technetium Tc 99m tilmanocept (Rx)

Brand and Other Names:Lymphoseek
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

Kit

  • 5 vials each containing tilmanocept 250 mcg powder
  • 5 vials each containing 4.5 mL of sterile buffered saline
  • End product after radiolabeling with technetium: Tc 99m 92.5 MBq (2.5 mCi) and 250 mcg of technetium Tc 99m tilmanocept in 0.5 mL to 5 mL total volume
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Lymphatic Mapping & Node Biopsy

Indications

  • 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

Dosing

  • Recommended dose: 18.5 MBq (0.5 mCi) as a radioactivity dose and 50 mcg as a mass dose
  • Administer at least 15 minutes before initiating intraoperative lymphatic mapping and sentinel node biopsy
  • Complete these procedures within 15 hr after dose injection
  • See Administration

Head & Neck Cancers (Orphan)

Orphan designation for use in sentinel lymph node detection with a hand-held gamma-counter, with scintigraphic imaging, in patients with cancer of the head and neck

Sponsor

  • Navidea Biopharmaceuticals; 5600 Blazer Parkway, Suite 200; Dublin, OH 43017

Safety and efficacy not established

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Adverse Effects

<1%

Injection site reactions

Pain

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Warnings

Contraindications

None

Cautions

Risk of hypersensitivity reactions due to its chemical similarity to dextran; serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (eg, iron dextran); have resuscitation equipment and trained personnel immediately available during administration

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

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Pregnancy & Lactation

Pregnancy

There are no adequate or well-controlled studies in pregnant women

Animal reproduction studies with technetium Tc 99m tetrofosmin not performed

All radiopharmaceuticals have potential to cause fetal harm depending on fetal stage of development and magnitude of radiation dose; if technetium Tc 99m tetrafosmin administration to a pregnant woman necessary, advise pregnant woman of risk to fetus

Lactation

Unknown if present in human milk

Based on the half-life of technetium Tc 99m, advise breastfeeding women to pump and discard breast milk for 60 hr (10 half-lives) after technetium Tc 99m tetrofosmin administration

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Radioactive diagnostic agent; accumulates in lymphatic tissue and selectively binds to mannose binding receptors (CD206) located on the surface of macrophages and dendritic cells

Technetium Tc 99m tilmanocept is a macromolecule consisting of multiple units of diethylenetriaminepentaacetic acid (DTPA) and mannose, each covalently attached to a 10 kDa dextran backbone

Mannose acts as a ligand for the receptor and DTPA serves as a chelating agent for labeling with technetium Tc 99m

Distribution

Detectable in lymph nodes within 15 min and up to 30 hr after injection

Elimination

Half-life (at injection site): 1.8-3.1 hr

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Administration

Preparation

Kit for the preparation contains 5 sets of 2 vials - a tilmanocept powder vial and a diluent vial

Tilmanocept powder vial contains 250 mcg of tilmanocept from which 50 mcg is intended for administration to a patient

The diluent for technetium Tc 99m tilmanocept vial contains 4.5 mL of sterile buffered saline and is used to dilute technetium Tc 99m tilmanocept after the radiolabeling procedure

Amount of diluent used varies, depending on the total injection volume and the number of syringes used for each patient (see planned number of injections per patient)

Once the reconstituted vial volume is established, following the instructions in the prescribing information to prepare for the tilmanocept powder for radiolabeling and reconstitution

The vial components of the kit for the preparation are sterile, nonpyrogenic, and are intended solely for use in the preparation of technetium Tc 99m tilmanocept; do not administer the unprepared vial components of the kit directly to a patient

Follow aseptic procedures during preparation and administration

Administer reconstituted product within 6 hr of its preparation

Administration Route and Injection Method

Administration route depends on tumor location and the planned injection technique and includes: subcutaneous, intradermal, subareolar, or peritumoral injection

May be administered as a single injection or as multiple injections

The lymphatic system architecture and function may be changed by prior surgery, radiation, edema, inflammation, or metastatic disease, and may result in changes to lymph node localization by a radiopharmaceutical or other tracers, including colorimetric agents

Avoid injections into biopsy wound areas that show evidence of edema or inflammation

In animal studies, locally injected anesthetics have been reported to reduce lymphatic flow; therefore, coadministration with local anesthetics is not recommended and may impair lymph nodal mapping

Planned number of injections per patient

  • 1 syringe (0.1 mL): 0.1 mL total injection volume (reconstitute vial to 0.5 mL)
  • 1 syringe (0.5 mL) or 2 syringes (0.25 mL) or 5 syringes (0.1 mL): 0.5 mL total injection volume (reconstitute vial to 2.5 mL)
  • 2 syringes (0.5 mL) or 4 syringes (0.25 mL) or 5 syringes (0.2 mL): 1 mL total injection volume (reconstitute vial to 5 mL)

Storage

Unopened kit

  • Store in the original packaging controlled room temperature 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)

Reconstituted product

  • Store reconstituted product in radiation shielding at room temperature
  • Use radiolabeled product within 6 hr of preparation
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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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