Gallium Ga-68 Psma-11- Gallium Ga-68 Gozetotide injection, Solution

Gallium Ga 68 Gozeotide Injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

• with suspected metastasis who are candidates for initial definitive therapy.
• with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

• Use appropriate aseptic technique and radiation safety handling measures to maintain sterility during all operations involved in the manipulation and administration of Gallium Ga 68 Gozetotide Injection. (
  
  
  
  2.1 Radiation Safety – Drug Handling

  Handle Gallium Ga 68 Gozetotide Injection with appropriate safety measures to minimize radiation exposure

  [see Warnings and Precautions (5.2)]

  . Use waterproof gloves, effective radiation shielding, and other appropriate safety measures when preparing and handling Gallium Ga 68 Gozetotide Injection.

  Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides.
  )
  
  
• The recommended adult dose is 111 MBq to 259 MBq (3 mCi to 7 mCi) as a bolus intravenous injection. (
  
  
  
  2.2 Recommended Dosage and Administration Instructions

  Recommended Dosage

  In adults, the recommended amount of radioactivity to be administered for PET is 111 MBq to 259 MBq (3 mCi to 7 mCi) administered as an intravenous bolus injection.

  Administration

  • Use aseptic technique and radiation shielding when withdrawing and administering Gallium Ga 68 Gozetotide Injection.
  • Calculate the necessary volume to administer based on calibration time and required dose.
  • Inspect Gallium Ga 68 Gozetotide Injection visually for particulate matter and discoloration before administration. Do not use the drug if the solution contains particulate matter or is discolored.
  • Gallium Ga 68 Gozetotide Injection may be diluted with sterile 0.9% Sodium Chloride Injection, USP.
  • Assay the final dose immediately before administration to the patient in a dose calibrator.
  • After injection of Gallium Ga 68 Gozeotide Injection, administer an intravenous flush of sterile 0.9% Sodium Chloride Injection, USP to ensure full delivery of the dose.
  • Dispose of any unused drug in a safe manner in compliance with applicable regulations.
  • Unless contraindicated, a diuretic expected to act within the uptake time period may be administered at the time of radiotracer injection to potentially decrease artifact from radiotracer accumulation in the urinary bladder and ureters.
  )
  
  
• A diuretic expected to act within the uptake time period may be administered at the time of radiotracer injection. (
  
  
  
  2.2 Recommended Dosage and Administration Instructions

  Recommended Dosage

  In adults, the recommended amount of radioactivity to be administered for PET is 111 MBq to 259 MBq (3 mCi to 7 mCi) administered as an intravenous bolus injection.

  Administration

  • Use aseptic technique and radiation shielding when withdrawing and administering Gallium Ga 68 Gozetotide Injection.
  • Calculate the necessary volume to administer based on calibration time and required dose.
  • Inspect Gallium Ga 68 Gozetotide Injection visually for particulate matter and discoloration before administration. Do not use the drug if the solution contains particulate matter or is discolored.
  • Gallium Ga 68 Gozetotide Injection may be diluted with sterile 0.9% Sodium Chloride Injection, USP.
  • Assay the final dose immediately before administration to the patient in a dose calibrator.
  • After injection of Gallium Ga 68 Gozeotide Injection, administer an intravenous flush of sterile 0.9% Sodium Chloride Injection, USP to ensure full delivery of the dose.
  • Dispose of any unused drug in a safe manner in compliance with applicable regulations.
  • Unless contraindicated, a diuretic expected to act within the uptake time period may be administered at the time of radiotracer injection to potentially decrease artifact from radiotracer accumulation in the urinary bladder and ureters.
  )
  
  
• Initiate imaging 50 to 100 minutes after administration. The patient should void immediately prior to initiation of imaging. Scan should begin caudally and proceed cranially. (
  
  
  
  2.4 Image Acquisition

  Position the patient supine with arms above the head. Begin PET scanning 50 to 100 minutes after the intravenous administration of Gallium Ga 68 Gozetotide Injection. Patients should void immediately prior to image acquisition and that image acquisition should begin at the proximal thighs and proceed cranially to the skull base or skull vertex. Adapt imaging technique according to the equipment used and patient characteristics in order to obtain the best image quality possible.
  )
  
  
• See full prescribing information for additional preparation, administration, imaging, and radiation dosimetry information. (
  
  
  
  2 DOSAGE AND ADMINISTRATION

  • Use appropriate aseptic technique and radiation safety handling measures to maintain sterility during all operations involved in the manipulation and administration of Gallium Ga 68 Gozetotide Injection.
  • The recommended adult dose is 111 MBq to 259 MBq (3 mCi to 7 mCi) as a bolus intravenous injection.
  • A diuretic expected to act within the uptake time period may be administered at the time of radiotracer injection.
  • Initiate imaging 50 to 100 minutes after administration. The patient should void immediately prior to initiation of imaging. Scan should begin caudally and proceed cranially.
  • See full prescribing information for additional preparation, administration, imaging, and radiation dosimetry information.

  2.1 Radiation Safety – Drug Handling

  Handle Gallium Ga 68 Gozetotide Injection with appropriate safety measures to minimize radiation exposure

  [see Warnings and Precautions (5.2)]

  . Use waterproof gloves, effective radiation shielding, and other appropriate safety measures when preparing and handling Gallium Ga 68 Gozetotide Injection.

  Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides.

  2.2 Recommended Dosage and Administration Instructions

  Recommended Dosage

  In adults, the recommended amount of radioactivity to be administered for PET is 111 MBq to 259 MBq (3 mCi to 7 mCi) administered as an intravenous bolus injection.

  Administration

  • Use aseptic technique and radiation shielding when withdrawing and administering Gallium Ga 68 Gozetotide Injection.
  • Calculate the necessary volume to administer based on calibration time and required dose.
  • Inspect Gallium Ga 68 Gozetotide Injection visually for particulate matter and discoloration before administration. Do not use the drug if the solution contains particulate matter or is discolored.
  • Gallium Ga 68 Gozetotide Injection may be diluted with sterile 0.9% Sodium Chloride Injection, USP.
  • Assay the final dose immediately before administration to the patient in a dose calibrator.
  • After injection of Gallium Ga 68 Gozeotide Injection, administer an intravenous flush of sterile 0.9% Sodium Chloride Injection, USP to ensure full delivery of the dose.
  • Dispose of any unused drug in a safe manner in compliance with applicable regulations.
  • Unless contraindicated, a diuretic expected to act within the uptake time period may be administered at the time of radiotracer injection to potentially decrease artifact from radiotracer accumulation in the urinary bladder and ureters.

  2.3 Patient Preparation Prior to PET Imaging

  Instruct patients to drink a sufficient amount of water to ensure adequate hydration prior to administration of Gallium Ga 68 Gozeotide Injection and to continue to drink and void frequently following administration to reduce radiation exposure, particularly during the first hour after administration

  [see Warnings and Precautions (5.2)]

  .

  2.4 Image Acquisition

  Position the patient supine with arms above the head. Begin PET scanning 50 to 100 minutes after the intravenous administration of Gallium Ga 68 Gozetotide Injection. Patients should void immediately prior to image acquisition and that image acquisition should begin at the proximal thighs and proceed cranially to the skull base or skull vertex. Adapt imaging technique according to the equipment used and patient characteristics in order to obtain the best image quality possible.

  2.5 Image Interpretation

  Gallium Ga 68 Gozetotide binds to prostate-specific membrane antigen (PSMA). Based on the intensity of the signals, PET images obtained using Gallium Ga 68 Gozetotide Injection indicate the presence of PSMA in tissues. Lesions should be considered suspicious if uptake is greater than physiologic uptake in that tissue or greater than adjacent background if no physiologic uptake is expected. Tumors that do not bear PSMA will not be visualized. Increased uptake in tumors is not specific for prostate cancer

  [see Warnings and Precautions (5.1)]

  .

  2.6 Radiation Dosimetry

  Estimated radiation absorbed doses per injected activity for organs and tissues of adult male patients following an intravenous bolus of Gallium Ga 68 Gozetotide Injection are shown in Table 1.

  The effective radiation dose resulting from the administration of 259 MBq (7 mCi) is about 4.4 mSv. The radiation doses for this administered dose to the critical organs, which are the kidneys, urinary bladder, and spleen, are 96.2 mGy, 25.4 mGy, and 16.8 mGy, respectively.

  These radiation doses are for Gallium Ga 68 Gozetotide Injection alone. If CT or a transmission source are used for attenuation correction, the radiation dose will increase by an amount that varies by technique.

  Table 1: Estimated Radiation Absorbed Dose per Injected Activity in Selected Organs and Tissues of Adults after Intravenous Administration of Gallium Ga 68 Gozetotide Injection

  Organ	Absorbed dose (mGy/MBq)
  	Mean	SD
  Adrenals	0.0156	0.0014
  Brain	0.0104	0.0011
  Breasts	0.0103	0.0011
  Gallbladder	0.0157	0.0012
  Lower Colon	0.0134	0.0009
  Small Intestine	0.0140	0.0020
  Stomach	0.0129	0.0008
  Heart	0.0120	0.0009
  Kidneys	0.3714	0.0922
  Liver	0.0409	0.0076
  Lungs	0.0111	0.0007
  Muscle	0.0103	0.0003
  Pancreas	0.0147	0.0009
  Red Marrow	0.0114	0.0016
  Skin	0.0091	0.0003
  Spleen	0.0650	0.0180
  Testes	0.0111	0.0006
  Thymus	0.0105	0.0006
  Thyroid	0.0104	0.0006
  Urinary Bladder	0.0982	0.0286
  Total Body	0.0143	0.0013
  Effective Dose (mSv/MBq)	0.0169	0.0015
  )
  
  

Injection: supplied as a clear, colorless solution in a 20 mL multiple-dose vial containing 18.5 MBq/mL to 185 MBq/mL (0.5 mCi/mL to 5 mCi/mL) of Gallium Ga 68 Gozetotide at calibration time.

Gallium Ga 68 Gozetotide Injection is not indicated for use in females. There are no available data with Gallium Ga 68 Gozetotide Injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. All radiopharmaceuticals, including Gallium Ga 68 Gozetotide Injection, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. Animal reproduction studies have not been conducted with gallium Ga 68 gozetotide Injection.

• Risk for misdiagnosis: Gallium Ga 68 gozetotide uptake can be seen in a variety of tumor types and in non-malignant processes. Image interpretation errors can occur with gallium Ga 68 gozetotide PET. (
  
  
  
  5.1 Risk for Misdiagnosis

  Image interpretation errors can occur with gallium Ga 68 gozetotide PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of Gallium Ga 68 Gozetotide Injection for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease

  [See Clinical Studies (14)]

  . The performance of Gallium Ga 68 Gozetotide Injection for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score

  [See Clinical Studies (14)]

  . Gallium Ga 68 Gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget's disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.
  )
  
  
• Radiation risk: Ensure safe handling to protect patients and health care workers from unintentional radiation exposure. (
  
  
  
  2.1 Radiation Safety – Drug Handling

  Handle Gallium Ga 68 Gozetotide Injection with appropriate safety measures to minimize radiation exposure

  [see Warnings and Precautions (5.2)]

  . Use waterproof gloves, effective radiation shielding, and other appropriate safety measures when preparing and handling Gallium Ga 68 Gozetotide Injection.

  Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides.
  ,
  
  
  
  5.2 Radiation Risks

  Gallium Ga 68 Gozetotide Injection contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and health care workers. Advise patients to hydrate before and after administration and to void frequently after administration

  [see Dosage and Administration (2.1, 2.3)]

  .
  )