31/19.Fluorodopa F18- (Oct 2019)
Drug Name:31/19.Fluorodopa F18- (Oct 2019)
List Of Brands:
Indication Type Description:
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Indication:
BRIEF SUMMARY
FLUORODOPA F18-(Oct 2019)
Indn- Fluorodopa F 18 Injection indicated for use in positron emission tomography (PET) to evaluate patients with suspected Parkinsonian syndromes (PS).
Comp- Injection: clear, colorless solution in a multiple-dose glass vial containing 15.5 MBq/mL to 308.2 MBq/mL (0.42 mCi/mL to 8.33 mCi/mL) of Fluorodopa F 18 Injection.
• The recommended adult dose is 185 megabecquerels (MBq) [5 millicuries (mCi)] by intravenous injection infused over 1 minute.
ADR- Injection site pain occurred with administration based on a review of the published literature.
CI- None
WARNINGS-
Radiation risks: Use smallest dose necessary for imaging and ensure safe handling to protect the patient and healthcare worker from radiation exposure (
Pat Inform-
Patient Preparation Instruct patients to: • Drink water in the 4 hours before their PET study and continue hydration with water or other fluids (as tolerated) after the study.
• Void 70 minutes after the administration of Fluorodopa F 18, before the start of the imaging study, and as frequently as possible after the study is complete for a total of 12 hours
Lactation To decrease radiation exposure to a nursing infant, advise a lactating woman to pump and discard breastmilk for at least 24 hours (12 half-lives) after administration of Fluorodopa F 18 Injection. (
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U.S. FDA APPROVED DRUGS DURING 2019
Sr.No- 31
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
FLUORODOPA F 18 Injection safely and effectively. See full prescribing information for FLUORODOPA F 18 Injection. FLUORODOPA F 18 Injection, for intravenous use
Initial U.S. Approval: 2019
INDICATIONS AND USAGE-
Fluorodopa F 18 Injection is a radioactive diagnostic agent indicated for use in positron emission tomography (PET) to visualize dopaminergic nerve terminals in the striatum for the evaluation of adult patients with suspected Parkinsonian syndromes (PS). Fluorodopa F 18 PET is an adjunct to other diagnostic evaluations.
Adverse Reaction:
ADVERSE REACTIONS
Injection site pain occurred with administration based on a review of the published literature.
Contra-Indications:
CONTRAINDICATIONS
None
WARNINGS AND PRECAUTIONS-
Radiation risks: Use smallest dose necessary for imaging and ensure safe handling to protect the patient and healthcare worker from radiation exposure (5.1).
Dosages/ Overdosage Etc:
DOSAGE AND ADMINISTRATION-
• The recommended adult dose is 185 megabecquerels (MBq) [5 millicuries (mCi)] by intravenous injection infused over 1 minute.
• Use aseptic techniques and radiation shielding to maintain sterility during all operations involved in the manipulation and administration of Fluorodopa F 18 Injection.
• Instruct patients to void immediately before imaging and start imaging at approximately 80 minutes post administration (with a 9 second CT scan for attenuation correction) followed by 3D PET scan from 80 to 100 minutes post administration.
• See full prescribing information for additional preparation, administration, imaging and radiation dosimetry information.
DOSAGE FORMS AND STRENGTHS-
Injection: clear, colorless solution in a multiple-dose glass vial containing 15.5 MBq/mL to 308.2 MBq/mL (0.42 mCi/mL to 8.33 mCi/mL) of Fluorodopa F 18 Injection.
Patient Information:
PATIENT COUNSELING INFORMATION
Patient Preparation Instruct patients to: • Drink water in the 4 hours before their PET study and continue hydration with water or other fluids (as tolerated) after the study.
• Void 70 minutes after the administration of Fluorodopa F 18, before the start of the imaging study, and as frequently as possible after the study is complete for a total of 12 hours [see Dosage and Administration (2.3).
Lactation To decrease radiation exposure to a nursing infant, advise a lactating woman to pump and discard breastmilk for at least 24 hours (12 half-lives) after administration of Fluorodopa F 18 Injection. (8.2).
Manufactured & Distributed by: The Feinstein Institutes for Medical ResearchCyclotro n/Radiochemistry Facility 350 Community Drive Manhasset, New York, 11030
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1 Mechanism of Action
In dopaminergic nerve terminals in the brain, Fluorodopa (FDOPA) F 18 is decarboxylated by amino acid decarboxylase to Fluorodopamine (FDA) F 18 and stored in presynaptic vesicles in the brain. The accumulation of F 18 FDA in the striatum is visually detected in the PET scan.
2. Pharmacodynamics -
Optimal PET imaging is achieved between 75 to 90 minutes after administration of Fluorodopa F 18 Injection based on its pharmacokinetics. The relationship between Fluorodopa F 18 dose and plasma concentration is not fully characterized.
3. Pharmacokinetics-
Distribution Following the intravenous administration, Fluorodopa F 18 is cleared from the blood with a biologic half-life of about 1 to 3 hours. The time course of “background” brain radioactivity after Fluorodopa F 18 was evaluated. F 18 activity in the cerebellum was greater than the parietal or occipital cortex during the first 30 minutes after Fluorodopa F 18 suggesting regional differences in amino acid transport.
Elimination-
Fluorodopa F 18 is cleared from the blood and tissue within 24 hours.
Metabolism: Fluorodopa F 18 is decarboxylated by aromatic amino acid decarboxylase in the striatum to Fluorodopamine F 18. Fluorodopamine F 18 is also metabolized via monoamine oxidase to yield [18F] 6-fluoro-3,4-dihydroxyphenylacetic acid (18FDOPAC) and subsequently by COMT to yield [18F]6-fluorohomovanillic acid (18FHVA). Page 8 of 10 Reference ID: 4504654
Elimination: 80% of the radioactivity is eliminated through the urine. Urine radioactivity peaks at about 30 minutes post-injection. The radiation absorbed dose to the bladder wall is reduced by emptying the bladder just before scannin
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy Risk Summary
There are no available data on Fluorodopa F 18 Injection use in pregnant women. Additionally, animal reproductive and developmental toxicity studies have not been conducted with Fluorodopa F 18 Injection.
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 to 4% and 15 to 20%, respectively, regardless of drug exposure.
2. Lactation- Risk Summary No data are available regarding the presence of Fluorodopa F 18 Injection in human milk, the effects of the drug on the breastfed child, or the effects of the drug on milk production.
Exposure of Fluorodopa F 18 Injection to a breast fed infant can be minimized by temporary discontinuation of breastfeeding [see Clinical Considerations
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Fluorodopa F 18 Injection and any potential adverse effects on the breastfed child from Fluorodopa F 18 Injection or from the underlying maternal condition.
The body of scientific information related to radioactivity decay, drug tissue distribution and drug elimination shows that less than 0.01% of the radioactivity administered remains in the body after 24 hours.
4. Pediatric Use The safety and effectiveness of Fluorodopa F 18 Injection for visualization of dopaminergic neurons in the striatum has not been established in pediatric patients