Technetium Tc 99m-labeled tilmanocept

What is Technetium Tc 99m-labeled tilmanocept?

• Technetium Tc 99m-labeled tilmanocept (Lymphoseek) is a radioactive diagnostic agent used to locate lymph nodes which may be draining from tumors, and assist doctors in locating lymph nodes for removal during surgery.

What are the uses of this medicine?

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.

How does this medicine work?

• Upon injection, the mannose moiety of technetium Tc 99m-labeled tilmanocept binds to mannose-binding protein (MBP).
• As MBPs reside on the surface of dendritic cells and macrophages, this gamma-emitting macromolecule tends to accumulate in lymphatic tissue where it may be imaged using gamma scintigraphy.
• This agent exhibits rapid clearance from the injection site, rapid uptake and high retention within the first draining lymph node, and low uptake by the remaining lymph nodes.
• MBP is a C-type lectin that binds mannose or fucose carbohydrate residues, such as those found on the surfaces of many pathiogens, and once bound activates the complement system.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with Lymphoseek.

Is this medicine FDA approved?

• FDA approved this drug in the year of 2013.

How should this medicine be used?

• Lymphoseek is a radioactive drug and should be handled with appropriate safety measures to decrease radiation exposure .
• Use waterproof gloves, effective radiation shielding, and appropriate safety measures when preparing and handling Lymphoseek.

Recommended Dosage:

• The recommended dose of Lymphoseek is 18.5 MBq (0.5 mCi) as a radioactivity dose and 50 mcg as a mass dose.
• Administer Lymphoseek at least 15 minutes prior to initiating intraoperative lymphatic mapping and sentinel node biopsy; complete these procedures within 15 hours after Lymphoseek injection.

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.
• 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.
• Recommended routes of administration are intradermal, subcutaneous, subareolar, or peritumoral.
• Use radiolabeled Lymphoseek within 6 hours of its preparation.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Injection: The Kit for preparation of Lymphoseek contains five Tilmanocept Powder 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 and dilution, Lymphoseek contains approximately 92.5 MBq (2.5 mCi) and 250 mcg of technetium Tc 99m tilmanocept in 0.5 mL to 5 mL total volume for injection.

This medicine is available in fallowing brand namesː

• Lymphoseek

What side effects can this medication cause?

The most common side effects of this medicine include:

• injection site irritation and/or pain

What special precautions should I follow?

• Lymphoseek may increase risk of hypersensitivity reactions. Ask patients about prior reactions to drugs, especially dextran or modified forms of dextran. Observe for hypersensitivity signs and symptoms following Lymphoseek injection. Have resuscitation equipment and trained personnel immediately available.
• Any radiation-emitting product may increase the risk for cancer, especially in pediatric patients. Adhere to the dose recommendations and ensure safe handling to decrease the risk for excessive radiation exposure to either patients or health care workers.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no available data on Lymphoseek use in pregnant women.

Can this medicine be used in children?

• The safety and effectiveness of Lymphoseek have been established in pediatric patients 1 month of age and older.

What are the active and inactive ingredients in this medicine?

Active ingredient: TECHNETIUM TC-99M TILMANOCEPT

Inactive ingredients: TREHALOSE DIHYDRATE GLYCINE SODIUM ASCORBATE STANNOUS CHLORIDE SODIUM HYDROXIDE HYDROCHLORIC ACID NITROGEN

Who manufactures and distributes this medicine?

Distributed by: Cardinal Health 414, LLC Dublin

What should I know about storage and disposal of this medication?

Storage

• Store Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) injection in the original packaging at USP controlled room temperature, 20°C to 25°C (68°F to 77°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.

• Dailymed label info on Technetium Tc 99m-labeled tilmanocept
• FDA Technetium Tc 99m-labeled tilmanocept

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