Cerianna (Intravenous)

Fluoroestradiol F 18 injection is used along with a biopsy to help find estrogen receptor (ER)-positive lesions in patients with recurrent or metastatic breast cancer (cancer that comes back 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 for your doctor to check your progress very closely while you are receiving this medicine. This will help your doctor see if the medicine is working properly and decide if you should keep receiving 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, you and your doctor will need to think about the risks of the test compared to the benefits it may provide. Other factors can also affect the results of the test. For this test, consider the following:

Allergies

The dose of this medicine may vary for different patients. Follow your doctor's instructions 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 you take depends on its strength. 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 you are treating.

Pediatric

There have not been appropriate studies on how age affects the use of fluoroestradiol F 18 injection in children. Safety and effectiveness have not been established for this age group.

Geriatric

Studies conducted so far have not found any specific problems in older adults that would limit the use of fluoroestradiol F 18 injection.

Breast Feeding

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

Interactions with Medicines

Some medicines should never be used together, while others can be used together even if they might interact. In such cases, your doctor may adjust the dose or take other precautions. It is especially important that your healthcare provider knows if you are taking any of the medicines listed below when you are receiving this diagnostic test. The following interactions are highlighted for their potential significance but are not all-inclusive.

Using this diagnostic test with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may change the dose or frequency of one or both medicines.

• Fulvestrant
• Tamoxifen

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating or with certain foods because interactions may happen. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare provider about using your medicine with food, alcohol, or tobacco.

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

Some side effects might occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Additionally, your health care professional may be able to provide ways to prevent or reduce some of these side effects. Talk to your health care professional if any of the following side effects persist, 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, consult 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.