Gadavist

Gadavist is an FDA-registered drug product whose active ingredient is GADOBUTROL. It is labelled by Bayer HealthCare Pharmaceuticals Inc. taken by intravenous and marketed as a human prescription drug product. Identifiers on file: NDC 50419-325, application NDA201277, label effective 20260501. It is one of 3 FDA drug label records sharing the active ingredient GADOBUTROL. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing GADOBUTROL are most often described in connection with: pediatric patients, including term, disease adult, known suspected, magnetic resonance, imaging mri, central nervous, visualize areas. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE GADAVIST is indicated for: Magnetic resonance imaging (MRI) of the central nervous system (CNS) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity in adult and pediatric patients including term neonates MRI of the breast to assess the presence and extent of malignant breast disease in adult patients Magnetic resonance angiography (MRA) to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients including term neonates Cardiac MRI (CMRI) to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD) GADAVIST 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 To assess the presence and extent of malignant breast disease in adult patients To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients including term neonates To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD) ( 1 )

2 DOSAGE AND ADMINISTRATION Recommended dose for adults and pediatric patients, including term neonates, is 0.1 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered by intravenous bolus injection. ( 2.1 , 2.2 ) See Full Prescribing Information for administration, imaging, and handling. ( 2.2 , 2.3 ) 2.1 Recommended Dose The recommended dose of GADAVIST for adult and pediatric patients, including term neonates, is 0.1 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered intravenously. For CMRI, the dose is divided into two separate, equal injections [see Dosage and Administration (2.2) ]. Refer to Table 1 for volumes to be administered for example body weights. Table 1: Volume of GADAVIST for Example Body Weights 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 2.2 Administration and Imaging Instructions General 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 [see Dosage and Administration (2.1) ]. GADAVIST is for intravenous use only and must not be administered intrathecally [see Warnings and Precautions (5.1) ] . Use aseptic technique when preparing and administering GADAVIST. 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. If solidification occurs due to cold exposure, bring GADAVIST to room temperature before use and inspect to ensure that the solution is clear and colorless to pale yellow. Do not mix GADAVIST with other medications and do not administer GADAVIST in the same intravenous line simultaneously with other medications. MRI of the CNS in Adult and Pediatric Patients Including Term Neonates Administer GADAVIST as an intravenous injection, manually or by power injector, at a flow rate of approximately 2 mL/sec. Follow GADAVIST injection with a flush of 0.9% Sodium Chloride Injection to ensure complete administration of the contrast. Post contrast MRI can commence immediately following contrast administration. MRI of the Breast in Adults Administer GADAVIST as an intravenous bolus by power injector, followed by a flush of 0.9% Sodium Chloride Injection to ensure complete administration of the contrast. Start image acquisition following GADAVIST administration and then repeat sequentially to determine peak intensity and wash-out. MR Angiography in Adult and Pediatric Patients Including Term Neonates Image acquisition should coincide with peak arterial concentration, which varies among patients. For adults, administer GADAVIST as an intravenous injection by power injector, at a flow rate of approximately 1.5 mL/sec, followed by a 30 mL flush of 0.9% Sodium Chloride Injection at the same rate to ensure complete administration of the contrast. For pediatric patients including term neonates, administer GADAVIST as an intravenous injection by power injector or manually, followed by a flush of 0.9% Sodium Chloride Injection to ensure complete administration of the contrast. Cardiac MRI in Adults 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 separate bolus injections: 0.05 mmol/kg actual body weight (equivalent to 0.05 mL/kg) at peak pharmacologic stress followed by 0.05 mmol/kg (equivalent to 0.05 mL/kg) at rest. Administer GADAVIST via a power injector at a flow rate of approximately 4 mL/sec and follow each injection with a 20 mL flush of 0.9% Sodium Chloride Injection at the same flow rate. 2.3 Directions for Use of Pharmacy Bulk Package GADAVIST Pharmacy Bulk Package (PBP) is not for direct infusion. The PBP contains many single doses for use with an appropriate transfer device for filling empty sterile syringes. Perform the transfer of GADAVIST from the PBP in an aseptic work area, such as a laminar flow hood, using aseptic technique. Penetrate the closure only one time. Once the PBP is punctured, do not remove from the aseptic work area. Use the contents of the PBP within 24 hours at 20°C to 25°C (68°F to 77°F) after puncture. Discard any unused portion.

4 CONTRAINDICATIONS GADAVIST is contraindicated in patients with history of severe hypersensitivity reactions to GADAVIST [see Warnings and Precautions (5.3) ] . History of severe hypersensitivity reaction to GADAVIST ( 4 )

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed elsewhere in labeling: Nephrogenic Systemic Fibrosis [see 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) ] Most common adverse reactions (incidence ≥ 0.5%) are headache, nausea, and dizziness ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 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 safety of GADAVIST was evaluated in 7,713 subjects (including 184 pediatric population, ages 0 to 17 years) who received GADAVIST in clinical trials. Approximately 52% of the subjects were male and the racial and ethnic distribution was 62% White, 28% Asian, 5% Hispanic or Latino, 2.5% Black or African American, and 2.5% other ethnic groups. The average age was 56 years (range from 1 week to 93 years). Table 2 lists adverse reactions that occurred in ≥ 0.1% subjects who received GADAVIST. Table 2: Adverse Reactions Reported in ≥0.1% Subjects who Received GADAVIST in Clinical Trials Adverse Reaction GADAVIST n=7,713 Rate (%) Headache 1.7 Nausea 1.2 Dizziness 0.5 Dysgeusia 0.4 Feeling Hot 0.4 Injection site reactions 0.4 Vomiting 0.4 Rash (includes generalized, macular, papular, pruritic) 0.3 Erythema 0.2 Paresthesia 0.2 Pruritus (includes generalized) 0.2 Dyspnea 0.1 Urticaria 0.1 Adverse reactions that occurred with a frequency of < 0.1% in subjects who received GADAVIST include: hypersensitivity/anaphylactic reaction, loss of consciousness, convulsion, parosmia, tachycardia, palpitation, dry mouth, malaise and feeling cold. Adverse Reactions in Pediatric Patients The frequency, type, and severity of adverse reactions observed in pediatric patients from the clinical studies were similar to adverse reactions in adults [ s ee Use in Specific Populations (8.4) ] . 6.2 Postmarketing Experience The following additional adverse reactions have been identified during postmarketing use of GADAVIST or other GBCAs. 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 Disorders: Cardiac arrest Gastrointestinal Disorders: Acute pancreatitis with onset within 48 hours after GBCA administration General Disorders and Administration Site Conditions: Fatigue, asthenia, pain syndromes, and heterogeneous clusters of symptoms in the neurological, cutaneous, and musculoskeletal systems with variable onset and duration after GBCA administration [see Warnings and Precautions (5.5) ] Immune System Disorders: Hypersensitivity reactions (anaphylactic shock, circulatory collapse, respiratory arrest, bronchospasm, cyanosis, oropharyngeal swelling, laryngeal edema, blood pressure increased, chest pain, angioedema, conjunctivitis, hyperhidrosis, cough, sneezing, burning sensation, and pallor) Renal Disorders: Nephrogenic systemic fibrosis Respiratory, Thoracic, and Mediastinal Disorders: Acute respiratory distress syndrome, pulmonary edema Skin Disorders: Gadolinium associated plaques

FDA lists 3 drug label records with GADOBUTROL as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Gadavist used for?
1 INDICATIONS AND USAGE GADAVIST is indicated for: Magnetic resonance imaging (MRI) of the central nervous system (CNS) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity in adult and pediatric patients including term neonates MRI of the breast to assess the presence and extent of malignant breast disease in adult patients Magnetic resonance angiography …

Who makes Gadavist?
Bayer HealthCare Pharmaceuticals Inc. is the labeler of record for Gadavist. 3 FDA label records share the active ingredient GADOBUTROL, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Gadavist come in?
administered by intravenous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Gadavist prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing GADOBUTROL?
Yes. 3 FDA drug label records list GADOBUTROL as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Gadavist been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.