Draximage Dtpa

DRAXIMAGE^® DTPA, after radiolabeling with Technetium Tc 99m, is indicated for

• During preparation and handling, use water proof gloves
  and effective shielding, to minimize radiation exposure (
  2.1 Radiation Safety
  – Drug Handling

  Tc 99m labeled DRAXIMAGE^®DTPA injection is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure to the patient and healthcare worker. During preparation and handling, use water proof gloves and effective shielding, including syringe shields

  [see Warnings and Precautions ]

  .
  ,
  5.3 Radiation
  Exposure Risk

  Technetium Tc 99m contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Use the lowest dose of Technetium Tc 99m pentetate necessary for imaging. Encourage patients to drink fluids and void as frequently as possible after intravenous administration

  [see Dosage and Administration ]

  .

  Radiation risks associated with the use of Technetium Tc 99m pentetate are greater in pediatric patients than in adults due to greater radiosensitivity and longer life expectancy.
  ).
• See the Full Prescribing Information for detailed information
  regarding recommended Dosage and Image Acquisition Instructions (
  2.2 Recommended Dosage
  and Image Acquisition Instructions

  • The recommended dose ranges for intravenous or inhalation administration of DRAXIMAGE® DTPA, after reconstitution, are presented in Table 1 through Table 3.
  • Do not administer more than one dose.

  Table 1 Tc 99m Labeled DRAXIMAGE^®DTPA Injection – Intravenous Administration, Adults

  Indication	Route of Administration	Dose	Image Acquisition
  Brain Imaging	Intravenous Injection	370 MBq to 740 MBq (10 mCi to 20 mCi)	Immediate dynamic imaging. Obtain at least one blood-pool image in same position as flow. Delayed images can be obtained 1 hour later.
  Renal Visualization and Perfusion Assessment	Intravenous Injection	370 MBq to 740 MBq (10 mCi to 20 mCi)	Immediate dynamic imaging. Static imaging 1 to 30 minutes after injection.
  Renal Visualization with Estimation of Glomerular Filtration Rate	Intravenous Injection	111 MBq to 185 MBq (3 mCi to 5 mCi)	Immediate dynamic imaging. Static imaging 1 to 30 minutes after injection.
  Estimation of Glomerular Filtration Rate (with no renal imaging)	Intravenous Injection	7.4 MBq to 18.5 MBq (0.2 mCi to 0.5 mCi)	Blood sampling only is performed.

  Table 2 Tc 99m Labeled DRAXIMAGE^®DTPA Injection – Intravenous Administration, Pediatric Patients

  Indication	Route of Administration	Dose	Image Acquisition
  Renal Visualization and Perfusion Assessment	Intravenous Injection	3.7 MBq/kg to 7.4 MBq/kg (0.1 mCi/kg to 0.2 mCi/kg) Minimum 37 MBq (1 mCi) Maximum 185 MBq (5 mCi)	Immediate dynamic imaging. Static imaging 1 to 30 minutes after injection.
  Estimation of Glomerular Filtration Rate (with no renal imaging)	Intravenous Injection	7.4 MBq to 18.5 MBq (0.2 mCi to 0.5 mCi)	Blood sampling only is performed.

  Table 3 Tc 99m Labeled DRAXIMAGE^®DTPA – Aerosol Inhalation Administration

  * For lung imaging performed after perfusion imaging, target count rate should be approximately three times that of perfusion count rate.
  Indication	Route of Administration	Dose	Image Acquisition
  Lung Ventilation Adults	Aerosol Inhalation	925 MBq to 1850 MBq (25 mCi to 50 mCi) in the nebulizer to achieve a lung dose of approximately 18.5 MBq to 37 MBq (0.5 mCi to 1.0 mCi)	For lung imaging performed prior to perfusion imaging, the target administered dose to the lungs is achieved after 3 to 5 minutes of inhalation or at an imaging count rate of 50,000 to 100,000 per minute *.
  Lung Ventilation Pediatric Patients	Aerosol Inhalation	925 MBq (25 mCi) in the nebulizer to achieve a lung dose of approximately 18.5 MBq (0.5 mCi)	For lung imaging performed prior to perfusion imaging, the target administered dose to the lungs is achieved at an imaging count rate of approximately 10,000 to 50,000 per minute *.
  ) and Instructions for Drug Preparation
  (
  2.4 Instructions for
  Drug Preparation

  • The prepared solution can either be administered via intravenous injection or aerosolized by nebulizer for inhalation use.
  • Before reconstitution, inspect the integrity of the vial.
  • Add 2 to 10 mL [maximum amount 18.5 gigabecquerels (500 mCi)] of sodium pertechnetate Tc 99m injection USP to the reaction vial. The volume of pertechnetate added should be balanced by the removal of the same volume of air. Cover the vial shield and invert to mix the contents.
  • Assay the preparation in a calibrator, record the radio assay information on the label with radiation warning symbol, and affix it to the reaction vial.
  • After reconstitution, store the solution at 25 °C (77 °F) in a lead shield and discard after 12 hours; excursions permitted between 15 °C and 30 °C (59 °F and 86°F).
  • Allow the preparation to stand for 15 minutes before determining the radiochemical purity of Tc 99m labeled DRAXIMAGE^®DTPA injection.
  • After reconstitution, do not vent the vial.
  ).
• Do not administer more than one dose (
  2.2 Recommended Dosage
  and Image Acquisition Instructions

  • The recommended dose ranges for intravenous or inhalation administration of DRAXIMAGE® DTPA, after reconstitution, are presented in Table 1 through Table 3.
  • Do not administer more than one dose.

  Table 1 Tc 99m Labeled DRAXIMAGE^®DTPA Injection – Intravenous Administration, Adults

  Indication	Route of Administration	Dose	Image Acquisition
  Brain Imaging	Intravenous Injection	370 MBq to 740 MBq (10 mCi to 20 mCi)	Immediate dynamic imaging. Obtain at least one blood-pool image in same position as flow. Delayed images can be obtained 1 hour later.
  Renal Visualization and Perfusion Assessment	Intravenous Injection	370 MBq to 740 MBq (10 mCi to 20 mCi)	Immediate dynamic imaging. Static imaging 1 to 30 minutes after injection.
  Renal Visualization with Estimation of Glomerular Filtration Rate	Intravenous Injection	111 MBq to 185 MBq (3 mCi to 5 mCi)	Immediate dynamic imaging. Static imaging 1 to 30 minutes after injection.
  Estimation of Glomerular Filtration Rate (with no renal imaging)	Intravenous Injection	7.4 MBq to 18.5 MBq (0.2 mCi to 0.5 mCi)	Blood sampling only is performed.

  Table 2 Tc 99m Labeled DRAXIMAGE^®DTPA Injection – Intravenous Administration, Pediatric Patients

  Indication	Route of Administration	Dose	Image Acquisition
  Renal Visualization and Perfusion Assessment	Intravenous Injection	3.7 MBq/kg to 7.4 MBq/kg (0.1 mCi/kg to 0.2 mCi/kg) Minimum 37 MBq (1 mCi) Maximum 185 MBq (5 mCi)	Immediate dynamic imaging. Static imaging 1 to 30 minutes after injection.
  Estimation of Glomerular Filtration Rate (with no renal imaging)	Intravenous Injection	7.4 MBq to 18.5 MBq (0.2 mCi to 0.5 mCi)	Blood sampling only is performed.

  Table 3 Tc 99m Labeled DRAXIMAGE^®DTPA – Aerosol Inhalation Administration

  * For lung imaging performed after perfusion imaging, target count rate should be approximately three times that of perfusion count rate.
  Indication	Route of Administration	Dose	Image Acquisition
  Lung Ventilation Adults	Aerosol Inhalation	925 MBq to 1850 MBq (25 mCi to 50 mCi) in the nebulizer to achieve a lung dose of approximately 18.5 MBq to 37 MBq (0.5 mCi to 1.0 mCi)	For lung imaging performed prior to perfusion imaging, the target administered dose to the lungs is achieved after 3 to 5 minutes of inhalation or at an imaging count rate of 50,000 to 100,000 per minute *.
  Lung Ventilation Pediatric Patients	Aerosol Inhalation	925 MBq (25 mCi) in the nebulizer to achieve a lung dose of approximately 18.5 MBq (0.5 mCi)	For lung imaging performed prior to perfusion imaging, the target administered dose to the lungs is achieved at an imaging count rate of approximately 10,000 to 50,000 per minute *.
  ).

Kit for the preparation of Technetium Tc 99m pentetate injection: multiple-dose 10 mL glass vial contains a non-radioactive (white) lyophilized powder with 20 mg of pentetic acid, 5 mg of p-aminobenzoic acid, 3.73 mg of calcium chloride dihydrate, and not less than 0.25 mg stannous chloride dihydrate and not more than 0.385 mg maximum tin expressed as stannous chloride dihydrate. The lyophilized product is sealed under an atmosphere of nitrogen.

Following reconstitution with the Technetium Tc 99m eluate, the radioactive solution produced is a clear solution not exceeding 9250 MBq/mL (250 mCi/mL) of Tc 99m.

Limited available data with Technetium Tc 99m pentetate use in pregnant women are insufficient to inform a drug associated risk for major birth defects and miscarriage. Technetium Tc 99m pentetate is transferred across the placenta

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S., general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively.