AdreView

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

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.

• If you have an allergy to iobenguane or any other part of AdreView (iobenguane I 123).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• This medicine may interact with other drugs or health problems.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take AdreView with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Check blood pressure and heart rate as the doctor has told you. Talk with the doctor.
• Unsafe allergic effects may rarely happen.
• Some other drugs and health problems may cause false results of the test AdreView is being used for. There are many drugs and health problems that can do this. Ask the doctor or pharmacist if you are not sure.
• A drug to protect the thyroid gland will be given to you. Take it as you have been told. If this is not done, the chance of thyroid cancer later in life may be raised. Talk with your doctor.
• This medicine is radioactive. You will need to follow what the doctor has told you to lessen being exposed to this medicine. Talk with the doctor.
• This medicine has benzyl alcohol in it. Benzyl alcohol may cause very bad and sometimes deadly side effects in newborns or infants. Talk with the doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using AdreView while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad headache.
• Very bad dizziness or passing out.

Single use vials containing 5 mL solution for intravenous injection (2 mCi/mL at calibration time).

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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Iobenguane hemisulfate was not mutagenic in vitro in the Ames bacterial mutation assay and in the in vitro mouse lymphoma test, and was negative in the in vivo micronucleus test in rats.

Long-term animal studies have not been conducted to evaluate AdreView's carcinogenic potential or potential effects on fertility.

Animal Toxicology and/or Pharmacology

Iobenguane sulfate testing in dogs revealed electrocardiographic (ECG) changes after administration of 202 times the mg/m2 conversion of the maximum human dose for a 60 kg adult; the no observable effect level (NOEL) was not determined. When iobenguane was tested in a cell system stably expressing hERG-1 potassium channels, inhibition of potassium channels was not observed at an 80 µM iobenguane concentration and the IC50 was 487 µM.

AdreView is supplied in 10 mL glass vials containing a total volume of 5 mL of solution with a total radioactivity of 370 MBq (10 mCi) at calibration time. Each vial is enclosed in a lead container of appropriate thickness.

NDC 17156-235-01

Storage

Store AdreView at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP]. This product does not contain a preservative. Store within the original lead container or equivalent radiation shielding.

In accordance with USP recommendations Iobenguane I 123 Injection preparations should not be used after the expiration date and time stated on the label.

Handling

This preparation is approved for use by persons licensed by the Illinois Emergency Management Agency pursuant to 32 Ill. Adm. Code Section 330.260(a) and 355.4010 or equivalent licenses of the Nuclear Regulatory Commission or an Agreement State.

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Do not allow yourself to become dehydrated during the first few days after receiving AdreView. 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.