MEDICATION GUIDEDOTAREM® (doh TAH rem)(gadoterate meglumine)
Injection for intravenous use
What is DOTAREM?
DOTAREM is a prescription medicine called a gadolinium-based contrast agent (GBCA). DOTAREM, likeother GBCAs, is injected into your vein and used with a magnetic resonance imaging (MRI) scanner.
An MRI exam with a GBCA, including DOTAREM, 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 DOTAREM?
DOTAREM 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 inpatients with normal kidneys.
Rarely patients have reported pains, tiredness, and skin, muscle or bone ailments for a long time, but thesesymptoms 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 thebody is different for different gadolinium medicines. Gadolinium stays in the body more after Omniscan orOptimark than after Eovist, Magnevist or MultiHance. Gadolinium stays in the body the least afterDotarem, Gadavist or ProHance.
People who get many doses of gadolinium medicines, women who are pregnant and young children may beat 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
DOTAREM.
Do not receive DOTAREM if you have had a severe allergic reaction to DOTAREM.
Before receiving DOTAREM, 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 DOTAREM can harm your unborn baby. Talk to
your healthcare provider about the possible risks to an unborn baby if a GBCA such as DOTAREM is
received during pregnancy.
have kidney problems, diabetes, or high blood pressure.
have had an allergic reaction to dyes (contrast agents) including GBCA
What are possible side effects of DOTAREM?
See What is the most important information I should know about DOTAREM?
Allergic reactions. DOTAREM 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 DOTAREM include: nausea, headache, pain, or cold feeling at theinjection site, and rash.
These are not all the possible side effects of DOTAREM.
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 DOTAREM.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask
your healthcare provider for information about DOTAREM that is written for health professionals.
What are the ingredients in DOTAREM?
Active ingredient: gadoterate meglumine
Inactive ingredients: DOTA, water for injection
Manufactured by: Catalent (glass pre-filled syringes), Liebel-Flarsheim Company LLC (plastic pre-filledsyringes and vials) and Recipharm (vials) for Guerbet
For more information, go to www.guerbet-us.com or call 1-877-729-6679.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Rev. 4/2019
Revised: 4/2020

Guerbet LLC