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.
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