gallium Ga 68-dota-tate (Rx)

Brand and Other Names:Netspot
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

single-dose kit

  • Reaction vial (lyophilized powder): 40mcg dota-tate
  • Buffer vial: 1mL of reaction buffer solution

Neuroendocrine Tumors

Radioactive diagnostic agent after radiolabeling with Ga 68; indicated for use with positron-emission tomography (PET) for localization of somatostatin receptor-positive neuroendocrine tumors (NETs) in adults and children

2 MBq/kg of body weight (0.054 mCi/kg) up to 200 MBq (5.4 mCi) administered as an IV bolus injection

See Administration

Dosage Forms & Strengths

single-dose kit

  • Reaction vial (lyophilized powder): 40mcg dota-tate
  • Buffer vial: 1mL of reaction buffer solution

Neuroendocrine Tumors

Radioactive diagnostic agent after radiolabeling with Ga 68; indicated for use with positron-emission tomography (PET) for localization of somatostatin receptor-positive neuroendocrine tumors (NETs) in adults and children

2 MBq/kg of body weight (0.054 mCi/kg) up to 200 MBq (5.4 mCi) administered as an IV bolus injection

See Administration

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Interactions

Interaction Checker

and gallium Ga 68-dota-tate

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            Adverse Effects

            Postmarketing Reports

            Gastrointestinal disorders: Nausea and vomiting

            General disorders and administration site conditions: Injection site pain and burning sensation

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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 is associated with an increased risk of cancer
            • Ensure safe handling and preparation reconstitution procedures to protect patients and healthcare workers from unintentional radiation exposure

            Risk for image misinterpretation

            • Uptake of Ga 68 dota-tate reflects the level of somatostatin receptor density in NETs
            • However, uptake can also be seen in a variety of other tumor types (eg, those derived from neural crest tissue)
            • Increased uptake might also be seen in other pathologic conditions (eg, thyroid disease or subacute inflammation) or might occur as a normal physiologic variant (eg, uncinate process of the pancreas)
            • The 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 Ga 68 dota-tate
            • Image patients with Ga 68 dota-tate PET just prior to dosing with long-acting analogs of somatostatin
            • Short-acting analogs of somatostatin can be used up to 24 hr before imaging with Ga 68 dota-tate
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            Pregnancy & Lactation

            Pregnancy

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

            Lactation

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

            Advise breastfeeding women to interrupt breastfeeding and pump and discard breast milk for 12 hr after gallium Ga 68 dota-tate 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

            Ga 68 dota-tate binds to somatostatin receptors with highest affinity for subtype 2 receptors (sstr2); dota-tate, 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

            Gallium 68 (68Ga) is a beta-emitting radionuclide with an emission yield that allows positron-emission tomography (PET) imaging

            Distribution

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

            There is no uptake in the cerebral cortex or in the heart, and usually thymus and lung uptakes are low

            Elimination

            12% of the injected dose is excreted in urine in the first 4 hr postinjection

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            Administration

            IV Preparation

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

            Drug handling

            • After reconstitution and radiolabeling, handle the Ga 68 dota-tate injection with appropriate safety measures to minimize radiation exposure
            • Use waterproof gloves, effective radiation shielding, and appropriate safety measures when preparing and handling Ga 68 dota-tate injection
            • 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

            Patient preparation

            • Instruct patients to drink a sufficient amount of water to ensure adequate hydration prior to administration of Ga 68 dota-tate

            IV Administration

            Verify the injected radioactivity by measuring the radioactivity of the vial containing the Ga 68 dota-tate injection with a dose calibrator before administration to the patient

            Ensure that the injected radioactivity is within ±10% of the recommended dose

            Inject as an IV bolus

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

            Image acquisition

            • For Ga 68 dota-tate PET imaging, the acquisition must include a whole body acquisition from skull to mid thigh
            • Images can be acquired 40-90 minutes after the IV bolus
            • Adapt imaging acquisition delay and duration according to the equipment used, and the patient and tumor characteristics, in order to obtain the best image quality possible

            Storage

            The radionuclide is not part of the kit

            Before reconstitution and radiolabelling with Ga 68, the contents of this kit are not radioactive

            For prolonged storage, store kit in its original packaging at room temperature <25°C

            Do not freeze

            After reconstitution and radiolabeling

            • Keep Ga 68 dota-tate injection upright with an appropriate shielding to protect from radiation, at a temperature <25°C (do not freeze) for a maximum of 4 hr
            • The storage of the radiolabelled product must comply with regulatory requirements for radioactive materials
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            Images

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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.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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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.