piflufolastat F 18 (Rx)

Brand and Other Names:Pylarify
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 37-2,960 MBq/mL (1-80 mCi/mL) per vial at calibration date and time

Prostate Cancer PET Imaging

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 or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level

333 MBq (9 mCi), range of 296-370 MBq (8-10 mCi), administered as a single bolus IV injection

Safety and efficacy not established

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Interactions

Interaction Checker

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                  Minor (0)

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                    Adverse Effects

                    1-10%

                    Headache (2%)

                    Dysgeusia (2%)

                    Fatigue (1%)

                    <1%

                    Hypersensitivity (0.2%)

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                    Warnings

                    Contraindications

                    None

                    Cautions

                    Monitor for hypersensitivity reactions, particularly in patients with a history of allergy to other drugs and foods; reactions may not be immediate; trained staff and resuscitation equipment should always be available

                    Risk of image misinterpretation

                    • Imaging interpretation errors can occur
                    • A negative image does not rule out presence of prostate cancer and a positive one does not confirm presence of prostate cancer
                    • Drug uptake is not specific for prostate cancer and may occur with other types of cancer, nonmalignant processes, and in normal tissues
                    • Clinical correlation, which may include histopathological evaluation of suspected prostate cancer site, is recommended

                    Radiation risks

                    • Diagnostic radiopharmaceuticals expose patients to radiation
                    • Radiation exposure is associated with a dose-dependent increased risk of cancer
                    • Ensure safe drug handling and patient preparation procedures to protect patients and healthcare providers from unintentional radiation exposure

                    Drug interaction overview

                    • Androgen-deprivation therapy (ADT) and other therapies targeting the androgen pathway
                      • ADT and other therapies targeting the androgen pathway (eg, androgen receptor antagonists) may result in changes in uptake of piflufolastat F18 in prostate cancer
                      • Effect of these therapies on performance has not been established
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                    Pregnancy & Lactation

                    Pregnancy

                    Not indicated for use in females

                    There is no information on the risk of adverse developmental outcomes in pregnant females or animals

                    All radiopharmaceuticals, including piflufolastat F18, may potentially cause fetal harm depending on fetal stage of development and magnitude of radiation dose

                    Lactation

                    Not indicated for use in females

                    There is no information on drug presence in human milk, effects on breastfed infants, or effects 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

                    Radiolabeled PSMA inhibitor imaging agent

                    Binds to cells that express PSMA, including malignant prostate cancer cells

                    Fluorine-18 (F18) is a beta-positive–emitting radionuclide that enables PET

                    Distribution

                    Distributes to kidneys (16.5% of administered activity), liver (9.3%), and lung (2.9%), within 60 minutes of IV administration

                    Distribution half-life: 0.17 hr

                    Elimination

                    Half-life: 3.47 hr

                    Excretion: Urine (~50% [first 8 hr post dose])

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                    Administration

                    IV Preparation

                    Use aseptic technique and radiation shielding when withdrawing and administering

                    Visually inspect solution; do not use if it contains particulate matter or is cloudy or discolored; solution is clear and colorless

                    Calculate the necessary volume to administer based on calibration time and required dose; piflufolastat F18 may be diluted with 0.9% NaCl

                    Assay dose in a suitable dose calibrator before administration

                    Radiation safety

                    • Piflufolastat F18 is a radioactive drug; only authorized persons qualified by training and experience should receive, use, or administer
                    • Handle with appropriate safety measures to minimize radiation exposure during administration
                    • Use waterproof gloves and effective radiation shielding, including syringe shields, when preparing and handling

                    Patient preparation

                    • Instruct patients to drink water to ensure adequate hydration before administration and continue drinking and voiding frequently during the first few hours following administration to reduce radiation exposure

                    IV Administration

                    Administer IV over 1-2 minutes

                    Follow injection with IV flush of 0.9% NaCl

                    Dispose of any unused drug in compliance with radiopharmaceutical regulations

                    Image acquisition

                    Start 60 minutes after administration

                    Starting image acquisition >90 minutes after injection may affect imagining performance

                    Advise patients to void immediately before image acquisition

                    Position patient supine with arms above head

                    Start image acquisition from mid thigh and proceed to skull vertex

                    Scan duration: 12-40 minutes depending on number of bed positions (typically 6-8) and acquisition time per bed position (typically 2-5 minutes)

                    Storage

                    Unopened vials

                    • Store at 20-25ºC (68-77ºF)
                    • Store upright in original container with radiation shielding
                    • Expiration date and time are provided on container label
                    • Use within 10 hr from the time of the end of synthesis
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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

                    Adding plans allows you to compare formulary status to other drugs in the same class.

                    To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                    Adding plans allows you to:

                    • View the formulary and any restrictions for each plan.
                    • Manage and view all your plans together – even plans in different states.
                    • 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.