Elucirem FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 2, 2022.
FDA Approved: Yes (First approved September 21, 2022)
Brand name: Elucirem
Generic name: gadopiclenol
Dosage form: Injection
Company: Guerbet
Treatment for: Diagnosis and Investigation
Elucirem (gadopiclenol) is a macrocyclic gadolinium-based contrast agent (GBCA) for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the CNS and the body.
- Elucirem is indicated in adult and pediatric patients aged 2 years and older 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), and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).
- The Elucirem product label carries a boxed waring for Nephrogenic Systemic Fibrosis (NSF). Other warnings and precautions associated with Elucirem include hypersensitivity reactions, gadolinium retention, acute kidney injury, extravasation and injection site reactions, and interference with visualization of lesions visible with non-contrast MRI.
- The most frequent adverse reactions observed in clinical trials included injection site pain, headache, nausea, injection site warmth, injection site coldness, dizziness, and localized swelling. Less frequent adverse reactions included maculopapular rash, vomiting, worsened renal impairment, feeling hot, pyrexia, oral paresthesia, dysgeusia, diarrhea, pruritus, allergic dermatitis, erythema, injection site paresthesia, Cystatin C increase, and blood creatinine increase.
Development timeline for Elucirem
| Date | Article |
|---|---|
| Sep 21, 2022 | Approval FDA Approves Elucirem (gadopiclenol) for Contrast-Enhanced Magnetic Resonance Imaging (MRI) |
Further information
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