AZEDRA (Iobenguane I-131)

AZEDRA (Iobenguane I-131)

OFFICE ADMINISTRATION

Indications for Prior Authorization:

• Indicated for the treatment of adult and pediatric patients 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy

Patients must meet the following criteria for the indication(s) above:

Pheochromocytoma:

• Patient is 12 years of age or older, AND
• Patient has iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma, AND
• Prescribed by or in consultation with an oncologist or radiologist

Paraganglioma:

• Patient is 12 years of age or older, AND
• Patient has iobenguane scan positive, unresectable, locally advanced or metastatic paraganglioma, AND
• Prescribed by or in consultation with an oncologist or radiologist

Dosing:

• Dosimetric dose:
  • >50 kg: 185 to 222 MBq (5 to 6 mCi)
  • 50 kg or less: 3.7 MBq/kg (0.1 mCi/kg)
• Therapeutic dose:
  • >62.5 kg: 18,500 MBq (500 mCi)
  • 62.5 kg or less: 296 MBq/kg (8 mCi/kg)
• Administer dosimetric dose followed by two therapeutic doses 90 days apart
• Adjust therapeutic doses based on radiation dose estimate results from dosimetry if needed
• Do not administer if platelet count is less than 80,000/mcL or absolute neutrophil count is less than 1,200/mcL

Approval:

• 6 months