Fludeoxyglucose f 18 (Intravenous)

Fludeoxyglucose F 18 injection is used to help diagnose cancer, heart disease, and epilepsy. It is used in a procedure called a positron emission tomography (PET) scan to help your doctor see parts of the body, like the heart or brain. Fludeoxyglucose F 18 is part of a group of medicines called radiopharmaceuticals (radioactive agents).

This medicine will be used only by or under the direct supervision of your doctor.

It is very important for your doctor to monitor the progress of you or your child closely while receiving this medicine. This will help your doctor determine if the medicine is working correctly and decide whether to continue treatment. Blood tests may be necessary.

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

In deciding to use a medicine, you and your doctor will consider the risks of taking the medicine compared to the benefits it may provide. For this medicine, please consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, tell your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. When using non-prescription products, carefully read the label or package ingredients.

Pediatric

So far, studies have not shown any specific problems in children with epilepsy that would limit the use of fludeoxyglucose F 18 injection. However, the safety and effectiveness of fludeoxyglucose F 18 injection have not been established in children with cancer or heart disease.

Geriatric

There is no information available about how age affects the effects of fludeoxyglucose F 18 injection in older patients.

Breast Feeding

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

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if there is a chance of interaction. In these cases, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtime or with certain types of food due to possible interactions. Drinking alcohol or using tobacco with some medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may impact the use of this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

• Diabetes, poorly controlled—May affect the results of the PET scan.

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

Check with your doctor or nurse immediately if any of the following side effects occur:

Incidence not known

• Difficulty with breathing or swallowing
• fever
• hives
• itching skin
• nausea
• rash
• reddening of the skin, especially around the ears
• swelling of the eyes, face, or inside of the nose
• unusual tiredness or weakness

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. Your health care professional may also 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:

Incidence not known

• Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth 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.

In the U.S.

• Gludef
• Metatrace FDG

Available Dosage Forms:

• Solution

Therapeutic Class: Diagnostic Agent, Radiopharmaceutical Imaging

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

Your doctor will have you or your child drink water or other fluids during the 4 hours before you have the PET scan. Your doctor will also give you instructions about eating food before the test.

You or your child will need to urinate right away and as often as possible for at least one hour after the PET scan.