Tilmanocept
FDA Drug Information • Also known as: Kit For The Preparation Of Lymphoseek (Technetium Tc 99M Tilmanocept)
- Brand Names
- Kit For The Preparation Of Lymphoseek (Technetium Tc 99M Tilmanocept)
- Dosage Form
- KIT
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 DESCRIPTION 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 6 H 10 O 5 ] n .(C 19 H 28 N 4 O 9 S 99m Tc) b .(C 13 H 24 N 2 O 5 S 2 ) c .(C 5 H 11 NS) a . It contains 3-8 conjugated DTPA (diethylenetriaminepentaacetic acid) molecules (b); 12-20 conjugated mannose molecules (c) with 0-17 amine side chains (a) remaining free. 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...What Is Tilmanocept Used For?
1 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 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. ( 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
2 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 ) See Full Prescribing Information for important preparation and administration instructions. ( 2 ) 2.1 Radiation Safety - Drug Handling Lymphoseek is a radioactive drug and should be handled with appropriate safety measures to decrease radiation exposure [see Warnings and Precautions ( 5.2 )] . Use waterproof gloves, effective radiation shielding, and appropriate safety measures when preparing and handling Lymphoseek. Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. 2.2 Recommended Dosing 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. Route of Administration and Injection Method The route of administration depends on the tumor location and the planned injection technique and includes: subcutaneous, intradermal, subareolar, or peritumoral injection. Lymphoseek may be administered to a patient as a single injection or as multiple injections. The recommended total injection volume for each patient ( Table 1 ) 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). The lymphatic system architecture and function may be changed by prior surgery, radiation, edema, inflammation or metastatic disease, and may result in changes to lymph node localization by a radiopharmaceutical or other tracers, including colorimetric agents. Avoid injections into biopsy wound areas that show evidence of edema or inflammation. In animal studies, locally injected anesthetics have been reported to reduce lymphatic flow....Side Effects (Adverse Reactions)
6 ADVERSE REACTIONS The most common adverse reactions (incidence < 1%) are injection site irritation and/or pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cardinal Health at 1-800-618-2768 or www.lymphoseek.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In open label, single arm clinical trials, 553 adult patients with either breast cancer, melanoma, or squamous cell carcinoma of the oral cavity, skin, and lip received Lymphoseek. No patients experienced serious adverse reactions. Injection site irritation (4 patients; 0.7%) and pain (1 patient; 0.2%) were reported.
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Pregnancy and Breastfeeding
8.1 Pregnancy Risk Summary There are no available data on Lymphoseek use 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 depending on the fetal stage of development and the magnitude of the radiation dose. If considering Lymphoseek administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively, regardless of drug exposure.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied The Lymphoseek (kit for the preparation of technetium Tc 99m tilmanocept injection) (NDC 65857-425-05) includes:
Five Lymphoseek kit vials (250 mcg tilmanocept per vial) NDC 65857-400-01 Prescribing information Five labels for shields Twenty-five labels for product vials and individual syringes The Lymphoseek (kit for the preparation of technetium Tc 99m tilmanocept injection) (NDC 65857-450-05) includes: 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 labels for shields Twenty-five labels for product vials and individual syringes 16.2 Storage and Handling Storage Store Lymphoseek (kit for the preparation of technetium Tc 99m tilmanocept injection) in the original packaging at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store radiolabeled Lymphoseek in radiation shielding at room temperature. Use radiolabeled Lymphoseek within 6 hours of preparation. Discard unused portion. Handling This Lymphoseek (kit for the preparation of 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. 16.1 How Supplied The Lymphoseek (kit for the preparation of technetium Tc 99m tilmanocept injection) (NDC 65857-425-05) includes: Five Lymphoseek kit vials (250 mcg tilmanocept per vial) NDC 65857-400-01 Prescribing information Five labels for shields Twenty-five labels for product vials and individual syringes The Lymphoseek (kit for the preparation of technetium Tc 99m tilmanocept injection) (NDC 65857-450-05) includes: Five Lymphoseek kit vials (250 mcg tilmanocept per vial) NDC 65857-400-01 Five vials of DILUENT for Lymphoseek (NDC...About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.