gallium Ga 68 PSMA-11 (Rx)

Brand and Other Names:
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Dosing & Uses

AdultPediatric

Dosage Forms and Strengths

injection

  • 18.5-185 MBq/mL (20-mL multidose vial)
  • Equivalent to 0.5-5 mCi/mL at calibration time

Prostate Cancer

Indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in males with prostate cancer who are either candidates for initial definitive therapy with suspected metastasis OR with suspected recurrence based on elevated serum prostate-specific antigen (PSA) levels

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

No Results

     activity indicator 
    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 (0)

                  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

                    0.9% NaCl

                    IV Preparation

                    Use aseptic technique and radiation shielding when withdrawing or administering dose

                    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

                    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

                    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

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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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                    • Compare formulary status to other drugs in the same class.
                    • Access your plan list on any device – mobile or desktop.

                    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.
                    Code Definition
                    PA Prior Authorization
                    Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                    QL Quantity Limits
                    Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                    ST Step Therapy
                    Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                    OR Other Restrictions
                    Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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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.