ProHance

PROHANCE- gadoteridol injection, solution
Bracco Diagnostics Inc

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS

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. NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs [see Warnings and Precautions (5.1)].

  • 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 (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 ProHance dose and allow a sufficient period of time for elimination of the drug from the body prior to re-administration [see Warnings and Precautions (5.1)].

1  INDICATIONS AND USAGE

1.1 MRI of the Central Nervous System (CNS)

ProHance is indicated for use in magnetic resonance imaging (MRI) in adults and pediatric patients over 2 years of age to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues.

1.2 MRI of Extracranial/Extraspinal Tissues

ProHance is indicated for use in MRI in adults to visualize lesions in the head and neck.

2  DOSAGE AND ADMINISTRATION

2.1 Dosing and Imaging Instructions

MRI of the CNS
Adults:

  • Recommended dose is 0.1 mmol/kg (0.2 mL/kg) administered as a rapid intravenous infusion (10 mL/min-60 mL/min) or bolus (> 60 mL/min)
  • A supplementary dose of 0.2 mmol/kg (0.4 mL/kg) may be given up to 30 minutes after the first dose in patients with normal renal function suspected of having poorly enhancing lesions, in the presence of negative or equivocal scans
  • Immediately after injection, inject at least a 5 mL normal saline flush to ensure complete administration of contrast medium
  • Imaging procedure should be completed within 1 hour of the first injection of ProHance

Pediatric Use (2-17 years):

  • Recommended dose is 0.1 mmol/kg (0.2 mL/kg) administered as a rapid intravenous infusion (10 mL/min-60 mL/min) or bolus (> 60 mL/min)
  • Safety and efficacy of doses > 0.1 mmol/kg, and sequential and/or repeat procedures have not been studied
  • Follow injection by at least a 5 mL normal saline flush

MRI of Extracranial/Extraspinal Tissues
Adults:

  • Recommended dose 0.1 mmol/kg (0.2 mL/kg) administered as a rapid intravenous infusion (10 mL/min-60 mL/min) or bolus (> 60 mL/min)
  • To ensure complete injection of the contrast medium, the injection should be followed by at least a 5 mL normal saline flush

Pediatric Use: Safety and efficacy for extracranial/extraspinal tissues have not been established.

2.2 Administration

  • Visually inspect ProHance for particulate matter and discoloration prior to use
  • Do not administer the solution if it is discolored or particulate matter is present
  • Concurrent medications or parenteral nutrition should not be physically mixed with contrast agents and should not be administered in the same intravenous line because of the potential for chemical incompatibility

2.3 Directions for Proper Use of Pharmacy Bulk Package

NOT FOR DIRECT INFUSION The pharmacy bulk package is used as a multiple dose container with an appropriate transfer device to fill empty sterile syringes. Use the following procedures when transferring ProHance from the pharmacy bulk package to individual syringes:

  • Use of this product is restricted to a suitable work area, such as a laminar flow hood, utilizing aseptic technique
  • Prior to entering the vial, remove the seal and cleanse the rubber closure with a suitable antiseptic agent
  • The container closure may be penetrated only one time, utilizing a suitable transfer device or dispensing set that allows measured dispensing of the contents
  • Once the pharmacy bulk package is punctured, it should not be removed from the aseptic work area during the entire period of use
  • Withdrawal of container contents should be accomplished without delay. A maximum time of 8 hours from initial closure entry is permitted to complete fluid transfer operations
  • Any unused contents must be discarded by 8 hours after initial puncture of the bulk package
  • Once drawn into syringe, administer transferred agent promptly

3  DOSAGE FORMS AND STRENGTHS

ProHance Multipack is supplied as a sterile, nonpyrogenic, and colorless to slightly yellow solution available in a 50 mL Pharmacy Bulk Package for intravenous administration. Each mL contains 279.3 mg of gadoteridol for injection.

4  CONTRAINDICATIONS

ProHance is contraindicated in patients with known allergic or hypersensitivity reactions to ProHance [see Warnings and Precautions (5.2)].

5  WARNINGS AND PRECAUTIONS

5.1 Nephrogenic Systemic Fibrosis (NSF)

Gadolinium-based contrast agents (GBCAs) increase the risk for 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. 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 ProHance Multipack administration to Bracco Diagnostics (1-800-257-5181) 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 (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 ProHance dose and allow a sufficient period of time for elimination of the drug prior to re-administration. For patients receiving hemodialysis, physicians may consider the prompt initiation of hemodialysis following the administration of a GBCA in order to enhance the contrast agent’s elimination. The usefulness of hemodialysis in the prevention of NSF is unknown. [see Clinical Pharmacology (12)].

5.2 Hypersensitivity Reactions

Severe and fatal hypersensitivity reactions including anaphylaxis have been observed with administration of gadolinium products, including ProHance. Prior to ProHance administration, ensure the availability of trained personnel and medications to treat hypersensitivity reactions. Patients with a history of allergy, drug reactions or other hypersensitivity-like disorders should be closely monitored during the procedure and for several hours after drug administration. If a reaction occurs, stop ProHance and immediately begin appropriate therapy including resuscitation.

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