has no noted serious interactions with any other drugs.
• Gadodiamide has no noted moderate interactions with any other drugs.
• Gadodiamide has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Acute kidney disease or chronic, severe kidney disease (ie, GFR less than 30 mL/min/1.73m²); use associated with increased risk for nephrogenic systemic fibrosis (NSF)
• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Gadodiamide?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Gadodiamide?”

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 more than 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 and Lactation

• 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 the potential risks of the drug to the fetus, use the drug only if imaging is essential during pregnancy and cannot be delayed
• Lactation
  • There are no data on the presence of the drug in human milk, its effects on the breastfed infant or 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 an underlying maternal condition