Chemical formula: C₁₄H₁₁FN₂OS Molecular mass: 273.32 g/mol PubChem compound: 15950376
There are no available data on flutemetamol F 18 use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. All radiopharmaceuticals, including flutemetamol F 18, have the potential to cause fetal harm depending on the stage of fetal development, and the magnitude of the radiopharmaceutical dose. If considering flutemetamol F 18 administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from flutemetamol F 18 and the gestational timing of exposure.
The estimated background risk of major birth defects and miscarriage for the indicated population(s) 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.
There are no data on the presence of Flutemetamol (F 18) or metabolites in human milk or its effects on the breastfed infant or milk production. Exposure of flutemetamol F 18 to a breastfed infant can be minimized by temporary discontinuation of breastfeeding. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for flutemetamol F 18 and any potential adverse effects on the breastfed child from flutemetamol F 18 or from the underlying maternal condition.
To decrease radiation exposure to the breastfed infant, advise a lactating woman to interrupt breastfeeding, and pump and discard breast milk for 24 hours after administration of flutemetamol F 18.
Animal studies have not been performed to evaluate the carcinogenicity potential of flutemetamol. Flutemetamol was positive for mutagenicity in two in vitro assays: the bacterial reverse mutation assay (Ames test) and the mouse lymphoma assay.
Flutemetamol was negative for genotoxicity after in vivo exposure in rats to flutemetamol at the highest cumulative dose level tested, as measured in bone marrow micronucleus assays (157 and 27 microgram/kg/day for 2 and 14 days respectively) and an unscheduled DNA synthesis assay in rat hepatocytes (39 microgram/kg/day).
Clinical trials are conducted under widely varying conditions and adverse reaction rates observed in the clinical trials of flutemetamol F 18 cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In clinical trials, 761 adults (367 men and 394 women, 91% Caucasian) with a mean age of 62 years (range 18-93 years) received flutemetamol F 18. Most subjects (530, 70%) received a dose of 185 MBq (5 mCi).
One subject out of 761 administered flutemetamol F 18 experienced a serious hypersensitivity reaction with flushing, dyspnea and chest pressure within minutes following flutemetamol F 18 administration and recovered with treatment.
Most adverse reactions were mild to moderate in intensity and resolved spontaneously. The most commonly reported adverse reactions (occurring in at least 1% of subjects) in flutemetamol F 18-treated subjects are shown in the following table.
Adverse Reactions Reported in Clinical Trials of Flutemetamol F 18 (N=761 subjects):
| Adverse Reaction | N (percent of patients) |
|---|---|
| Flushing | 16 (2%) |
| Increased blood pressure | 13 (2%) |
| Headache | 10 (1%) |
| Nausea | 8 (1%) |
| Dizziness | 8 (1%) |
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