lymphoseek kit
Lymphoseek Kit (Technetium Tc-99m Tilmanocept) is a medication supplied as a kit.
Technetium Tc-99m Tilmanocept · by Cardinal Health 414
Key facts
- Active ingredient
- Technetium Tc-99m Tilmanocept
- Form
- Kit
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Cardinal Health 414
- FDA application
- NDA202207
What is Lymphoseek Kit?
From the FDA label: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…
How to use
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…
Side effects
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.
Warnings
Important safety information
Hypersensitivity: 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. ( 5.1 ) 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). Before administering Lymphoseek, ask patients about prior hypersensitivity 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 decrease the risk for excessive radiation exposure to either patients or health care workers.
Who should not take Lymphoseek Kit
None. None. ( 4 )
Dosage forms
Kit
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- Is there a coupon or discount for Lymphoseek Kit?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Lymphoseek Kit. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Lymphoseek Kit?
- Lymphoseek Kit is marketed by Cardinal Health 414. You can see Cardinal Health 414's full profile, rating, and other products on pharmaranks.
- Is Lymphoseek Kit a brand-name or generic drug?
- Lymphoseek Kit is a brand-name product with the active ingredient Technetium Tc-99m Tilmanocept.
- Is Lymphoseek Kit available over the counter?
- No. Lymphoseek Kit is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Lymphoseek Kit come in?
- Lymphoseek Kit is currently marketed as kit, per the FDA's National Drug Code Directory.
- Is Lymphoseek Kit FDA-registered?
- Lymphoseek Kit is on record with the U.S. FDA under application number NDA202207. You can verify this on its official FDA label.
- Is Lymphoseek Kit safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Lymphoseek Kit. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Lymphoseek Kit?
- Lymphoseek Kit's side effects are taken directly from its FDA label. From the label: 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 clinica… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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