Technetium tc 99m tilmanocept (Injection)

Technetium Tc 99m tilmanocept injection is a special type of medicine that contains radioactive materials. These radioactive agents can help find and treat certain diseases or examine how the body's organs work.

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

This medicine should only be given by a doctor who has specialized training in nuclear medicine or under their direct supervision.

It is very important that your doctor monitors you closely while you are receiving this medicine. This allows your doctor to see if the medicine is working properly and to decide if you should keep getting it.

This medicine may cause serious allergic reactions that can be life-threatening and need immediate attention. Contact 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 receive this medicine. This may increase the risk of cancer, especially for children. Discuss any concerns you have with your doctor.

In deciding to use a diagnostic test, any risks of the test must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. Other factors may also impact test results. For this test, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your health care professional know 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

Studies conducted so far have not shown any specific problems in children 1 month of age and older that would limit the usefulness of technetium Tc 99m tilmanocept injection. Safety and effectiveness have been established.

Geriatric

Studies conducted so far have not shown any specific problems in the elderly that would limit the usefulness of technetium Tc 99m tilmanocept injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could occur. In such instances, your doctor may want to adjust the dose, or other precautions may be necessary. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around mealtime or with certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this diagnostic test. Make sure to inform your doctor if you have any other medical conditions, especially:

• Allergy to dextran and other forms of dextran (e.g., iron dextran)—Use with caution. This may trigger an allergic reaction again.

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

Check with your doctor or nurse right away if any of the following side effects happen:

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 happen that usually do not need medical attention. These side effects may go away during treatment as your body adapts to the medicine. Also, your healthcare professional may be able to tell you about ways to prevent or lessen some of these side effects. Check with your healthcare 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 happen 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.

In the U.S.

• Lymphoseek

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Diagnostic Agent, Radiopharmaceutical Imaging

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.