Technetium Tc 99m Tilmanocept

Technetium Tc 99m tilmanocept is a radioactive diagnostic agent used 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, and for 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.

Technetium Tc 99m tilmanocept is available under the following different brand names: Lymphoseek.

Dosages of Technetium Tc 99m Tilmanocept:

Dosage Forms and Strengths

Kit

• 5 vials each containing tilmanocept 250 mcg powder
• 5 vials each containing 4.5 mL of sterile buffered saline
• The 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

Dosage Considerations – Should be Given as Follows:

Lymphatic Mapping and Node Biopsy

Indications

• The 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 hours after dose injection

Safety and efficacy not established in pediatric patients

Side effects of technetium Tc 99m tilmanocept include:

• Injection site reactions
• Pain

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Technetium Tc 99m tilmanocept has no listed severe interactions with other drugs.
• Technetium Tc 99m tilmanocept has no listed serious interactions with other drugs.
• Technetium Tc 99m tilmanocept has no listed moderate interactions with other drugs.
• Technetium Tc 99m tilmanocept has no listed mild interactions with other drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings
This medication contains technetium Tc 99m tilmanocept. Do not take Lymphoseek if you are allergic to technetium Tc 99m tilmanocept or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• None

Effects of Drug Abuse

• No information is available

Short-Term Effects

• See "What Are Side Effects Associated with Using Technetium Tc 99m Tilmanocept?”

Long-Term Effects

• See "What Are Side Effects Associated with Using Technetium Tc 99m Tilmanocept?”

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 (e.g., 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

Pregnancy and Lactation

There are no adequate or well-controlled studies of technetium Tc 99m tilmanocept in pregnant women. All radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and magnitude of radiation dose; if technetium Tc 99m tetrafosmin administration to a pregnant woman is necessary, pregnant women should be advised of the risk to a fetus.