ELUCIREM- gadopiclenol injection

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

Gadopiclenol (UNII: S276568KOY) (Gadopiclenol - UNII:S276568KOY)

MAH:

Guerbet LLC

administration_route:

INTRAVENOUS

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

ELUCIREMTM 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), - the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system). ELUCIREM is contraindicated in patients with history of hypersensitivity reactions to ELUCIREM. Risk Summary 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. GBCAs cross the human placenta and result in fetal exposure and gadolinium retention. The available human data on GBCA exposure during pregnancy and adverse fetal outcomes are limited and inconclusive (see Data). In animal reproduction studies, there were no adverse developmental effects observed in rats or rabbits with intravenous administration of ELUCIREM during organogenesis (see Data). Because of the potential risks of gadolinium to the fetus, use ELUCIREM only if imaging is essential during pregnancy and cannot be delayed. The estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20% respectively. Data Human Data Contrast enhancement is visualized in the placenta and fetal tissues after maternal GBCA administration. Cohort studies and case reports on exposure to GBCAs during pregnancy have not reported a clear association between GBCAs and adverse effects in the exposed neonates. However, a retrospective cohort study comparing pregnant women who had a GBCA MRI to pregnant women who did not have an MRI reported a higher occurrence of stillbirths and neonatal deaths in the group receiving GBCA MRI. Limitations of this study include a lack of comparison with non-contrast MRI and lack of information about the maternal indication for MRI. Overall, these data preclude a reliable evaluation of the potential risk of adverse fetal outcomes with the use of GBCAs in pregnancy. Animal Data Gadolinium Retention: GBCAs administered to pregnant non-human primates (0.1 mmol/kg on gestational days 85 and 135) result in measurable gadolinium concentration in the offspring in bone, brain, skin, liver, kidney, and spleen for at least 7 months. GBCAs administered to pregnant mice (2 mmol/kg daily on gestational days 16 through 19) result in measurable gadolinium concentrations in the pups in bone, brain, kidney, liver, blood, muscle, and spleen at one-month postnatal age. Reproductive Toxicology: Animal reproduction studies conducted with gadopiclenol showed some signs of maternal toxicity in rats at 10 mmol/kg and rabbits at 5 mmol/kg (corresponding to 52 times and 57 times the recommended human dose, respectively). This maternal toxicity was characterized in both species by swelling, decreased activity, and lower gestation weight gain and food consumption. No effect on embryo-fetal development was observed in rats at 10 mmol/kg (corresponding to 52 times the recommended human dose). In rabbits, a lower mean fetal body weight was observed at 5 mmol/kg (corresponding to 57 times the recommended human dose) and this was attributed as a consequence of the lower gestation weight gain. Risk Summary There are no data on the presence of gadopiclenol 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. Additionally, there is limited GBCA gastrointestinal absorption in the breast-fed infant. Gadopiclenol is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk (see Data) . The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ELUCIREM and any potential adverse effects on the breastfed infant from ELUCIREM or from the underlying maternal condition. Data In lactating rats receiving single intravenous injection of [153 Gd]-gadopiclenol, 0.3% and 0.2% of the total administered radioactivity was transferred to the pups via maternal milk at 6 hours and 24 hours after administration, respectively. Furthermore, in nursing rat pups, oral absorption of gadopiclenol was 3.6%. The safety and effectiveness of ELUCIREM for use with MRI to detect and visualize lesions with abnormal vascularity in the CNS (brain, spine, and associated tissues), and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) have been established in pediatric patients aged 2 years and older. Use of ELUCIREM in this age group is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic and safety data from an open-label, uncontrolled, multicenter, single dose study of ELUCIREM (0.05 mmol/kg) in 80 pediatric patients aged 2 to 17 years. The 80 patients consisted of 60 patients who underwent a CNS MRI and 20 patients who underwent a body MRI [see Adverse Reactions (6.1) and Clinical Pharmacology (12.3)]. The safety and effectiveness of ELUCIREM have not been established in pediatric patients younger than 2 years of age. Of the total number of ELUCIREM-treated patients in clinical studies, 270 (26%) patients were 65 years of age and over, while 62 (6%) patients were 75 years of age and over. No overall differences in safety or efficacy were observed between these subjects and younger subjects. 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. Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function. 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 nephrogenic systemic fibrosis (NSF). Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities. No dose adjustment of ELUCIREM is recommended for patients with renal impairment. ELUCIREM can be removed from the body by hemodialysis [see Warnings and Precautions (5.2, 5.4, 5.5) and Clinical Pharmacology (12.3)].

leaflet_short:

HOW SUPPLIED ELUCIREM is a clear, colorless to yellow aqueous solution supplied in the following presentations: Strength Sale Unit NDC Single-Dose Vial (glass) 1.5 mmol/3 mL (0.5 mmol/mL) Carton of 1 67684-4230-1 Carton of 10 67684-4230-2 3.75 mmol/7.5 mL (0.5 mmol/mL) Carton of 1 Carton of 10 67684-4231-2 5 mmol/10 mL (0.5 mmol/mL) Carton of 1 67684-4232-1 Carton of 10 67684-4232-2 7.5 mmol/15 mL (0.5 mmol/mL) Carton of 1 67684-4233-1 Carton of 10 67684-4233-2 Single-Dose Prefilled Syringe (plastic)  3.75 mmol/7.5 mL (0.5 mmol/mL) Carton of 1 67684-4240-1 Carton of 10 67684-4240-2 5 mmol/10 mL (0.5 mmol/mL) Carton of 1 67684-4241-1 Carton of 10 67684-4241-2 7.5 mmol/15 mL (0.5 mmol/mL) Carton of 1 67684-4242-1 Carton of 10 67684-4242-2 Pharmacy Bulk Package (glass) 15 mmol/30 mL (0.5 mmol/mL) Carton of 1 67684-4250-1 Carton of 25 67684-4250-2 25 mmol/50 mL (0.5 mmol/mL) Carton of 1 67684-4250-3 Carton of 25 67684-4250-4 50 mmol/100 mL (0.5 mmol/mL) Carton of 1 67684-4250-5 Carton of 6 67684-4250-6 Carton of 12 67684-4250-7 Storage and Handling Store at 25°C (77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP, Controlled Room Temperature]. Do not freeze Pre-filled syringes.

authorization_status:

New Drug Application

PIL

Guerbet LLC
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MEDICATION GUIDE
ELUCIREMTM (ah LOOS er em)
(gadopiclenol)
injection, for intravenous use
What is ELUCIREM?
•
ELUCIREM is a prescription medicine called a gadolinium-based contrast
agent (GBCA).
ELUCIREM, like other GBCAs, is injected into your vein and used with a
magnetic resonance
imaging (MRI) scanner.
•
An MRI exam with a GBCA, including ELUCIREM, helps your healthcare
provider to see
problems better than an MRI exam without a GBCA.
•
Your healthcare provider has reviewed your medical records and has
determined that you would
benefit from using a GBCA with your MRI exam.
What is the most important information I should know about ELUCIREM?
•
GBCAs like ELUCIREM may cause serious side effects including death,
coma, encephalopathy,
and seizures when it is given intrathecally (injection given into the
spinal canal). It is not known if
ELUCIREM is safe and effective with intrathecal use. ELUCIREM is not
approved for this use.
•
ELUCIREM contains a metal called gadolinium. Small amounts of
gadolinium can stay in your
body including the brain, bones, skin and other parts of your body for
a long time (several months
to years).
•
It is not known how gadolinium may affect you, but so far, studies
have not found harmful effects
in patients with normal kidneys.
•
Rarely patients have reported pains, tiredness, and skin, muscle or
bone ailments for a long time,
but these symptoms have not been directly linked to gadolinium.
•
There are different GBCAs that can be used for your MRI exam. The
amount of gadolinium that
stays in the body is different for different gadolinium medicines.
Gadolinium stays in the body
more after gadodiamide than after gadoxetate disodium or gadobenate
dimeglumine. Gadolinium
stays in the body the least after, gadoterate meglumine, gadobutrol,
gadoteridol, and gadopiclenol.
•
People who get many doses of gadolinium medicines, women who are
pregnant and young
children may be at increased risk from gadolinium staying in the body.
•
Some people with kidney

SPC

ELUCIREM- GADOPICLENOL INJECTION
GUERBET LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ELUCIREM SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ELUCIREM.
ELUCIREM (GADOPICLENOL) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2022
WARNING: RISK ASSOCIATED WITH INTRATHECAL USE AND NEPHROGENIC SYSTEMIC
FIBROSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
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. (5.1)
GBCAS INCREASE THE RISK FOR NEPHROGENIC SYSTEMIC FIBROSIS (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. THE RISK FOR NSF APPEARS HIGHEST AMONG
PATIENTS WITH:
CHRONIC, SEVERE KIDNEY DISEASE (GFR <30 ML/MIN/1.73 M ), 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. (5.2)
RECENT MAJOR CHANGES
Boxed Warning 1/2024
Warnings and Precautions, Risk Associated with Intrathecal Use (5.1)
1/2024
INDICATIONS AND USAGE
ELUCIREM is a gadolinium-based contrast agent 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: (1)
the central nervous system (brain, spine, and associated tissues),
the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal
system). (1)
DOSAGE AND ADMINISTRATION
The recommended dose for adult and pediatric patients aged 2 years and
older is 0.05 mmol/kg actual
body weight (equivalent to 0.1 mL/kg) a