Brand Name
Lymphoseek
Generic Name
Tilmanocept
View Brand Information FDA approval date: September 20, 2017
Form: Kit
What is Lymphoseek (Tilmanocept)?
Lymphoseek is a 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 adult and pediatric patients age one month and older 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. Lymphoseek is a 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 adult and pediatric patients age one month and older 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.
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Brand Information
Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) (tilmanocept)
1INDICATIONS AND USAGE
Lymphoseek is a 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 adult and pediatric patients age one month and older 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.
2DOSAGE FORMS AND STRENGTHS
For Injection: Lymphoseek (kit for preparation of technetium Tc 99m tilmanocept injection) is supplied as five vials each containing 250 mcg tilmanocept, and is packaged either with or without five DILUENT for Lymphoseek vials each containing 4.5 mL of sterile buffered saline with phenol. After radiolabeling with technetium Tc 99m, Lymphoseek contains approximately 92.5 MBq (2.5 mCi) and 250 mcg technetium Tc 99m tilmanocept in 0.5 mL to 5 mL total volume.
3CONTRAINDICATIONS
None.
4DESCRIPTION
Chemical Characteristics
The active ingredient in Lymphoseek, a radioactive diagnostic agent, is technetium Tc 99m tilmanocept. Technetium Tc 99m binds to the diethylenetriaminepentaacetic acid (DTPA) moieties of the tilmanocept molecule.
- Chemically, technetium Tc 99m tilmanocept consists of technetium Tc 99m, dextran 3-[(2-aminoethyl)thio]propyl 17-carboxy-10,13,16-tris(carboxymethyl)-8-oxo-4-thia-7,10,13,16-tetraazaheptadec-1-yl 3-[[2-[[1-imino-2-(D-mannopyranosylthio)ethyl]amino]ethyl]thio]propyl ether complexes.
- The molecular formula of technetium Tc 99m tilmanocept is [C
- The calculated average molecular weight of tilmanocept ranges from 15,281 to 23,454 g/mol.
- Technetium Tc 99m tilmanocept has the following structural formula:
Lymphoseek is supplied as a kit which contains five vials, 250 mcg tilmanocept per vial. Each Lymphoseek vial contains the non-radioactive ingredients needed to produce technetium Tc 99m tilmanocept. The vial contains a sterile, non-pyrogenic, white to off-white lyophilized powder (under nitrogen) that consists of a mixture of 250 mcg tilmanocept, 20 mg trehalose dihydrate, 0.5 mg glycine, 0.5 mg sodium ascorbate, and 0.075 mg stannous chloride dihydrate. Sodium hydroxide and hydrochloric acid may be used to adjust the pH prior to lyophilization.
The DILUENT for Lymphoseek contains 4.5 mL sterile buffered saline consisting of 0.04% (w/v) potassium phosphate, 0.11% (w/v) sodium phosphate (heptahydrate), 0.5% (w/v) sodium chloride, and 0.4% (w/v) phenol.
Physical Characteristics
Technetium Tc 99m decays by isomeric transition with a physical half-life of approximately 6 hours. The principal photon that is useful for detection and imaging studies is listed in
External Radiation
The linear mass energy absorption attenuation coefficient for Tc 99m is 18.9 cm
To correct for physical decay of the radionuclide, the fractions that remain at selected intervals after the time of calibration are shown in
5PATIENT COUNSELING INFORMATION
- Advise patients to seek medical attention for reactions following injection of Lymphoseek such as difficulty breathing, skin rash, or other allergy manifestations.
- Inform nursing women to pump and discard breast milk for at least 24 hours following administration of Lymphoseek injection
Distributed by:
Cardinal Health 414, LLC
Lymphoseek is a registered trademark of Cardinal Health 414, LLC.
Patent:
6PRINCIPAL DISPLAY PANEL - Carton
Principal Display Panel
NDC 65857-450-05
Lymphoseek
250 mcg Tilmanocept per Vial
Multiple-Dose Kit
Contents:
- Five Lymphoseek kit vials (250 mcg tilmanocept per vial) NDC 65857-400-01
- Five vials of DILUENT for Lymphoseek NDC 65857-401-45
- Prescribing information
- Five Radioassay information shield labels
- Twenty-five labels for product vials and individual syringes
Store kit in the original packaging at 20° to 25°C (68° to 77°F); excursions
See Prescribing Information for preparation and administration instructions.
For subcutaneous, intradermal, subareolar, or peritumoral use.
Use within 6 hours after reconstitution. Discard unused portion.
Pat: www.lymphoseek.com/patent-information
Distributed by Cardinal Health 414, LLC
Rx Only
Back Panel
Lymphoseek
250 mcg Tilmanocept per Vial
Each sterile, non-pyrogenic, lyophilized powder vial contains:
Tilmanocept 250 mcg
DILUENT for Lymphoseek contains:
Rx Only
For Customer Service call: 1-800-476-5270
CardinalHealth™
7-C001685E
Lot:
Exp:
Left Side Panel
Lymphoseek
WARNING: Radiopharmaceuticals should be used by persons who are qualified by specific training in the safe
Right Side Panel
Storage Conditions:
Store kit in the original packaging at 20° to 25°C (68° to 77°F); excursions permitted
7PRINCIPAL DISPLAY PANEL - DILUENT
NDC 65857-401-45
DILUENT for Lymphoseek
For diluting radiolabeled Lymphoseek only
Not for direct administration
See package insert for preparation and
Single Dose Vial - Discard unused portion.
Rx Only 23001105-C04
Contents: 4.5 mL non-pyrogenic, aqueous
Store in the original packaging at 20° to 25°C
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