technetium Tc 99m tilmanocept (Rx)

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Brand and Other Names:Lymphoseek

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

Kit

  • 5 Tilmanocept powder vials each containing 250 mcg tilmanocept
  • 5 diluent vials for technetium Tc 99m tilmanocept vials 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

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

Breast cancer: May administer through intradermal, subcutaneous, subareolar, and peritumoral injections

Melanoma: May administer through intradermal or subcutaneous injections

Administer 18.5 MBq (0.5 mCi) of technetium Tc 99m tilmanocept at least 15 minutes before initiating intraoperative lymphatic mapping or sentinel node biopsy; complete lymphatic mapping/biopsy within 15 hr of administration

Recommended total injection volume for each patient is 0.1 mL administered in a single syringe; 0.5 mL administered in a single syringe or in multiple syringes (0.1 mL to 0.25 mL each); or 1 mL administered in multiple syringes (0.2 mL to 0.5 mL each)

Administration

Technetium Tc 99m tilmanocept administration should be handled with appropriate safety measures to minimize radiation exposure; use waterproof gloves, effective radiation shielding, and appropriate safety measures when preparing and handling technetium Tc 99m tilmanocept

Total injection volume and the number of sites to be injected should be known before preparing technetium Tc 99m tilmanocept

Each radiolabled technetium Tc 99m tilmanocept vial contains sufficient amount to provide doses for up to four patients when prepared according to the instructions

Radiolabeled technetium Tc 99m tilmanocept is to be used within 6 hr of its preparation

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

Observe for hypersensitivity signs and symptoms following injection

Have resuscitation equipment and trained personnel available at the time of administration

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Pregnancy & Lactation

Pregnancy Category: C

Lactaion: Excercise caution when administering to a nursing mother

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

The macromolecule accumulates in lymphatic tissue and selectively binds to mannose binding receptor (CD206) located on the surface of macrophages and dendritic cells; macromolecule consists of multiple units of diethylenetriaminepentaacetic acid (DTPA) and mannose, each covalently attached to a 10 kDa dextran backbone; the mannose acts as a ligand for the receptor, and the DTPA serves as a chelating agent for labeling with technetium Tc 99m

Used with a hand-held gamma counter to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma

Distribution

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

Elimination

Half-life: 1.75-3.05 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

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

Use reconstituted product within 6 hours of its preparation

Storage

Store reconstituted product in radiation shielding at room temperature

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
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  • Compare formulary status to other drugs in the same class.
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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.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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