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.

Table 1: Estimated Absorbed Radiation Doses after Intravenous Administration of Sodium Fluoride F 18 Injection
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
*
Data from Nuclear Regulatory Commission Report, Radiation Dose Estimates for Radiopharmaceuticals, NUREG/CR-6345, page 10, 1996.
Data from ICRP publication 53, Radiation Dose to Patients from Radiopharmaceuticals (), Ann ICRP, Volume 18, , pages15 and 74, 1987
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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