Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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.
5 WARNINGS AND PRECAUTIONS 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).
Like all medications, Kit For The Preparation Of Lymphoseek (technetium Tc 99m Tilmanocept) can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: