KIT FOR THE PREPARATION OF LYMPHOSEEK (TECHNETIUM TC 99M TILMANOCEPT)- tilmanocept

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TECHNETIUM TC-99M TILMANOCEPT (UNII: 8IHI69PQTC) (TECHNETIUM TC-99M TILMANOCEPT - UNII:8IHI69PQTC)

Available from:

Navidea Biopharmaceuticals, Inc.

INN (International Name):

TECHNETIUM TC-99M TILMANOCEPT

Composition:

TILMANOCEPT 250 ug

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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. None. Pregnancy Category C There are no adequate or well-controlled studies of Lymphoseek in pregnant women. Additionally, animal reproduction studies have not been conducted with technetium Tc 99m tilmanocept. However, all radiopharmaceuticals, including Lymphoseek, have a potential to cause fetal harm. Lymphoseek should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus. It is not known whether technetium Tc 99m tilmanocept is present in human milk.  Based on the half-life of technetiu

Product summary:

The Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) injection (NDC 52579-1604-5) includes: The Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) injection (NDC 52579-1600-5) includes: Storage Store Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) injection in the original packaging at USP controlled room temperature 20 o C - 25 o C (68 o F - 77 o F), excursions permitted to 15°C to 30°C (59°F to 86°F).  Store radiolabeled Lymphoseek in radiation shielding at room temperature.  Use radiolabeled Lymphoseek within 6 hours of preparation. Handling This Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) injection is approved for distribution to persons licensed by the U.S. Nuclear Regulatory Commission to use by product material identified in 10 CFR 35.200 or under an equivalent license issued by an Agreement State.

Authorization status:

New Drug Application

Summary of Product characteristics

KIT FOR THE PREPARATION OF LYMPHOSEEK (TECHNETIUM TC 99M
TILMANOCEPT)- TILMANOCEPT
NAVIDEA BIOPHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LYMPHOSEEK SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR LYMPHOSEEK.
LYMPHOSEEK (TECHNETIUM TC 99M TILMANOCEPT) INJECTION FOR SUBCUTANEOUS,
INTRADERMAL, SUBAREOLAR, OR
PERITUMORAL USE
INITIAL U.S. APPROVAL: 2013
RECENT MAJOR CHANGES
Dosage and Administration, Drug Preparation ( 2.3) 10/2016
INDICATIONS 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 patients
with solid tumors for which this procedure is a component of
intraoperative management. ( 1)
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.
( 1)
DOSAGE AND ADMINISTRATION
Lymphoseek is supplied as a Kit and must be prepared by radiolabeling
with technetium Tc 99m and diluting with the
supplied diluent or pharmacy-available sterile 0.9% sodium chloride
injection prior to use. ( 2.3)
Use aseptic technique and radiation safety precautions during
Lymphoseek preparation and handling. Determine the
total injection volume and number of sites to be injected for each
patient before preparing Lymphoseek. ( 2.1, 2.3)
Recommended dose of Lymphoseek is 18.5 MBq (0.5 mCi) administered at
least 15 minutes before initiating
intraoperative lymphatic mapping or sentinel node biopsy procedures:
complete these procedures within 15 hours of
Lymphoseek injection. ( 2.2, 2.3)
Recommended routes of administration are intradermal, subcutaneous,
subareolar, or peritumoral. ( 2.3)
Use radiolabeled Lymphoseek within 6 hours of its preparation. ( 2.3)
DOSAGE FORMS AND STRENGTHS
The Kit for preparation of Lymphoseek contains five Tilmanocept Powder
vials ea