Gadavist

Gadavist

Generic Name: gadobutrol

Date of Approval: March 14, 2011

Company: Bayer HealthCare Pharmaceuticals Inc.

Treatment for: Diagnostic Magnetic Resonance Imaging

FDA Approves Gadavist

The U.S. Food and Drug Administration has approved Gadavist (gadobutrol) Injection, a macrocyclic gadolinium-based contrast agent (GBCA), for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system (CNS).

Highlights of Gadavist Prescribing Information

These highlights do not include all the information needed to use Gadavist safely and effectively. See full prescribing information for Gadavist.

Warning: Nephrogenic Systemic Fibrosis (NSF)

See full prescribing information for complete boxed warning Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities.

The risk for NSF appears highest among patients with:

Chronic, severe kidney disease (GFR < 30 mL/min/1.73m2), or

Acute kidney injury.

Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age >60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.

Indications and Usage

Gadavist is a gadolinium-based contrast agent indicated for intravenous use in diagnostic MRI in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system.

Dosage and Administration

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 the table in section 2.1 to determine the volume of Gadavist to be administered.

The recommended dose of Gadavist is 0.1 mL/kg body weight (0.1 mmol/kg), administered as an intravenous bolus injection at a flow rate of approximately 2 mL/second. Flush the intravenous cannula with physiological saline solution after the injection.

Dosage Forms and Strengths

Pharmacy Bulk Packages are not for use in direct intravenous infusions. Gadavist injection contains 1 mmol gadobutrol/mL (equivalent to 604.72 mg gadobutrol/mL).

Contraindications

None

Warnings and Precautions

Nephrogenic Systemic Fibrosis has occurred in patients with impaired elimination of GBCAs. Higher than recommended dosing or repeated dosing appears to increase the risk.

Hypersensitivity: Anaphylactoid/anaphylactic reactions with cardiovascular, respiratory or cutaneous manifestations, ranging from mild to severe, including death, have uncommonly occurred. Monitor patients closely for need of emergency cardiorespiratory support.

Gadavist Side Effects

The most frequent (? 0.5%) adverse reactions associated with Gadavist in clinical studies were headache, nausea, injection site reaction, dysgeusia and feeling hot.

Use in Specific Populations

Pregnancy: Based on animal data, may cause fetal harm.

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

Patient Counseling Information

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 Gadavist administration, such as burning, itching, swelling, scaling, hardening and tightening of the skin; red or dark patches on the skin; stiffness in joints with trouble moving, bending or straightening the arms, hands, legs or feet; pain in the hip bones or ribs; or muscle weakness.

Common Side Effects

Inform patients that they may experience:

Reactions along the venous injection site, such as mild and transient burning or pain or feeling of warmth or coldness at the injection site

Side effects of headache, nausea, abnormal taste and feeling hot

General Precautions

Instruct patients receiving Gadavist to inform their physician if they:

Are pregnant or breastfeeding

Have a history of allergic reaction to contrast media, bronchial asthma or allergic respiratory disorder,

Are taking any medications