Choline C 11 331 mCi/mL INJECTION

Choline C 11 injection is a radiopharmaceutical used to help in detecting hidden tumors using positron emission tomography for the diagnosis of recurrent prostate cancer.

This drug is to be given only by or under the direct supervision of a healthcare professional with specialized training in nuclear medicine.

Before doing any diagnostic test, the risks and benefits for your body should be discussed with your healthcare provider. Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals. Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications. Studies on the relationship of age to the effects of choline C11 injection in the pediatric population have not been performed while safety and efficacy have not been established. There is insufficient data regarding the relationship of age to the effects of choline c11 injection in geriatric patients.

Adverse effects have been reported in animal studies but studies regarding the effects in pregnant women or animals are inadequate. Infant risk is undetermined in studies of using this drug during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects. Inform your healthcare professional if you are taking any other prescription or non-prescription drugs.

Inform your healthcare professional if you are taking any other vaccines such as yellow fever vaccines.

Intake of specific food or using alcohol or tobacco with this vaccine is associated with an increased risk of certain side effects. Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco.

A trained health professional is the only one allowed to give you this drug. This drug is given intravenously through a needle placed in one of your veins just before you have a PET scan. You will be advised to drink plenty of water or other fluids during the four hours before the PET/CT scan. After the PET/CT scan, you will need to urinate right away and as often as possible for at least one hour.

Your healthcare provider should closely monitor the effectiveness of this drug as well as check for unwanted effects.

Consult with your healthcare professional if after being injected you have any symptoms of an allergic reaction such as:

• Ash
• Itching
• Swelling of the face, tongue, and throat
• Trouble breathing
• Chest pain

Exposure to radiation cannot be avoided when taking this drug and you should consult with your healthcare provider for any concerns.

Consult with your healthcare professional before taking any other prescription or nonprescription drugs, and herbal or vitamin supplements.

Side effects may vary for each individual and prompt medical attention should be given if they occur.

Inform your healthcare professional if you have symptoms of:

• Chills
• Hives or welts
• Itching
• Skin rash
• Nausea
• Redness of the skin

Side effects such as cough, difficulty swallowing, dizziness,s fast heartbeat, hives, itching, or skin rash puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue shortness of breath tightness in the chest, unusual tiredness or weakness, burning, pain, or stinging at the injection site, coldness or numbness at the injection site, Inflammation, redness, swelling, or warmth at the injection site have unknown incidence.

If any of the following side effects persists, or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional.

Report any side effects to the FDA hotline at 1-800-FDA-1088.