Magnevist

MAGNEVIST- gadopentetate dimeglumine injection
Bayer HealthCare Pharmaceuticals Inc.

1 INDICATIONS AND USAGE

1.1 Central Nervous System

Magnevist injection is indicated for use with magnetic resonance imaging (MRI) in adults, and pediatric patients (2 years of age and older) to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues. Magnevist injection has been shown to facilitate visualization of intracranial lesions including but not limited to tumors.

1.2 Extracranial/Extraspinal Tissues

Magnevist injection is indicated for use with MRI in adults and pediatric patients (2 years of age and older) to facilitate the visualization of lesions with abnormal vascularity in the head and neck.

1.3 Body

Magnevist injection is indicated for use in MRI in adults and pediatric patients (2 years of age and older) to facilitate the visualization of lesions with abnormal vascularity in the body.

2 DOSAGE AND ADMINISTRATION

The recommended dosage of Magnevist injection is 0.2 mL/kg (0.1 mmol/kg) administered intravenously, at a rate not to exceed 10 mL per 15 seconds. Dosing for patients in excess of 286 lbs has not been studied systematically.

To ensure complete injection of Gadopentetate dimeglumine, administer 5-mL normal saline flush after the injection. The imaging procedure should be completed within 1 hour of injection of Magnevist injection.

Visually inspect 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.

Discard any unused portion in accordance with regulations dealing with the disposal of such materials.

DOSE AND DURATION OF MAGNEVIST INJECTION
BODY WEIGHT		Total Volume, mL*
lb	kg
22	10	2
44	20	4
66	30	6
88	40	8
110	50	10
132	60	12
154	70	14
176	80	16
198	90	18
220	100	20
242	110	22
264	120	24
286	130	26
*Rate of Injection: 10 mL/15 seconds

3 DOSAGE FORMS AND STRENGTHS

Magnevist is a clear, colorless to slightly yellow solution containing 0.5 mmol gadopentetate dimeglumine/mL (equivalent to 469.01 mg/mL of gadopentetate dimeglumine) for intravenous use.

4 CONTRAINDICATIONS

Magnevist is contraindicated in patients with:

•

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

•

Acute kidney injury, or

•

History of severe hypersensitivity reactions to Gadopentetate dimeglumine.

5 WARNINGS AND PRECAUTIONS

5.1 Nephrogenic Systemic Fibrosis (NSF)

Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with non-contrast enhanced MRI or other modalities. The GBCA-associated NSF risk appears highest for patients with chronic, severe kidney disease (GFR < 30 mL/min/1.73m²) as well as patients with acute kidney injury. Do not administer Magnevist to these patients. The risk appears lower for patients with chronic, moderate kidney disease (GFR 30- 59 mL/min/1.73m²) and little, if any, for patients with chronic, mild kidney disease (GFR 60- 89 mL/min/1.73m²). NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs. Report any diagnosis of NSF following Magnevist administration to Bayer HealthCare (1-888-842-2937) or FDA (1-800-FDA-1088 or www.fda.gov/medwatch).

Screen patients for acute kidney injury and other conditions that may reduce renal function. Features of acute kidney injury consist of rapid (over hours to days) and usually reversible decrease in kidney function, commonly in the setting of surgery, severe infection, injury, or drug-induced kidney toxicity. Serum creatinine levels and estimated GFR may not reliably assess renal function in the setting of acute kidney injury. For patients at risk for chronically reduced renal function (for example, age > 60 years, diabetes mellitus or chronic hypertension), estimate the GFR through laboratory testing.

Among the factors that may increase the risk for NSF are repeated or higher than recommended doses of a GBCA and degree of renal impairment at the time of exposure. Record the specific GBCA and the dose administered to a patient. When administering Gadopentetate dimeglumine, do not exceed the recommended dose and allow a sufficient period of time for elimination of the drug prior to re-administration [see Clinical Pharmacology (12.3) and Dosage and Administration (2)].