Version May 2024
Note: The route of administration, number of injections, and total injection volume per patient will vary depending on cancer and planned injection technique.
Breast cancer lymphatic mapping: Intradermal, SUBQ, subareolar, or peritumoral: 18.5 MBq (0.5 mCi) as radioactivity dose and 50 mcg as a mass dose at least 15 minutes prior to intraoperative lymphatic mapping.
Melanoma lymphatic mapping: Intradermal or SUBQ: 18.5 MBq (0.5 mCi) as radioactivity dose and 50 mcg as a mass dose at least 15 minutes prior to intraoperative lymphatic mapping.
Oral cavity squamous cell carcinoma sentinel lymph node biopsy: Peritumoral: 18.5 MBq (0.5 mCi) as radioactivity dose and 50 mcg as a mass dose at least 15 minutes prior to intraoperative sentinel node biopsy.
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.
Refer to adult dosing.
(For additional information see "Technetium Tc-99m tilmanocept: Pediatric drug information")
Note: The route of administration, number of injections, and total injection volume per patient will vary depending on cancer and planned injection technique.
Lymphatic mapping, primary solid tumor: Infants, Children, and Adolescents: Intradermal, SUBQ, or peritumoral: 18.5 MBq (0.5 mCi) as radioactivity dose and 50 mcg as a mass dose at least 15 minutes prior to intraoperative lymphatic mapping.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
<1%: Irritation at injection site, pain at injection site
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Hypersensitivity: Hypersensitivity reactions with technetium Tc 99m tilmanocept may be possible (due to a chemical similarity to dextran), although no serious cases of hypersensitivity were reported in clinical trials. Medications and equipment for management of hypersensitivity should be available during administration.
• Malignancy: Radiating-emitting products may increase the risk for cancer, particularly in children.
Special handling:
• Radiopharmaceutical: Use appropriate precautions for handling, disposal, and minimizing exposure to patients and healthcare personnel. Use only under supervision of individuals with experience/training in the handling of radioactive materials approved by the applicable regulatory authority.
Other warnings/precautions:
• Appropriate use: Intended to supplement palpation, visual inspection, and other traditional lymph node localization procedures. Lymphatic drainage and function may be altered by prior surgery, radiation, edema, inflammation, or metastatic disease. Alterations in the lymphatic system may result in changes to node localization. Avoid injections into biopsy wound areas with evidence of edema or inflammation.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Kit, Injection:
Lymphoseek: Tilmanocept 250 mcg [vial contents to be combined with Technetium Tc 99m pertechnetate sodium (not included)] [contains phenol]
No
Lymphoseek may only be obtained through Cardinal Health’s Nuclear Pharmacy Services.
Route of administration (intradermal, subcutaneous, subareolar, or peritumoral) is determined by cancer and planned injection technique; dose may be administered as a single injection or as multiple injections.
Breast cancer lymphatic mapping: May be administered by intradermal, subQ, subareolar, or peritumoral injection.
Melanoma lymphatic mapping: May be administered by intradermal or subQ injection.
Oral cavity squamous cell carcinoma sentinel lymph node biopsy: May be administered by peritumoral injection (Ref).
Administer at least 15 minutes prior to intraoperative lymphatic mapping and sentinel lymph node biopsy; do not delay mapping or sentinel node biopsy more than 15 hours beyond administration. Use a handheld gamma counter to identify radioactivity concentrated within lymph nodes (refer to manufacturer’s instructions for further details). Avoid injections into biopsy wound areas with evidence of edema or inflammation.
Radiopharmaceutical; use appropriate precautions for handling and disposal. Use waterproof gloves and effective radiation shielding when handling.
Note: Radiopharmaceutical; use appropriate precautions for handling and disposal. Use waterproof gloves and effective radiation shielding when handling.
Parenteral: Route of administration (intradermal, subcutaneous, or peritumoral) is determined by cancer and planned injection technique; dose may be administered as a single injection or as multiple injections. In adults with breast cancer, subareolar injections can be used.
Administer at least 15 minutes prior to intraoperative lymphatic mapping and sentinel lymph node biopsy; complete mapping or sentinel node biopsy within 15 hours from administration. Use a handheld gamma counter to identify radioactivity concentrated within lymph nodes (refer to manufacturer's instructions for further details). Avoid injections into biopsy wound areas with evidence of edema or inflammation.
Diagnostic imaging: Radioactive diagnostic agent indicated with or without scintigraphic imaging (using a handheld gamma counter) for:
- Lymphatic mapping to locate lymph nodes draining a primary tumor site in pediatric patients ≥1 month of age and adults with solid tumors for which this procedure is a component of intraoperative management.
- Guiding sentinel lymph node biopsy in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer, or melanoma.
Radiopharmaceutical: Use appropriate precaution for handling, disposal, and minimizing exposure to patients and healthcare personnel. Use under supervision of experienced personnel. Should be stored in original lead container or adequate radiation shield.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Local Anesthetics: May diminish the diagnostic effect of Technetium Tc 99m Tilmanocept. Management: Avoid mixing and simultaneously co-injecting technetium Tc 99m tilmanocept with local anesthetics. This interaction does not appear to apply to other uses of these agents in combination. Risk C: Monitor therapy
Pregnancy status should be evaluated prior to administration in women of childbearing potential (EANM/SNMMI [Giammarile 2013]; SNM 2010).
Unbound technetium crosses the placenta. Technetium Tc 99m can be detected in fetal tissue; the amount depends upon the specific formulation, route of administration, and stage of pregnancy (Adelstein 1999).
In general, the potential for a radiopharmaceutical to cause fetal harm depends on the dose absorbed by the fetus and the stage of pregnancy. High doses of radiopharmaceuticals used for therapeutic procedures are more likely to result in fetal harm. A medically required diagnostic procedure can usually be modified to decrease fetal risk. Elective diagnostic procedures should be delayed until after delivery (ACR/SPR 2018; Adelstein 1999; EANM/SNMMI [Giammarile 2013]; ICRP 2000; SNM 2010).
Technetium Tc 99m is present in breast milk; information specific to technetium Tc 99m tilmanocept has not been located.
Breastfeeding status should be evaluated prior to administration. Available guidelines recommend lactating women interrupt breastfeeding for a period 24 hours after receiving Tc 99m tilmanocept (EANM/SNMMI [Giammarile 2013]). During this time, women can continue to express and discard milk. Women can pump and store breast milk prior to the procedure, which can be bottle-fed (Harding 1995).
Elective diagnostic procedures should be delayed until breastfeeding has stopped (SNM 2010). Women who are breastfeeding and caring for individuals undergoing nuclear medicine procedures do not need any additional precautions (ABM [Mitchell 2019]).
Excretion of technetium Tc 99m into colostrum is widely variable and information is limited; therefore, recommendations related to early breastfeeding cannot be made (Mountford 1989; Rubow 1994).
Radioactive diagnostic agent which accumulates in lymphatic tissue and binds (selectively) to a mannose binding receptor (CD206) on macrophage and dendritic cell surfaces.
Onset of action: Detectable in lymph nodes within 10 minutes (wait at least 15 minutes before mapping)
Duration: Has been detected for up to 30 hours after administration (mapping should be conducted within 15 hours following administration)
Distribution: Radioactivity also distributes to liver, kidney, and bladder (accumulated radioactive dose reached a maximum at 1 hour after administration and was ~1% to 2% of injected dose in each tissue)
Half-life elimination at injection site: 1.8-3.1 hours
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