ELUCIREM™ (gadopiclenol) injection Important
Safety Information
WARNING: RISK ASSOCIATED WITH INTRATHECAL
USE and NEPHROGENIC SYSTEMIC FIBROSIS
(NSF)
Risk Associated with Intrathecal
Use
Intrathecal administration of gadolinium-based
contrast agents (GBCAs) can cause serious adverse
reactions including death, coma, encephalopathy, and
seizures.
ELUCIREM is not approved for intrathecal use.
Nephrogenic Systemic Fibrosis
GBCAs increase the risk for NSF among patients with
impaired elimination of the drugs. Avoid use of
ELUCIREM in these patients unless the diagnostic
information is essential and not available with
non-contrasted MRI or other modalities. NSF may
result in fatal or debilitating fibrosis affecting
the skin, muscle and internal organs.
The risk for NSF appears highest among patients
with:
-
Chronic, severe kidney disease (GFR <30
mL/min/1.73m2), or
-
Acute kidney injury
Screen patients for acute kidney injury and other
conditions that may reduce renal function. For
patients at risk for chronically reduced renal
function (for example, age >60 years,
hypertension or diabetes), estimate the glomerular
filtration rate (GFR) through laboratory
testing.
For patients at highest risk for NSF, do not exceed
the recommended ELUCIREM dose and allow a sufficient
period of time for elimination of the drug from the
body prior to any re-administration.
Indications and Usage
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).
Contraindications
Contraindicated in patients with history of
hypersensitivity reactions to ELUCIREM.
Warnings and Precautions
-
Risk Associated with Intrathecal Use: Intrathecal administration of GBCAs can cause
serious adverse reactions including death, coma,
encephalopathy, and seizures. The safety and
effectiveness of ELUCIREM have not been established
with intrathecal use. ELUCIREM is not approved for
intrathecal use.
-
Nephrogenic Systemic Fibrosis: GBCAs increase the risk for NSF among patients with
impaired elimination of the drugs. Avoid use of
ELUCIREM among these patients unless the diagnostic
information is essential and not available with
non-contrast MRI or other modalities.
-
Hypersensitivity Reactions: With
GBCAs, serious hypersensitivity reactions have
occurred. Before ELUCIREM administration, assess all
patients for any history of a reaction to contrast
media, bronchial asthma and/or allergic disorders.
These patients may have an increased risk for a
hypersensitivity reaction to ELUCIREM.
-
Gadolinium Retention: Gadolinium is
retained for months or years in several organs. The
highest concentrations have been identified in the
bone, followed by other organs (e.g. brain, skin,
kidney, liver, and spleen). While clinical
consequences of gadolinium retention have not been
established in patients with normal renal function,
certain patients might be at higher risk. These
include patients requiring multiple lifetime doses,
pregnant and pediatric patients, and patients with
inflammatory conditions. Minimize repetitive GBCA
imaging studies, particularly closely spaced studies
when possible.
-
Acute Kidney Injury: In patients
with chronically reduced renal function, acute
kidney injury requiring dialysis has occurred with
the use of GBCAs. The risk of acute kidney injury
may increase with increasing dose of the contrast
agent.
-
Extravasation and Injection Site Reactions: Injection site reactions such as injection site
pain have been reported in the clinical studies with
ELUCIREM. Extravasation during ELUCIREM
administration may result in tissue irritation.
Ensure catheter and venous patency before the
injection of ELUCIREM.
-
Interference with Visualization of Lesions
Visible with Non-Contrast MRI:
As with any GBCA, ELUCIREM may impair the
visualization of lesions seen on non-contrast MRI.
Adverse Reactions:
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.
Postmarketing Experience: Acute pancreatitis with onset
within 48 hours after GBCA administration.
Use in Specific Populations
-
Pregnancy: GBCAs cross the human
placenta and result in fetal exposure and gadolinium
retention. There are no available data on ELUCIREM
use in pregnant women to evaluate for a
drug-associated risk of major birth defects,
miscarriage or other adverse maternal or fetal
outcomes.
-
Lactation: There are no data on the
presence of ELUCIREM in human milk, the effects on
the breastfed infant, or the effects on milk
production. However, published lactation data on
other GBCAs indicate that 0.01 to 0.04% of the
maternal gadolinium dose is excreted in breast milk.
-
Pediatric Use: The safety and
effectiveness of ELUCIREM have not been established
in pediatric patients younger than 2 years of age.
-
Geriatric Use: This drug is known
to be substantially excreted by the kidney, and the
risk of adverse reactions to this drug may be
greater in patients with impaired renal function.
-
Renal Impairment: In patients with
renal impairment, the exposure of gadopiclenol is
increased compared to patients with normal renal
function. This may increase the risk of adverse
reactions such as NSF. No dose adjustment of
ELUCIREM is recommended for patients with renal
impairment.
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.
Please see the full
Prescribing Information, including the Medication Guide, for additional
important safety information.
GU04230047