PROHANCE- gadoteridol injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

gadoteridol (UNII: 0199MV609F) (gadoteridol - UNII:0199MV609F)

Tilgjengelig fra:

BRACCO DIAGNOSTICS INC

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

ProHance is indicated for magnetic resonance imaging (MRI) in adults and pediatric patients including term neonates to visualize lesions with disrupted blood brain barrier and/or abnormal vascularity in the brain (intracranial lesions), spine and associated tissues. ProHance is indicated for MRI in adults to visualize lesions in the head and neck. ProHance is contraindicated in patients with known allergic or hypersensitivity reactions to ProHance [see Warnings and Precautions (5.3)]. Risk Summary GBCAs cross the 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). Because of the potential risks of gadolinium to the fetus, use ProHance only if imaging is essential during pregnancy and cannot be delayed. In animal reproduction studies in rats, gadoteridol doubled the incidence of post-implantation loss at up to 16 times the recommended human dose (RHD). There were no adverse developmental effects observed in rabbits with intravenous administration of gadoteridol during organogenesis at doses up to 19 times the recommended human dose of 0.1 mmol/kg (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is 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 is 15 to 20%, respectively. Data Human Data Contrast agent 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. 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 Gadoteridol was administered in intravenous doses of 0, 0.375, 1.5, 6.0, and 10 mmol/kg/day [0.6, 2.4, 9.7, and 16 times the recommended human dose (RHD) based on body surface area (BSA)] to female rats from gestational day (GD)6 until GD17. Gadoteridol at 10 mmol/kg/day for 12 days during gestation doubled the incidence of post-implantation loss. When rats were administered 6.0 or 10.0 mmol/kg/day for 12 days, an increase in spontaneous locomotor activity was observed in the offspring. Pregnant rabbits were administered gadoteridol in intravenous doses of 0, 0.4, 1.5, and 6 mmol/kg/day (1.3, 4.8, and 19.4 times the RHD based on BSA) from GD6 to GD18. Gadoteridol increased the incidence of spontaneous abortion and early delivery in rabbits administered 6 mmol/kg/day for 13 days during gestation. Risk Summary There are no data on the presence of gadoteridol 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 and there is limited GBCA gastrointestinal absorption in the breast-fed infant. Gadoteridol is present in rat milk (see Data). The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ProHance and any potential adverse effects on the breastfed infant from ProHance or from the underlying maternal condition. Data ProHance excretion in the milk of lactating rats was evaluated at 30 minutes, 6 and 24 hours after intravenous administration of 0.1 mmol/kg of 153 Gd-gadoteridol to nursing mothers. Small amounts of compound were found in milk immediately after injection (0.14% of the ID), with the amount declining to a low level 24 hours after injection (<0.01% of the ID). The safety and effectiveness of ProHance have been established for use with MRI to visualize lesions with abnormal blood brain barrier or abnormal vascularity of the brain, spine, and associated tissues in pediatric patients from birth, including term neonates, to 17 years of age. Pediatric use is based on evidence of effectiveness in adults and in 103 pediatric patients 2 years of age and older, in addition to experience in 125 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)] . The safety and efficacy of > 0.1 mmol/kg, and sequential and/or repeat procedures have not been studied in pediatric patients [see Indications and Usage (1) and Dosage and Administration (2)] . No case of NSF associated with ProHance or any other GBCA has been identified in pediatric patients ages 6 years and younger. Pharmacokinetic studies suggest that weight normalized clearance of ProHance is similar in pediatric patients and adults, including pediatric patients age younger than 2 years. Normal estimated GFR (eGFR) is around 30 mL/min/1.73m2 at birth and increases to mature levels around 1 year of age, reflecting growth in both glomerular function and relative body surface area. Clinical studies in pediatric patients younger than 1 year of age have been conducted in patients with the following minimum eGRF; 59.37 mL/min/1.73m2 (age just after birth to < 30 days), 118.84 mL/min/1.73m2 (age 30 days to < 6 months), 140.44 mL/min/1.73m2 (age 6 to 12 months). Of the total number of 2673 adult subjects in clinical studies of ProHance, 22% were 65 and over. No overall differences in safety were observed between these elderly subjects and the younger subjects. ProHance is known to be substantially excreted by the kidneys, and the risk of toxic reactions from ProHance 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. No ProHance dosage adjustment is recommended for patients with renal impairment. Gadoteridol can be removed from the body by hemodialysis [see Warning and Precautions (5.2) and Clinical Pharmacology (12.3)] .

Produkt oppsummering:

How Supplied ProHance is supplied as a sterile, nonpyrogenic, and colorless to slightly yellow solution containing 279.3 mg/mL (0.5 mmol/mL) of gadoteridol in single-dose rubber stoppered vials or prefilled syringes; ProHance is available in boxes of: Five 5 mL fills in single dose 15 mL vials (NDC 0270-1111-04) Five 10 mL fills in single dose 30 mL vials (NDC 0270-1111-01) Five 15 mL fills in single dose 30 mL vials (NDC 0270-1111-02) Five 20 mL fills in single dose 30 mL vials (NDC 0270-1111-03) Storage and Handling Store at 25°C (77° F). Excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Protect from light. DO NOT FREEZE. Should freezing occur in the vial, ProHance should be brought to room temperature before use. If allowed to stand at room temperature for a minimum of 60 minutes, ProHance should return to a clear, colorless to slightly yellow solution. Before use, examine the product to assure that all solids are redissolved and that the container and closure have not been damaged. Should solids persist, discard vial.

Autorisasjon status:

New Drug Application

Informasjon til brukeren

BRACCO DIAGNOSTICS INC
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This Medication Guide has been approved by the U.S. Food and Drug
Administration
Issued: 01/2024
COEB505
MEDICATION GUIDE
PROHANCE®(prō-ˈhan(t)s)
(Gadoteridol injection)
for intravenous use
What is PROHANCE?
•
PROHANCE is a prescription medicine called a gadolinium-based contrast
agent (GBCA).
PROHANCE, like other GBCAs, is used with a magnetic resonance imaging
(MRI) scanner.
•
An MRI exam with a GBCA, including PROHANCE, 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 PROHANCE?
•
GBCAs like PROHANCE 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
PROHANCE is safe and effective with intrathecal use. PROHANCE is not
approved for this use.
•
PROHANCE 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 Dotarem, 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.
•
S

Preparatomtale

PROHANCE- GADOTERIDOL INJECTION, SOLUTION
BRACCO DIAGNOSTICS INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PROHANCE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PROHANCE.
PROHANCE (GADOTERIDOL INJECTION) SINGLE DOSE, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1992
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.
PROHANCE 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 PROHANCE 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
SYSTEMIC FIBROSIS
AFFECTING THE SKIN, MUSCLE AND INTERNAL ORGANS. THE RISK FOR NSF
APPEARS HIGHEST
AMONG PATIENTS WITH:
CHRONIC, SEVERE KIDNEY DISEASE (GFR LESS THAN 30 ML/MIN/1.73M ), 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
(E.G. AGE GREATER
THAN 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
ProHance is a gadolinium-based contrast agent indicated for magnetic
resonance imaging (MRI) to
visualize:
lesions with disrupted blood brain barrier and/or abnormal vascularity
in the brain (intracranial lesions),
spine and associated tissues in adults and pediatric patients,
including term neonates (1.1)
lesions in the head and neck in adults (1.2)
DOSAGE AND ADMINISTRATION
Recommended