Metatrace FDG (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 areas of the body, such as 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 monitor the progress of you or your child while receiving this medicine. This will help your doctor determine if the medicine is working properly and decide if 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 will weigh the risks of taking the medicine against the benefits it may provide. For this medicine, you should 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, let your healthcare professional know if you have any other 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 any specific problems that would limit the use of fludeoxyglucose F 18 injection in children with epilepsy. 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 may affect 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 while breastfeeding. Consider the potential benefits and risks before using this medication during 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 take other precautions. 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 the time of eating food or certain types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to 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 issues, especially:

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

Along with its necessary effects, a medicine may 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 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 happen 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 how 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:

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 can 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.