Sodium Fluoride F 18 Drug Information

Generic name: SODIUM FLUORIDE F 18

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Uses of Sodium Fluoride F 18

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

Dosage & Administration of Sodium Fluoride F 18

OrganEstimated Radiation Dose mGy/MBq
Adult 70 kg [1]15 year 56.8 kg [2]
Adrenals0.0062
Brain0.0056
Bone surfaces0.060
Breasts0.0028
GIGallbladder wall
Stomach wall0.0038
Small intestine0.0066
Upper large intestine wall0.0058
Lower large intestine wall0.012
Heart wall0.0039
Kidneys0.019
Liver0.0040
Lungs0.0041
Muscle0.0060
Ovaries0.011
Pancreas0.0048
Red marrow0.028
Skin0.0040
Spleen0.0042
Testes0.0078
Thymus0.0035
Thyroid0.0044
Urinary bladder wall0.25
Uterus0.019
Other tissueN/A
Effective Dose Equivalent mSv/MBq0.027

Side Effects of Sodium Fluoride F 18

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. 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.

To report SUSPECTED ADVERSE REACTIONS, contact The University of Utah DBA Cyclotron Radiochemistry Lab Hunstman Cancer Institute at 1-801-581-8745 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Warnings & Cautions for Sodium Fluoride F 18

Allergic Reactions As with any injectable drug product, allergic reactions and anaphylaxis

may occur. Emergency resuscitation equipment and personnel should be immediately available.

Radiation Risks 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 .

Drug Interactions with Sodium Fluoride F 18

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

Pregnancy Safety for Sodium Fluoride F 18

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 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.

Pediatric Use of Sodium Fluoride F 18

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.

Clinical Studies of Sodium Fluoride F 18

Metastatic Bone Disease

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.

Other Bone Disorders

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).

Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.

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