AdreView

What Is AdreView?

AdreView (iobenguane I 123) Injection is a diagnostic radiopharmaceutical used to detect certain kinds of cancer of the adrenal glands.

What Are Side Effects of AdreView?

Common side effects of AdreView include:

• dizziness
• mild skin rash or itching
• bleeding around your IV needle, or
• flushing (warmth, tingling, or cold feeling) where the medicine was injected

Dosage for AdreView

For adults ( ≥ 16 years of age), the recommended dose of AdreView is 10 mCi (370 MBq). For pediatric patients < 16 years of age weighing ≥ 70 kg, the recommended dose of AdreView is 10 mCi (370 MBq).

What Drugs, Substances, or Supplements Interact with AdreView?

AdreView may interact with atomoxetine, labetalol, maprotiline, reserpine, decongestant cold medicines, diet pills, other stimulants, antidepressants, or street drugs, especially cocaine. Tell your doctor all medications and supplements you use.

AdreView During Pregnancy and Breastfeeding

It is unknown if AdreView will harm a fetus. Tell your doctor if you are pregnant before you are treated with this drug. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Do not breastfeed 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.

Additional Information

Our AdreView (iobenguane I 123) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

AdreView 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.

Common side effects may include:

• dizziness;
• rash, itching;
• flushing (warmth, redness, or tingly feeling);
• headache; or
• bleeding around your IV needle.

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 AdreView (Iobenguane I 123 Injection for Intravenous Use)

 

AdreView Professional Information

SIDE EFFECTS

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 occurrences (≤ 2 patients) of one of the following reactions: dizziness, rash, pruritus, flushing or injection site hemorrhage.

Congestive Heart Failure

No serious adverse reactions to AdreView were observed in clinical studies. Adverse reactions that occurred with a frequency > 1% were associated with the injection site (1.3%), problems such as hematoma and bruising. The other most common reactions were flushing (0.3%) and headache (0.4%). The adverse reactions were predominantly of mild to moderate intensity.

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].

Read the entire FDA prescribing information for AdreView (Iobenguane I 123 Injection for Intravenous Use)