Tilmanocept Dosage

Applies to the following strengths: 250 mcg

Usual Adult Dose for Diagnostic

50 mcg as a mass dose and 18.5 MBq (0.5 mCi) as a radioactivity dose

Comments:

Administer 15 minutes prior to initiating intraoperative lymphatic mapping
The route of administration depends on the tumor location: Subcutaneous, intradermal, subareolar, or peritumoral injection

Uses:

Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.
Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.

Data not available

Data not available

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Data not available

Administration advice:

The recommended total injection volume is 0.1 mL administered in a single syringe, 0.5 mL administered in a single syringe or in multiple syringes (0.1 to 0.25 mL each), or 1 mL administered in multiple syringes (0.2 to 0.5 mL each).
For breast cancer, administer via the intradermal, subcutaneous, subareolar, or peritumoral routes.
For melanoma, administer via the intradermal or subcutaneous routes.

Storage requirements:

Store the preparation kit in the original packaging at controlled room temperature 20C to 25C (68F to 77F).
Store reconstituted tilmanocept in radiation shielding at room temperature and use within 6 hours of preparation.

Reconstitution/preparation techniques:

For information about the preparation, see the manufacturer's product information.
Use waterproof gloves, effective radiation shielding, and appropriate safety measures when preparing and handling.

General:

The preparation kit is approved for distribution to those licensed by the U.S. Nuclear Regulatory Commission to use byproduct material identified in 10 Code of Federal Regulation (CFR) 35.200 or an equivalent license.

Patient advice: