Pronunciation:

floor-oh-es-tra-DYE-ol F 18

Brand Names:

• Cerianna

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Diagnostic Agent, Radiological Contrast Media

Uses of This Medicine:

Fluoroestradiol F 18 injection is used together with biopsy to help detect estrogen receptor (ER)-positive lesions in patients with recurrent or metastatic breast cancer (cancer that keeps coming back or has spread to the other parts of the body). It is used in a procedure called positron emission tomography (PET) scan to help your doctor see an image of your breast. This medicine is not used to detect other types of lesion receptors, including human epidermal growth factor receptor 2 (HER2) and progesterone receptor (PR).

Fluoroestradiol F 18 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.

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

Before Using This Medicine:

In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, the following should be considered:

Allergies—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of fluoroestradiol F 18 injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fluoroestradiol F 18 injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this diagnostic test, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this diagnostic test with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Fulvestrant
• Tamoxifen

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine:

A doctor or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins just before you have a PET scan.

You will need to drink enough water to be hydrated before the PET scan.

Continue to drink and urinate as often as possible during the first few hours after receiving the medicine to minimize your radiation exposure.

Precautions While Using This Medicine:

It is very important that your doctor check your progress very closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

While receiving this medicine, you will be exposed to radiation. If you have any questions about this, talk to your doctor.

It is important to tell your doctor if you are pregnant before receiving this medicine.

Some medicines can also act on the estrogen receptors (eg, fulvestrant, tamoxifen), which may affect how this medicine works. Make sure to tell your doctor of all other medicines that you are using before receiving the injection.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare

Change in or loss of taste

pain, redness, or irritation at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.