Technetium tc 99m tilmanocept (injection route)


    Brand Name

    US Brand Name

    Lymphoseek


    Description

    Technetium Tc 99m tilmanocept injection is a radiopharmaceutical. Radiopharmaceuticals are radioactive agents, which may be used to find and treat certain diseases or to study the function of the body's organs.

    Technetium Tc 99m tilmanocept injection is used to find lymph nodes in patients with solid tumors. It is also used to find sentinel lymph nodes in patients with breast, skin, or oral cavity cancer.

    This medicine is to be given only by or under the direct supervision of a doctor with specialized training in nuclear medicine.

    This product is available in the following dosage forms:

    • Powder for Solution

    Before Using

    In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of technetium Tc 99m tilmanocept injection in children 1 month of age and older. Safety and efficacy have been established.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of technetium Tc 99m tilmanocept injection in the elderly.

    Breastfeeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    Other Medical Problems

    The presence of other medical problems may affect the use of this diagnostic test. Make sure you tell your doctor if you have any other medical problems, especially:

    • Allergy to dextran and other forms of dextran (eg, iron dextran)—Use with caution. May cause an allergic reaction to occur again.

    Proper Use

    A doctor or other trained health professional will give you this medicine in a medical facility. Depending on your medical problem, this medicine is given as a shot under your skin, into your skin, around the tumor, or below the areola (area around the nipple) of the breast at least 15 minutes before a surgical or test procedure.


    Precautions

    It is very important that your doctor check you closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

    This medicine may cause serious allergic reactions, which can be life-threatening and require immediate attention. Check with your doctor right away if you have a rash, itching, swelling of the face, tongue, and throat, trouble breathing, or chest pain after you get the injection.

    You will be exposed to radiation when you are given this medicine. This could increase the risk of cancer, especially for children. Talk with your doctor if you have concerns about this.


    Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor or nurse immediately if any of the following side effects occur:

    Incidence not known

    • Chest tightness
    • difficulty with breathing or swallowing
    • fast heartbeat
    • fever
    • hives, itching, skin rash
    • hoarseness
    • irritation
    • joint pain, stiffness, or swelling
    • redness of the skin
    • swelling of the eyelids, face, lips, hands, or feet

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    Rare

    • Pain or irritation at the injection site

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.






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