Gadoxetate

Gadoxetate is a contrast agent indicated for intravenous use in magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in patients with known or suspected focal liver disease.

• Gadoxetate is available under the following different brand names: Eovist, Gadoxetic Acid.

Common side effects of Gadoxetate include:

• headache
• dizziness
• changes in sense of taste or smell
• unusual or unpleasant taste in the mouth
• nausea
• vomiting
• mild itching of the skin or eyes
• skin rash
• flushing (warmth, redness, or tingly feeling)
• feeling unusually hot
• injection site reactions (cold feeling, pain, mild burning, warmth, bruising, or swelling)

Serious side effects of Gadoxetate include:

• kidney problems (such as a change in the amount of urine)
• swelling of ankles/feet
• dark patches on the skin
• hardening/tightening of the skin
• joint stiffness
• hip/rib pain
• muscle weakness
• trouble moving
• Nephrogenic systemic fibrosis 
• Hypersensitivity reactions

Rare side effects of Gadoxetate 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 dosage

Injectable solution

• 0.25 mol/L

MRI of Liver Lesions

Adult dosage

• 0.1 mL/kg (0.025 mmol/kg) IV bolus; not to exceed infusion rate of 10 mL/15 seconds

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.

• Carglumic Acid has no noted severe interactions with any other drugs
• Carglumic Acid has no noted serious interactions with any other drugs
• Carglumic Acid has no noted moderate interactions with any other drugs
• Carglumic Acid 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

• None

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• Plasma concentrations of Carglumic Acid increased in patients with renal impairment; reduce the dosage in patients with moderate or severe renal impairment; the pharmacokinetics of Carglumic Acid have not been evaluated in patients with end-stage renal disease
• Hyperammonemia
  • Monitor serum ammonia levels and adjust the dose to maintain within the normal range for age
  • Treat acute hyperammonemia episodes as a life-threatening emergency
  • Treatment of severe hyperammonemia may require dialysis, preferably hemodialysis and/or hemofiltration, to reduce plasma ammonia concentration
  • Untreated hyperammonemia can result in brain damage and death, and prompt use of all therapies necessary to reduce plasma ammonia levels is essential
  • Protein restriction during an acute hyperammonemic episode is recommended for no longer than 12-36 hours while maximizing caloric supplementation to reverse catabolism; protein should be reintroduced as early as possible, following improvement of metabolic and clinical abnormalities in this setting; during long-term management, dietary protein restriction should be instituted to maintain blood ammonia level within an acceptable range for age
  • Ongoing monitoring of plasma ammonia level, neurological status, growth parameters, protein intake/nutritional status (both during acute hyperammonemic episodes and long-term), and relevant laboratory tests in patients receiving therapy should be part of evaluating clinical response to treatment

Pregnancy and Lactation

• Rare case reports of use in pregnant women are insufficient to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Pregnancy pharmacovigilance program for Carglumic Acid exposures: 1-888-575-8344
• Pregnant women with urea cycle disorders may experience an increase in catabolic stress which can trigger a hyperammonemic crisis both in intrapartum and in postpartum (3-14 days post-partum) periods
• Maternal complications related to hyperammonemia crisis can include neurological impairment, coma, and in some cases death
• Lactation
  • Unknown whether a drug is excreted in human milk
  • Present in rat milk and an increase in mortality and impairment of body weight gain occurred in neonatal rats nursed by mothers receiving Carglumic Acid
  • Breastfeeding is not recommended during therapy; treatment is continuous and life-long for NAGS deficiency patients