MEDICATION GUIDE Vueway (VIEW-way) (gadopiclenol) injection, for intravenous use |
What is Vueway?
- Vueway is a prescription medicine called a gadolinium-based
contrast agent (GBCA). Vueway, like other GBCAs, is injected into
your vein and used with a magnetic resonance imaging (MRI) scanner.
- An MRI exam with a GBCA, including Vueway, 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.
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What is the
most important information I should know about Vueway?
- GBCAs like Vueway 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 Vueway
is safe and effective with intrathecal use. Vueway is not approved
for this use.
- Vueway 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 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 Vueway.
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Do not receive
Vueway if you have had a severe allergic reaction to Vueway. |
Before receiving
Vueway, tell your healthcare provider about all your medical conditions,
including if you:
- have had any MRI procedures in the past where you received
a GBCA. Your healthcare provider may ask you for more information
including the dates of these MRI procedures.
- are pregnant or plan to become pregnant. It is not known
if Vueway can harm your unborn baby. Talk to your healthcare provider
about the possible risks to an unborn baby if a GBCA such as Vueway
is received during pregnancy.
- have kidney problems, diabetes, or high blood pressure.
- have had an allergic reaction to dyes (contrast agents)
including GBCAs.
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What are possible
side effects of Vueway?
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See “What is the most important information I should
know about Vueway?”
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Allergic reactions. Vueway can cause allergic reactions
that can sometimes be serious. Your healthcare provider will monitor
you closely for symptoms of an allergic reaction.
The most common side effects of Vueway include: injection
site pain, headache, nausea, injection site coldness, injection site
warmth, dizziness, and localized swelling.
These
are not all the possible side effects of Vueway. Call
your doctor for medical advice about side effects. You may report
side effects to FDA at 1-800-FDA-1088. |
General information
about the safe and effective uses of Vueway.
Medicines
are sometimes prescribed for purposes other than those listed in a
Medication Guide. You can ask your healthcare provider for information
about Vueway that is written for health professionals. |
What are the
ingredients in Vueway?
Active ingredient:
gadopiclenol
Inactive ingredients: tetraxetan;
trometamol; hydrochloric acid or sodium hydroxide for pH adjustment;
and water for injection
Manufactured for Bracco
Diagnostics Inc. by: Liebel-Flarsheim Company LLC, 8800
Durant Road, Raleigh, North Carolina (NC) 27616-3104, USA Distributed by: Bracco Diagnostics Inc., 259 Prospect Plains Road,
Monroe Township, New Jersey 08831, USA
For more information, go to www.imaging.bracco.com or call 800-257-5181. |