KIT FOR THE PREPARATION OF LYMPHOSEEK (TECHNETIUM TC 99M TILMANOCEPT)- tilmanocept
Navidea Biopharmaceuticals, Inc.
1 INDICATIONS AND USAGELymphoseek (technetium Tc 99m tilmanocept) Injection is indicated for lymphatic mapping with a hand-held gamma counter to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma.

2 DOSAGE AND ADMINISTRATION2.1 Radiation Safety – Drug HandlingLymphoseek is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure. [see Warnings and Precautions (5.2)] Use waterproof gloves, effective radiation shielding, and appropriate safety measures when preparing and handling Lymphoseek.

Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides.

2.2 Recommended Dose
The recommended dose of Lymphoseek is 18.5 MBq (0.5 mCi) as a radioactivity dose and 50 mcg as a mass dose, administered at least 15 minutes prior to initiating intraoperative lymphatic mapping. The recommended total injection volume for each patient (Table 1) is 0.1 mL administered in a single syringe; 0.5 mL administered in a single syringe or in multiple syringes (0.1 mL to 0.25 mL each); or 1 mL administered in multiple syringes (0.2 mL to 0.5 mL each).

2.3 Drug Preparation and Administration General Considerations:

◦Kit for the preparation of Lymphoseek contains five sets of two vials: a Tilmanocept Powder vial and a DILUENT for Lymphoseek vial.
◦Tilmanocept Powder vial contains 250 mcg of tilmanocept from which 50 mcg is intended for administration to a patient.
◦The DILUENT for Lymphoseek vial contains 4.5 mL of sterile buffered saline. It is used to dilute Lymphoseek after the radiolabeling procedure. The amount of diluent used varies, depending on the total injection volume and the number of syringes used for each patient.
◦The vial components of the Kit for the preparation of Lymphoseek are sterile, non-pyrogenic, and are intended solely for use in the preparation of Lymphoseek (technetium Tc 99m tilmanocept) Injection. Do not administer the unprepared vial components of the Kit directly to a patient.
◦Follow aseptic procedures during preparation and administration.
◦Follow appropriate radiation safety precautions during preparation and administration. Use radiation shielding for radiolabeled Lymphoseek to prevent radiation exposure.
Drug Preparation Instructions:

Lymphoseek may be administered to a patient as a single injection or as multiple injections. Prior to preparation of Lymphoseek, determine the planned injection technique and the number of injections that will be used for a given patient. For each injection prepare a separate syringe. Based on the planned number of injection syringes and the planned total injection volume per patient, determine (from Table 1 below) the Reconstituted Vial Volume of radiolabeled Lymphoseek.

Table 1. Preparation of Lymphoseek for Administration  Planned Number of Injections for a Patient Total Injection Volume Per Patient Reconstituted Vial Volume of Radiolabeled Lymphoseek
1 syringe x 0.1 mL 0.1 mL 0.5 mL
5 syringes x 0.1 mL or
2 s