LYMPHOSEEK KIT
Clinical safety rating
cautionComprehensive 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. |
| Molecular Weight | 537.6 |
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 | Limited data; radioactive iodine (I-123) exposure may cause fetal thyroid ablation. Use only if clearly needed. |
| 2nd trimester | Fetal thyroid begins concentrating iodine at 10-12 weeks; radioactive iodine can cause fetal hypothyroidism. Use with caution. |
| 3rd trimester | Radioactive iodine crosses placenta and may accumulate in fetal thyroid. Avoid unless benefit outweighs risk. |
Clinical note
Comprehensive clinical and safety monograph for LYMPHOSEEK KIT (LYMPHOSEEK KIT).
| Placental transfer | Crosses placenta; fetal thyroid uptake of I-123 occurs after 10-12 weeks gestation. |
| Breastfeeding | Two weeks of interrupted breastfeeding or formula feeding recommended due to radioactive iodine excretion in breast milk. |
| Lactation Rating | L4 (Hazardous) |
| 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. |
| 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. |
■ FDA Black Box Warning
This drug does not have a black box warning.
| Serious Effects |
Hypersensitivity to tilmanocept or any componentPregnancy (relative)
| Precautions | Risk of hypersensitivity reactions including anaphylaxis., Not for intrathecal administration., Radiation exposure risk. |
| Food/Dietary | No known food interactions. No dietary restrictions required. |
| Clinical Pearls | Lymphoseek (technetium Tc 99m tilmanocept) is a receptor-targeted radiotracer for sentinel lymph node mapping. Administer intradermally, subcutaneously, or peritumorally. Optimal imaging time: 15-60 min post-injection. Can be used in patients with penicillin allergy as it contains no penicillin. Ensure patient is not pregnant or lactating. May cause injection site reactions. |
| Patient Advice | This is a radioactive dye used to find lymph nodes during surgery. · You will receive a small injection near the tumor site. · The procedure is generally safe, but inform your doctor if you are pregnant or breastfeeding. · You may experience mild pain, redness, or swelling at the injection site. · No special dietary restrictions are needed before the procedure. |
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