25/19. Ga-68- Dotatoc- (Ga -68- DOTAC)-@- (Aug 2019)- Neuroendocrine Tumors
Drug Name:25/19. Ga-68- Dotatoc- (Ga -68- DOTAC)-@- (Aug 2019)- Neuroendocrine Tumors
List Of Brands:
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
DRUG INTERACTION
Summary
Somatostatin Analogs: Somatostatin analogs competitively bind to the same somatostatin receptors as Ga 68 DOTATOC Injection and may affect imaging –
Discontinue short-acting somatostatin analogs 24 hours before imaging with Ga 68 DOTATOC and image just prior to dosing with long-acting somatostatin analogs
Details
Non-radioactive somatostatin analogs bind to the same somatostatin receptors as Ga 68 DOTATOC Injection. Image patients with Ga 68 DOTATOC Injection just prior to dosing with long-acting analogs of somatostatin.
Short-acting analogs of somatostatin can be used up to 24 hours before imaging with Ga 68 DOTATOC Injection
Indication:
BRIEF SUMMARY
Ga-68-(DOTAC)- (Aug 2019)
Indn- For use with positron emission tomograpjy (PET) for localization of somastatin receptor positive neuroendocrine tumors(NET)
Comp- Injection: 18.5 MBq/mL to 148 MBq/mL (0.5 mCi/mL to 4 mCi/mL) of
injection in a multiple-dose glass vial
ADR- Reported adverse reactions include: Nausea, pruritis, and flushing.
CI- None
WARNINGS-
• Radiation Risk: Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure Advise patients to hydrate before and after administration and to void frequently after administration
Pat Inform-
Radiation Risk
Advise patients to drink water to ensure adequate hydration prior to their PET study and recommend they drink and urinate as often as possible during the first hours following the administration of Injection, in order to reduce radiation exposure .
Lactation
Advise a lactating woman to interrupt breastfeeding and pump and discard breast milk for 8 hours after Injection administration in order to minimize radiation
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U.S. FDA APPROVED DRUGS DURING 2019
Sr.No.25.
Name of the Drug- Ga-68-DOTAC
Active Ingredient - Ga-68-Dototac
Pharmacological Classification-
For use with positron emission tomograpjy (PET) for localization
of somastatin receptor positive neuroendocrine tumors(NET)
Date of Approval - 8/21/2019
(Ref- FDA approved List 2019
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Ga 68 DOTATOC INJECTION safely and effectively. See full prescribing information for Ga 68 DOTATOC INJECTION. Ga 68 DOTATOC Injection, for intravenous use
Initial U.S. Approval: 2019
INDICATIONS AND USAGE
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.
Adverse Reaction:
ADVERSE REACTIONS
Reported adverse reactions include: Nausea, pruritis, and flushing.
Contra-Indications:
CONTRAINDICATIONS
None
WARNINGS AND PRECAUTIONS
• Radiation Risk: Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure Advise patients to hydrate before and after administration and to void frequently after administration
• Risk for Image Misinterpretation: Uptake of Ga 68 DOTATOC injection can be seen in a variety of tumor types that contain somatostatin receptors, and in other pathologic conditions, and as a normal physiologic variant (e.g. uncinate process of the pancreas)
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
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.
DOSAGE AND ADMINISTRATION
• Recommended dose for adults is 148 MBq (4 mCi) as a bolus intravenous injection (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
• Initiate imaging 55 to 90 minutes after drug administration
• See full prescribing information for additional preparation, administration, imaging and radiation dosimetry information
DOSAGE FORMS AND STRENGTHS
Injection: 18.5 MBq/mL to 148 MBq/mL (0.5 mCi/mL to 4 mCi/mL) of Ga 68 DOTATOC Injection in a multiple-dose glass vial
Patient Information:
PATIENT COUNSELING INFORMATION
Radiation Risk
Advise patients to drink water to ensure adequate hydration prior to their PET study and recommend they drink and urinate as often as possible during the first hours following the administration of Ga 68 DOTATOC Injection, in order to reduce radiation exposure .
Lactation
Advise a lactating woman to interrupt breastfeeding and pump and discard breast milk for 8 hours after Ga 68 DOTATOC Injection administration in order to minimize radiation
Manufactured and Distributed by:
UIHC – P E T Imaging Center 0911Z JPP 200 Hawkins Drive Iowa City, IA 52242
Page
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action
Ga 68 DOTATOC binds to somatostatin receptors, with highest affinity (Ki = 2.5± 0.5 nanomolar) for subtype 2 receptors (sstr2). Ga 68 DOTATOC binds to cells that express somatostatin receptors including malignant neuroendocrine cells, which overexpress sstr2 receptors. Gallium 68 is a ß+ emitting radionuclide with associated 511 keV annihilation photons that allow positron emission tomography (PET) imaging.
2. Pharmacodynamics
The relationship between Ga 68 DOTATOC plasma concentrations and successful imaging was not explored in clinical trials.
3. Pharmacokinetics
Distribution
Ga 68 DOTATOC distributes 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 are lower as compared to other sstr-2 expressing organs.
Elimination
Radiotracer elimination is exclusively via urine. Approximately 16% of the injected dose is excreted in urine in the first two to four hours post-injection.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
Risk Summary
There are no available data on the use of Ga 68 DOTATOC Injection in pregnant women to identify a risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
Animal reproduction studies have not been conducted with Ga 68 DOTATOC. However, all radiopharmaceuticals, including Ga 68 DOTATOC Injection have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.
If considering Ga 68 DOTATOC Injection administration to a pregnant woman, inform the patient of the potential for adverse pregnancy outcomes based on the radiation dose from Ga 68 DOTATOC Injection and the gestational timing of exposure.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively.
2. Lactation
Risk Summary
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.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Ga 68 DOTATOC Injection and any potential adverse effects on the breastfed child from Ga 68 DOTATOC Injection or from the underlying maternal condition.
Clinical Considerations To decrease exposure to the breastfed infant, advise a lactating woman to interrupt breastfeeding and pump and discard breast milk for 8 hours after Ga 68 DOTATOC Injection administration.
3.Pediatric Use
The safety and efficacy of Ga 68 DOTATOC Injection have been established in pediatric patients with neuroendocrine tumors.
Efficacy is based on data from 14 patients in Study A and B demonstrating the ability of Ga 68 DOTATOC to image NETs.
The safety profile of Ga 68 DOTATOC Injection is similar in adult and pediatric patients with somatostatin receptor positive tumors.
The recommended Ga 68 DOTATOC injected dose in pediatric patients is weight based
4.Geriatric Use
Clinical studies of Ga 68 DOTATOC did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
OVERDOSAGE
In the event of a radiation overdose, reduce the absorbed dose to the patient by increasing the elimination of the radionuclide from the body by reinforced hydration, frequent bladder voiding, and diuretics, if needed. If possible, perform an estimate of the radioactive dose given to the patient.
