Gadopiclenol

Gadopiclenol is a prescription medication used with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine, and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).

• Gadopiclenol is available under the following different brand names: Elucirem, Vueway

Common side effects of Gadopiclenol include:

• injection site reactions (pain, warmth, coldness, localized swelling)
• headache
• nausea
• dizziness

Serious side effects of Gadopiclenol include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat, and
• dizziness

Rare side effects of Gadopiclenol 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 as a result 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

IV solution, single-dose vials

• 1.5 mmol/3 mL (0.5 mmol/mL)
• 3.75 mmol/7.5 mL (0.5 mmol/mL)
• 5 mmol/10 mL (0.5 mmol/mL)
• 7.5 mmol/15 mL (0.5 mmol/mL)

IV solution, single-dose prefilled syringes

• 3.75 mmol/7.5 mL (0.5 mmol/mL)
• 5 mmol/10 mL (0.5 mmol/mL)
• 7.5 mmol/15 mL (0.5 mmol/mL)

IV solution, pharmacy bulk package

• 15 mmol/30 mL (0.5 mmol/mL)
• 25 mmol/50 mL (0.5 mmol/mL)
• 50 mmol/100 mL (0.5 mmol/mL)

MRI Contrast

Adult dosage 

• 0.05 mmol/kg actual body weight (0.1 mL/kg) IV bolus infused ~2 mL/second

Pediatric dosage 

• Children aged below 2 years: Safety and efficacy not established
• Children aged 2 years and above: 0.05 mmol/kg actual body weight (0.1 mL/kg) IV bolus infused ~2 mL/second

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, healthcare provider, or pharmacist first.

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

• History of hypersensitivity reactions to gadopiclenol

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• Gadolinium-based contrast agents increase the risk for NSF among patients with impaired drug elimination
• Anaphylactic and anaphylactoid reactions reported and may involve cardiovascular, respiratory, and/or cutaneous manifestations, including reports of patients experiencing cardiovascular collapse and death
• Acute kidney injury requiring dialysis has occurred in patients with chronically reduced renal function; serum creatinine levels and estimated GFR may not reliably assess renal function in the setting of acute kidney injury
• Injection site extravasation reported
  • GBCAs may impair visualization of lesions seen on noncontrast MRI; caution when MRI scans are interpreted without a companion noncontrast MRI scan
• Nephrogenic systemic fibrosis (NSF)
  • Gadolinium-based contrast agents increase the risk for NSF among patients with impaired drug elimination
  • Report any diagnosis of NSF following administration to Guerbet LLC (1-877-729-6679) or FDA (1-800-FDA-1088 or www.fda.gov/medwatch)
  • For patients receiving hemodialysis, physicians may consider prompt initiation of hemodialysis following administration of a GBCA to enhance contrast agent’s elimination; the usefulness of hemodialysis in the prevention of NSF is unknown
• 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)
  • 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
  • Consequences of gadolinium retention in the brain have not been established
  • Pathologic and clinical consequences of GBCA administration and retention in skin and other organs have been established in patients with impaired renal function
  • Rare reports of pathologic skin changes in patients with normal renal function

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
• Lactation
  • Estimated infant exposure is 0.01%-0.04% of the maternal dose
  • Data are not available regarding the presence of gadopiclenol in human milk, its effects on breastfed infants, or milk production