Azedra iobenguane I-131

Get an overview of AZEDRA (iobenguane i-131 injection, solution), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in Azedra can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as Azedra.

Drug Basics

Brand Name: Azedra

Generic Name: IOBENGUANE I-131

Drug Type: HUMAN PRESCRIPTION DRUG

Route: INTRAVENOUS

Dosage Form: INJECTION, SOLUTION

Data Current As Of: 2019-03-11

indications & usage

AZEDRA is 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.

drug interactions

drugs that reduce catecholamine uptake or deplete stores

Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells and therefore interfere with dosimetry calculations or the efficacy of AZEDRA. These drugs were not permitted in clinical trials that assessed the safety and efficacy of AZEDRA. Discontinue drugs that reduce catecholamine uptake or deplete catecholamine stores, such as those listed below, for at least 5 half-lives before administration of either the dosimetry or a therapeutic dose of AZEDRA. Do not administer these drugs until at least 7 days after each AZEDRA dose [see Dosage and Administration (2.3)].

  • CNS stimulants or amphetamines (e.g. cocaine, methylphenidate, dextroamphetamine)
  • Norepinephrine and dopamine reuptake inhibitors (e.g. phentermine)
  • Norepinephrine and serotonin reuptake inhibitors (e.g. tramadol)
  • Monoamine oxidase inhibitors (e.g. phenelzine and linezolid)
  • Central monoamine depleting drugs (e.g. reserpine)
  • Non-select beta adrenergic blocking drugs (e.g. labetalol)
  • Alpha agonists or alpha/beta agonists (e.g. pseudoephedrine, phenylephrine, ephedrine, phenylpropanolamine, naphazoline)
  • Tricyclic antidepressants or norepinephrine reuptake inhibitors (e.g. amitriptyline, buproprion, duloxetine, mirtazapine, venlafaxine)
  • Botanicals that may inhibit reuptake of norepinephrine, serotonin or dopamine (e.g. ephedra, ma huang, St John’s Wort, yohimbine)

patient counseling information

Hydration

Advise patients to drink at least 2 liters of liquid a day before and for one week following each dose of AZEDRA to minimize irradiation of the bladder [see Dosage and Administration (2.3)].

Radiation Risks

Advise patients to minimize radiation exposure to household contacts consistent with institutional good radiation safety practices and patient management procedures [see Dosage and Administration (2.3), Warnings and Precautions(5.1)].

Myelosuppression

Advise patients to contact their health care provider for any signs or symptoms of neutropenia, thrombocytopenia, or anemia [see Warnings and Precautions (5.2)].

Secondary Myelodysplastic Syndrome, Leukemia and Other Malignancies

Advise patients of the potential for secondary cancers, including myelodysplastic syndrome, acute leukemia, and other malignancies [see Warnings and Precautions (5.3)].

Hypothyroidism

Advise patients to take thyroid-blocking agents as prescribed. Advise patients of the need for life-long monitoring for hypothyroidism [see Warnings and Precautions (5.4)].

Elevations in Blood Pressure

Advise patients to contact their health care provider for signs or symptoms that may occur following tumor-hormone catecholamines release and possible risk of increased blood pressure during or 24 hours following each therapeutic AZEDRA dose [see Warnings and Precautions (5.5)].

Pneumonitis

Advise patients to contact their health care provider for signs or symptoms of pneumonitis [see Warnings and Precautions (5.7)].

Drug Interactions

Advise patients that some medicines interact with AZEDRA and to contact their health care provider before starting any over the counter medicines or herbal or dietary supplements.

Embryo-Fetal Toxicity

Advise pregnant women and males and females of reproductive potential of the potential risk to a fetus. Advise females to inform their health care provider of a known or suspected pregnancy [see Warnings and Precautions (5.8), Use in Specific Populations (8.1), (8.3)].

Advise females of reproductive potential to use effective contraception during treatment with AZEDRA and for 7 months after the final dose [see Use in Specific Populations (8.1), (8.3)].

Advise male patients with female partners of reproductive potential to use effective contraception during treatment with AZEDRA and for 4 months after the final dose [see Warnings and Precautions (5.8), Use in Specific Populations (8.3)].

Lactation

Advise females not to breastfeed during treatment with AZEDRA and for 80 days after the final dose [see Use in Specific Populations (8.2)].

Infertility

Advise females and males patients that AZEDRA may impair fertility [see Warnings and Precautions (5.9), Use in Specific Populations (8.3)].

Manufactured for:
Progenics Pharmaceuticals, Inc.
One World Trade Center, 47th floor, Suite J
New York, NY 10007

AZEDRA® is a registered trademark of Progenics.

AZEDRA® (iobenguane I 131) injection, for intravenous use
Package Handling Instructions


Always handle dry ice with care and wear personal protective equipment
IMPORTANT: Make sure to save the following items for courier to pick up (see directions below):
  • Items that will be collected at time of delivery:
    • Temperature monitor
    • Aluminum tubes
    • Shipping box
  •  Lead pot (this is to be collected during the next scheduled delivery date)
  • Reading the Temperature Monitor
    • Locate the temperature monitor on top of the Styrofoam lid in the shipper (Figure 1)
      • Note: do not disconnect the monitor from the probe
    • Immediately read the display screen for the running icon in the upper left corner of the screen (Figures 2 and 3).
    • If the running icon is not present, do not use the product and call AZEDRA Service Connection immediately at 1-844-AZEDRA1 (1-844-293-3721) for further instructions.
    • If the running icon is present, immediately read the display screen for alarm status: (X) for alarm and (✓) for no alarm at the top of the screen (Figures 2 and 3).
    • Press and hold the stop button for 5 – 10 seconds until the stop icon appears in the upper right corner of the screen (Figures 4 and 5)
      • Note: the running icon will disappear when the monitor is stopped
      azedra 02.jpg

      azedra 03.jpg

      azedra 04.jpg

    • If an alarm icon is displayed after holding the stop button for 5/10 seconds (Figure 4), an (X) will be displayed on the temperature monitor screen, do not use. Store the drug product in the lead pot in a -70°C freezer, and call AZEDRA Service Connection immediately at 1-844-AZEDRA1 (1-844-293-3721) for further instructions.
    • If “no alarm” icon is displayed after holding the stop button for 5/10 seconds (Figure 5), a check mark (✓) will be displayed on the temperature monitor screen. Store the drug product in the lead pot in a -70°C freezer, or thaw for use.
    • The courier will remain on site or return the same day as the delivery date to retrieve the “stopped” temperature monitor with probe attached along with the other packaging items. Lead pot will be collected during the next scheduled delivery date.
  • Unpacking Procedures
    • Remove the temperature monitor probe by unwrapping the probe from around the handle of the assembly container.
    • Remove the assembly container and holding tube containing the lead pot from the square center aluminum tube (Figure 6).
    • Remove the lead pot by unscrewing the assembly container.
    • Place the lead pot containing AZEDRA into ≤ -70°C storage or thaw for use.
    • Place the assembly container and holding tube back into the square center aluminum tube and save for pick up by the courier.
      azedra 05.jpg

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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