Gludef (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 known as radiopharmaceuticals (radioactive agents).

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

It is very important that your doctor closely monitors you or your child while receiving this medicine. This will help your doctor determine if the medicine is effective and whether you should keep receiving it. Blood tests may be required.

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

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

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know 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.

Pediatric

Studies done so far have not shown specific problems in children with epilepsy that would limit the usefulness 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 on 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 medication during breastfeeding. Weigh 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 needed. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around mealtime or with certain types of food because interactions may occur. 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.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical conditions, especially:

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

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

Check with your doctor or nurse right away if you experience any of the following side effects:

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 happen that usually do not need medical attention. These side effects may go away as your body adjusts to the medicine. Your healthcare professional may also be able to suggest ways to prevent or lessen some of these side effects. Check with your healthcare 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 mentioned may also happen in some patients. If you notice any other effects, consult 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.