Gadobutrol

Gadobutrol injection is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI): • To detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in adult and pediatric patients, including term neonates ( 1.1 ) • To assess the presence and extent of malignant breast disease in adult patients ( 1.2 ) • To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients, including term neonates ( 1.3 ) • To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD). ( 1.4 ). …

• Recommended dose for adults and pediatric patients (including term
• Neonates) is 0.1 mL/kg body weight • Administer as an intravenous bolus injection • Follow injection with a normal saline flush Recommended Dose The recommended dose of gadobutrol injection 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* Body Weight (kg) Volume to be Administered (mL) 2.5 0.25 5 0.5 10 1 15 1.5 20 2 25 2.5 30 3 35 3.5 40 4 45 4.5 50 5 60 6 70 7 80 8 90 9 100 10 110 11 120 12 130 13 140 14 *for Cardiac MRI, the dose is divided into 2 separate, equal injections Administration Guidelines • Gadobutrol injection 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 gadobutrol injection
• MRI of the Central Nervous System • Administer gadobutrol injection as an intravenous 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. • Post contrast MRI can commence immediately following contrast administration. …

Gadobutrol injection 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. Gadobutrol injection contains 604.72 mg gadobutrol/mL (equivalent to 1 mmol gadobutrol/mL) and is available in vials ( 3 )

• The safety and effectiveness of gadobutrol injection have been established
• In pediatric patients, including term
• Neonates, for use with MRI to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system and for use in MRA to evaluate known or suspected supra-aortic or renal artery disease. …

In clinical studies of gadobutrol injection, 1,377 patients were 65 years of age and over, while 104 patients were 80 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. …

• Advise the patient to read the FDA-approved patient labeling (Medication Guide)
• Nephrogenic Systemic Fibrosis Instruct patients to inform their physician if they: • Have a history of kidney disease and/or liver disease, or • Have recently received a GBCA GBCAs increase the risk of NSF among patients with impaired elimination of drugs
• To counsel patients at risk of NSF: • Describe the clinical manifestation of NSF • Describe procedures to screen for the detection of renal impairment Instruct the patients to contact their physician if they develop signs or symptoms of NSF following gadobutrol injection administration, such as burning, itching, swelling, scaling, hardening and tightening of …

• Gadobutrol injection is contraindicated in patients with history of severe hypersensitivity reactions to gadobutrol injection
• History of severe hypersensitivity reaction to gadobutrol injection

• Hypersensitivity Reactions: Anaphylactic and other hypersensitivity reactions with cardiovascular, respiratory or cutaneous manifestations, ranging from mild to severe, including death, have occurred. Monitor patients closely during and after administration of gadobutrol injection. ( 5.3 ) • Acute Respiratory Distress Syndrome: For Patients demonstrating respiratory distress after administration, assess oxygen requirement and monitor for worsening respiratory function. ( 5.4 ) • Gadolinium Retention: Gadolinium is retained for months or years in brain, bone, and other organs. …

The following clinically significant adverse reactions are discussed elsewhere in labeling: • Nephrogenic Systemic Fibrosis (NSF) [see Boxed Warning and Warnings and Precautions ( 5.2 )] . • Hypersensitivity reactions [see Contraindications ( 4 ) and Warnings and Precautions ( 5.3 )] . • Acute Respiratory Distress Syndrome [see Warnings and Precautions ( 5.4 )] . • Gadolinium Retention [see Warnings and Precautions ( 5.5 )] . …

8.1 Pregnancy Risk Summary 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 (see Data ) . In animal reproduction studies, although teratogenicity was not observed, embryolethality was observed in monkeys, rabbits and rats receiving intravenous gadobutrol during organogenesis at doses 8 times and above the recommen …

The maximum dose of gadobutrol injection tested in healthy volunteers, 1.5 mL/kg body weight (1.5 mmol/kg; 15 times the recommended dose), was tolerated in a manner similar to lower doses. Gadobutrol can be removed by hemodialysis [see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3 )] .

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.