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Azedra Generic Name & Formulations
Legal Class
Rx
General Description
Iobenguane I 131 555MBq/mL (15mCi/mL); soln for IV inj.
Pharmacological Class
Radioactive therapeutic agent.
How Supplied
Single-dose vial (30mL)—1
Manufacturer
Generic Availability
NO
Azedra Indications
Indications
Treatment of patients with iobenguane scan (+), unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy.
Azedra Dosage and Administration
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.
Azedra Contraindications
Not Applicable
Azedra Boxed Warnings
Not Applicable
Azedra Warnings/Precautions
Warnings/Precautions
Should only be used by trained and experienced physicians in the safe use and handling of radionuclides to minimize radiation exposure. 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 and for 7 months (females of reproductive potential) or 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).
Azedra Pharmacokinetics
See Literature
Azedra Interactions
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.
Azedra Adverse Reactions
Adverse Reactions
Lymphopenia, neutropenia, thrombocytopenia, fatigue, anemia, increased INR, nausea, dizziness, hypertension, vomiting; secondary myelodysplastic syndrome, leukemia, malignancy, hypothyroidism, renal toxicity, pneumonitis (monitor).
Azedra Clinical Trials
See Literature
Azedra Note
Not Applicable
Azedra Patient Counseling
See Literature
