Fluoroestradiol f 18 (Intravenous)

Fluoroestradiol F 18 injection is used along with biopsy to help find estrogen receptor (ER)-positive lesions in patients with recurrent or metastatic breast cancer (cancer that keeps returning or has spread to 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 find 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 that may be used to find and treat certain diseases or to study how the body's organs work.

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

It is very important that your doctor checks 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 (for example, fulvestrant, tamoxifen), which may affect how this medicine works. Make sure to tell your doctor about all other medicines that you are using before receiving the injection.

In deciding to use a diagnostic test, any risks of the test must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. Also, other factors may influence test results. For this test, consider the following:

Allergies

The dose of this medicine can vary for different patients. Follow your doctor's instructions or the directions on the label. The information provided includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to.

The amount of medicine you take depends on the strength of the medicine. The number of doses you take each day, the time between doses, and how long you take the medicine also depend on the medical issue for which you are using it.

Pediatric

Appropriate studies have not been done on how age affects the effects of fluoroestradiol F 18 injection in children. Safety and effectiveness have not been established.

Geriatric

Studies conducted so far have not found any age-related problems in older adults that would limit the usefulness of fluoroestradiol F 18 injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to adjust the dose, or other precautions may be necessary. When you are receiving this diagnostic test, it is especially important for your healthcare provider to know if you are taking any of the medicines listed below. The following interactions have been selected based on 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 necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you take one or both of the medicines.

• Fulvestrant
• Tamoxifen

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Along with its needed effects, a medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Some side effects might happen that usually do not need medical attention. These side effects may go away during treatment as your body gets used to the medicine. Your health care professional may also be able to suggest ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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 can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Cerianna

Available Dosage Forms:

• Solution

Therapeutic Class: Diagnostic Agent, Radiological Contrast Media

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.