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 (≥0.4%) are diarrhea, blood pressure increase, and injection site pain.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Blue Earth Diagnostics Ltd at 1-844-POSLUMA (1-844-767-5862) 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 POSLUMA was evaluated in 747 patients with prostate cancer [see Clinical Studies ( 14.1 , 14.2 )] .
All patients received a single administration of POSLUMA with an administered radioactivity (mean ± SD) of 307 ± 23 MBq (8.3 ± 0.6 mCi).
The mean age of patients was 67 years (range: 43 to 86 years);
distribution by race was 78% White, 12% Black or African American, 2% other, and 7% unreported;
and distribution by ethnicity was 5% Hispanic/Latino, 87% non-Hispanic/Latino, and 8% unreported.
The adverse reactions reported in ≥ 0.4% of patients are shown in Table 2 .
Table 2: Adverse Reactions in ≥ 0.4% of Patients with Prostate Cancer Receiving POSLUMA Adverse Reaction POSLUMA N = 747 n (%) Diarrhea 5 (0.7%) Blood pressure increase 4 (0.5%) Injection site pain 3 (0.4%)
5 WARNINGS AND PRECAUTIONS Risk of Image Misinterpretation: Image interpretation errors can occur with POSLUMA imaging.
Interpretation of POSLUMA PET may differ depending on imaging readers in patients with suspected recurrence of prostate cancer.
Consider multidisciplinary consultation and histopathological confirmation.
( 5.1 , 14.2 ) Radiation risk: POSLUMA contributes to a patient's long-term cumulative radiation exposure.
Ensure safe handling to protect patients and health care workers from unintentional radiation exposure.
Like all medications, Posluma 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: