gallium Ga 68 dotatoc (Rx)

Brand and Other Names:
  • Print

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
Next:

Interactions

Interaction Checker

and gallium Ga 68 dotatoc

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (3)

                • lanreotide

                  lanreotide decreases effects of gallium Ga 68 dotatoc by receptor binding competition. Modify Therapy/Monitor Closely. Somatostatin analogs competitively bind to the same somatostatin receptors as Ga 68 dotatoc and may affect imaging. Image patients with Ga 68 dotatoc PET just prior to dosing with long-acting somatostatin analogs. Short-acting somatostatin analogs can be used up to 24 hr before imaging with Ga 68 dotatoc.

                • octreotide

                  octreotide decreases effects of gallium Ga 68 dotatoc by receptor binding competition. Modify Therapy/Monitor Closely. Somatostatin analogs competitively bind to the same somatostatin receptors as Ga 68 dotatoc and may affect imaging. Image patients with Ga 68 dotatoc PET just prior to dosing with long-acting somatostatin analogs. Short-acting somatostatin analogs can be used up to 24 hr before imaging with Ga 68 dotatoc.

                • pasireotide

                  pasireotide decreases effects of gallium Ga 68 dotatoc by receptor binding competition. Modify Therapy/Monitor Closely. Somatostatin analogs competitively bind to the same somatostatin receptors as Ga 68 dotatoc and may affect imaging. Image patients with Ga 68 dotatoc PET just prior to dosing with long-acting somatostatin analogs. Short-acting somatostatin analogs can be used up to 24 hr before imaging with Ga 68 dotatoc.

                Minor (0)

                  Previous
                  Next:

                  Adverse Effects

                  1-10%

                  Nausea (<2%)

                  <1%

                  Pruritus

                  Flushing

                  Previous
                  Next:

                  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
                  Previous
                  Next:

                  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.

                  Previous
                  Next:

                  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%)

                  Previous
                  Next:

                  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

                  Previous
                  Next:

                  Images

                  No images available for this drug.
                  Previous
                  Next:

                  Patient Handout

                  A Patient Handout is not currently available for this monograph.
                  Previous
                  Next:

                  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.
                  Additional Offers
                  Email to Patient

                  From:

                  To:

                  The recipient will receive more details and instructions to access this offer.

                  By clicking send, you acknowledge that you have permission to email the recipient with this information.

                  Email Forms to Patient

                  From:

                  To:

                  The recipient will receive more details and instructions to access this offer.

                  By clicking send, you acknowledge that you have permission to email the recipient with this information.

                  Previous
                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.