ELUCIREM 485.1 mg/mL
gadopiclenol · INJECTION · Guerbet LLC
ELUCIREM is a injection containing gadopiclenol at 485.1 mg/mL, taken intravenous. Manufactured by Guerbet LLC.
Key Facts
- Brand Name
- ELUCIREM
- Generic Name
- gadopiclenol
- NDC Code (Product)
67684-4231- Manufacturer
- Guerbet LLC
- Strength
- 485.1 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA216986
- Marketing Start
- 09/21/2022
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE ELUCIREM is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: the central nervous system (brain, spine, and associated tissues), the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system). ELUCIREM is a gadolinium-based contrast agent indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: the central nervous system (brain, spine, and associated tissues), the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system). ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The recommended dose for adult and pediatric patients, including term neonates, is 0.05 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered intravenously at approximately 2 mL/sec. ( 2.1 ) 2.1 Recommended Dosage The recommended dose of ELUCIREM for adult and pediatric patients, including term neonates, is 0.05 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered intravenously at approximately 2 mL/sec. 2.2 Administration and Imaging Instructions Administer ELUCIREM as an intravenous bolus injection, manually or by compatible power injector, at approximately 2 mL/sec followed by a flush of 0.9% sodium chloride injection. For pediatric patients, adjust the flow rate and flush volume based on age. Use aseptic technique for all handling and administration of ELUCIREM. Visually inspect ELUCIREM for particulate matter and discoloration prior to administration. Do not use the solution if any particulate matter is present or the solution is discolored. Do not mix with other medications because of the potential for chemical incompatibility. Prime intravenous line before use. Contrast MRI can begin immediately following the injection of …
Contraindications
4 CONTRAINDICATIONS ELUCIREM is contraindicated in patients with history of hypersensitivity reactions to ELUCIREM. History of hypersensitivity reactions to ELUCIREM ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed elsewhere in labeling: Nephrogenic Systemic Fibrosis [see Warnings and Precautions ( 5.2 )] Hypersensitivity Reactions [see Contraindications ( 4 ) and Warnings and Precautions ( 5.3 )] Most common adverse reactions (incidence >0.2%) are injection site pain, headache, nausea, injection site warmth and coldness, dizziness, localized swelling, and erythema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS contact GUERBET LLC at 1-877-729-6679 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of ELUCIREM was evaluated in 1,083 patients who received ELUCIREM at doses ranging from 0.025 mmol/kg (one half the recommended dose) to 0.3 mmol/kg (six times the recommended dose). A total of 744 patients (including 116 pediatric patients) received the recommended dose of 0.05 mmol/kg. Among patients …
Frequently Asked Questions
What is ELUCIREM used for?
ELUCIREM contains gadopiclenol. It is a injection taken intravenous. Consult your doctor for specific uses.
Is ELUCIREM a controlled substance?
ELUCIREM is not classified as a controlled substance by the DEA.
What is the generic name for ELUCIREM?
The generic name for ELUCIREM is gadopiclenol. There are 5 other brand versions of gadopiclenol.
What is the NDC code for ELUCIREM 485.1 mg/mL?
The NDC (National Drug Code) for ELUCIREM 485.1 mg/mL is 67684-4231, listed by Guerbet LLC.