Gadobutrol

Magnetic Resonance Imaging (MRI) of the Central Nervous System (CNS)

Gadobutrol is indicated for use with magnetic resonance imaging (MRI) in adult and pediatric patients (including term neonates) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system.​

MRI of the Breast

Gadobutrol is indicated for use with MRI to assess the presence and extent of malignant breast disease.

Magnetic Resonance Angiography (MRA)

​Gadobutrol is indicated for use in magnetic resonance angiography (MRA) in adult and pediatric patients (including term neonates) to evaluate known or suspected supra-aortic or renal artery disease.

Gadobutrol injection is a magnetic resonance imaging (MRI) contrast agent. Contrast agents are used to help create a clear picture of the body during MRI scans. MRI scans are a special kind of procedure that let a doctor look at the inside of the body, such as the brain. They use magnets and computers to create images or “pictures” of the body. Unlike x-rays, MRI scans do not involve radiation. Gadobutrol is a gadolinium-based contrast agent (GBCA) that is given by injection before the MRI to help diagnose problems in the brain, spine, breast, and other parts of your body.

Gadobutrol is to be used only by or under the direct supervision of a doctor.

Recommended Dose

The recommended dose of Gadobutrol 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 Gadobutrol Injection by Body Weight

Administration Guidelines

• Gadobutrol is formulated at a higher concentration (1 mmol/mL) compared to certain other gadolinium based contrast agents, resulting in a lower volume of administration. Closely examine Table 1 to determine the volume to be administered.
• Use sterile technique when preparing and administering Gadobutrol.
• Administer Gadobutrol as an intravenous bolus injection, manually or by power injector, at a flow rate of approximately 2 mL/second.
• Follow Gadobutrol injection with a normal saline flush to ensure complete administration of the contrast.
• Contrast-enhanced MRI can commence immediately following contrast administration.

Drug Handling

• Visually inspect Gadobutrol 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 Gadobutrol with other medications and do not administer Gadobutrol in the same intravenous line simultaneously with other medications because of the potential for chemical incompatibility.

Vials

• Draw Gadobutrol 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.

How supplied

Dosage Forms And Strengths

Gadobutrol is a sterile, clear, and colorless to pale yellow solution for injection containing 604.72 mg Gadobutrol per mL (equivalent to 1 mmol Gadobutrol/ mL) supplied in single-dose vials and pre-filled disposable syringes.

Gadobutrol is a sterile, clear and colorless to pale yellow solution containing 604.72 mg Gadobutrol per mL (equivalent to 1 mmol Gadobutrol) per mL. Gadobutrol is supplied in the following sizes:

Single-Dose Vials

Single-Dose Pre-Filled Syringes

Storage And Handling

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

Should freezing occur, Gadobutrol should be brought to room temperature before use. If allowed to stand at room temperature, Gadobutrol should return to a clear and colorless to pale yellow solution. Visually inspect Gadobutrol 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.

Manufactured for: Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ 07981. Revised: December 2014

See also:
What is the most important information I should know about Gadobutrol?

Gadobutrol can cause a life-threatening condition in people with advanced kidney disease. The symptoms of this condition include:

• burning, itching, swelling, scaling, and tightening or hardening of your skin;
• muscle weakness;
• joint stiffness in your arms, hands, legs, or feet;
• deep bone pain in your ribs or your hips;
• trouble moving; or
• skin redness or discoloration.

Before receiving this medication, tell your doctor if you have kidney disease or if you are on dialysis. You may not be able to receive Gadobutrol. Also tell your doctor if you have recently received any contrast agents similar to Gadobutrol.

Also tell your doctor if you have diabetes, high blood pressure, liver disease, asthma or allergies, a history of seizures, if you are over 60 years old, if you have ever had a reaction to a contrast agent, or if you have recently had an injury, surgery, or severe infection.

Your doctor or other healthcare provider may want to watch you for a short time after your test is over. This is to make sure you do not have any unwanted side effects or delayed reactions.

Use: Labeled Indications

US labeling:

Breast malignancy imaging: Contrast medium for use with MRI to assess the presence and extent of malignant breast disease.

Cardiac imaging: MRI (CMRI) to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease.

CNS imaging: MRI in adults, adolescents, and pediatric patients (including term neonates) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the CNS.

Supra-aortic or renal artery angiography: Magnetic resonance angiography (MRA) in adult and pediatric patients (including term neonates) to evaluate known or suspected supra-aortic or renal artery disease.

Canadian labeling:

Breast malignancy imaging: Contrast medium for use with MRI to assess the presence and extent of malignant breast disease.

CNS imaging: Contrast medium for MRI of CNS lesions (brain, spine, and associated tissues) and for perfusion studies to diagnose stroke, or to detect focal cerebral ischemia or tumor perfusion.

Contrast-enhanced magnetic resonance angiography: Contrast medium for contrast-enhanced magnetic resonance angiography (CE-MRA).

Renal imaging: Contrast medium for MRI of the kidney.

See also:
What other drugs will affect Gadobutrol?

As for all other Gadolinium containing contrast media no interactions with other medicaments have been observed. Formal drug interaction studies have not been carried out.

See also:
What are the possible side effects of Gadobutrol?

The following serious adverse reactions are discussed elsewhere in labeling:

• Nephrogenic Systemic Fibrosis (NSF).
• Hypersensitivity reactions.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The adverse reactions described in this section reflect Gadobutrol exposure in 6,330 subjects (including 184 pediatric patients, ages 0 to 17 years) with the majority receiving the recommended dose. Approximately 50% of the subjects were male and the ethnic distribution was 60% Caucasian, 30% Asian, 6% Hispanic, 2% Black, and 3% patients of other ethnic groups. The average age was 55 years (range from1 week to 93 years).

Overall, approximately 4% of subjects reported one or more adverse reactions during a follow-up period that ranged from 24 hours to 7 days after Gadobutrol administration.

Adverse reactions associated with the use of Gadobutrol were usually mild to moderate in severity and transient in nature.

Table 2 lists adverse reactions that occurred in ≥ 0.1% subjects who received Gadobutrol.

Table 2: Adverse Reactions

Adverse reactions that occurred with a frequency of < 0.1% in subjects who received Gadobutrol include: loss of consciousness, convulsion, parosmia, tachycardia, palpitation, dry mouth, malaise and feeling cold.

Postmarketing Experience

The following additional adverse reactions have been reported during postmarketing use of Gadobutrol. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

• Cardiac arrest
• Nephrogenic Systemic Fibrosis (NSF)
• Hypersensitivity reactions (anaphylactic shock, circulatory collapse, respiratory arrest, pulmonary edema, bronchospasm, cyanosis, oropharyngeal swelling, laryngeal edema, blood pressure increased, chest pain, angioedema, conjunctivitis, hyperhidrosis, cough, sneezing, burning sensation, and pallor)

Intravenous Gadobutrol is a second-generation extracellular non-ionic macrocyclic GBCA (gadolinium-based contrast agent) used in magnetic resonance imaging (MRI) in adults and children older than 2 years of age. It may help visualize and detect vascular abnormalities in the blood brain barrier (BBB) and central nervous system (CNS). In patients with impaired renal function, gadolinium based contrast agents increase the risk of nephrogenic systemic fibrosis (NSF). A physician should be contacted if symptoms of NSF are encountered, such as dark or red patches on the skin; stiffness in joints; trouble moving, bending or straightening arms, hands, legs or feet; burning, itching, swelling, scaling, hardening and tightening of skin; pain in hip bones or ribs; or muscle weakness. Common adverse reactions that may be experienced include headache, nausea, feeling hot, abnormal taste, and warmth, burning or pain local to the injection site. General precautions should be taken in patients who are pregnant or breastfeeding, or who have a history of allergic reaction to contrast media, bronchial asthma or an allergic respiratory disorder.