Pronunciation:

floo-de-ox-i-GLOO-kose F 18

Brand Names:

• Gludef
• Metatrace FDG

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Diagnostic Agent, Radiopharmaceutical Imaging

Uses of This Medicine:

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, such as the heart or brain. Fludeoxyglucose F 18 belongs to the group of medicines called radiopharmaceuticals (radioactive agents).

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fludeoxyglucose F 18 injection in children with epilepsy. However, safety and efficacy of fludeoxyglucose F 18 injection have not been established in children with cancer or heart disease.

Older adults—

No information is available on the relationship of age to the effects of fludeoxyglucose F 18 injection in geriatric patients.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check the progress of you or your child 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. Blood tests may be needed.

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

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.

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. 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:

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.