Indium-111 capromab pendetide (DISCONTINUED 2018)

Approved Use:

• Indicated as a diagnostic imaging agent in newly-diagnosed patients with biopsy-proven prostate cancer, thought to be clinically-localized after standard diagnostic evaluation (e.g. chest x-ray, bone scan, CT scan, or MRI), who are at high-risk for pelvic lymph node metastases
• Indicated as a diagnostic imaging agent in post-prostatectomy patients with a rising PSA and a negative or equivocal standard metastatic evaluation in whom there is a high clinical suspicion of occult metastatic disease

Dose: 0.5 mg capromab pendetide radiolabeled with 5 mCi of In-111 chloride
 
Brand Name: ProstaScint®
​Manufacturer: Aytu (distributed by Sonexus Health)
Package Insert
How Supplied: Each kit contains:

• 1 vial ProstaScint® (capromab pendetide) 0.5 mg/mL (1 mL), in PBS pH 6
• 1 vial Sodium Acetate Buffer Solution 0.5M (2 mL) 
• 1 Millex® GV Filter (0.22 μm)

In-111 chloride must be purchased separately from GE Healthcare or Mallinckrodt  
Storage: Refrigerate
Availability: Ships Monday-Thursday for next day delivery Fed Ex.  Order by 14:00 CT.
NDC #: 57902-817-01

Patient Guide (JAN 2016)
​Letter from Manufacturer APR 2018 (product discontinued)
Letter from Manufacturer 27JUL2015 (ordering update)
Letter from Manufacturer 13JUL2015 (ordering update)
Letter from Manufacturer 26MAY2015 (sale from Jazz to Aytu)
Letter from Manufacturer 29OCT2010 (update to QC)

Clinical Guidelines:
ACR-SPR Practice Parameter for the Performance of Tumor Scintigraphy (2015)