gallium Ga 68 PSMA-11 (Rx)

Brand and Other Names:Illuccix, gallium Ga 68 gozetotide
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Dosing & Uses

AdultPediatric

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

Indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer and the following

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

111-259 MBq (3-7 mCi) IV bolus

Safety and efficacy not established

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Interactions

Interaction Checker

and gallium Ga 68 PSMA-11

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            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)

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                  Adverse Effects

                  <1%

                  Nausea

                  Diarrhea

                  Dizziness

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                  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
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                  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.

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                  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)

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                  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
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                  Images

                  No images available for this drug.
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                  Patient Handout

                  A Patient Handout is not currently available for this monograph.
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                  Formulary

                  FormularyPatient Discounts

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                  The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                  Tier Description
                  1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                  2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                  3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                  4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  NC NOT COVERED – Drugs that are not covered by the plan.
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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.