MAGNEVIST- gadopentetate dimeglumine injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GADOPENTETATE DIMEGLUMINE (UNII: RH248G8V27) (GADOPENTETATE - UNII:V7OK6J19HQ)

Available from:

Bayer HealthCare Pharmaceuticals Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Magnevist injection is indicated for use with magnetic resonance imaging (MRI) in adults, and pediatric patients (2 years of age and older) to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues. Magnevist injection has been shown to facilitate visualization of intracranial lesions including but not limited to tumors. Magnevist injection is indicated for use with MRI in adults and pediatric patients (2 years of age and older) to facilitate the visualization of lesions with abnormal vascularity in the head and neck. Magnevist injection is indicated for use in MRI in adults and pediatric patients (2 years of age and older) to facilitate the visualization of lesions with abnormal vascularity in the body. Magnevist is contraindicated in patients with: 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). In animal

Product summary:

Magnevist injection is a clear, colorless to slightly yellow solution containing 469.01 mg/mL of gadopentetate dimeglumine. Magnevist injection is supplied in the following sizes: Single-Dose Vials Single-Dose Pre-Filled Syringes Magnevist injection should be stored at controlled room temperature, between 15 - 30° C (59 - 86° F) and protected from light. DO NOT FREEZE. Should freezing occur in the vial, Magnevist injection should be brought to room temperature before use. If allowed to stand at room temperature for a minimum of 90 minutes, Magnevist injection 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.

Authorization status:

New Drug Application

Patient Information leaflet

Bayer HealthCare Pharmaceuticals Inc.
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MEDICATION GUIDE
MAGNEVIST
(mag-na-vist)
(gadopentetate dimeglumine)
Injection for intravenous use
What is Magnevist?
•
Magnevist is a prescription medicine called a gadolinium-based
contrast agent (GBCA).
Magnevist, like other GBCAs, is injected into your vein and used with
a magnetic resonance
imaging (MRI) scanner.
•
An MRI exam with a GBCA, including Magnevist, 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 Magnevist?
•
Magnevist 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 can feel 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.
•
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 Magnevist.
Do not receive Magnevist if you hav

Summary of Product characteristics

MAGNEVIST- GADOPENTETATE DIMEGLUMINE INJECTION
BAYER HEALTHCARE PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MAGNEVIST SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR MAGNEVIST.
MAGNEVIST (GADOPENTETATE DIMEGLUMINE) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1988
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.
•
•
DO NOT EXCEED THE RECOMMENDED MAGNEVIST DOSE AND ALLOW A SUFFICIENT
PERIOD OF TIME FOR ELIMINATION OF
THE DRUG FROM THE BODY PRIOR TO ANY RE-ADMINISTRATION. (5.1)
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Magnevist is a gadolinium-based contrast agent indicated for
intravenous use in diagnostic MRI in adults and children (2
years of age and older) to facilitate the visualization of lesions and
abnormal vascularity in:
•
•
•
DOSAGE AND ADMINISTRATION
Magnevist is administered intravenously, 0.2 mL/kg (0.1 mmol/kg), at a
rate not to exceed 10 mL per 15 seconds. See the
dosage table to determine the amount to be administered based on body
weight. (2)
DOSAGE FORMS AND STRENGTHS
Magnevist contains 0.5 mmol gadopentetate dimeglumine/mL (equivalent
to 469.01 mg gadopentetate dimeglumine/mL)
and is available in vials and prefilled syringes. (3)
CONTRAINDICATIONS
Magnevist is contraindicated in patients with chronic, severe kidney
disease (GFR < 30 mL/min/1.73m ) or acute kidney
injury, or history of severe hypersensitivity reactions to
gadopentetate dimeglumine. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
®
DO NOT ADMINISTER MAGNEVIST TO PATIENTS WITH:
•
•
CHRONIC, SEVERE KIDNEY DISEASE (GFR < 30 ML/MIN/1.73M ), OR
2
ACUTE KIDNEY INJURY. (4)
SCREEN PATIENTS F