Ga-68-DOTATOC
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Omid Afkhami-Ardakani
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Overview
Ga-68-DOTATOC is a radiopharmaceutical diagnostic agent that is FDA approved for the procedure of positron emission tomography (PET) imaging for the localization of somatostatin receptor-positive neuroendocrine tumors (NETs) in adult and pediatric patients.. Common adverse reactions include Nausea, Vomiting, Flushing, Injection site pain.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Ga-68-DOTATOC FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Ga-68-DOTATOC in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ga-68-DOTATOC in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Ga-68-DOTATOC FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Ga-68-DOTATOC in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ga-68-DOTATOC in pediatric patients.
Contraindications
There is limited information regarding Ga-68-DOTATOC Contraindications in the drug label.
Warnings
Radiation Exposure: Ga-68 DOTATOC contributes to a patient's overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Ensure safe handling to minimize radiation exposure to patients and healthcare workers.
Hypersensitivity Reactions: Monitor patients for hypersensitivity reactions during and after administration. If a serious reaction occurs, initiate appropriate medical management.
Adverse Reactions
Clinical Trials Experience
Injection Site Reactions: Pain, redness, and swelling at the injection site.
Gastrointestinal Reactions: Nausea and vomiting.
General Reactions: Flushing and dizziness.
Postmarketing Experience
There is limited information regarding Ga-68-DOTATOC Postmarketing Experience in the drug label.
Drug Interactions
Somatostatin Analogs: Concurrent use of somatostatin analogs may affect the uptake of Ga-68 DOTATOC. Discontinue long-acting analogs 4 weeks and short-acting analogs 24 hours prior to imaging when possible.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
Ga-68 DOTATOC can cause fetal harm due to radiation exposure. Use only if the potential benefit justifies the potential risk to the fetus.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ga-68-DOTATOC in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Ga-68-DOTATOC during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Ga-68-DOTATOC in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Ga-68-DOTATOC in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Ga-68-DOTATOC in geriatric settings.
Gender
There is no FDA guidance on the use of Ga-68-DOTATOC with respect to specific gender populations.
Race
There is no FDA guidance on the use of Ga-68-DOTATOC with respect to specific racial populations.
Renal Impairment
Use with caution in patients with severe renal impairment as they may have increased radiation exposure.
Hepatic Impairment
There is no FDA guidance on the use of Ga-68-DOTATOC in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Ga-68-DOTATOC in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Ga-68-DOTATOC in patients who are immunocompromised.
Administration and Monitoring
Administration
Dosage: The recommended activity is 111 MBq (3 mCi) administered as an intravenous bolus injection. Preparation: Use aseptic technique and appropriate radiation shielding. Imaging Timing: Perform PET imaging 55 to 90 minutes after injection.
Monitoring
Radiation Exposure: Use waterproof gloves and effective radiation shielding to minimize exposure. Hypersensitivity Reactions: Monitor patients during and after administration for hypersensitivity reactions.
IV Compatibility
Ga-68 DOTATOC is supplied ready to use and does not require dilution. Use within 4 hours of calibration time.
Overdosage
In case of overdose, provide supportive care, including monitoring for radiation toxicity. Encourage hydration to promote urinary excretion of the radiopharmaceutical.
Pharmacology
There is limited information regarding Ga-68-DOTATOC Pharmacology in the drug label.
Mechanism of Action
Mechanism of Action: Ga-68 DOTATOC binds to somatostatin receptors, which are overexpressed in neuroendocrine tumors, allowing for PET imaging of these tumors.
Structure
There is limited information regarding Ga-68-DOTATOC Structure in the drug label.
Pharmacodynamics
The degree of Ga-68 DOTATOC binding correlates with the level of somatostatin receptor expression in tumors.
Pharmacokinetics
Distribution: Rapidly distributes to somatostatin receptor-rich tissues. Elimination: Primarily eliminated through the kidneys.
Nonclinical Toxicology
There is limited information regarding Ga-68-DOTATOC Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Ga-68-DOTATOC Clinical Studies in the drug label.
How Supplied
Injection: 148 MBq/mL (4 mCi/mL) of Ga-68 DOTATOC in a multiple-dose vial.
Storage
Store at controlled room temperature (20°C to 25°C [68°F to 77°F]) in original lead-shielded container.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
Radiation Risks: Inform patients about the potential risks of radiation exposure.
Pregnancy and Lactation: Advise pregnant and breastfeeding women of potential risks and appropriate precautions.
Precautions with Alcohol
Alcohol-Ga-68-DOTATOC interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
Ga-68 DOTATOC is marketed under the brand name NETSPOT, which is used for PET imaging of somatostatin receptor-positive neuroendocrine tumors.
Look-Alike Drug Names
There is limited information regarding Ga-68-DOTATOC Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.