Ruby-Fill Generator (Intravenous)

Rubidium Rb 82 injection is used in adults to help diagnose heart disease. It is used in a procedure called a positron emission tomography (PET) scan to help your doctor see an image of your heart. This medicine shows how much blood is reaching your heart muscle when you are resting or exercising (stressed). Rubidium Rb 82 is part of a group of medicines called 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 check your progress 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.

You might receive a medicine to make your heart beat faster. This is called a pharmacologic stress test. It is used with the PET scan to show how well your heart muscle works when it is stressed. If you have questions about this test, talk to your doctor.

While receiving this medicine, you 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 need to weigh the risks against the benefits. Here are some important considerations for this medicine:

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 may have, such as to foods, dyes, preservatives, or animals. For over-the-counter products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on the effects of rubidium Rb 82 injection in children. Safety and effectiveness have not been established.

Geriatric

Studies so far have not shown any specific problems in elderly patients that would limit the use of rubidium Rb 82 injection. However, older adults are more likely to have heart problems related to aging, which may require caution when using rubidium Rb 82 injection.

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 taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if interactions could occur. In these cases, your doctor may want to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or over-the-counter (OTC) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or specific types of food, as interactions may happen. Using alcohol or tobacco with some medicines can also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Be sure to tell your doctor about any other medical problems you have, especially:

• Congestive heart failure—Use with caution. May worsen side effects.

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.

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body gets used to the medicine. Your health care professional may also have suggestions 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 health care 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.

• Cardiogen-82 Generator
• Ruby-Fill Generator

Available Dosage Forms:

• Kit

Therapeutic Class: Diagnostic Agent, Radiopharmaceutical Imaging

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.

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