Flutemetamol f-18
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From MedlinePlus, U.S. National Library of Medicine
Radioactive Diagnostic Agent
Dosing in kidney impairment
| Organ/Tissue | Absorbed Dose Per Unit Administered Activity (microGy/MBq) |
|---|---|
| Adrenals | 13 |
| Brain | 11 |
| Breasts | 5 |
| Gallbladder wall | 287 |
| Heart wall | 14 |
| Kidneys | 31 |
| Liver | 57 |
| Lower large intestine wall | 42 |
| Lungs | 16 |
| Muscle | 9 |
| Osteogenic cells | 11 |
| Ovaries | 25 |
| Pancreas | 15 |
| Red marrow | 13 |
| Skin | 5 |
| Small intestine wall | 102 |
| Spleen | 15 |
| Stomach wall | 12 |
| Testes | 8 |
| Thymus | 6 |
| Thyroid | 6 |
| Upper large intestine wall | 117 |
| Urinary bladder wall | 145 |
| Uterus | 25 |
| Total body | 12 |
| Effective Dose | 32 (microSv/MBq) |
Preparation and administration
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Recommended Dosage and Administration Instructions Recommended Dosage The recommended amount of activity of VIZAMYL is 185 MBq (5 mCi) in a total volume of up to 10 mL, administered as a single intravenous bolus within 40 seconds. The maximum mass dose is 20 mcg. Follow the injection with an intravenous flush of 5 mL to 15 mL of 0.9% sodium chloride injection.
Patient Preparation Instruct patients to hydrate before and after VIZAMYL administration and to void frequently following VIZAMYL administration to reduce radiation exposure [see Warnings and Precautions ] . Administration Use aseptic technique and radiation shielding to withdraw and administer VIZAMYL. Visually inspect VIZAMYL for particulate matter and discoloration prior to administration.
Do not use VIZAMYL if it contains particulate matter or if it is discolored. Do not dilute VIZAMYL. Calculate the necessary volume to administer based on calibration time and required dose. Measure the activity of VIZAMYL with a dose calibrator immediately prior to administration to the patient. Dispose of unused product in a safe manner in compliance with applicable regulations.
Contraindications
4 CONTRAINDICATIONS VIZAMYL is contraindicated in patients with a history of hypersensitivity reaction to VIZAMYL or polysorbate 80 [see Warnings and Precautions (5.1) ] . Known hypersensitivity to VIZAMYL or polysorbate 80 ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for flutemetamol f-18. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on VIZAMYL use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with flutemetamol F 18 to evaluate its effect on female reproduction and embryo-fetal development. All radiopharmaceuticals, including VIZAMYL, have the potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiation dose.
If considering VIZAMYL administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Breastfeeding (LactMed)
Information in this record refers to the use of flutemetamol F 18 as a diagnostic agent. No information is available on the use of flutemetamol F 18 during breastfeeding. The manufacturer recommends withholding breastfeeding for 24 hours after a diagnostic dose of 185 MBq (5 mCi). This length of time 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. When the radioactivity is at a safe level she may resume breastfeeding.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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