8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary
POSLUMA is not indicated for use in females. There are no available data on the use of POSLUMA 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 flotufolastat F 18. Radioactive drugs, including POSLUMA, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. 8.2 Lactation Risk Summary POSLUMA is not indicated for use in females. There are no data on the presence of flotufolastat F 18 in human milk, the effect on the breastfed infant, or the effect on milk production. 8.4 Pediatric Use The safety and effectiveness of POSLUMA have not been established in pediatric patients. 8.5 Geriatric Use Among the total number of patients receiving POSLUMA in clinical studies of prostate cancer, 463 ( 62%) were 65 years of age and older, while 118 (16 %) were 75 years of age and older [see Clinical Studies (14.1,14.2)] . No overall differences in safety or effectiveness were observed between these patients and younger adult patients. 10 OVERDOSAGE In the event of an overdose of POSLUMA, maintain hydration of the patient and frequent voiding to minimize radiation exposure. A diuretic might also be considered. If possible, an estimate of the radiation effective dose administered to the patient should be made. Chemical Characteristics POSLUMA (flotufolastat F 18) injection is a radioactive diagnostic agent for intravenous use. The active ingredient of POSLUMA is flotufolastat F 18 gallium, of which the molecular structure includes a DOTAGA complex with nonradioactive gallium. Radioactive fluorine-18 is covalently bound to silicon. Chemically, flotufolastat F 18 gallium is gallate(6-), [(4 S ,8 S ,13 R ,27 R ,30 R ,35 S )-35-[4,10-bis[(carboxy- k O )methyl]-7-(carboxymethyl)-1,4,7,10-tetraazacyclododec-1-yl-k N 1 ,k N 4 ,k N 7 ,k N 10 ]-30-[[[4-[bis(1,1- dimethylethyl)fluoro- 18 F -silyl]benzoyl]amino]methyl]-1,36-dihydroxy-1,6,11,18,21,29,32,36-octaoxo- 5,7,12,17,22,28,31-heptaazahexatriacontane-4,8,13,27-tetracarboxylato(9-)]-, hydrogen (1:6). The molecular weight is 1537.3 g/mol and the structural formula is: 11 DESCRIPTION 11.1
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Reference ID: 5180081
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