Pancreatic, thyroid, and other endocrine cancers:
Indications for AZEDRA:
Treatment of patients with iobenguane scan (+), unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy.
Adults and Children:
<12yrs: not established. Administer thyroid blockade and other pre- and concomitant medications as recommended (see full labeling). ≥12yrs: Dosimetric dose (administer by IV inj over 60secs): ≤50kg: 3.7MBq/kg (0.1mCi/kg); >50kg: 185–222MBq (5 or 6mCi). Following the dosimetric dose, perform biodistribution assessment (see full labeling). Therapeutic dose (give total of 2 doses at minimum 90 days apart); administer over 30mins at 100mL/hr (adults) or over 60mins at 50mL/hr (children ≥12yrs): ≤62.5kg: 296MBq/kg (8mCi/kg); >62.5kg: 18,500MBq (500mCi). Dose modifications for adverse reactions: see full labeling.
Should be used by physicians trained and experienced in radiopharmaceuticals. Handle with appropriate safety measures to minimize radiation exposure during and after Azedra. Increased risk for cancer with long-term cumulative radiation exposure (esp. children). Monitor CBCs weekly for up to 12 weeks or until levels normalize; withhold and reduce dose based on severity of cytopenia. Evaluate for hypothyroidism; measure TSH levels prior to initiation and yearly thereafter. Monitor BP frequently during the first 24hrs after each dose. Monitor renal function during and after treatment; assess more frequently in mild or moderate impairment. Severe renal impairment (CrCl <30mL/min) or ESRD: not studied. Risk of infertility. Embryo-fetal toxicity. Use effective contraception during therapy and for 7 months (females), and 4 months (males w. female partners) after final dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during therapy and for 80 days after final dose).
Radioactive therapeutic agent.
Discontinue drugs that reduce catecholamine uptake or deplete catecholamine stores (eg, CNS stimulants, amphetamines, norepinephrine and dopamine reuptake inhibitors, norepinephrine and serotonin reuptake inhibitors, MAOIs, central monoamine depleting drugs, non-selective beta-blockers, alpha agonists or alpha/beta agonists, tricyclic antidepressants, norepinephrine reuptake inhibitors, botanicals that may inhibit reuptake of norepinephrine, serotonin or dopamine) for ≥5 half-lives before dosimetry or therapeutic dose; do not give until ≥7 days after each Azedra dose.
Lymphopenia, neutropenia, thrombocytopenia, fatigue, anemia, increased INR, nausea, dizziness, hypertension, vomiting; secondary myelodysplastic syndrome, leukemia, malignancy, hypothyroidism, renal toxicity, pneumonitis (monitor).
Single-dose vial (30mL)—1