Choline c 11 (Intravenous)

Choline C 11 injection is used to help find recurrent prostate cancer. It is used during a procedure called positron emission tomography (PET) scan to locate tumors that cannot be seen with other scanning methods, such as bone scan, computed tomography (CT), or magnetic resonance imaging (MRI).

Choline C 11 is a radiopharmaceutical. Radiopharmaceuticals are radioactive agents that may be used to find and treat certain diseases or to examine how the body's organs work.

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

It is very important that your doctor checks you closely while you are receiving this medicine. This will help your doctor see if the medicine is working correctly and to decide if you should keep receiving it.

This medicine may cause a serious allergic reaction called anaphylaxis. Anaphylaxis needs immediate medical help. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in the color of the skin on the face, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, and puffiness or swellings of the eyelids or around the eyes. If these side effects happen, tell your doctor right away.

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

Do not take other medicines unless your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a diagnostic test, you and your doctor will need to consider the risks of the test compared to the benefits. Other factors may also affect the test results. For this test, keep the following in mind:

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 about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to determine how age affects the effects of choline c 11 injection in children. Safety and effectiveness have not been established.

Geriatric

There is no information available on how age affects the effects of choline c 11 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 against the potential risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two medicines may be used together even if an interaction could 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]) medicines.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food because interactions may occur. Using alcohol or tobacco with some medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

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 need medical attention.

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

Incidence not known

• Cough
• Difficulty swallowing
• Dizziness
• 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

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 lessen 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

• Burning, pain, or stinging at the injection site
• Coldness or numbness at the injection site
• Inflammation, redness, swelling, 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.

Available Dosage Forms:

• Solution

Therapeutic Class: Diagnostic Agent

A doctor or other trained health professional will give you 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 drink plenty of water or other fluids (as tolerated) during the four hours before you have the PET/CT scan.

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