Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)
tilmanocept · KIT · Cardinal Health 414, LLC
Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) is a prescription kit containing tilmanocept. Manufactured by Cardinal Health 414, LLC.
Key Facts
- Brand Name
- Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)
- Generic Name
- tilmanocept
- NDC Code (Product)
65857-425- Manufacturer
- Cardinal Health 414, LLC
- Dosage Form
- KIT
- Marketing Status
- HUMAN PRESCRIPTION DRUG
- Application #
- NDA202207
- Marketing Start
- 09/20/2017
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
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 & 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 (…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
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.
Frequently Asked Questions
What is Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) used for?
Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) contains tilmanocept. It is a kit taken as directed. Consult your doctor for specific uses.
Is Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) a controlled substance?
Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) is not classified as a controlled substance by the DEA.
What is the generic name for Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)?
The generic name for Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) is tilmanocept. There are no other listed brand versions of tilmanocept.
What is the NDC code for Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) ?
The NDC (National Drug Code) for Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) is 65857-425, listed by Cardinal Health 414, LLC.
Other Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)