Dosing & Uses
Dosage Forms and Strengths
injection
- 18.5-185 MBq/mL (20-mL multidose vial) (generic)
- Equivalent to 0.5-5 mCi/mL at calibration time
kit
-
Illuccix
- Contains the following
- Vial 1 containing 25 mcg gozetotide and D-mannose as lyophilized powder
- Vial 2 containing acetate buffer (configuration A for use with cyclotron produced Ga 68 via GE FASTlabTM or EZAG generator; configuration B for use with IRE generator)
- Vial 3 is a sterile vacuum reaction vial for collection of gallium Ga 68 chloride and radiolabeling reaction
Prostate Cancer
After radiolabeling with GA 68, it is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer
Specifically indicated for patients
- With suspected metastasis who are candidates for initial definitive therapy
- With suspected recurrence based on elevated serum prostate-specific antigen (PSA) level
- For selection of patients with metastatic prostate cancer, for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated
Dose
- 111-259 MBq (3-7 mCi) IV bolus
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (13)
- abiraterone
abiraterone will decrease the level or effect of gallium Ga 68 PSMA-11 by unspecified interaction mechanism. Modify Therapy/Monitor Closely. Androgen deprivation therapy and other therapies targeting the androgen pathway may result in changes in the uptake of gallium Ga 68 PSMA-11 in prostate cancer. The effect of ADT on the performance of gallium Ga 68 PSMA-11 is unknown.
- apalutamide
apalutamide will decrease the level or effect of gallium Ga 68 PSMA-11 by unspecified interaction mechanism. Modify Therapy/Monitor Closely. Androgen deprivation therapy and other therapies targeting the androgen pathway may result in changes in the uptake of gallium Ga 68 PSMA-11 in prostate cancer. The effect of ADT on the performance of gallium Ga 68 PSMA-11 is unknown.
- bicalutamide
bicalutamide will decrease the level or effect of gallium Ga 68 PSMA-11 by unspecified interaction mechanism. Modify Therapy/Monitor Closely. Androgen deprivation therapy and other therapies targeting the androgen pathway may result in changes in the uptake of gallium Ga 68 PSMA-11 in prostate cancer. The effect of ADT on the performance of gallium Ga 68 PSMA-11 is unknown.
- darolutamide
darolutamide will decrease the level or effect of gallium Ga 68 PSMA-11 by unspecified interaction mechanism. Modify Therapy/Monitor Closely. Androgen deprivation therapy and other therapies targeting the androgen pathway may result in changes in the uptake of gallium Ga 68 PSMA-11 in prostate cancer. The effect of ADT on the performance of gallium Ga 68 PSMA-11 is unknown.
- degarelix
degarelix will decrease the level or effect of gallium Ga 68 PSMA-11 by unspecified interaction mechanism. Modify Therapy/Monitor Closely. Androgen deprivation therapy and other therapies targeting the androgen pathway may result in changes in the uptake of gallium Ga 68 PSMA-11 in prostate cancer. The effect of ADT on the performance of gallium Ga 68 PSMA-11 is unknown.
- enzalutamide
enzalutamide will decrease the level or effect of gallium Ga 68 PSMA-11 by unspecified interaction mechanism. Modify Therapy/Monitor Closely. Androgen deprivation therapy and other therapies targeting the androgen pathway may result in changes in the uptake of gallium Ga 68 PSMA-11 in prostate cancer. The effect of ADT on the performance of gallium Ga 68 PSMA-11 is unknown.
- flutamide
flutamide will decrease the level or effect of gallium Ga 68 PSMA-11 by unspecified interaction mechanism. Modify Therapy/Monitor Closely. Androgen deprivation therapy and other therapies targeting the androgen pathway may result in changes in the uptake of gallium Ga 68 PSMA-11 in prostate cancer. The effect of ADT on the performance of gallium Ga 68 PSMA-11 is unknown.
- goserelin
goserelin will decrease the level or effect of gallium Ga 68 PSMA-11 by unspecified interaction mechanism. Modify Therapy/Monitor Closely. Androgen deprivation therapy and other therapies targeting the androgen pathway may result in changes in the uptake of gallium Ga 68 PSMA-11 in prostate cancer. The effect of ADT on the performance of gallium Ga 68 PSMA-11 is unknown.
- histrelin
histrelin will decrease the level or effect of gallium Ga 68 PSMA-11 by unspecified interaction mechanism. Modify Therapy/Monitor Closely. Androgen deprivation therapy and other therapies targeting the androgen pathway may result in changes in the uptake of gallium Ga 68 PSMA-11 in prostate cancer. The effect of ADT on the performance of gallium Ga 68 PSMA-11 is unknown.
- leuprolide
leuprolide will decrease the level or effect of gallium Ga 68 PSMA-11 by unspecified interaction mechanism. Modify Therapy/Monitor Closely. Androgen deprivation therapy and other therapies targeting the androgen pathway may result in changes in the uptake of gallium Ga 68 PSMA-11 in prostate cancer. The effect of ADT on the performance of gallium Ga 68 PSMA-11 is unknown.
- nilutamide
nilutamide will decrease the level or effect of gallium Ga 68 PSMA-11 by unspecified interaction mechanism. Modify Therapy/Monitor Closely. Androgen deprivation therapy and other therapies targeting the androgen pathway may result in changes in the uptake of gallium Ga 68 PSMA-11 in prostate cancer. The effect of ADT on the performance of gallium Ga 68 PSMA-11 is unknown.
- relugolix
relugolix will decrease the level or effect of gallium Ga 68 PSMA-11 by unspecified interaction mechanism. Modify Therapy/Monitor Closely. Androgen deprivation therapy and other therapies targeting the androgen pathway may result in changes in the uptake of gallium Ga 68 PSMA-11 in prostate cancer. The effect of ADT on the performance of gallium Ga 68 PSMA-11 is unknown.
- triptorelin
triptorelin will decrease the level or effect of gallium Ga 68 PSMA-11 by unspecified interaction mechanism. Modify Therapy/Monitor Closely. Androgen deprivation therapy and other therapies targeting the androgen pathway may result in changes in the uptake of gallium Ga 68 PSMA-11 in prostate cancer. The effect of ADT on the performance of gallium Ga 68 PSMA-11 is unknown.
Minor (0)
Adverse Effects
<1%
Nausea
Diarrhea
Dizziness
Warnings
Contraindications
None
Cautions
Image interpretation errors can occur; Ga 68 PSMA-11 uptake can be seen in a variety of tumor types and in nonmalignant processes
Ensure safe handling to protect patients and health care workers from unintentional radiation exposure
Drug interaction overview
-
Androgen deprivation therapy (ADT) and other therapies targeting androgen pathway
- ADT and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of Ga 68 PSMA-11 in prostate cancer
- Effect of these therapies on Ga 68 PSMA-11 PET has not been established
Pregnancy & Lactation
Pregnancy
Not indicated for use in females
No data available on use in pregnant females
All radiopharmaceuticals, including Ga 68 PSMA-11, have the potential to cause fetal harm depending on fetal stage of development and radiation dose
No animal reproduction studies have been conducted
Lactation
Not indicated for use in females
There are no data on drug presence in human milk, effect on breastfed infants, or effect on milk production
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Gallium-68 (Ga 68) is a beta-positive emitting radionuclide that allows PET
Ga 68 PSMA-11 binds to cells that express PSMA, including malignant prostate cancer cells, which usually overexpress PSMA
Distribution
Accumulated preferentially in liver (15%), kidneys (7%), spleen (2%), and salivary glands (0.5%)
Uptake also seen in adrenal glands and prostate; no uptake in cerebral cortex or heart; low lung uptake
Elimination
Excretion: 14% (urine; first 2 hr post-injection)
Administration
See full prescribing information for radiation handling, image preparation, and radiation dosimetry
IV Compatibilities
Gallium Ga 68 PSMA-11: 0.9% NaCl
IV Preparation
Use aseptic technique and suitable shielding to reduce radiation exposure; wear waterproof gloves
Gallium Ga 68 PSMA-11
- Calculate necessary volume to administer based on calibration time and required dose
- Visually inspect for particulate matter and discoloration before administration; do not use if solution contains particulate matter or is discolored
- May dilute with 0.9% NaCl injection
- Assay final dose immediately before administration in a dose calibrator
Illuccix
- If Ga 68 is generator produced, test Ga 68 chloride eluate for Ge 68 breakthrough weekly by a suitable method according to manufacturer recommendations; if Ga 68 is cyclotron produced, test for Ga 66 and Ga 67 (with specification of ≤2% combined total) when a new Zn 68 is introduced for manufacturing
- Place a “radioactive” label on Vial 3 (sterile vacuumed reaction vial) with product name, lot number and date.
- Remove vial cap and swab with alcohol each of the 3 vials
- Note: Minimize any potential metallic contamination by using shortest possible needle for transfer of gallium solution from generator; needle should be clean and dilute acid resistant
- Use only plastic syringes for preparation and administration; do not use syringes with rubber plungers
- Before using any vial, confirm the correct vial is being used by a visual check of vial label
- Refer to prescribing information for specific reconstitution procedure depending on Ga 68 source
Patient preparation
Instruct patients to drink water to ensure adequate hydration before administration
Continue to drink water and void frequently during first hours following administration to reduce radiation exposure
IV Administration
Administer by IV bolus
After injection, flush line with 0.9% NaCl to ensure full delivery of dose
Dispose of any unused drug in a safe manner in compliance with applicable regulations
Unless contraindicated, consider administering a diuretic expected to act within the uptake time period at time of radiotracer injection to potentially decrease artifact from radiotracer accumulation in the urinary bladder and ureters
Image acquisition
- Position patient supine with arms above head
- Begin PET scanning 50-100 minutes after IV bolus
- Patients should void immediately before image acquisition and that image acquisition should begin at the proximal thighs and proceed cranially to skull base or skull vertex
- Adapt imaging technique according to equipment used and patient characteristics in order to obtain the best image quality possible
Storage
Gallium ga 68 PSMA-11
- Store upright in a lead shielded container at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF)
- Store and dispose of injection in accordance with the regulations and a general license, or its equivalent, of an agreement state or a licensing state
Illuccix
- Refrigerate at 2-8°C (36-46°F); do NOT freeze
- After radiolabeling: Store at ambient temperature (25ºC [77ºF]; excursions permitted to 15-30ºC [59-86ºF]); keep injection upright with appropriate shielding to protect from radiation
- Use within 4 hr of preparation
Images
Formulary
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