Sodium fluoride f-18

FDA label, Biomedical Research Foundation of Northwest Louisiana, intravenous, effective 2026-06-10. Full label on DailyMed

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Dosing in kidney impairment

Table 1: Estimated Absorbed Radiation Doses after Intravenous Administration of Sodium Fluoride F 18 Injection
Organ	Adult 70 kgData from Nuclear Regulatory Commission Report, Radiation Dose Estimates for Radiopharmaceuticals, NUREG/CR-6345, page 10, 1996.	15 year 56.8 kgData from ICRP publication 53, Radiation Dose to Patients from Radiopharmaceuticals, Ann ICRP, Volume 18, pages15 and 74, 1987	10 year 33.2 kg	5 year 19.8 kg	1 year 9.7 kg
			Estimated Radiation Dose mGy/MBq
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

Preparation and administration

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Your numbers for sodium fluoride f-18. Take vial strength, diluent, and limits from the label below.

Dose

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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.

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.

Imaging Guidelines Imaging of Sodium Fluoride F 18 Injection can begin 1 to 2 hours after administration; optimally at 1 hour post administration. Encourage the patient to void immediately prior to imaging the fluoride F 18 radioactivity in the lumbar spine or bony pelvis.

Table 1: Estimated Absorbed Radiation Doses after Intravenous Administration of Sodium Fluoride F 18 Injection
Organ	Adult 70 kgData from Nuclear Regulatory Commission Report, Radiation Dose Estimates for Radiopharmaceuticals, NUREG/CR-6345, page 10, 1996.	15 year 56.8 kgData from ICRP publication 53, Radiation Dose to Patients from Radiopharmaceuticals, Ann ICRP, Volume 18, pages15 and 74, 1987	10 year 33.2 kg	5 year 19.8 kg	1 year 9.7 kg
			Estimated Radiation Dose mGy/MBq
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

Drug interactions

Check sodium fluoride f-18 against a medication list

Label text (1 paragraph)

The possibility of interactions of Sodium Fluoride F 18 Injection with other drugs taken by patients undergoing PET imaging has not been studied.

Contraindications

None. None (4).

Safety data

Reported adverse events (FAERS)

Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for sodium fluoride f-18. Check the label's hepatic warnings.

Source: LiverTox, NIDDK

Pregnancy and lactation

Pregnancy

8.1 Pregnancy Pregnancy Category C Any radiopharmaceutical including Sodium Fluoride F 18 Injection has a potential to cause fetal harm. The likelihood of fetal harm depends on the stage of fetal development, and the radionuclide dose. Animal reproduction studies have not been conducted with Sodium Fluoride F 18 Injection. Prior to the administration of Sodium Fluoride F 18 Injection to women of childbearing potential, assess for presence of pregnancy. Sodium Fluoride F 18 Injection should be given to a pregnant woman only if clearly needed.

Lactation

8.3 Nursing Mothers It is not known whether Sodium Fluoride F 18 Injection is excreted into human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to interrupt nursing after administration of Sodium Fluoride F 18 Injection or not to administer Sodium Fluoride F 18 Injection, taking into account the importance of the drug to the mother. 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 (10 half-lives).

To minimize the risks to a nursing infant, interrupt nursing for at least 24 hours.

Breastfeeding (LactMed)

Information in this record refers to the use of sodium fluoride F 18 as a diagnostic agent. The manufacturer recommends withholding breastfeeding for 24 hours after a diagnostic dose of 300-450 MBq (8 to 12 mCi); however, this time might be longer than necessary given the minimal amount of fluoride that appears in breastmilk. Twenty-four hours is about 10 half-lives of fluoride F 18 and less than 0.01% of the radioactivity administered will remain in the body. The mother can nurse just before administration of the radiopharmaceutical. If the mother has expressed and saved milk prior to the examination, she can feed it to the infant during the period of nursing interruption. Mothers concerned about the level of radioactivity in their milk could ask to have it tested at a nuclear medicine facility at their hospital.

Source: LactMed: Sodium Fluoride F 18 (NICHD, public domain)Revised Dec 15, 2024

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