Gadavist

What is Gadavist?

Gadavist is a prescription medicine called a gadolinium-based contrast agent (GBCA). Gadavist, like other GBCAs, is injected into your vein and used with a magnetic resonance imaging (MRI) scanner.

An MRI exam with a GBCA, including Gadavist, 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.

Description

Gadavist (gadobutrol) injection is a paramagnetic macrocyclic contrast agent administered for magnetic resonance imaging. The chemical name for gadobutrol is 10–[(1SR,2RS)–2,3–dihydroxy–1–hydroxymethylpropyl]–1,4,7,10–tetraazacyclododecane–1,4,7–triacetic acid, gadolinium complex. Gadobutrol has a molecular formula of C18H31GdN4O9 and a molecular weight of 604.72.

Gadavist is a sterile, clear, colorless to pale yellow solution containing 604.72 mg (1.0 mmol) of gadobutrol per mL as the active ingredient with 0.513 mg of calcobutrol sodium, 1.211 mg of trometamol, hydrochloric acid (for pH adjustment) and water for injection. Gadavist contains no preservatives.

The main physicochemical properties of Gadavist (1 mmol/mL solution for injection) are listed below:

The thermodynamic stability constants for gadobutrol (log Ktherm and log Kcond at pH 7.4) are 21.8 and 15.3, respectively.

Mechanism of Action

In MRI, visualization of normal and pathological tissue depends in part on variations in the radiofrequency signal intensity that occurs with:

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Differences in proton density

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Differences of the spin-lattice or longitudinal relaxation times (T1)

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Differences in the spin-spin or transverse relaxation time (T2)

When placed in a magnetic field, Gadavist shortens the T1 and T2 relaxation times. The extent of decrease of T1 and T2 relaxation times, and therefore the amount of signal enhancement obtained from Gadavist, is based upon several factors including the concentration of Gadavist in the tissue, the field strength of the MRI system, and the relative ratio of the longitudinal and transverse relaxation times. At the recommended dose, the T1 shortening effect is observed with greatest sensitivity in T1-weighted magnetic resonance sequences. In T2*-weighted sequences the induction of local magnetic field inhomogeneities by the large magnetic moment of gadolinium and at high concentrations (during bolus injection) leads to a signal decrease.

What is the most important information I should know about Gadavist?

• Gadavist 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 Gadavist.

Who should not use Gadavist?

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

What should I tell my healthcare provider before using Gadavist?

Before receiving Gadavist, 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 Gadavist can harm your unborn baby. Talk to your healthcare provider about the possible risks to an unborn baby if a GBCA such as Gadavist is received during pregnancy.
• have kidney problems, diabetes, or high blood pressure.
• have had an allergic reaction to dyes (contrast agents) including GBCAs

How should I use Gadavist?

• Gadavist, like other GBCAs, will be injected into your vein by a healthcare professional.

What are the possible side effects of Gadavist?

• See “What is the most important information I should know about Gadavist?”
• Allergic reactions. Gadavist 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 Gadavist include: headache, nausea, and dizziness.

These are not all the possible side effects of Gadavist.

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 Gadavist

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your healthcare provider for information about Gadavist that is written for health professionals.

How should I store Gadavist?

Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F).

Should freezing occur, Gadavist should be brought to room temperature before use. If allowed to stand at room temperature, Gadavist should return to a clear and colorless to pale yellow solution. Visually inspect Gadavist for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored, if particulate matter is present or if the container appears damaged.

What are the ingredients in Gadavist?

Active ingredient: gadobutrol

Inactive ingredients: calcobutrol sodium, trometamol, hydrochloric acid (for pH adjustment) and water for injection

Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Gadavist Imaging Bulk Pack 65 mL Label

• Dose: 0.1 mL/kg
• NDC 50419-325-09
  65 mL
• Rx only
• sterile solution
• Gadavist
• sterile solution
• Gadavist
• (gadobutrol) injection
  1 mmol/mL
• For Intravenous Administration.
  Multiple-Dose container.
• Discard unused portion 24 hours after initial puncture.

SRC: NLM .