Jeffrey Weinreb, MD, FACR, FISMRM,
FSABI
Chief, Radiology Services,
Director of MRI Services
Yale New Haven Hospital
Blake Johnson, MD, FACR
Medical Director,
Medical Scanning Consultants,
RAYUS Radiology
Donna Roberts, MD, MS
Professor, Department of Radiology
and Radiological Sciences
Medical University of South Carolina
Bill Faulkner, BSRT(R)(MR)(CT), FSMRT,
MRSO (MRSC™),
William Faulkner & Associates
Frank Shellock, PhD, FACR, FACC,
FISMRM
Director of MRI Safety
USC Stevens Neuroimaging and Informatics
Institute
Adjunct Clinical Professor of Radiology
and Medicine
Keck School of Medicine, University of
Southern California
Los Angeles, California
ELUCIREM™ (gadopiclenol) injection Important Safety Information
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS
(NSF)
See full prescribing information for complete boxed
warning
Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities.
ELUCIREM™ (gadopiclenol) injection 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).
History of hypersensitivity reactions to ELUCIREM
In clinical trials, the most frequent adverse reactions that occurred in > 0.2% of patients who received ELUCIREM included: injection site pain, headache, nausea, injection site warmth, injection site coldness, dizziness, and localized swelling. Adverse reactions that occurred with a frequency ≤ 0.2% in patients who received 0.05 mmol/kg BW ELUCIREM 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.
Please see the full Prescribing Information, including the Medication Guide, for additional important safety information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
GU04230047