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Azedra

iobenguane I-131
Radiopharmaceutical FDA Approved 2018 Progenics
Route
IV
Half-Life
~9 days
FDA Approved
2018
Manufacturer
Progenics
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1. Indications and Usage

Iobenguane I-131-avid unresectable pheo/para.

2. Dosage and Administration

2 therapeutic doses ~500 mCi, 90+ days apart.

3. Dosage Forms and Strengths

Injection for IV

4. Contraindications

None listed.

5. Warnings and Precautions
  • Myelosuppression: Prolonged cytopenias.
  • Hypothyroidism: Block thyroid.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Thrombocytopenia (89%), Lymphopenia (82%), Neutropenia (63%), Anemia (61%), Fatigue (47%), Nausea (42%)

Thrombocytopenia
89%
Lymphopenia
82%
Neutropenia
63%
Anemia
61%
Fatigue
47%
Nausea
42%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

Catecholamine uptake drugs may interfere.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Radiopharmaceutical delivering I-131 beta radiation via norepinephrine transporter.

Pharmacokinetics

Whole-body t1/2: ~36-48h.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
FDA-Approved Tumor Types

Azedra has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

External Resources
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Azedra. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Azedra (iobenguane I-131) approved for?

Azedra (iobenguane I-131) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Azedra (iobenguane I-131) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Azedra (iobenguane I-131) work?

Radiopharmaceutical delivering I-131 beta radiation via norepinephrine transporter.

What are the most common side effects?

Thrombocytopenia (89%), Lymphopenia (82%), Neutropenia (63%), Anemia (61%), Fatigue (47%), Nausea (42%) Thrombocytopenia 89% Lymphopenia 82% Neutropenia 63% Anemia 61% Fatigue 47% Nausea 42%