LYMPHOSEEK® (technetium Tc 99m tilmanocept) injection 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.
Important safety information
Warnings and Precautions
- LYMPHOSEEK® may pose a risk of hypersensitivity 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). No serious hypersensitivity reactions were reported in clinical trials with LYMPHOSEEK®.
- Before administering LYMPHOSEEK®, ask patients about prior hypersensitivity reactions to drugs, especially to dextran and modified forms of dextran. Have resuscitation equipment and trained personnel immediately available at the time of LYMPHOSEEK® administration.
- LYMPHOSEEK® is a radioactive drug and should be handled by or under the control of qualified and licensed physicians with appropriate safety measures to help minimize radiation exposure.
- Any radiation-emitting product may increase the risk for cancer, especially in pediatric patients. Adhere to the dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to either patients or health care workers.
- The most common adverse reactions are injection site irritation and injection site pain (<1%).
- There were no serious adverse reactions seen in clinical trials.
Use in Specific Populations
- No data are available on LYMPHOSEEK® use in pregnant women. If considering LYMPHOSEEK® administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure.
- No data are available regarding the presence of technetium Tc 99m tilmanocept in human milk, the effects of the drug on the breastfed child, or the effects of the drug on milk production. The benefits of breastfeeding should be considered along with the mother’s clinical need for LYMPHOSEEK® and any potential adverse effects on the breastfed child. If considering LYMPHOSEEK® administration to a lactating woman, advise to pump and discard breast milk for 24 hours after injection to decrease radiation exposure to the breastfed infant.
- Safety and effectiveness of LYMPHOSEEK® in patients less than 18 years of age have not been established.
- In clinical studies, no differences in safety or efficacy have been identified between elderly patients (65 to 90 years of age) and younger patients (18 to 65 years of age).
Please see full Prescribing Information.
To report suspected adverse reactions, contact Cardinal Health at 1.800.618.2768 or FDA at 1.800.FDA.1088 or www.fda.gov/medwatch.