gallium Ga 68 dotatoc (Rx)

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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 30mL, multidose vial
  • Contains 18.5-148 MBq/mL (0.5-4 mCi/mL) of Ga 68 dotatoc injection at calibration date and time

Neuroendocrine Tumors

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

4 mCi (148 MBq); range of 3-5 mCi (111-185 MBq) administered as an IV bolus injection

Dosing Considerations

Somatostatin analogs

  • Somatostatin analogs (eg, lanreotide, octreotide, pasireotide) bind to the same somatostatin receptors as Ga 68 dotatoc
  • Discontinue short-acting somatostatin analogs 24 hr before imaging
  • Image with Ga 68 dotatoc just before dosing with long-acting analogs of somatostatin

Dosage Forms & Strengths

injectable solution

  • 30mL, multidose vial
  • Contains 18.5-148 MBq/mL (0.5-4 mCi/mL) of Ga 68 dotatoc injection at calibration date and time

Neuroendocrine Tumors

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

0.043 mCi/kg of body weight (1.59 MBq/kg); range of 0.3-3 mCi (11.1-111 MBq) as an IV bolus injection

Dosing Considerations

Somatostatin analogs

  • Somatostatin analogs (eg, octreotide) bind to the same somatostatin receptors as Ga 68 dotatoc
  • Discontinue short-acting somatostatin analogs 24 hr before imaging
  • Image with Ga 68 dotatoc just before dosing with long-acting somatostatin analogs
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Interactions

Interaction Checker

and gallium Ga 68 dotatoc

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Nausea (<2%)

            <1%

            Pruritus

            Flushing

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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 Ga 68 dotatoc reflects somatostatin receptor density level in NETs
            • Uptake can also be seen in other tumors that express somatostatin receptors
            • Increased uptake might also be seen in other pathologic conditions (eg, thyroid disease, subacute inflammation) or might occur as a normal physiologic variant (eg, uncinate process of the pancreas)
            • Negative scan after administration in patients without history of NET disease does not rule out disease

            Drug interaction overview

            • Nonradioactive somatostatin analogs (eg, lanreotide, octreotide, pasireotide) competitively bind to the same somatostatin receptors as Ga 68 dotatoc
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            Pregnancy & Lactation

            Pregnancy

            No data available on use in pregnant women to identify a risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

            Animal data

            • Animal reproduction studies have not been conducted
            • All radiopharmaceuticals may cause fetal harm depending on fetal stage of development and radiation dose magnitude
            • If considering administration to a pregnant woman, inform of potential for adverse pregnancy outcomes based on the radiation dose from Ga 68 dotatoc and the gestational timing of exposure

            Lactation

            There is no information on the presence of Ga 68 dotatoc in human milk, the effect on the breastfed infant, or the effect on milk production

            Consider developmental and health benefits of breastfeeding along with the mother’s clinical need and any potential adverse effects on the breastfed child from injection or from the underlying maternal condition

            Clinical considerations

            • Advise a lactating woman to interrupt breastfeeding and pump and discard breast milk for 8 hr after administration

            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

            Ga 68 dotatoc binds to somatostatin receptors, with highest affinity for subtype 2 receptors (sstr2)

            Drug binds to cells that express somatostatin receptors including malignant neuroendocrine cells, which overexpress sstr2 receptors

            Gallium 68 is a beta-emitting radionuclide with associated 511 keV annihilation photons that allow PET imaging

            Distribution

            Distributed to all sstr2-expressing organs such as pituitary, thyroid, spleen, adrenals, kidney, pancreas, prostate, liver, and salivary glands

            Uptake in the lung and lymph nodes is lower compared with other sstr-2 expressing organs

            Elimination

            Excretion: Exclusively via urine (~16%)

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            Administration

            IV Preparation

            Drug handling

            • Handle injection with appropriate safety measures to minimize radiation exposure
            • Use waterproof gloves, effective radiation shielding, and appropriate safety measures when preparing and handling injection

            • Use radiopharmaceuticals under the control of physicians 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 of radionuclides

            Patient hydration

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

            IV Administration

            Use injection within 3 hr of calibration time

            Visually inspect injection for particulate matter and discoloration before administration; do not use if solution contains particulate matter or is discolored

            Calculate the necessary volume to administer based on measured activity, volume, calibration time, and date

            Measure dose immediately before administration in a dose calibrator; refer to prescribing information for dose and estimated radiation absorbed

            Inject IV bolus at ~ 10 sec/mL

            After administration, flush IV with 0.9% NaCl to ensure dose is fully delivered

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

            Image Acquisition

            For Ga 68 dotatoc PET imaging, acquisition must include a whole body acquisition from skull to mid-thigh

            Image can be acquired at 60 min (range 55-90 min) after IV bolus

            Adapt injection uptake time and scan duration according to the equipment used, the patient, and tumor characteristics, to obtain optimal image quality

            Image Interpretation

            Drug binds to somatostatin receptors

            Based upon the intensity of the signals, PET images obtained indicate presence and density of somatostatin receptors in tissues

            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

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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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            • 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.
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            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for 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.