Efficacy analyses were based upon comparisons of the number and proportion of resected lymph nodes that contained a lymph node tracer (Lymphoseek and/or blue dye) or neither tracer. eva luable lymph nodes were resected from 138 Study One patients and 150 Study Two patients who received Lymphoseek at the dose of 0.5 mCi in 50 mcg administered 15 minutes to 15 hours prior to surgery. Table 9 shows the distribution of resected lymph nodes by the presence or absence of a tracer. Most of the resected lymph nodes were identified by either Lymphoseek (LS) or blue dye (BD) or both.
Table 9. Resected Lymph Nodes and Content of Lymphoseek (LS) and/or Blue Dye (BD)  M = melanoma; B = breast cancer; The percents may not add to 100% due to rounding.
95% Confidence Intervals are based on Exact Binomial and represent the spread in the individual estimates.
Study Tumor Nodesn BD Present%(95% CI) LS Present%(95% CI) Only BDPresent%(95% CI) Only LSPresent%(95% CI) Neither BDnor LSPresent%(95% CI)
One M 155 64%

(56% , 71%)
 94%

(89% , 97%)
 1%

(0 , 4%)
 30%

(23% , 38%)
 6%

(3% , 11%)
 
B 154 70%

(62% , 77%)
 95%

(90% , 98%)
 5%

(2% , 9%)
 29%

(22% , 37%)
 1%

(0 , 4%)
 
Two M 196 59%

(51% , 66%)
 100%

(98% , 100%)
 0

(0 , 2%)
 41%

(34% , 49%)
 0

(0 , 2%)
 
B 180 62%

(55% , 69%)
 100%

(98% , 100%)
 0

(0 , 2%)
 38%

(31% , 45%)
 0

(0
M = melanoma; B = breast cancer; The percents may not add to 100% due to rounding.
95% Confidence Intervals are based on Exact Binomial and represent the spread in the individual estimates.
Among all patients in both studies, Lymphoseek localized an average of 2.4 lymph nodes per patient (range 1 to 11) when the mapping procedure was performed 15 minutes to 15 hours following injection of the drug.

16 HOW SUPPLIED/STORAGE AND HANDLING The Kit for the Preparation of Lymphoseek (technetium Tc 99m tilmanocept) Injection

includes:

◦Five vials of Tilmanocept Powder, 250 mcg NDC 52579-1695-1
◦Five vials of DILUENT for Lymphoseek NDC 52579-1649-1
◦Prescribing information
◦Five labels for shields
◦Twenty-five labels for product vials and individual syringes
Storage

Store Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) Injection in the original packaging at USP controlled room temperature 20o C -- 25o C (68o F -- 77o F), excursions permitted to 15°C to 30°C (59°F to 86°F). Store reconstituted Lymphoseek in radiation shielding at room temperature.

Use reconstituted Lymphoseek within 6 hours of its preparation.

Handling

This Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) Injection is approved for distribution to persons licensed by the U.S. Nuclear Regulatory Commission to use byproduct material identified in 10 CFR 35.200 or under an equivalent license issued by an Agreement State.
17 PATIENT COUNSELING INFORMATION Instruct patients to inform their physician or healthcare provider if they:

◦are pregnant or breast feeding, or
◦have had prior reactions to dextran, dextran containing compounds, or tilmanocept, or
◦are sensitive to a technetium-containing contrast