Label Changes for:
Magnevist (brand of gadopentetate dimeglumine) Injection and Pharmacy Bulk Package
Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
WARNINGS AND PRECAUTIONS
- The risk of hypersensitivity reactions is higher in patients with a history of reaction to contrast media, bronchial asthma, or allergic disorders.
- Hypersensitivity reactions can occur with or without prior exposure to GBCAs. Have appropriately trained personnel administer Magnevist in a facility that has immediate availability of resuscitative equipment. If a hypersensitivity reaction occurs, stop Magnevist Injection and immediately begin appropriate therapy.
- In a study with pediatric patients aged 2 months to < 2 years the pharmacokinetics (body weight-normalized clearance, body weight-normalized distribution volume, and terminal halflife) of gadopentetate were similar to adults
- Delayed hypersensitivity reactions have been reported up to several hours after administration of Magnevist.
- Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
- For patients at highest risk for NSF do not exceed the recommended Magnevist dose and allow a sufficient period of time for elimination of the drug from the body prior to re-administration.
Magnevist is contraindicated in patients with:
- chronic, severe kidney disease (glomerular filtration rate, GFR < 30 mL/min/1.73m2), or
- acute kidney injury
WARNINGS AND PRECAUTIONS
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...
- 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 (e.g., 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 the degree of renal impairment at the time of exposure. Record the specific GBCA and the dose administered to a patient. For patients at highest risk for NSF, do not exceed the recommended Magnevist dose and allow a sufficient period of time for elimination of the drug prior to re-administration…
PATIENT COUNSELING INFORMATION
Additionally, instruct patients to inform their
physician if they:
- have a history of kidney and/or liver disease, or
- have recently received a GBCA.
GBCAs increase the risk for NSF among patients with impaired elimination of the drugs.
To counsel patients at risk for NSF:
- Describe the clinical manifestations 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 MAGNEVIST 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.