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.

Warnings/Precautions:

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).

Pharmacologic Class:

Radioactive therapeutic agent.

Interactions:

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.

Adverse Reactions:

Lymphopenia, neutropenia, thrombocytopenia, fatigue, anemia, increased INR, nausea, dizziness, hypertension, vomiting; secondary myelodysplastic syndrome, leukemia, malignancy, hypothyroidism, renal toxicity, pneumonitis (monitor).

Generic Availability:

NO

How Supplied:

Single-dose vial (30mL)—1

Pricing for AZEDRA

2ml of 30mCi/ml vial (Qty: 1)
Appx. price $8970
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