Sodium Fluoride F 18
SODIUM FLUORIDE F 18- sodium fluoride f-18 injection
Kreitchman PET Center
HIGHLIGHTS OF PRESCRIBING INFORMATION
INDICATIONS AND USAGE
Sodium Fluoride F 18 Injection is a radioactive diagnostic agent for positron emission tomography (PET) indicated for imaging of bone to define areas of altered osteogenic activity (1).
DOSAGE AND ADMINISTRATION
- Sodium Fluoride F18 Injection emits radiation and must be handled with appropriate safety measures (2.1).
- Administer 300-450 MBq (8 to 12 mCi) as an intravenous injection in adults (2.4).
- Administer approximately 2.1 MBq/kg in children with a minimum of 19 MBq (0.5 mCi) and a maximum of 148 MBq (4 mCi) as an intravenous injection (2.5).
- Imaging can begin 1–2 hours after administration; optimally at one hour post administration (2.7).
- Encourage patients to void immediately prior to imaging the lumbar spine and bony pelvis (2.7).
CONTRAINDICATIONS
None (4).
WARNINGS AND PRECAUTIONS
- Allergic Reactions: As with any injectable drug product, allergic reactions and anaphylaxis may occur. Emergency resuscitation equipment and personnel should be immediately available.(5.1).
- Cancer Risk: Sodium Fluoride F 18 Injection may increase the risk of cancer. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker (5.2).
(5).
USE IN SPECIFIC POPULATIONS
- Pregnancy: No human or animal data. Any radiopharmaceutical, including Sodium Fluoride F18 injection, may cause fetal harm. Use only if clearly needed (8.1)
- Nursing: A decision should be made whether to interrupt nursing after Sodium Fluoride F 18 Injection administration or not to administer Sodium Fluoride F 18 Injection taking into consideration the importance of the drug to the mother.(8.3).
- Pediatrics: Children are more sensitive to radiation and may be at higher risk of cancer from Sodium Fluoride F18 injection (8.4).
See 17 for Patient Counseling Information
Revised: 01/2024
FULL PRESCRIBING INFORMATION: CONTENTS *
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Radiation Safety — Drug Handling
2.2 Radiation Safety — Patient Preparation
2.3 Drug Preparation and Administration
2.4 Recommended Dose for Adults
2.5 Recommended Dose for Pediatric Patients
2.6 Radiation Dosimetry
2.7 Imaging Guidelines
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Allergic Reactions
5.2 Radiation Risks
6 ADVERSE REACTIONS
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
11 DESCRIPTION
11.1 Chemical Characteristics
11.2 Physical Characteristics
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Metastatic Bone Disease
14.2 Other Bone Disorders
15 REFERENCES
16 HOW SUPPLIED
Storage
Handling
17 PATIENT COUNSELING INFORMATION
17.1 Pre-study Hydration
17.2 Post-study Voiding
- *
- Sections or subsections omitted from the full prescribing information are not listed
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
Sodium Fluoride F 18 Injection is indicated for diagnostic positron emission tomography (PET) imaging of bone to define areas of altered osteogenic activity.
2 DOSAGE AND ADMINISTRATION
2.1 Radiation Safety — Drug Handling
- Wear waterproof gloves and effective shielding when handling Sodium Fluoride F 18 Injection. Use appropriate safety measures, including shielding, consistent with proper patient management to avoid unnecessary radiation exposure to the patient, occupational workers, clinical personnel, and other persons.
- 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.
- Use aseptic technique to maintain sterility during all operations involved in the manipulation and administration of Sodium Fluoride F 18 Injection.
- The dose of Sodium Fluoride F 18 Injection should be minimized consistent with the objectives of the procedure, and the nature of the radiation detection devices employed.
- The final dose for the patient should be calculated using proper decay factors from the time of EOS, and measured by a suitable radioactivity calibration system before administration [Description (11.2) ].
2.2 Radiation Safety — Patient Preparation
- To minimize the radiation-absorbed dose to the bladder, encourage adequate hydration. Encourage the patient to ingest at least 500 mL of fluid immediately prior and subsequent to the administration of Sodium Fluoride F 18 Injection.
- Encourage the patient to void one-half hour after administration of Sodium Fluoride F 18 Injection and as frequently thereafter as possible for the next 12 hours.
2.3 Drug Preparation and Administration
- Calculate the necessary volume to administer based on calibration time and dose.
- Inspect Sodium Fluoride F 18 Injection visually for particulate matter and discoloration before administration, whenever solution and container permit.
- Do not administer Sodium Fluoride F 18 Injection containing particulate matter or discoloration; dispose of these unacceptable or unused preparations in a safe manner, in compliance with applicable regulations.
- Aseptically withdraw Sodium Fluoride F 18 Injection from its container.
2.4 Recommended Dose for Adults
Administer 300–450 MBq (8–12 mCi) as an intravenous injection.
2.5 Recommended Dose for Pediatric Patients
In reported clinical experience in approximately 100 children, weight based doses (2.1 MBq/kg) ranging from 19 MBq– 148 MBq (0.5 mCi- 4 mCi) were used.
2.6 Radiation Dosimetry
The age/weight- based estimated absorbed radiation doses (mGy/MBq) from intravenous injection of Sodium Fluoride F 18 Injection are shown in Table 1. These estimates were calculated based on human data and using the data published by the Nuclear Regulatory Commission [1] and the International Commission on Radiological Protection for Sodium Fluoride Injection [2]. The bone, bone marrow and urinary bladder are considered target and critical organs.
Estimated Radiation Dose mGy/MBq | |||||
Organ | Adult 70 kg * | 15 year 56.8 kg † | 10 year 33.2 kg † | 5 year 19.8 kg † | 1 year 9.7 kg † |
---|---|---|---|---|---|
Adrenals | 0.0062 | 0.012 | 0.018 | 0.028 | 0.052 |
Brain | 0.0056 | N/A | N/A | N/A | N/A |
Bone surfaces | 0.060 | 0.050 | 0.079 | 0.13 | 0.30 |
Breasts | 0.0028 | 0.0061 | 0.0097 | 0.015 | 0.030 |
Gallbladder wall | 0.0044 | N/A | N/A | N/A | N/A |
Stomach wall | 0.0038 | 0.008 | 0.013 | 0.019 | 0.036 |
Small intestine | 0.0066 | 0.012 | 0.018 | 0.028 | 0.052 |
Upper large intestine wall | 0.0058 | 0.010 | 0.016 | 0.026 | 0.046 |
Lower large intestine wall | 0.012 | 0.016 | 0.025 | 0.037 | 0.063 |
Heart wall | 0.0039 | N/A | N/A | N/A | N/A |
Kidneys | 0.019 | 0.025 | 0.036 | 0.053 | 0.097 |
Liver | 0.0040 | 0.0084 | 0.013 | 0.021 | 0.039 |
Lungs | 0.0041 | 0.0084 | 0.013 | 0.020 | 0.039 |
Muscle | 0.0060 | N/A | N/A | N/A | N/A |
Ovaries | 0.011 | 0.016 | 0.023 | 0.036 | 0.063 |
Pancreas | 0.0048 | 0.0096 | 0.015 | 0.023 | 0.044 |
Red marrow | 0.028 | 0.053 | 0.088 | 0.18 | 0.38 |
Skin | 0.0040 | N/A | N/A | N/A | N/A |
Spleen | 0.0042 | 0.0088 | 0.014 | 0.021 | 0.041 |
Testes | 0.0078 | 0.013 | 0.021 | 0.033 | 0.062 |
Thymus | 0.0035 | N/A | N/A | N/A | N/A |
Thyroid | 0.0044 | 0.0084 | 0.013 | 0.020 | 0.036 |
Urinary bladder wall | 0.25 | 0.27 | 0.4 | 0.61 | 1.1 |
Uterus | 0.019 | 0.023 | 0.037 | 0.057 | 0.099 |
Other tissue | N/A | 0.010 | 0.015 | 0.024 | 0.044 |
Effective Dose Equivalent mSv/MBq | 0.027 | 0.034 | 0.052 | 0.086 | 0.17 |
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