copper CU 64 dotatate (Rx)

Brand and Other Names:Detectnet
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, solution

  • 148 MGq (4mCi)/vial (37 MBq [1 mCi]/mL)

Neuroendocrine Tumors

Indicated for use with positron-emission tomography (PET) for localization of somatostatin receptor-positive neuroendocrine tumors (NETs)

148 MBq (4 mCi) IV bolus over ~1 minute

Dosage Modifications

Renal or hepatic impairment: Not studied

Dosing Considerations

Assess pregnancy status in females of reproductive potential before administering

Safety and efficacy not established

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Interactions

Interaction Checker

and copper CU 64 dotatate

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Nausea (<2%)

            Vomiting (<2%)

            Flushing (<2%)

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            Warnings

            Contraindications

            None

            Cautions

            Radiation risk

            • Contributes to a patient’s overall long-term cumulative radiation exposure; long-term cumulative radiation exposure associated with increased cancer risk
            • Ensure safe handling and preparation procedures to protect patients and healthcare workers from unintentional radiation exposure

            Risk for image misinterpretation

            • Uptake of copper CU 64 dotatate reflects somatostatin receptor density in NETs
            • Uptake can also be seen in a variety of other tumor types that express somatostatin receptors (eg, thyroid disease) or in subacute inflammation, or a normal physiologic variant (eg, uncinate process of the pancreas)
            • Uptake may need to be confirmed by histopathology or other assessments to confirm NET diagnosis

            Drug interaction overview

            • Nonradioactive somatostatin analogs competitively bind to the same somatostatin receptors as copper CU 64 dotatate
            • Long-acting somatostatin analogs: 28-day washout period recommended before imaging
            • Short-acting somatostatin analogs: 2-day washout period recommended before imaging
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            Pregnancy & Lactation

            Pregnancy

            There are no studies in pregnant females to inform any drug-associated risks; however, all radiopharmaceuticals have the potential to cause fetal harm

            Assess pregnancy status in females of reproductive potential before administering

            Lactation

            There is no information on the presence of copper CU 64 dotatate in human milk, the effect on the breastfed infant, or the effect on milk production

            Advise breastfeeding females to interrupt breastfeeding and pump and discard breast milk for 12 hr after administration to minimize radiation exposure to a breastfed infant

            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

            Copper Cu 64 dotatate binds to somatostatin receptors with highest affinity for subtype 2 receptors (SSTR2); dotatate, also known as DOTA-0-Tyr3-octreotate, is a cyclic 8-amino acid peptide with a covalently bound chelator (dota)

            It binds to cells that express somatostatin receptors, including malignant cells, which overexpress SSTR2 receptors

            Copper CU 64 is a positron beta-emitting radionuclide with an emission yield that allows PET imaging

            Distribution

            After 1-3 hr following single dose, maximum radioactivity observed in in SSTR2-expressing organs (eg, adrenal glands, kidneys, pituitary glands, spleen, liver)

            Metabolism

            Unknown

            Elimination

            Excretion: 16-40% recovered in urine over 6 hours after injection

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            Administration

            IV Preparation

            See full prescribing information for drug preparation using a lead glass shield for radioprotection purposes

            Drug handling

            • Use waterproof gloves, effective radiation shielding, and appropriate safety measures when preparing and handling
            • Radiopharmaceuticals should be used by or under the control of physicians and nuclear pharmacists who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use/preparation of radionuclides
            • Inspect visually for particulate matter and discoloration before administration; do not use if solution contains particulate matter or is discolored; copper CU 64 dotatate is a clear, colorless- to-yellow solution
            • Calculate necessary volume to administer based on measured activity, volume, calibration time, and date
            • Use dose calibrator to measure dose immediately before administration

            Patient preparation

            • Instruct patients to drink a sufficient amount of water to ensure adequate hydration prior to administration

            IV Administration

            Administer as IV bolus over ~1 minute; flush IV with 0.9% NaCl

            Use within 2 hr after calibration time

            Dispose of any unused drug in a safe manner in compliance with applicable regulations

            Patients must drink and void frequently during the first hours following administration to reduce radiation exposure

            Image patients just prior to dosing with somatostatin analogs (also see warnings for washout period)

            A negative scan after administration in patients without history of NET disease does not rule out disease

            Image acquisition

            • A whole-body acquisition from the skull vertex to mid thigh recommended
            • Image acquisition can begin 45-90 minutes after IV bolus
            • Adapt copper CU 64 dotatate uptake time and scan duration according to the equipment used and the patient and tumor characteristics, to obtain the optimal image quality

            Storage

            Store in upright position within lead shielding to protect handlers from exposure to radiation

            Store at controlled room temperature 20-25ºC (68-77ºF)

            Do not use and discard 2 hr after calibration date and time

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            Images

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            Formulary

            FormularyPatient Discounts

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

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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.
            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.
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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.