AdreView

Name: AdreView

What Is Iobenguane I-123?

Iobenguane I-123 is in a group of drugs called diagnostic radiopharmaceuticals (RAY dee oh far ma SOO tik als). Iobenguane I-123 is a radioactive agent that allows images of specific organs in the body to be detected by a gamma camera.

Iobenguane I-123 is used to detect certain kinds of cancer of the adrenal glands

Iobenguane I-123 may also be used for purposes not listed in this medication guide.

You should not receive this medication if you are allergic to iobenguane. Tell your doctor if you have ever had any type of reaction to another contrast agent, or to potassium.

Before you are treated with iobenguane I-123, tell your doctor if you have kidney disease, a thyroid disorder, if you are dehydrated or unable to urinate, or if you are allergic to iodine.

Tell your doctor about all other medications you are using, especially antidepressants, cold medicines, blood pressure medications, or ADHD medications. You may need to stop using certain drugs for a short time before you receive iobenguane I-123

Drink extra fluids before you receive iobenguane I-123, and for at least 48 hours afterward. Follow your doctor's instructions about the types and amount of liquids you should drink before and after your test. Iobenguane I-123 is radioactive and it can cause dangerous effects on your bladder if it is not properly eliminated from your body through urination.

Do not allow yourself to become dehydrated during the first few days after receiving iobenguane I-123. Call your doctor if you have any vomiting or diarrhea during this time. Follow your doctor's instructions about the types and amount of fluids you should drink.

You should not receive this medication if you are allergic to iobenguane. Tell your doctor if you have ever had any type of reaction to another contrast agent, or to potassium.

To make sure you can safely receive iobenguane I-123, tell your doctor if you have any of these other conditions:

  • kidney disease;
  • a thyroid disorder;
  • if you are dehydrated or unable to urinate; or
  • if you are allergic to iodine.

FDA pregnancy category C. It is not known whether iobenguane I-123 will harm an unborn baby. Tell your doctor if you are pregnant before you are treated with iobenguane I-123.

It is not known whether iobenguane I-123 passes into breast milk or if it could harm a nursing baby. Do not breast-feed within 6 days after receiving iobenguane I-123. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

Older adults may need kidney function tests before receiving iobenguane I-123. Your kidney function may also need to be watched closely after you have received this medication.

Iobenguane I-123 Interactions

Do not allow yourself to become dehydrated during the first few days after receiving iobenguane I-123. Call your doctor if you have any vomiting or diarrhea during this time. Follow your doctor's instructions about the types and amount of fluids you should drink.

You may need to stop using certain drugs for a short time before you receive iobenguane I-123. Tell your doctor about all other medications you are using, especially:

  • atomoxetine (Strattera);
  • labetalol (Normodyne, Trandate);
  • maprotiline (Ludiomil);
  • reserpine;
  • decongestant cold medicines, diet pills, and other stimulants;
  • an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), amoxapine (Asendin), bupropion (Wellbutrin, Zyban), citalopram (Celexa), desipramine (Norpramin), doxepin (Sinequan), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor), paroxetine (Paxil), sertraline (Zoloft), and others; or
  • street drugs, especially cocaine.

There may be other drugs that can affect iobenguane I-123. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

How is iobenguane I-123 given?

Iobenguane I-123 is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. It is usually given about 24 hours before your radiologic test.

At least 1 hour before you are treated with iobenguane I-123, you may be given a liquid drink that contains medicine to protect your thyroid from harmful radioactive effects of iobenguane I-123.

Drink extra fluids before you receive iobenguane I-123, and for at least 48 hours afterward. Follow your doctor's instructions about the types and amount of liquids you should drink before and after your test. Iobenguane I-123 is radioactive and it can cause dangerous effects on your bladder if it is not properly eliminated from your body through urination.

Expect to urinate often during the first 48 hours after your test. You will know you are getting enough extra fluid if you are urinating more than usual during this time. Urinating often will help rid your body of the radioactive iodine.

Uses For AdreView

Iobenguane I 123 is a radiopharmaceutical. Radiopharmaceuticals are radioactive agents, which may be used to find and treat certain diseases or to study the function of the body's organs.

Iobenguane I 123 is used to find certain kinds of cancer of the adrenal glands (eg, pheochromocytoma, neuroblastoma). When very small doses of iobenguane I 123 are given, the radioactivity taken up by the adrenal gland helps find tumors of the adrenal glands. An image of the gland on film or on a computer screen can be provided to help with the diagnosis.

Iobenguane I 123 is also used during a test for patients with congestive heart failure. This may help the doctor see certain heart problems.

This medicine is to be given only by or under the direct supervision of a doctor with specialized training in nuclear medicine.

Proper Use of AdreView

Your doctor or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.

Drink extra fluids before receiving this medicine so you will pass more urine. You should void frequently for the first 48 hours after receiving this medicine.

Precautions While Using AdreView

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly.

You will be exposed to radiation when you are given this medicine. Talk with your doctor if you have concerns about this.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, swelling of the face, tongue, and throat, trouble breathing, or chest pain after you receive this medicine.

This medicine contains benzyl alcohol which may cause serious reactions to premature or low-birthweight infants. Discuss this with your doctor if you are concerned.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Indications and Usage for AdreView

AdreView is a radiopharmaceutical indicated for use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests.

Warnings and Precautions

Hypersensitivity Reactions

Hypersensitivity reactions have been reported following AdreView administration. Prior to administration, question the patient for a history of prior reactions to iodine, an iodine-containing contrast agent or other products containing iodine. If the patient is known or strongly suspected to have hypersensitivity to iodine, an iodine-containing contrast agent or other products containing iodine, the decision to administer AdreView should be based upon an assessment of the expected benefits compared to the potential hypersensitivity risks. Have anaphylactic and hypersensitivity treatment measures available prior to AdreView administration [see Adverse Reactions (6.2)].

Risks for Benzyl Alcohol Toxicity in Infants

AdreView contains benzyl alcohol at a concentration of 10.3 mg/mL. Benzyl alcohol has been associated with a fatal "Gasping Syndrome" in premature infants and infants of low birth-weight. Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants. There have been rare reports of deaths, primarily in preterm infants, associated with exposure to excessive amounts of benzyl alcohol [see Description (11)].

Observe infants for signs or symptoms of benzyl alcohol toxicity following AdreView administration. AdreView safety and effectiveness have not been established in neonates (pediatric patients below the age of 1 month).

Increased Radiation Exposure in Patients with Severe Renal Impairment

AdreView is cleared by glomerular filtration and is not dialyzable. The radiation dose to patients with severe renal impairment may be increased due to the delayed elimination of the drug. Delayed AdreView clearance may also reduce the target to background ratios and decrease the quality of scintigraphic images. These risks importantly may limit the role of AdreView in the diagnostic evaluation of patients with severe renal impairment. AdreView safety and efficacy have not been established in these patients [see Clinical Pharmacology (12.2)].

Thyroid Accumulation

Failure to block thyroid uptake of iodine 123 may result in an increased long term risk for thyroid neoplasia. Administer thyroid blocking medications before AdreView administration [see Dosage and Administration (2.2)].

Risks with Concomitant Medication Withdrawal

Drugs which interfere with norepinephrine uptake or retention may decrease the uptake of AdreView in neuroendocrine tumors and lead to false negative imaging results. When medically feasible, stop these drugs before AdreView administration and monitor patients for the occurrence of clinically significant withdrawal symptoms, especially patients with elevated levels of circulating catecholamines and their metabolites [see Drug Interactions (7)].

Hypertension

Assess the patient's pulse and blood pressure before and intermittently for 30 minutes after AdreView administration. AdreView may increase release of norepinephrine from chromaffin granules and produce a transient episode of hypertension, although this was not observed in the clinical study. Prior to AdreView administration, ensure emergency cardiac and anti-hypertensive treatments are readily available.

Adverse Reactions

Clinical Study Experience

Serious adverse reactions were not observed in the AdreView clinical study. The data described below reflect AdreView exposure to 251 patients with known or suspected pheochromocytoma or neuroblastoma. The average ages were 49 years (range 17 - 88 years) for adults and, for pediatric patients, 4 years (range 1 month - 16 years). Slightly less than half the patients were male. All patients were monitored for adverse reactions over a 24 hour period following AdreView administration.

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.

Adverse reactions were all mild to moderate in severity and were predominantly isolated occurrences (≤ 2 patients) of one of the following reactions: dizziness, rash, pruritus, flushing or injection site hemorrhage.

Postmarketing Experience

Because postmarketing reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hypersensitivity reactions have uncommonly been reported during the postmarketing use of AdreView [see Warnings and Precautions (5.1)].

What happens if i miss a dose (adreview)?

Since iobenguane I-123 is used only given once before your radiologic test, you will not be on a daily dosing schedule. Call your doctor if for some reason you will not be able to complete your radiologic test within 24 hours after you receive your injection.

Before taking this medicine

You should not be treated with AdreView if you are allergic to iobenguane I-123.

To make sure AdreView is safe for you, tell your doctor if you have:

  • kidney disease;

  • a thyroid disorder;

  • Parkinson's disease or other neurologic disorder;

  • high blood pressure;

  • if you are dehydrated or unable to urinate; or

  • if you are allergic to iodine.

Older adults may need kidney function tests before receiving AdreView. Your kidney function may also need to be watched closely after you have received this medication.

It is not known whether iobenguane I-123 will harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether iobenguane I-123 passes into breast milk or if it could harm a nursing baby. You should not breast-feed within 6 days after receiving AdreView. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

What happens if I miss a dose?

Since AdreView is given only once before your radiologic test, you will not be on a dosing schedule.

Call your doctor if for some reason you will not be able to complete your radiologic test within 24 hours after you receive your injection.

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