Dosing & Administration
Radiation Safety—Drug Handling
- Lymphoseek® is a radioactive drug and should be prepared and handled with appropriate safety measures, including effective gloves and shielding, to minimize radiation exposure. Radiopharmaceuticals should be used by or under the control of physicians who are qualified, experienced and licensed by the appropriate governmental agency in the safe use of radionuclides.
Preparation of Lymphoseek
- For each patient, the total injection volume and the number of sites to be injected should be known before preparing Lymphoseek.
- Each radiolabeled Lymphoseek vial contains sufficient amount to provide doses for up to four patients when prepared according to the instructions. The radiolabeled Lymphoseek is to be used within 6 hours of its preparation.
- In animal studies, locally injected anesthetics have been reported to reduce lymphatic flow. Co-injection (mixture) of local anesthetics with Lymphoseek is not recommended and may impair the lymph nodal mapping.
Recommended Dose of Lymphoseek
- 18.5 MBq (0.5 mCi) radioactivity dose
- 50 mcg mass dose
Recommended Total Injection Volume
- 0.1 mL in 1 syringe
- 0.5 mL in 1 syringe or multiple syringes (0.1 or 0.25 mL each)
- 1 mL in multiple syringes (0.2, 0.25 or 0.5 mL each)
Recommended Injection Routes
- Recommended administration routes are subcutaneous, intradermal, subareolar, or peritumoral
Recommended Time from Administration to Lymphatic Mapping
- From 15 minutes up to 15 hours post-injection
Educational and technical support for the use of Lymphoseek is available through the Navidea Medical Science Liaison (MSL) and Medical Affairs teams.
Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:
- 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.
In clinical trials with Lymphoseek, no serious hypersensitivity reactions were reported, however Lymphoseek may pose a risk of such reactions due to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs).
Prior to the administration of Lymphoseek, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified forms of dextran. Resuscitation equipment and trained personnel should be available at the time of Lymphoseek administration, and patients observed for signs or symptoms of hypersensitivity following injection.
Any radiation-emitting product may increase the risk for cancer. Adhere to dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to patients or health care workers.
In clinical trials, no patients experienced serious adverse reactions and the most common adverse reactions were injection site irritation and/or pain (<1%).
Please see full Prescribing Information.
To report suspected adverse reactions, contact Navidea Biopharmaceuticals, Inc. at 1-800-476-5270 or FDA at 1 800-FDA-1088 or www.fda.gov/medwatch.