es to lymph node localization by a radiopharmaceutical or other tracers, including colorimetric agents. Avoid injections into biopsy wound areas that show evidence of edema or inflammation.
2.6 Radiation Dosimetry
The radiation doses to organs and tissues of an average patient (70 kg) per 18.5 MBq (0.5 mCi) of Lymphoseek are shown in Table 4 and Table 5.
Table 4. Estimated Absorbed Radiation Dose from 50 mcg Lymphoseek in Patients with Breast Cancera a Calculated from data of 18 patients with breast cancer who received four peritumoral injections of 4 mcg, 20 mcg, and 100 mcg doses of Lymphoseek.
Estimated Radiation Absorbed Dose for Breast Cancer, mGy (rad)
Target Organ 18.5 MBq (0.5 mCi) Tc 99m Dose for Lymphoseek
brain 0.003 (0.0003)
breast (injection site) 1.659 (0.1659)
gall bladder wall 0.0349 (0.0035)
lower large intestine wall 0.0123 (0.0012)
small intestine 0.0101 (0.001)
stomach 0.0184 (0.0018)
upper large intestine wall 0.0125 (0.0012)
kidney 0.1863 (0.0186)
liver 0.0324 (0.0032)
lungs 0.0374 (0.0037)
muscle 0.0092 (0.0009)
ovaries 0.187 (0.0187)
red marrow 0.0127 (0.0013)
bone 0.0177 (0.0018)
spleen 0.0285 (0.0029)
testes 0.0501 (0.005)
thymus 0.1168 (0.0117)
thyroid 0.088 (0.0088)
urinary bladder 0.0586 (0.0059)
total body 0.0195 (0.0019)
Effective Dose Equivalent (males, microSv) 296
Effective Dose Equivalent (females, microSv) 330.2
Table 5. Estimated Absorbed Radiation Dose from 50 mcg Lymphoseek in Patients with Melanomaa a Calculated from data of 18 patients with breast cancer who received four peritumoral injections of 4 mcg, 20 mcg, and 100 mcg doses of Lymphoseek.
b Due to the differences in injection sites among patients with melanoma, the injection site was assumed to be the breast for the purposes of this calculation, as it represents the nearest anatomical construct for the skin from the anatomical sites appropriately included in the estimates.
Estimated Radiation Absorbed Dose for Melanoma, mGy (rad)
Target Organ 18.5 MBq (0.5 mCi) Tc 99m Dose for Lymphoseek
brain 0.0927 (0.0093)
breast (injection site)b 0.7903 (0.079)
gall bladder wall 0.0712 (0.0071)
lower large intestine wall 0.057 (0.0057)
small intestine 0.0594 (0.0059)
stomach 0.0562 (0.0056)
upper large intestine wall 0.0582 (0.0058)
kidney 0.278 (0.0278)
liver 0.0929 (0.0093)
lungs 0.0599 (0.006)
muscle 0.0451 (0.0045)
ovaries 0.2991 (0.0299)
red marrow 0.0507 (0.0051)
bone 0.0878 (0.0088)
spleen 0.0598 (0.006)
testes 0.1043 (0.0104)
thymus 0.0577 (0.0058)
thyroid 0.0464 (0.0046)
urinary bladder 0.1401 (0.014)
total body 0.0547 (0.0055)
Effective Dose Equivalent (males, microSv) 202.4
Effective Dose Equivalent (females, microSv) 251.1
b Due to the differences in injection sites among patients with melanoma, the injection site was assumed to be the breast for the purposes of this calculation, as it represents the nearest anatomical construct for the skin from the anatomical sites appropriately included in the estimates.
The Effective Dose Equivalents for other technetium Tc 99m-based eva luations are: 1) bone scan = 4,000 microSv; 2) thyroid scan = 1,000 microSv; and 3) lung scan = 1,000 microSv.
3 DOSAGE FORMS AND STRENGTHS The Kit for preparation of Lymphoseek contains five Tilmanocept Powder vials each containing 250 mcg tilmanocept and five DILUENT for Lymphoseek v
