lutetium lu 177 dotatate - Generic Medications

Browse 1 brand name versions of lutetium lu 177 dotatate. Review brand names, dosage forms, strengths, and linked product records.

Lutathera LUTETIUM LU 177 DOTATATE
ADVANCED ACCELERATOR APPLICATIONS USA, INC FDA Rx Only

Lutetium Lu 177 dotatate is a radiolabeled somatostatin analog. The drug substance lutetium Lu 177 dotatate is a cyclic peptide linked with the covalently bound chelator 1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid to a radionuclide. Lutetium Lu 177 dotatate is described as lutetium (Lu 177)-N-[(4,7,10-Tricarboxymethyl-1,4,7,10-tetraazacyclododec-1-yl) acetyl]-D-phenylalanyl-L-cysteinyl-L-tyrosyl-D-tryptophanyl-L-lysyl-L-threoninyl-L-cysteinyl-L-threonine-cyclic (2-7) disulfide. The molecular weight is 1609.6 Daltons and the structural formula is as follows: LUTATHERA (lutetium Lu 177 dotatate) 370 MBq/mL (10 mCi/mL) Injection is a sterile, clear, colorless to slightly yellow solution for intravenous use. Each single-dose vial contains acetic acid (0.48 mg/mL), sodium acetate (0.66 mg/mL), gentisic acid (0.63 mg/mL), sodium hydroxide (0.64 mg/mL), ascorbic acid (2.8 mg/mL), diethylene triamine pentaacetic acid (0.05 mg/mL), sodium chloride (6.85 mg/mL), and Water for Injection (ad 1 mL). The pH range of the solution is 4.5 to 6. Lutetium Lu 177 dotatate structural formula 11.1 Physical Characteristics Lutetium-177 decays to stable hafnium-177 with a half-life of 6.647 days, by emitting beta-minus radiation with a maximum energy of 0.498 MeV (79%) and photonic radiation (γ) of 0.208 MeV (11%) and 0.113 MeV (6.2%). The main radiations of lutetium-177 are detailed in Table 7. Table 7. Lutetium-177 Main Radiations Radiation Energy (keV) Iβ - % Iγ% β - 176.5 12.2 β - 248.1 0.05 β - 384.9 9.1 β - 497.8 78.6 γ 71.6 0.15 γ 112.9 6.20 γ 136.7 0.05 γ 208.4 11.0 γ 249.7 0.21 γ 321.3 0.22 11.2 External Radiation Table 8 summarizes the radioactive decay properties of lutetium-177. Table 8. Physical Decay Chart: Lutetium-177 Physical Half-Life = 6.647 Days Hours Fraction remaining Hours Fraction remaining 0 1.000 48 (2 days) 0.812 1 0.996 72 (3 days) 0.731 2 0.991 168 (7 days) 0.482 5 0.979 336 (14 days) 0.232 10 0.958 720 (30 days) 0.044 24 (1 day) 0.901 1080 (45 days) 0.009

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