AdreView 2 mCi/mL
Iobenguane I-123 · INJECTION · Medi-Physics Inc.
AdreView is a injection containing iobenguane i-123 at 2 mCi/mL, taken intravenous. Manufactured by Medi-Physics Inc..
Key Facts
- Brand Name
- AdreView
- Generic Name
- Iobenguane I-123
- NDC Code (Product)
17156-235- Manufacturer
- Medi-Physics Inc.
- Strength
- 2 mCi/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA022290
- Marketing Start
- 09/19/2008
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE AdreView is a radiopharmaceutical agent for gamma-scintigraphy indicated for: use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests ( 1.1 ) scintigraphic assessment of sympathetic innervation of the myocardium by measurement of the heart to mediastinum (H/M) ratio of radioactivity uptake in patients with New York Heart Association (NYHA) class II or class III heart failure and left ventricular ejection fraction (LVEF) ≤ 35%. Among these patients, AdreView may be used to help identify patients with lower one and two year mortality risks, as indicated by an H/M ratio ≥ 1.6. ( 1.2 ) Limitations of Use: In patients with congestive heart failure, AdreView utility has not been established for: selecting a therapeutic intervention or for monitoring the response to therapy; using the H/M ratio to identify a patient with a high risk for death. 1.1 Pheochromocytoma and Neuroblastoma AdreView is a radiopharmaceutical indicated for use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests. 1.2 Congestive Heart Failure AdreView is indicated for …
Dosage & Administration
2 DOSAGE AND ADMINISTRATION AdreView emits radiation and must be handled with appropriate safety measures. ( 2.1 , 2.6 ) Administer thyroid blockade medications to patients at risk for thyroid accumulation of AdreView. ( 2.2 , 5.6 ) Measure patient dose by a suitable radioactivity calibration system immediately prior to administration. ( 2.4 ) For patients ≥ 16 years of age or < 16 years of age and ≥ 70 kg: administer 10 mCi (370 MBq). ( 2.4 , 2.5 ) For patients < 16 years of age and < 70 kg: amount scaled to the adult reference activity based on weight. ( 2.5 ) 2.1 Radiation Safety AdreView emits radiation and must be handled with appropriate safety measures to minimize radiation exposure to clinical personnel and patients. Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides. AdreView dosing is based upon the radioactivity determined using a suitable calibration system immediately prior to administration. To minimize radiatio…
Contraindications
4 CONTRAINDICATIONS AdreView is contraindicated in patients with known hypersensitivity to iobenguane or iobenguane sulfate. Known hypersensitivity to iobenguane or iobenguane sulfate. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS The following drugs have the potential to decrease the uptake of norepinephrine and cause false negative imaging results: antihypertensives that deplete norepinephrine stores or inhibit reuptake (e.g., reserpine, labetalol), antidepressants that inhibit norepinephrine transporter function (e.g., amitriptyline and derivatives, imipramine and derivatives, selective serotonin reuptake inhibitors), sympathomimetic amines (e.g., phenylephrine, phenylpropanolamine, pseudoephedrine and ephedrine), and cocaine. Clinical studies have not determined which specific drugs may cause false negative imaging results nor whether all drugs in any specific pharmacologic class have the same potential to produce the negative imaging results. Increasing the dose of AdreView will not overcome any potential uptake limiting effect of these drugs. Before AdreView administration, discontinue (for at least 5 biological half-lives) drugs known or expected to reduce norepinephrine uptake, as clinically tolerated. Amitryptiline and derivatives, imipramine and derivatives, other antidepressants that inhibit norepinephrine transporter, antihypertensives that deplete norepinephrine stores or inh…
Adverse Reactions
6 ADVERSE REACTIONS Serious hypersensitivity reactions have been reported following AdreView administration. The most common adverse reactions, dizziness, rash, pruritis, flushing, headache, and injection site hemorrhage occurred in < 1.3% of patients. ( 6.1 , 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 1-800-654-0118 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Study 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. During clinical development 1346 patients were exposed to AdreView, 251 patients with known or suspected pheochromocytoma or neuroblastoma, 985 patients with heart failure, and 110 control patients. All patients were monitored for adverse reactions over a 24 hour period following AdreView administration. Pheochromocytoma and Neuroblastoma Serious adverse reactions were not observed in the AdreView clinical study. Adverse reactions were all mild to moderate in severity and were predominantly isolated occur…
Frequently Asked Questions
What is AdreView used for?
AdreView contains Iobenguane I-123. It is a injection taken intravenous. Consult your doctor for specific uses.
Is AdreView a controlled substance?
AdreView is not classified as a controlled substance by the DEA.
What is the generic name for AdreView?
The generic name for AdreView is Iobenguane I-123. There are no other listed brand versions of Iobenguane I-123.
What is the NDC code for AdreView 2 mCi/mL?
The NDC (National Drug Code) for AdreView 2 mCi/mL is 17156-235, listed by Medi-Physics Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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