For: Pheochromocytoma; Paraganglioma
Azedra (iobenguane I 131) is a radioactive therapeutic agent for the treatment of locally advanced or metastatic pheochromocytoma and paraganglioma . AZEDRA injection, containing 555 MBq/mL (15 mCi/mL) of I-131 (as iobenguane I 131) and 0.006 mg/mL of iobenguane, is a sterile, clear, colorless to pale yellow solution for intravenous use supplied in a colorless Type 1 borosilicate glass 30 mL single-dose vial. AZEDRA is supplied in dosimetric (2 mL) and therapeutic (22.5 mL) presentations:
Dosimetric: 1,110 MBq (30 mCi) of iobenguane I 131 at calibration time (NDC 71258-015-02).
Therapeutic: 12,488 MBq (337.5 mCi) of iobenguane I 131 at calibration time (NDC 71258-015-22).
The product vial is in a lead shielded container placed in a re-sealable plastic bag. The product is shipped on dry ice in a USA DOT Type A Radioactive package.
Store at -70°C (-94°F).
The shelf life is 6 days post calibration time. Discard appropriately at 144 hours. These highlights do not include all the information needed to use AZEDRA safely and effectively. See full prescribing information for AZEDRA.
AZEDRAŽ (iobenguane I 131) solution for intravenous use
Initial U.S. Approval: 2018
INDICATIONS AND USAGE
AZEDRA is a radioactive therapeutic agent 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. (1)
DOSAGE AND ADMINISTRATION
Verify pregnancy status in females of reproductive potential prior to administering AZEDRA. (2.1)
Block thyroid prior to administering AZEDRA. (2.2)
Do not administer if platelet count is less than 80,000/mcL or absolute neutrophil count is less than 1,200/mcL. (2.4)
Administer AZEDRA intravenously as a dosimetric dose followed by two therapeutic doses administered 90 days apart. (2.2)
The recommended dosimetric dose is:
Patients greater than 50 kg: 185 to 222 MBq (5 to 6 mCi)
Patients 50 kg or less: 3.7 MBq/kg (0.1 mCi/kg)
The recommended therapeutic dose for each of the 2 doses is:
Patients greater than 62.5 kg: 18,500 MBq (500 mCi)
Patients 62.5 kg or less: 296 MBq/kg (8 mCi/kg)
Adjust AZEDRA therapeutic doses based on radiation dose estimates results from dosimetry, if needed. (2.2)
DOSAGE FORMS AND STRENGTHS
Injection: 555 MBq/mL (15 mCi/ml) at TOC as a clear solution in a single-dose vial. (3)
WARNINGS AND PRECAUTIONS
Risk from Radiation Exposure: Minimize radiation exposure consistent with institutional radiation safety practices and patient management procedures. (2.1), (5.1)
Myelosuppression: Monitor blood cell counts. Withhold and dose reduce AZEDRA as recommended based on severity of cytopenia. (5.2)
Secondary Myelodysplastic Syndrome, Leukemia and Other Malignancies: The time to development of MDS or acute leukemia ranged from 12 months to 7 years. (5.3)
Hypothyroidism: Initiate thyroid-blocking medication prior to administration and continue after each dose. Monitor for hypothyroidism and thyroid-stimulating hormone levels before starting AZEDRA and annually thereafter. (2.3, 5.4)
Elevations in blood pressure: Monitor blood pressure frequently during the first 24 hours after each therapeutic dose. (5.5)
Renal Toxicity: Monitor renal function during and after treatment. (5.6)
Pneumonitis: Monitor patients for signs and symptoms of pneumonitis and treat appropriately. (5.7)
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females and males of reproductive potential of the potential risk to a fetus and to use effective contraception. (5.8)
Risk of Infertility: May cause infertility (5.9)
The most common Grade 3-4 adverse reactions (? 10%) were lymphopenia, neutropenia, thrombocytopenia, fatigue, anemia, increased international normalized ratio, nausea, dizziness, hypertension, and vomiting. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Progenics Pharmaceuticals, Inc at 844-668-3950 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drugs that Reduce Catecholamine Uptake or Deplete Stores: Discontinue these drugs prior to and following AZEDRA administration. (2.3), (7)
USE IN SPECIFIC POPULATIONS
Lactation: Advise women not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION.