These highlights do not include all the information needed to use Sodium Fluoride F 18 Injection safely and effectively. See full prescribing information for Sodium Fluoride F 18 Injection. SODIUM FLUORIDE F 18 INJECTION For I | Sodium Fluoride F 18

05:33 EDT 27th August 2014 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

Sodium Fluoride F 18 Injection is indicated for diagnostic positron emission tomography (PET) imaging of bone to define areas of altered osteogenic activity.

Administer 300–450 MBq (8–12 mCi) as an intravenous injection.   

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.

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.

[1] Data from Nuclear Regulatory Commission Report, Radiation Dose Estimates for Radiopharmaceuticals, NUREG/CR-6345, page 10, 1996.

[2] Data from ICRP publication 53, Radiation Dose to Patients from Radiopharmaceuticals , Ann ICRP, Volume 18, pages 15 and 74, 1987

Table 1: Estimated Absorbed Radiation Doses after Intravenous Administration of Sodium Fluoride F 18 Injection
Organ Estimated Radiation Dose mGy/MBq
70 kg [1]
15 year
56.8 kg [2]
10 year
33.2 kg [2]
5 year
19.8 kg [2]
1 year
9.7 kg [2]
Adrenals 0.0062 0.012 0.018 0.028 0.052
Brain 0.0056 N/A N/A N/A N/A
0.060 0.050 0.079 0.13 0.30
Breasts 0.0028 0.0061 0.0097 0.015 0.030
GI 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

Multiple-dose vial containing 370–7.400 MBq/mL (10–200 mCi/mL) at EOS reference time of no-carrier-added sodium fluoride F18 in aqueous 0.9% sodium chloride solution.  Sodium Fluoride F 18 Injection is a clear, colorless, sterile, pyrogen-free and preservative-free solution for intravenous administration.


As with any injectable drug product, allergic reactions and anaphylaxis may occur. Emergency resuscitation equipment and personnel should be immediately available.

Sodium Fluoride F 18 Injection may increase the risk of cancer. Carcinogenic and mutagenic studies with Sodium Fluoride F18 injection have not been performed. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker [see Dosage and Administration (2.1)].

No adverse reactions have been reported for Sodium Fluoride F 18 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems. However, the completeness of these sources is not known.

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

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 reproductive and developmental toxicity 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.

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.

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. Sodium Fluoride F18 was shown to localize to areas of bone turnover including rapidly growing epiphyses in developing long bones. Children are more sensitive to radiation and may be at higher risk of cancer from Sodium Fluoride F18 injection.

Sodium Fluoride F 18 Injection is a positron emitting radiopharmaceutical, containing no-carrier-added, radioactive fluoride F18 that is used for diagnostic purposes in conjunction with PET imaging. It is administered by intravenous injection. The active ingredient, sodium fluoride F18, has the molecular formula Na[F] with a molecular weight of 40.99, and has the following chemical structure:  Na+ F

Sodium Fluoride F 18 Injection is provided as a ready-to-use, isotonic, sterile, pyrogen-free, preservative-free, clear and colorless solution. Each mL of the solution contains between 370 MBq to 7,400 MBq (10 mCi to 200 mCi) sodium fluoride F18, at the EOS reference time, in 0.9% aqueous sodium chloride. The pH of the solution is between 4.5 and 8. The solution is presented in 30 mL multiple- dose glass vials with variable total volume and total radioactivity in each vial.

Fluoride F18 decays by positron (β+) emission and has a half-life of 109.7 minutes. Ninety-seven percent of the decay results in emission of a positron with a maximum energy of 633 keV and 3% of the decay results in electron capture with subsequent emission of characteristic X-rays of oxygen. The principal photons useful for diagnostic imaging are the 511 keV gamma photons, resulting from the interaction of the emitted positron with an electron (Table 2). Fluorine F18 atom decays to stable O-oxygen.

* Produced by positron annihilation

[3] Kocher, D.C. Radioactive Decay Data Tables DOE/TIC-11026, 69, 1981.

The specific gamma ray constant for fluoride F18 is 5.7 R/hr/mCi (1.35 x 10 Gy/hr/kBq) at 1 cm. The half-value layer (HVL) for the 511 keV photons is 4.1 mm lead (Pb). A range of values for the attenuation of radiation results from the interposition of various thickness of Pb. The range of attenuation coefficients for this radionuclide is shown in Table 3. For example, the interposition of an 8.3 mm thickness of Pb with a coefficient of attenuation of 0.25 will decrease the external radiation by 75%.


Table 4 lists the fraction of radioactivity remaining at selected time intervals from the calibration time. This information may be used to correct for physical decay of the radionuclide.

* Calibration time

Table 2: Principal Emission Data for Fluoride F18
Radiation/Emission % per Disintegration Mean Energy
Positron (β+) 96.73 249.8 keV
Gamma (±)* 193.46 511.0 keV
Table 3:Radiation Attenuation of 511 keV Photons by Lead (Pb) Shielding
Shield Thickness (Pb) mm Coefficient of Attenuation
0 0.00
4 0.50
8 0.25
13 0.10
26 0.01
39 0.001
52 0.0001
Table 4: Physical Decay Chart for Fluoride F18
Time Since Calibration Fraction Remaining
0* 1.00
15 minutes 0.909
30 minutes 0.826
60 minutes 0.683
110 minutes 0.500
220 minutes 0.250
440 minutes 0.060
12 hours 0.011
24 hours 0.0001

Fluoride F18 ion normally accumulates in the skeleton in an even fashion, with greater deposition in the axial skeleton (e.g. vertebrae and pelvis) than in the appendicular skeleton and greater deposition in the bones around joints than in the shafts of long bones.

Increased fluoride F18 ion deposition in bone can occur in areas of increased osteogenic activity during growth, infection, malignancy (primary or metastatic) following trauma, or inflammation of bone.

After intravenous administration, fluoride F18 ion is rapidly cleared from the plasma in a biexponential manner. The first phase has a half-life of 0.4 h, and the second phase has a half-life of 2.6 h. Essentially all the fluoride F18 that is delivered to bone by the blood is retained in the bone. One hour after administration of fluoride, F18 only about 10% of the injected dose remains in the blood. Fluoride F18 diffuses through capillaries into bone extracellular fluid space, where it becomes bound by chemisorption at the surface of bone crystals, preferentially at sites of newly mineralizing bone.

Deposition of fluoride F18 in bone appears to be primarily a function of blood flow to the bone and the efficiency of the bone in extracting the fluoride F18. Fluoride F18 does not appear to be bound to serum proteins.

In patients with normal renal function, 20% or more of the fluorine ion is cleared from the body in the urine within the first 2 hours after intravenous administration.

Studies to assess reproductive toxicity, mutagenesis and carcinogenesis potential of Sodium Fluoride F 18 Injection have not been performed. 

The doses used in reported studies ranged from 2.7 mCi to 20 mCi (100 MBq to 740 MBq), with an average median dose of 10 mCi (370 MBq) and an average mean dose of 9.2 mCi (340 MBq). In PET imaging of bone metastases with Sodium Fluoride F 18 Injection, focally increased tracer uptake is seen in both osteolytic and osteoblastic bone lesions. Negative PET imaging results with Sodium Fluoride F 18 Injection do not preclude the diagnosis of bone metastases. Also, as benign bone lesions are also detected by Sodium Fluoride F 18 Injection, positive PET imaging results cannot replace biopsy to confirm a diagnosis of cancer.

The doses used in reported studies ranged from 2.43 mCi to 15 mCi (90 MBq to 555 MBq), with an average median dose of 8.0 mCi (300 MBq) and an average mean dose of 7.6 mCi (280 MBq).

Sodium Fluoride F 18 Injection is supplied in a multiple-dose Type I glass vial with elastomeric stopper and aluminum crimp seal containing between 370 and 7,400 MBq/mL (10–200 mCi/mL) of no carrier-added sodium fluoride F18, at the EOS reference time, in aqueous 0.9% sodium chloride solution. The total volume and total radioactivity per vial are variable. Each vial is enclosed in a shielded container of appropriate thickness.

The product is available in a 30 mL vial configuration with a variable fill volume. The NDC number is: 40028-512-30 (30 mL)



Store at 25°C (77°F) in a shielded container; excursions permitted to 15–30°C (59–86°F). Use the solution within 12 hours of the EOS reference time.


Receipt, transfer, handling, possession, or use of this product is subject to the radioactive material regulations and licensing requirements of the U.S. Nuclear Regulatory Commission, Agreement States or Licensing States as appropriate.

Encourage patients to drink at least 500 mL of water prior to drug administration.

To help protect themselves and others in their environment, patients should take the following precautions for 12 hours after injection: whenever possible, use a toilet and flush several times after each use; wash hands thoroughly after each voiding or fecal elimination. If blood, urine or feces soil clothing, wash the clothing separately.

Manufactured for:       National Cancer InstituteDivision of Cancer Treatment and DiagnosisCancer Imaging ProgramBethesda, MD 20892

Manufactured by:       Siemens Molecular ImagingPETNET Solutions Inc.810 Innovation DriveKnoxville, TN 37932

Distributed by:      

Siemens Molecular ImagingPETNET Solutions Inc.810 Innovation DriveKnoxville, TN 37932


Sodium Fluoride 18 Injection

10 - 200 mCi/mL at End of Synthesis (EOS)

Diagnostic - For Intravenous Use Only

Sterile, Non-pyrogenic

NDC# 40028-512-30

30 mL Multiple-Dose Vial


Manufactured by PETNET Solutions, Inc, Knoxville, TN 37932


PETNET Solutions, Inc.

Active Ingredients


Drugs and Medications [439 Associated Drugs and Medications listed on BioPortfolio]

Topical fluoride foam bumble bee bubble gum [Laclede, Inc.]

Package.Label Principal Display Panel

Fluoride drops [Fluoritab Corporation]


Fluoride [Libertas Pharma, Inc.]

Fluoride Chewable Tablets 0.5 mg

Fluoride [Libertas Pharma, Inc.]

Fluoride Chewable Tablets 1 mg

Act anticavity kids icarly fluoride [Chattem, Inc.]

ACT Anticavity Fluoride Rinse Kids iCarly

Clinical Trials [1711 Associated Clinical Trials listed on BioPortfolio]

In Situ Caries Model of Fluoride Toothpastes

This study is to evaluate the effect of fluoride dentrifrices on enamel with artificial caries lesions in an in situ model

Study to Investigate the Stain Control of Two Stannous Fluoride Dentifrices

The purpose of this study is to evaluate and compare the stain build up of two stannous fluoride (SnF2) / sodium tripolyphosphate (STP) dentifrices of differing abrasivity levels, with a m...

Evaluation of Sodium Fluoride PET in the Identification of Bone Metastases in Patients Having Undergone a Choline PET for Occult Recurrence of Prostatic Adenocarcinoma

The purpose is to evaluate if sodium fluoride PET in patients having already undergone a choline PET negative for bone extension (non-metastatic status) modifies the status of patients con...

A Clinical Study to Evaluate a Stannous Fluoride Toothpaste for the Relief of Dentinal Hypersensitivity

The purpose of this study is to provide evidence of clinical efficacy of an experimental dentifrice containing stannous fluoride (SnF2) compared to regular fluoride dentifrice in the reduc...

A Six Month Clinical Study Based in the US to Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste and Its Effect on Opportunistic or Resistant Organisms

This study will compare the Gingival Bleeding and Gingival Inflammation following twice daily use of a sodium bicarbonate experimental dentifrice compared to a 0% sodium bicarbonate toothp...

PubMed Articles [1935 Associated PubMed Articles listed on BioPortfolio]

An exploratory study to investigate stain build-up with long term use of a stannous fluoride dentifrice.

To monitor extrinsic stain formation over 24 weeks with twice-daily use of an anhydrous 0.454% SnF2 dentifrice containing 5% sodium tripolyphosphate (STP) ('Test'), compared to a standard fluoride den...

Arrest of Root Carious Lesions via Sodium Fluoride, Chlorhexidine and Silver Diamine Fluoride In Vitro.

To compare the root carious lesion arrest of chlorhexidine (CHX) and silver diamine fluoride (SDF) varnishes and/or sodium fluoride rinses (NaF) in vitro.

Functioning of nitric oxide cycle in gastric mucosa of rats under excessive combined intake of sodium nitrate and fluoride.

In the article the function of nitric oxide (·NO) cycle in rat’s gastric mucosa was assessed under excessive combined chronic fluoride and nitrate intake during 30 days. It was estimated that gener...

Possible protective effect of curcumin on the thyroid gland changes induced by sodium fluoride in albino rats: light and electron microscopic study.

Thyroid gland regulates the body's metabolic rate and plays an exquisitely important role in the human health. Fluoride exposure can affect thyroid function. Curcumin is a potent antioxidant that work...

A Randomized Clinical Trial to Measure the Erosion Protection Benefits of a Novel Stabilized Stannous Fluoride Dentifrice versus a Control Dentifrice.

The aim of this investigation was to assess the erosion protection ability of a novel stabilized stannous fluoride (SnF2) dentifrice and a control sodium fluoride dentifrice (NaF) using a well-credent...

Quick Search


Relevant Topics

Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Osteoporosis is a disease in which the bones become extremely porous, are subject to fracture, and heal slowly, occurring especially in women following menopause and often leading to curvature of the spine from vertebral collapse. Follow and track&n...

Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...

Drugs and Medication Quicklinks

Searches Linking to this Drug Record