GADOBUTROL injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GADOBUTROL (UNII: 1BJ477IO2L) (GADOLINIUM CATION (3+) - UNII:AZV954TZ9N)

Available from:

Slate Run Pharmaceuticals, LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Gadobutrol injection is indicated for use with magnetic resonance imaging (MRI) in adult and pediatric patients, including term neonates to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system. Gadobutrol injection is indicated for use with MRI in adult patients to assess the presence and extent of malignant breast disease. Gadobutrol injection is indicated for use in magnetic resonance angiography (MRA) in adult and pediatric patients, including term neonates, to evaluate known or suspected supra-aortic or renal artery disease. Gadobutrol injection is indicated for use in cardiac MRI (CMRI) to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD). Gadobutrol injection is contraindicated in patients with history of severe hypersensitivity reactions to gadobutrol injection. GBCAs cross the placenta and result in fetal exposure and gadolinium retention.

Product summary:

Gadobutrol injection is a sterile, clear and colorless to pale yellow solution containing 604.72 mg gadobutrol per mL (equivalent to 1 mmol gadobutrol) per mL. Gadobutrol injection is supplied in the following sizes: Single-Dose Containers (Vials) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Should freezing occur, gadobutrol injection should be brought to room temperature before use. If allowed to stand at room temperature, gadobutrol injection should return to a clear and colorless to pale yellow solution. Visually inspect gadobutrol injection for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored, if particulate matter is present or if the container appears damaged.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

GADOBUTROL- GADOBUTROL INJECTION
Slate Run Pharmaceuticals, LLC
----------
MEDICATION GUIDE
GADOBUTROL INJECTION
Gadobutrol (gad” oh bue’ trol)
Injection for intravenous use
What is the most important information I should know about gadobutrol
injection?
•
Gadobutrol 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 Dotarem, gadobutrol injection, 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 the skin, muscles and other organs in the body
(nephrogenic systemic
fibrosis). Your healthcare provider should screen you to see how well
your kidneys are working
before you receive gadobutrol injection.
What is gadobutrol injection?
•
Gadobutrol injection is a prescription medicine called a
gadolinium-based contrast agent (GBCA).
Gadobutrol 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 gadobutrol injection, helps your
doctor to see problems
better than an MRI exam without a GBCA.
•
Your doctor has reviewed your medical

Summary of Product characteristics

GADOBUTROL- GADOBUTROL INJECTION
SLATE RUN PHARMACEUTICALS, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GADOBUTROL INJECTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
GADOBUTROL INJECTION.
GADOBUTROL INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2011
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:
1. CHRONIC, SEVERE KIDNEY DISEASE (GFR <30 ML/MIN/1.73M
), OR
2. 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. ( 5.1)
INDICATIONS AND USAGE
Gadobutrol injection is a gadolinium-based contrast agent indicated
for use with magnetic resonance
imaging (MRI):
1. To detect and visualize areas with disrupted blood brain barrier
and/or abnormal vascularity of the
central nervous system in adult and pediatric patients, including term
neonates ( 1.1)
2. To assess the presence and extent of malignant breast disease in
adult patients ( 1.2)
3. To evaluate known or suspected supra-aortic or renal artery disease
in adult and pediatric patients,
including term neonates ( 1.3)
4. To assess myocardial perfusion (stress, rest) and late gadolinium
enhancement in adult patients with
known or suspected coronary artery disease (CAD) ( 1.4)
DOSAGE AND ADMINISTRATION
Recommended dose for adults and pediatric patients (including term
neonates) is 0.1 mL/kg body
weight ( 2.1)
Administer as an intravenous bolus inject