Gadoteridol

Gadoteridol is a contrast agent indicated for magnetic resonance imaging in adults and pediatric patients, including term neonates, to visualize lesions with disrupted blood-brain barrier and abnormal vascularity of intracranial lesions, spine, and associated tissues.

• Gadoteridol is available under the following different brand names: ProHance.

Common side effects of Gadoteridol include:

• nausea
• change in taste
• headache
• dizziness
• hives

Serious side effects of Gadoteridol include:

• difficulty breathing
• swelling of the face, lips, tongue, or throat
• fast heartbeat
• hunger
• sweating
• irritability
• swelling of the face, lips, tongue, or throat
• burning, itching, swelling, scaling, and tightening or hardening of the skin
• muscle weakness
• joint stiffness in the arms, hands, legs, or feet
• bone pain in ribs or hips
• trouble moving
• skin redness or discoloration
• little or no urination
• painful or difficult urination
• swelling in feet or ankles
• tiredness
• seizures
• lightheadedness

Rare side effects of Gadoteridol 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, coordination loss, 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

• 279.3 mg/mL

CNS MRI

Adult dosage

• 0.2 mL/kg (0.1 mmol/kg) IV rapid infusion (10-60 mL/min or IV bolus (more than 60 mL/min); may administer as the second dose of 0.4 mL/kg (0.2 mmol/kg); may be repeated once within 30 min of the first dose

Pediatric dosage

• 0.2 mL/kg (0.1 mmol/kg) IV rapid infusion (10-60 mL/min) or IV bolus (more than 60 mL/min)

Extracranial/Extraspinal Tissue MRI

Adult dosage

• 0.2 mL/kg (0.1 mmol/kg) IV rapid infusion (10-60 mL/min or IV bolus (more than 60 mL/min); may administer as the second dose of 0.4 mL/kg (0.2 mmol/kg); may be repeated once within 30 min of the first dose

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.

• Gadoteridol has no noted severe interactions with any other drugs
• Gadoteridol has no noted serious interactions with any other drugs
• Gadoteridol has no noted moderate interactions with any other drugs
• Gadoteridol 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 the products you use. 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, health questions, or concerns.

Contraindications

• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• Caution in hyperthyroidism, pheochromocytoma, renal/hepatic impairment
• Therapy in patients with sickle cell anemia not studied
• Screen patients for kidney disease before use and monitor renal function afterward; nephrogenic systemic fibrosis (NSF) associated with the use of gadolinium contrast media in patients with kidney disease; do not exceed the recommended dose 
• Gadolinium retention
  • Gadolinium is retained for months or years in several organs
  • The 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 gadolinium-based contrast agents (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
• Hypersensitivity reactions
  • Anaphylactic and anaphylactoid reactions reported, involving cardiovascular, respiratory, and/or cutaneous manifestations
  • Some patients experienced circulatory collapse and died; in most cases, initial symptoms occurred within minutes of administration and resolved with prompt emergency treatment
  • Before administration, ensure the availability of trained personnel and medications to treat hypersensitivity reactions
  • Consider the risk for hypersensitivity reactions, especially in patients with a history of hypersensitivity reactions or a history of asthma or other allergic disorders; if such a reaction occurs, stop the drug and immediately begin appropriate therapy
  • Observe patients for signs and symptoms of a hypersensitivity reaction during and for up to 2 hours after therapy administration

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
• The estimated background risk of major birth defects and miscarriage for the indicated population is unknown
• All pregnancies have a background risk of birth defect, loss, or other adverse outcomes
• Lactation
  • There are no data on the presence of the drug in human milk, its effects on the breastfed infant, or on milk production; however, published lactation data on other GBCAs indicate that 0.01 to 0.04% of maternal gadolinium dose is present in breast milk and there is limited GBCA gastrointestinal absorption in the breast-fed infant; the drug is present in rat milk
  • 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