Version May 2024
Diagnostic imaging: IV: 111 to 259 MBq (3 to 7 mCi); begin positron emission tomography (PET) scanning 50 to 100 minutes after completion of gallium Ga 68 PSMA-11 administration.
Imaging prior to initial definitive or suspected recurrence therapy: 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 not containing PSMA will not be visualized; increased uptake in tumors is not specific for prostate cancer.
Imaging to select patients for lutetium Lu 177 vipivotide tetraxetan therapy: Lesions should be considered positive if gallium Ga 68 PSMA-11 uptake is greater than normal liver and negative if uptake is less than or equal to normal liver. Patients should be considered eligible for lutetium Lu 177 vipivotide tetraxetan therapy if at least one tumor lesion is positive and all lesions on anatomical imaging larger in short axis than size criteria are also positive (size criteria: organs ≥1 cm, lymph nodes ≥2.5 cm, bones [soft tissue component] ≥1 cm). Patients should be considered ineligible for lutetium Lu 177 vipivotide tetraxetan therapy if all lesions are negative or any one lesion larger than size criteria is negative.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.
1% to 10%: Nervous system: Fatigue (1%)
<1%:
Gastrointestinal: Constipation, diarrhea, nausea, vomiting, xerostomia
Local: Injection-site reaction (including hematoma at injection site, warm sensation at injection site)
Nervous system: Chills, dizziness
There are no contraindications listed in the manufacturer's US labeling.
Canadian labeling: Hypersensitivity to gallium GA 68 PSMA-11 or any component of the formulation.
Concerns related to adverse effects:
• Radiation accumulation: Gallium Ga 68 PSMA-11 administration contributes to the patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to minimize radiation exposure to the patient and health care providers.
Special handling:
• Radiopharmaceutical: Use appropriate precautions for handling, disposal, and minimizing exposure to patients and health care personnel. Use only under supervision of individuals with experience/training in the handling of radioactive materials approved by the applicable regulatory authority.
Other warnings/precautions:
• Appropriate use: Gallium Ga 68 PSMA-11 binds to prostate-specific membrane antigen (PSMA); positron emission tomography (PET) images indicate the presence of PSMA in tissues. When imaging prior to initial definitive or suspected recurrence therapy, tumors may be suspicious if uptake is greater than physiologic uptake in that tissue or greater than adjacent background if no physiologic uptake was expected; tumors not containing PSMA are not visualized. When imaging to select patients for lutetium Lu 177 vipivotide tetraxetan therapy, compare uptake of gallium Ga 68 PSMA-11 at sites of suspected prostate cancer (lesions) with uptake in normal liver; lesions should be considered positive if gallium Ga 68 PSMA-11 uptake is greater than normal liver and negative if uptake is less than or equal to normal liver.
• Risk for misinterpretation: Uptake of gallium Ga 68 PSMA-11 is not specific to prostate cancer and may occur with other types of cancer and nonmalignant processes (eg, fibrous dysplasia, osteophytosis, Paget disease). A negative image does not rule out the presence of prostate cancer, and a positive image does not confirm prostate cancer. The performance of gallium Ga 68 PSMA-11 for recurrent prostate cancer may be affected by serum prostate-specific antigen levels and site of disease. The performance of gallium Ga 68 PSMA-11 for metastatic pelvic lymph nodes may be affected by Gleason score. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site/recurrence site, is recommended. When using to select patients for lutetium Lu 177 vipivotide tetraxetan therapy, PET scan interpretation may vary depending on imaging readers; interpretations may be more consistent when judging gallium Ga 68 PSMA-11 uptake in any one tumor lesion (compared to judging uptake for all lesions larger than size criteria). It is recommended to utilize a multidisciplinary approach to select patients for lutetium Lu 177 vipivotide tetraxetan therapy, especially for imaging that a single reader describes as borderline or difficult to interpret, or when patient eligibility depends only on judgment of gallium Ga 68 PSMA-11 uptake for all lesions larger than size criteria.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Kit, Intravenous:
Illuccix Configuration A: 25 mcg
Illuccix Configuration B: 25 mcg
Kit, Intravenous [preservative free]:
Locametz: 25 mcg
Solution, Intravenous:
Generic: 18.5 - 185 MBq/mL (0.5 - 5 mCi/mL) (1 ea)
May be product dependent
Kit (Illuccix Configuration A Intravenous)
25 mcg (per each): $5,904.00
Kit (Illuccix Configuration B Intravenous)
25 mcg (per each): $5,904.00
Kit (Locametz Intravenous)
25 mcg (per each): $6,921.60
Solution (Gallium Ga 68 Gozetotide Intravenous)
0.5-5 mci/mL (per each): $5,815.89 - $5,940.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Kit, Intravenous:
Illuccix: 25 mcg
Locametz: 25 mcg
IV: Administer as an IV bolus (Illuccix) or as a slow IV injection (Locametz). Immediately prior to administration, measure and verify the radioactivity in the syringe with a dose calibrator to ensure radioactivity administered. After administration, flush with NS to ensure full delivery of the dose. Refer to product labeling for further details.
Patients should void immediately prior to start of imaging. Imaging should begin at the proximal/mid thighs and proceed cranially to skull base or skull vertex. Begin positron emission tomography (PET) scanning 50 to 100 minutes after administration of gallium Ga 68 PSMA-11.
Patients should drink a sufficient amount of water to ensure adequate hydration prior to administration and in the first hours following administration and void frequently (particularly in the first hour) following administration to reduce radiation exposure.
Radiopharmaceutical; use appropriate precautions for handling and disposal. When handling and administering, follow appropriate safety measures to minimize radiation exposure during administration; use waterproof gloves and effective shielding, including syringe shields.
Diagnostic imaging: Use with positron emission tomography (PET) of prostate-specific membrane antigen 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 level, or for selection of patients with metastatic prostate cancer for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated.
Gallium Ga 68 PSMA-11 may be confused with gallium citrate Ga-67, gallium Ga 68 dotatate.
Radiopharmaceutical: Use appropriate precaution for handling, disposal, and minimizing exposure to patients and health care personnel. Use under supervision of experienced personnel. Should be stored in original lead container or adequate radiation shield.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Androgen Deprivation Therapy Agents: May diminish the therapeutic effect of Gallium Ga 68 PSMA-11. Management: Androgen deprivation therapy (ADT) may result in changes in the uptake of gallium Ga 68 PSMA-11 (gozetotide) in prostate cancer. The impact of ADT on the performance of gallium Ga 68 PSMA-11 is unknown, but use of alternative agents should be considered. Risk D: Consider therapy modification
Antiandrogens: May diminish the therapeutic effect of Gallium Ga 68 PSMA-11. Management: Therapies targeting the androgen pathway may result in changes in the uptake of gallium Ga 68 PSMA-11 (gozetotide) in prostate cancer. The impact on the performance of gallium Ga 68 PSMA-11 (gozetotide) is unknown; consider use of alternative agents. Risk D: Consider therapy modification
Animal reproduction studies have not been conducted; gallium Ga 68 PSMA-11 is not indicated for use in patients who could become pregnant.
It is not known if Ga 68 PSMA-11 is present in breast milk.
Gallium Ga 68 PSMA-11 is not indicated for use in females.
Gallium Ga-68 PSMA-11 is a radioactive diagnostic agent that binds to cells that express prostate-specific membrane antigen, including malignant prostate cancer cells. Gallium 68 (68Ga) is a beta+ emitting radionuclide with an emission yield that allows positron emission tomography (PET) imaging. Tumors that do not express prostate-specific membrane antigen will not be visualized by imaging.
Distribution: Distributes to the liver (15%), kidneys (7%), spleen (2%), salivary glands (0.5%), adrenals, and prostate.
Excretion: Urine (14% in the first 2 hours).
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