Pronunciation:

roo-BID-e-um KLOR-ide Rb 82

Brand Names:

• Cardiogen-82 Generator
• Ruby-Fill Generator

Dosage Forms:

• Kit

Warnings:

High Level Radiation Exposure with Use of Incorrect EluentUsing the incorrect eluent can cause high Strontium (Sr) 82 and Sr 85 breakthrough levels.Use only additive-free 0.9% Sodium Chloride Injection USP to elute the generator.Immediately stop the patient infusion .Permanently discontinue the use of the affected generator.Evaluate the patient’s radiation absorbed dose and monitor for the effects of radiation to critical organs such as bone marrow.Excess Radiation Exposure with Failure to Follow the Eluate Testing ProtocolExcess radiation exposure occurs when the levels of Sr 82 or Sr 85 in the Rubidium Chloride Rb 82 Injection exceed limits.Record eluate volume, including waste and test volumes.Strictly adhere to the generator eluate testing protocol.Stop using the generator if it reaches any of its Expiration Limits 17 L for the generators cumulative eluate volume42 days post generator calibration date An eluate Sr 82 level of 0.01 microCi/mCi Rb 82 An eluate Sr 85 level of 0.1 microCi/mCiRb 82 .

Classifications:

Therapeutic—

Diagnostic Agent, Radiopharmaceutical Imaging

Uses of This Medicine:

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 getting to your heart muscle when you are resting or exercising (stressed).

Rubidium Rb 82 injection is a radiopharmaceutical. Radiopharmaceuticals are radioactive agents, which may be used to find and treat certain diseases or to study the function of the body's organs.

This medicine will be used only by or under the direct supervision of a doctor with specialized training in nuclear medicine.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional 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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of rubidium Rb 82 injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rubidium Rb 82 injection in the elderly. However, elderly patients are more likely to have age-related heart problems, which may require caution in patients receiving rubidium Rb 82 injection.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine:

A doctor or other trained health professional will give you this medicine in a medical facility. This medicine is given through an IV catheter that is placed into 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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress very 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 together 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.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects may occur 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 about ways to prevent or reduce some of these side effects. Check with your health care 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 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.