LYMPHOSEEK KIT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for LYMPHOSEEK KIT (LYMPHOSEEK KIT).
Technetium Tc-99m tilmanocept is a receptor-targeted radiopharmaceutical that binds to the mannose-binding protein (CD206) expressed on macrophages and dendritic cells within lymph nodes. It is used for lymphatic mapping and sentinel lymph node detection.
| Metabolism | Technetium Tc-99m tilmanocept is not metabolized; it is cleared from the injection site via the lymphatic system and excreted renally. |
| Excretion | Renal: 100% (as technetium-99m pertechnetate). No biliary or fecal elimination. |
| Half-life | 6 hours (physical half-life of technetium-99m). Effective half-life is approximately 6 hours, allowing imaging up to 24 hours post-injection. |
| Protein binding | Negligible (<5%), primarily to albumin. |
| Volume of Distribution | Approximately 0.2 L/kg, indicating distribution within extracellular fluid. |
| Bioavailability | Not applicable (administered parenterally). |
| Onset of Action | Subcutaneous injection: 15-30 minutes for sentinel lymph node visualization. |
| Duration of Action | Up to 24 hours for imaging; optimal imaging within 1-6 hours post-injection. |
Pre-dose: 20 mcg (0.5 mL) intradermally followed by 0.5 mL subcutaneously of the same dose 15-30 minutes later. Imaging: After 24 hours, 2 mL (20 mcg) subcutaneously.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required based on GFR, but ensure adequate hydration. |
| Liver impairment | No specific guidelines available; use with caution in severe hepatic impairment. |
| Pediatric use | Not established; safety and efficacy in pediatric patients have not been studied. |
| Geriatric use | No specific dosage adjustment; monitor for adverse effects as elderly may have reduced immune response. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for LYMPHOSEEK KIT (LYMPHOSEEK KIT).
| Breastfeeding | It is unknown whether tilmanocept is excreted in human milk. Because of the low dose and local administration, systemic exposure is minimal. However, to minimize radiation exposure to the nursing infant, temporary cessation of breastfeeding for 4-6 hours after administration is recommended. M/P ratio not available. |
| Teratogenic Risk | Lymphoseek is not systemically absorbed; the radiolabeled tracer (technetium Tc 99m tilmanocept) is administered subcutaneously. No fetal radiation exposure occurs at recommended doses. However, if administered intravenously, radiation exposure to the fetus could occur. No teratogenic effects are expected from the non-radioactive component (tilmanocept). Pregnancy category not assigned by FDA for diagnostic radiopharmaceuticals. Use only if clearly needed. |
■ FDA Black Box Warning
This drug does not have a black box warning.
| Serious Effects |
["Known hypersensitivity to tilmanocept or any component of the formulation."]
| Precautions | ["Risk of hypersensitivity reactions including anaphylaxis.","Not for intrathecal administration.","Radiation exposure risk."] |
Loading safety data…
| Fetal Monitoring | No specific fetal monitoring required. Standard precautions for radiopharmaceuticals apply. Verify pregnancy status before administration. |
| Fertility Effects | No studies on fertility have been conducted. No expected effect on fertility due to minimal systemic absorption and low dose of tilmanocept. |