GADOTERATE MEGLUMINE injection

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

gadoterate meglumine (UNII: L0ND3981AG) (GADOLINIUM CATION (3+) - UNII:AZV954TZ9N)

Pieejams no:

Fresenius Kabi USA, LLC

Ievadīšanas:

INTRAVENOUS

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Gadoterate Meglumine Injection is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity. History of clinically important hypersensitivity reactions to Gadoterate Meglumine Injection [see Warnings and Precautions (5.2)] . Risk Summary GBCAs cross the human placenta and result in fetal exposure and gadolinium retention. The human data on the association between GBCAs 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 gadoterate meglumine during organogenesis at doses up to 16 and 10 times, respectively, the recommended human dose (see Data) . Because of the potential risks of gadolinium to the fetus, use Gadoterate Meglumine Injection 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 material 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 Gadoterate meglumine was administered in intravenous doses of 0, 2, 4 and 10 mmol/kg/day [3, 7 and 16 times the recommended human dose (RHD) based on body surface area (BSA)] to female rats for 14 days before mating, throughout the mating period and until gestation day (GD) 17. Pregnant rabbits were administered gadoterate meglumine in intravenous doses of 0, 1, 3 and 7 mmol/kg/day ( 3, 10 and 23 times the RHD based on BSA) from GD6 to GD19. No effects on embryo-fetal development were observed at doses up to 10 mmol/kg/day in rats and 3 mmol/kg/day in rabbits. Maternal toxicity was observed in rats at 10 mmol/kg/day and in rabbits at 7 mmol/kg/day. This maternal toxicity was characterized in rats by a slightly lower litter size and gravid uterus weight compared to the control group, and in rabbits by a reduction in body weight and food consumption. Risk Summary There are no data on the presence of gadoterate 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 present in breast milk. Additionally, there is limited GBCA gastrointestinal absorption in the breast-fed infant. Gadoterate is present in goat milk (see Data) . The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Gadoterate Meglumine Injection and any potential adverse effects on the breastfed infant from Gadoterate Meglumine Injection or from the underlying maternal condition. Data Nonclinical data demonstrate that gadoterate is detected in goat milk in amounts less than 0.1% of the dose intravenously administered. Furthermore, in rats, absorption of gadoterate via the gastrointestinal tract is poor (1.2% of the administered dose was absorbed and eliminated in urine). The safety and efficacy of gadoterate meglumine at a single dose of 0.1 mmol/kg have been established in pediatric patients from birth (term neonates ≥ 37 weeks gestational age) to 17 years of age based on clinical data in 133 pediatric patients 2 years of age and older, and clinical data in 52 pediatric patients birth to less than 2 years of age that supported extrapolation from adult data [see Clinical Studies (14)] . Adverse reactions in pediatric patients were similar to those reported in adults [see Adverse Reactions (6.1)] . No dosage adjustment according to age is necessary in pediatric patients [See Dosage and Administration (2.1), Pharmacokinetics (12.3)] . The safety of gadoterate meglumine has not been established in preterm neonates. No cases of NSF associated with gadoterate meglumine or any other GBCA have been identified in pediatric patients age 6 years and younger [see Warnings and Precautions (5.1)] . Normal estimated GFR (eGFR) is approximately 30 mL/minute/1.73m2 at birth and increases to adult values by 2 years of age. Juvenile Animal Data Single and repeat-dose toxicity studies in neonatal and juvenile rats did not reveal findings suggestive of a specific risk for use in pediatric patients including term neonates and infants. In clinical studies of gadoterate meglumine, 900 patients were 65 years of age and over, and 304 patients were 75 years of age and over. No overall differences in safety or efficacy were observed between these subjects and younger subjects. In general, use of Gadoterate Meglumine Injection in elderly patients should be cautious, reflecting the greater frequency of impaired renal function and concomitant disease or other drug therapy. No age-related dosage adjustment is necessary. No Gadoterate Meglumine Injection dosage adjustment is recommended for patients with renal impairment. Gadoterate can be removed from the body by hemodialysis [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ].

Produktu pārskats:

Gadoterate Meglumine Injection, USP is a clear, colorless to yellow solution containing 0.5 mmol per mL of gadoterate meglumine. Gadoterate Meglumine Injection, USP (5 mL, 10 mL, 15 mL and 20 mL) is supplied in single dose vials. Gadoterate Meglumine Injection, USP Pharmacy Bulk Package is available in vials. Each vial is closed with a rubber stopper and sealed with an aluminum cap and the contents are sterile. Gadoterate Meglumine Injection, USP single-dose vials are individually packaged in a box of 10, in the following configurations: Gadoterate Meglumine Injection, USP Pharmacy Bulk Package vials are individually packaged in a box of 6, in the following configurations: Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Should solidification occur in the vial because of exposure to the cold, bring Gadoterate Meglumine Injection, USP to room temperature before use. If allowed to stand at room temperature for a minimum of 90 minutes, Gadoterate Meglumine Injection, USP should return to a clear, colorless to yellow solution. Before use, examine the product to assure that all solids are dissolved and that the container and closure have not been damaged. Discard the vial if solids persist.

Autorizācija statuss:

Abbreviated New Drug Application

Lietošanas instrukcija

Fresenius Kabi USA, LLC
Reference Label Set Id: fbebe7f2-a0c2-4fd5-b421-8fbcbaf46709
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MEDICATION GUIDE
Gadoterate Meglumine (GAD oh TER ate MEG loo meen) Injection
(gadoterate meglumine)
Injection for intravenous use
What is Gadoterate Meglumine Injection?
•
Gadoterate Meglumine Injection is a prescription medicine called a
gadolinium-based contrast
agent (GBCA). Gadoterate Meglumine Injection, like other GBCAs, is
injected into your vein and
used with a magnetic resonance imaging (MRI) scanner.
•
An MRI exam with a GBCA, including Gadoterate Meglumine Injection,
helps your doctor to see
problems better than an MRI exam without a GBCA.
•
Your doctor 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 Gadoterate
Meglumine Injection?
•
Gadoterate Meglumine Injection 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 Omniscan or Optimark than after Eovist, Magnevist or
MultiHance. Gadolinium stays
in the body the least after Gadoterate Meglumine Injection, Gadavist
or ProHance.
•
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 problems who get gadolinium medicines can
develop a condition with
severe thickening of

Produkta apraksts

GADOTERATE MEGLUMINE- GADOTERATE MEGLUMINE INJECTION
FRESENIUS KABI USA, LLC
REFERENCE LABEL SET ID: FBEBE7F2-A0C2-4FD5-B421-8FBCBAF46709
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GADOTERATE MEGLUMINE
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
GADOTERATE
MEGLUMINE INJECTION.
GADOTERATE MEGLUMINE INJECTION FOR INTRAVENOUS USE
PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION
INITIAL U.S. APPROVAL: 2013
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.
THE RISK FOR NSF APPEARS HIGHEST AMONG PATIENTS WITH:
CHRONIC, SEVERE KIDNEY DISEASE (GFR LESS THAN 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 MORE THAN 60 YEARS, HYPERTENSION OR DIABETES), ESTIMATE
THE
GLOMERULAR FILTRATION RATE (GFR) THROUGH LABORATORY TESTING (5.1).
INDICATIONS AND USAGE
Gadoterate Meglumine Injection is a gadolinium-based contrast agent
indicated: for intravenous use with
magnetic resonance imaging (MRI) in brain (intracranial), spine and
associated tissues in adult and
pediatric patients (including term neonates) to detect and visualize
areas with disruption of the blood brain
barrier (BBB) and/or abnormal vascularity. (1)
DOSAGE AND ADMINISTRATION
Adult and pediatric patients: The recommended dose of Gadoterate
Meglumine Injection is 0.2 mL/kg (0.1
mmol/kg) body weight administered as an intravenous bolus injection at
a flow rate of approximately 2
mL/second for adults and 1 to 2 mL/second for pediatric patients
(including term neonates). The dose is
delivered