Clariscan (gadoterate meglumine)

• Clariscan (gadoterate meglumine) is a prescription medicine called a gadolinium-based contrast agent (GBCA). Clariscan, like other GBCAs, is injected into your vein and used with a magnetic resonance imaging (MRI) scanner.
• An MRI exam with a GBCA, including Clariscan, 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.

• Clariscan 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 Clariscan, 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 Clariscan.

Do not receive Clariscan if you have had a severe allergic reaction to Clariscan.

Before receiving Clariscan, 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.
• have kidney problems, diabetes, or high blood pressure.
• have had an allergic reaction to dyes (contrast agents) including GBCA.

Clariscan 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 Clariscan include: nausea, headache, pain, or cold feeling at the injection site, and rash.

These are not all the possible side effects of Clariscan.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For adult and pediatric patients (including term neonates), the recommended dose of Clariscan is 0.2 mL/kg (0.1 mmol/kg) body weight administered as an intravenous bolus injection, manually or by power injector, at a flow rate of approximately 2 mL/second for adults and 1-2 mL/second for pediatric patients.

To ensure complete injection of Clariscan, the injection may be followed by normal saline flush. Contrast MRI can begin immediately following Clariscan injection.

Gadoterate does not interfere with serum and plasma calcium measurements determined by colorimetric assays. Specific drug interaction studies with gadoterate meglumine have not been conducted.

Before receiving Clariscan, tell your healthcare provider about all your medical conditions, including if you:

• are pregnant or plan to become pregnant. It is not known if Clariscan can harm your unborn baby. Talk to your healthcare provider about the possible risks to an unborn baby if a GBCA such as Clariscan is received during pregnancy.