Ga-68-DOTATOC

Ga-68-DOTATOC is an FDA-registered drug product whose active ingredient is EDOTREOTIDE GALLIUM GA-68. It is labelled by UIHC P E T Imaging Center taken by intravenous and marketed as a human prescription drug product. Identifiers on file: NDC 24417-681, application NDA210828, label effective 20211208. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing EDOTREOTIDE GALLIUM GA-68 are most often described in connection with: dotatoc injection, positron emission, tomography pet, localization somatostatin, receptor positive, neuroendocrine tumors, nets adult, pediatric patients. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE Ga 68 DOTATOC Injection is indicated for use with positron emission tomography (PET) for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. Ga 68 DOTATOC Injection is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. ( 1 )

2 DOSAGE AND ADMINISTRATION Recommended dose for adults is 148 MBq (4 mCi) as a bolus intravenous injection ( 2.2 ) Recommended dose for pediatric patients is 1.59 MBq/kg (0.043 mCi/kg) with a range of 11.1 MBq (0.3 mCi) to 111 MBq (3 mCi), as a bolus intravenous injection ( 2.2 ) Initiate imaging 55 to 90 minutes after drug administration ( 2.4 ) See full prescribing information for additional preparation, administration, imaging and radiation dosimetry information ( 2 ) 2.1 Radiation Safety – Drug Handling Handle Ga 68 DOTATOC Injection with appropriate safety measures to minimize radiation exposure [see Warnings and Precautions (5.1) ] . Use waterproof gloves, effective radiation shielding and appropriate safety measures when preparing and handling Ga 68 DOTATOC Injection. Radiopharmaceuticals should be used by or 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. 2.2 Recommended Dosage and Administration Instructions Recommended Dosage In adults, the recommended amount of radioactivity to be administered for PET imaging is 4 mCi (148 MBq) with a range of 3 mCi to 5 mCi (111 MBq to 185 MBq) administered as an intravenous injection with an injection rate of approximately 10 seconds per mL. In pediatric patients, the recommended amount of radioactivity to be administered for PET imaging is 0.043 mCi/kg of body weight (1.59 MBq/kg) with a range of 0.3 mCi (11.1 MBq) to 3 mCi (111 MBq) as an intravenous injection with an injection rate of approximately 10 seconds per mL. Administration Use Ga 68 DOTATOC Injection within 3 hours of calibration time. Use aseptic technique and radiation shielding when withdrawing and administering Ga 68 DOTATOC Injection. Inspect Ga 68 DOTATOC Injection visually for particulate matter and discoloration before administration. Do not use the drug if the solution contains particulate matter or is discolored. Calculate the necessary volume to administer based on measured activity, volume, calibration time, and date. Measure the patient dose immediately prior to administration in a dose calibrator. After injection of Ga 68 DOTATOC Injection, administer an intravenous flush of sodium chloride injection, 0.9% to ensure full delivery of the dose. Dispose of any unused drug in a safe manner in compliance with applicable regulations. 2.3 Use with Somatostatin Analogs and Patient Hydration Somatostatin Analogs Somatostatin analogs bind to the same somatostatin receptors as Ga 68 DOTATOC Discontinue short-acting somatostatin analogs 24 hours before imaging with Ga 68 DOTATOC Injection . Image patients with Ga 68 DOTATOC Injection just prior to dosing with long-acting analogs of somatostatin [see Drug Interactions (7) ] . Patient Hydration Instruct patients to drink water to ensure adequate hydration prior to administration of Ga 68 DOTATOC Injection and to continue to drink and void frequently during the first hours following administration to reduce radiation exposure [see Warnings and Precautions (5.1) ] . 2.4 Image Acquisition For Ga 68 DOTATOC PET imaging, a whole-body acquisition from the skull vertex to mid-thigh is recommended. Image acquisition can begin at 60 minutes (range 55 to 90 minutes) after the intravenous administration of the Ga 68 DOTATOC Injection. Adapt Ga 68 DOTATOC Injection uptake time and scan duration according to the equipment used, and the patient and tumor characteristics, to obtain the optimal image quality. 2.5 Image Interpretation Ga 68 DOTATOC binds to somatostatin receptors. Based upon the intensity of the signals, PET images obtained using Ga 68 DOTATOC Injection indicate the presence and density of somatostatin receptors in tissues, .Uptake can also be seen in a variety of non-NET tumors that contain somatostatin receptors or as a normal physiologic variant [see Warnings and Precautions (5.2) ] . NET tumors that do not bear somatostatin receptors will not be visualized. 2.6 Radiation Dosimetry Estimated radiation absorbed doses per injected activity for organs and tissues of adult patients following an intravenous bolus of Ga 68 DOTATOC Injection are shown in Table 1. Estimated radiation effective doses per injected activity for adult and pediatric patients following an intravenous bolus administration of Ga 68 DOTATOC Injection are shown in Table 2. Table 1: Estimated Radiation Absorbed Dose per Injected Activity in Selected Organs with Ga 68 DOTATOC Site Absorbed Dose (mGy/MBq) Urinary bladder wall 0.119 ± 0.058 Spleen 0.108 ± 0.065 Kidney 0.082 ± 0.020 Adrenal gland 0.077 ± 0.028 Liver 0.041 ± 0.014 Red marrow 0.016 ± 0.003 Gallbladder wall 0.015 ± 0.001 Total body 0.014 ± 0.002 Lungs 0.007 ± 0.001 Effective dose (mSv/MBq) 0.021 ± 0.003 The effective radiation dose resulting from the administration of 148 MBq (4 mCi) to an adult weighing 75 kg, is about 3.11 mSv. For an administered activity of 148 MBq (4 mCi) the typical radiation dose to the critical organs, which are the urinary bladder wall, the spleen and the kidneys/adrenals, are about 18 mSv, 16 mSv and 12 mSv, respectively. Because the spleen has one of the highest physiological uptakes, higher uptake and radiation dose to other organs or pathologic tissues may occur in patients with splenectomy. Table 2: Estimated Radiation Effective Dose per Injected Activity after a Ga-68 DOTATOC Injection Age Model Weight (kg) Effective Dose per Injection Activity (mSv/MBq) Adult 73.7 0.019 15 years 56.8 0.026 10 years 33.2 0.041 5 years 19.8 0.066 1 year 9.7 0.13 Newborn 3.6 0.36

4 CONTRAINDICATIONS None None ( 4 )

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity reactions Reported adverse reactions include: Nausea, pruritis, and flushing. To report SUSPECTED ADVERSE REACTIONS, contact the UIHC – P E T Imaging Center at 1-319-356-1092 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch ( 6 ) 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Ga-68 DOTATOC injection was evaluated in 334 patients in clinical trials of patients receiving a single dose of Ga-68 DOTATOC injection for imaging known or suspected NET. The following adverse reactions occurred at a rate of < 2%: Gastrointestinal Disorders : nausea The following adverse reactions occurred at a rate of a < 1% Skin and Subcutaneous Tissue Disorders: pruritus Vascular Disorders : flushing 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of other somatostatin receptor imaging agents. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the drug. Immune System Disorders : Hypersensitivity reactions , predominantly rash, pruritus, less frequently angioedema or features of anaphylaxis

What is Ga-68-DOTATOC used for?
1 INDICATIONS AND USAGE Ga 68 DOTATOC Injection is indicated for use with positron emission tomography (PET) for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. Ga 68 DOTATOC Injection is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive …

Who makes Ga-68-DOTATOC?
UIHC P E T Imaging Center is the labeler of record for Ga-68-DOTATOC.

What form does Ga-68-DOTATOC come in?
administered by intravenous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Ga-68-DOTATOC prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Ga-68-DOTATOC been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.