Gadavist (gadobutrol)

• 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.

Possible side effects of Gadavist include:

• 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.

Recommended Dose

The recommended dose of Gadavist for adult and pediatric patients (including term neonates) is 0.1 mL/kg body weight (0.1 mmol/kg). Refer to Table 1 to determine the volume to be administered.

Table 1: Volume of Gadavist Injection by Body Weight*

Administration Guidelines

• Gadavist is formulated at a higher concentration (1 mmol/mL) compared to certain other gadolinium based contrast agents, resulting in a lower volume of administration. Use Table 1 to determine the volume to be administered.
• Use sterile technique when preparing and administering Gadavist.

MRI Of The Central Nervous System

• Administer Gadavist as an intravenous injection, manually or by power injector, at a flow rate of approximately 2 mL/second.
• Follow Gadavist injection with a normal saline flush to ensure complete administration of the contrast.
• Post contrast MRI can commence immediately following contrast administration.

MRI Of The Breast

• Administer Gadavist as an intravenous bolus by power injector, followed by a normal saline flush to ensure complete administration of the contrast.
• Start image acquisition following contrast administration and then repeat sequentially to determine peak intensity and wash-out.

MR Angiography

Image acquisition should coincide with peak arterial concentration, which varies among patients.

Adults

• Administer Gadavist by power injector, at a flow rate of approximately 1.5 mL/second, followed by a 30 mL normal saline flush at the same rate to ensure complete administration of the contrast.

Pediatric patients

• Administer Gadavist by power injector or manually, followed by a normal saline flush to ensure complete administration of the contrast.

Cardiac MRI

• Administer Gadavist through a separate intravenous line in the contralateral arm if concomitantly providing a continuous infusion of a pharmacologic stress agent.
• Administer Gadavist as two (2) separate bolus injections: 0.05 mL/kg (0.05 mmol/kg) body weight at peak pharmacologic stress followed by 0.05 mL/kg (0.05 mmol/kg) body weight at rest.
• Administer Gadavist via a power injector at a flow rate of approximately 4 mL/second and follow each injection with a normal saline flush of 20 mL at the same flow rate.

Drug Handling

• 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.
• Do not mix Gadavist with other medications and do not administer Gadavist in the same intravenous line simultaneously with other medications because of the potential for chemical incompatibility.

Vials

• Draw Gadavist into the syringe immediately before use.
• Do not pierce the rubber stopper more than once. Discard any unused vial contents.

Pre-Filled Syringes

• Remove the tip cap from the pre-filled syringe immediately before use. Discard any unused syringe contents.

• GBCAs cross the placenta and result in fetal exposure and gadolinium retention.
• The human data on the association between GBCAs and adverse fetal outcomes are limited and inconclusive.
• Because of the potential risks of gadolinium to the fetus, use Gadavist only if imaging is essential during pregnancy and cannot be delayed.
• There are no data on the presence of gadobutrol in human milk, the effects on the breastfed infant, or the effects on milk production.
• However, published lactation data on other GBCAs indicate that 0.01 to 0.04% of the maternal gadolinium dose is present in breast milk and there is limited GBCA gastrointestinal absorption in the breast-fed infant.
• The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Gadavist and any potential adverse effects on the breastfed infant from Gadavist or from the underlying maternal condition.