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 following clinically important adverse reactions are described elsewhere in the labeling: Anaphylaxis and Other Serious Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Most common adverse reactions (≥1%) were hypersensitivity and chromaturia.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lumicell at 1-833-458-6387 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.
The safety of LUMISIGHT was evaluated in 726 patients who received a single dose of 1 mg/kg of LUMISIGHT.
Among these 726 patients, 703 (97%) had breast cancer and 23 (3%) had other types of cancer.
The mean age of the patients was 62 years (range: 36 years to 95 years), and 98% of them were female.
Distribution by race was 82% White, 7% Black or African American, 6% Asian, and 5% other or unreported.
Distribution by ethnicity was 3% Hispanic/Latino, 93% non-Hispanic/Latino, and 4% unknown or unreported.
Adverse reactions occurring in ≥ 1% of patients receiving LUMISIGHT were hypersensitivity (1.4%, including anaphylaxis [4 out of 726]) and chromaturia (85%).
Chromaturia resolved within 48 hours after administration in 93% of patients, with the longest time to resolution of 15 days.
5 WARNINGS AND PRECAUTIONS Risk of Misdiagnosis : Absence of signal in the surgical field does not rule out the presence of cancer.
Positive signal may be seen in non-cancerous tissue.
( 5.2 ) Interference from Dyes Used for Sentinel Lymph Node Mapping : Avoid administration of dyes before imaging the lumpectomy cavity in patients receiving LUMISIGHT.
( 5.3 , 7 ) 5.1 Anaphylaxis and Other Serious Hypersensitivity Reactions Prepare for the possibility of drug hypersensitivity reactions (including anaphylaxis), which can occur during or following administration, and take the necessary precautions.
In clinical studies, 4 of 726 (0.6%) patients treated with LUMISIGHT experienced signs and symptoms consistent with anaphylaxis.
Like all medications, Lumisight 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: