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.
- 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 PROHANCE.
|
Do not receive
PROHANCE if you have had a severe allergic reaction to PROHANCE. |
Before receiving
PROHANCE, 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 PROHANCE can harm your unborn baby. Talk to your healthcare provider
about the possible risks to an unborn baby if a GBCA such as PROHANCE
is received during pregnancy
- have kidney problems, diabetes, or high blood pressure
- have had an allergic reaction to dyes (contrast agents)
including GBCAs
|
What are the
possible side effects of PROHANCE?
-
See “What is the most important information I should
know about PROHANCE?”
-
Allergic reactions. PROHANCE 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 PROHANCE include: nausea,
distortion of the sense of taste, and headache.
These
are not all the possible side effects of PROHANCE. 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 use of PROHANCE.
Medicines
are sometimes prescribed for purposes other than those listed in a
Medication Guide. You can ask your healthcare provider for information
about PROHANCE that is written for health professionals. |
What are the
ingredients in PROHANCE?
Active ingredient:
gadoteridol
Inactive ingredients: calteridol
calcium, tromethamine
Manufactured by: BIPSO GmbH-78224
Singen (Germany) Manufactured for: Bracco Diagnostics Inc.,
Monroe Township, NJ 08831 For more information, go to www.imaging.bracco.com
or call 1-800-257-5181. |