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Azedra

Last reviewed on RxList: 8/1/2019
Azedra Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 8/1/2019

Azedra (iobenguane I 131) is a radioactive therapeutic agent 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. Common side effects of Azedra include:

The recommended dose of Azedra for patients greater than 50 kg is 185 to 222 MBq (5 to 6 mCi) and for patients 50 kg or less the dose is 3.7 MBq/kg (0.1 mCi/kg). The recommended therapeutic dose of Azedra for each of the 2 doses for patients greater than 62.5 kg is 18,500 MBq (500 mCi), and for patients 62.5 kg or less the dose is 296 MBq/kg (8 mCi/kg). Azedra may interact with CNS stimulants or amphetamines, norepinephrine and dopamine reuptake inhibitors, norepinephrine and serotonin reuptake inhibitors, monoamine oxidase inhibitors (MAOIs), central monoamine depleting drugs, beta-blockers, alpha agonists or alpha/beta agonists, tricyclic antidepressants or norepinephrine reuptake inhibitors, and some botanicals (ephedra, ma huang, St John's wort, yohimbine). Tell your doctor all medications and supplements you use. Azedra is not recommended for use during pregnancy; it may harm a fetus. It is unknown if Azedra passes into breast milk. Because of the potential for adverse effects on nursing infants, breastfeeding while using Azedra is not recommended.

Our Azedra (iobenguane I 131) Injection, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Azedra Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • chest pressure, dry cough, feeling short of breath;
  • easy bruising, unusual bleeding, purple or red spots under your skin;
  • thyroid symptoms--extreme tired feeling, dry skin, joint pain or stiffness, muscle pain or weakness, hoarse voice, feeling more sensitive to cold temperatures, weight gain;
  • low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough, trouble breathing; or
  • low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common side effects may include:

  • low blood cell counts;
  • feeling tired;
  • nausea, vomiting;
  • dizziness; or
  • low blood pressure (feeling light-headed).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Azedra (Iobenguane I 131 Injection)

Azedra Professional Information

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in the labeling:

  • Myelosuppression [see WARNINGS AND PRECAUTIONS]
  • Secondary Myelodysplastic Syndrome, Leukemia and Other Malignancies [see WARNINGS AND PRECAUTIONS]
  • Hypothyroidism [see WARNINGS AND PRECAUTIONS]
  • Elevations in Blood Pressure [see WARNINGS AND PRECAUTIONS]
  • Renal Toxicity [see WARNINGS AND PRECAUTIONS]
  • Pneumonitis [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data in Warnings and Precautions reflect exposure to AZEDRA in 88 patients with iobenguane-scan positive recurrent or unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (PPGL) who received a therapeutic dose of AZEDRA in one of two clinical studies (IB12 or IB12B). The Warnings and Precautions also include data from 11 patients enrolled in an expanded access program for Study IB12B [see WARNINGS AND PRECAUTIONS].

The safety data below was evaluated in two studies in patients with recurrent or unresectable, locally advanced or metastatic PPGL. Study IB12 was an open-label, multi-center, single-arm dose-finding study in adult patients with malignant or recurrent PPGL. The study consisted of a 12-month efficacy phase with a 1 year follow-up. Twenty-one patients received a dosimetric dose (~5 mCi), followed by one therapeutic dose (~500 mCi) of AZEDRA. Study IB12B was an open-label, multi-center, single-arm study in 68 adult and pediatric patients age 12 years and older with recurrent or unresectable, locally advanced or metastatic PPGL [see Clinical Studies].

Patients with evidence of liver dysfunction (aspartate aminotransferase or alanine aminotransferase ≥ 2.5 times the upper limit of normal or total bilirubin > 1.5 times the upper limit of normal), a history of liver disease (including hepatitis and chronic alcohol abuse), or severe renal impairment (creatinine clearance < 30 mL/min) were excluded. Patients who had received external beam radiation to > 25% of bone marrow, received whole body radiotherapy, or who had received any systemic radiotherapy resulting in myelosuppression within 3 months of study entry, were also excluded. The safety data described below are based on pooled safety data from studies IB12 and IB12B. A total of 88 patients received at least one therapeutic dose of AZEDRA and 50 patients received two therapeutic doses (one patient received treatment in both studies).

Adverse reactions from studies IB12 and IB12B are presented in Table 5. The most common severe (Grade 3-4) adverse reactions were lymphopenia (78%), neutropenia (59%), thrombocytopenia (50%), fatigue (26%), anemia (24%), increased international normalized ratio (18%), nausea (16%), dizziness (13%), hypertension (11%), and vomiting (10%). Twelve percent of patients discontinued treatment due to adverse reactions (thrombocytopenia, anemia, lymphopenia, nausea and vomiting, multiple hematologic adverse reactions).

Table 5: Adverse Reactions Occurring in ≥10% of Patients with PPGL Receiving Therapeutic Dose of AZEDRA in Studies IB12B and IB12

Adverse Reaction All Gradesa, (%) Gradesa 3 - 4, (%)
Hematologicb
  Lymphopenia 96 78
  Anemia 93 24
  Thrombocytopenia 91 50
  Neutropenia 84 59
Gastrointestinal
  Nausea 78 16
  Vomitingc 58 10
  Dry mouth 48 2
  Sialadenitisd 39 1
  Diarrhea 25 3
  Abdominal paine 23 6
  Constipation 19 7
  Oropharyngeal pain 14 0
  Dyspepsia 10 0
General
  Fatiguef 71 26
  Pyrexia 14 2
  Injection site pain 10 0
  Hyperhidrosis 10 0
  Alopecia 10 0
Infections
  Upper respiratory tract infectiong 16 2
  Urinary tract infection 11 1
Investigationsb
  Increased international normalized ratioh 85 18
  Increased blood alkaline phosphatase 53 5
  Increased aspartate aminotransferase 50 2
  Increased alanine aminotransferase 43 2
Metabolism and nutrition
  Decreased appetite 30 5
  Dehydration 16 4
  Decreased weight 16 1
Musculoskeletal and connective tissue disorders
  Back pain 17 2
  Pain in extremity 15 0
Nervous system
  Dizzinessi 34 13
  Headache 32 6
  Dysgeusiaj 24 1
Respiratory, thoracic, and mediastinal disorders
  Cough 18 0
  Dyspnea 18 7
Vascular
  Hypotension 24 4
  Hypertensionk 20 11
  Tachycardia 10 3
a NCI CTCAE version 3.0
b Based on laboratory data
c Includes vomiting and retching
d Includes sialoadenitis, salivary gland pain, and salivary gland enlargement
e Includes abdominal pain, abdominal pain upper, and abdominal pain lower.
f Incudes fatigue, asthenia.
g Includes upper respiratory tract infection, sinusitis, rhinorrhea, upper-airway cough syndrome, nasopharyngitis
h Only assessed in Study IB12B (N=68)
i Includes dizziness and dizziness postural
j Includes dysgeusia, hypogeusia and ageusia
k Includes blood pressure increased and hypertension.

The following clinically significant adverse reactions were observed in < 10% of patients treated with AZEDRA:

Cardiac: palpitations (9%), syncope and presyncope (8%)
Endocrine: decreased TSH (5%), hypothyroidism (3%)
Gastrointestinal: dysphagia (7%), abdominal distension (6%), gastroesophageal reflux disease (6%), stomatitis (3%)
General: insomnia (9%), chills (8%), chest pain (6%)
Infections: candida infection (6%)
Investigations: prolonged prothrombin time (9%)
Musculoskeletal and connective tissue: arthralgia (8%), neck pain (8%), pain in jaw (7%), muscle spasms (6%)
Renal and urinary disorders: proteinuria (9%), renal failure (7%),
Respiratory: epistaxis (9%), nasal congestion (7%), pulmonary embolism (3%)
Skin and subcutaneous tissue: dry skin (8%), rash (8%), petechiae (7%)
Vascular: orthostatic hypotension (9%)

Read the entire FDA prescribing information for Azedra (Iobenguane I 131 Injection)

Related Resources for Azedra

Related Health

© Azedra Patient Information is supplied by Cerner Multum, Inc. and Azedra Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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