ials each containing 4.5 mL of sterile buffered saline. After radiolabeling with technetium Tc 99m, the diluted Lymphoseek contains approximately 92.5 MBq (2.5 mCi) and 250 mcg technetium Tc 99m tilmanocept in 0.5 mL to 5 mL total volume.
4 CONTRAINDICATIONS None.
5 WARNINGS AND PRECAUTIONS 5.1 Hypersensitivity Reactions Lymphoseek may pose a risk of hypersensitivity reactions due to its chemical similarity to dextran. [see Description (11)] Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs). In clinical trials, no serious hypersensitivity reactions were reported.
Before administering Lymphoseek, ask patients about prior reactions to drugs, especially to dextran and modified forms of dextran. Have resuscitation equipment and trained personnel immediately available at the time of Lymphoseek administration.
5.2 Radiation Risks
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 the patient or health care workers.
6 ADVERSE REACTIONS 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 clinical trials, 542 patients received Lymphoseek. No patients experienced serious adverse reactions.
Injection site irritation (3 of 542 patients; 0.6%) and pain (1 of 542 patients; 0.2%) were reported. Other adverse reactions were uncommon, of mild severity and short duration.
7 DRUG INTERACTIONS In animal studies, locally injected anesthetics have been reported to reduce lymphatic flow. Co-injection (mixture) of local anesthetics with Lymphoseek is not recommended and may impair the lymph nodal mapping.
8 USE IN SPECIFIC POPULATIONS8.1 PregnancyPregnancy Category C: There are no adequate or well-controlled studies of Lymphoseek in pregnant women.
Unbound technetium crosses the placenta. All radiopharmaceuticals, including Lymphoseek, have a potential to cause fetal harm. The likelihood of fetal harm depends on the stage of fetal development and the radiopharmaceutical dose. No reproduction and developmental studies have been conducted with Lymphoseek. Lymphoseek should be given to a pregnant woman only if clearly needed.
8.3 Nursing Mothers It is not known whether Lymphoseek is excreted in human milk. Based on the clearance of the drug, advise patients to express and discard milk for at least four hours after administration of Lymphoseek.
Exercise caution when administering Lymphoseek to a nursing mother.
8.4 Pediatric Use Safety and effectiveness of Lymphoseek in pediatric patients have not been established.
8.5 Geriatric Use Of the 468 patients enrolled in breast cancer and melanoma clinical studies, 136 patients were aged 65 or older. Review of the clinical data, including eva luation of the frequency of adverse reactions, has not identified differences in safety or efficacy between elderly patients (65 to 90 years of age) and younger patients (18 to 65 years of age).
8.6 Females of Reproductive Potential In females of reproductive potential, any Lymphoseek administration should be performed withi
