Rubidium chloride rb-82

What is Rubidium chloride rb-82?

• Rubidium chloride rb-82 (cardiogen-82; Ruby-Fill) is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the myocardium.

What are the uses of this medicine?

• Rubidium chloride rb-82 (cardiogen-82; Ruby-Fill) is a closed system used to produce rubidium Rb 82 chloride injection for intravenous administration.
• Rubidium Rb 82 chloride injection is indicated for Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease.

How does this medicine work?

• Rubidium-82 chloride is a form of rubidium chloride containing a radioactive isotope of rubidium.
• It is marketed under the brand name cardiogen-82 by Bracco diagnostics for use in Myocardial perfusion imaging.
• It is rapidly taken up by heart muscle cells, and therefore can be used to identify regions of heart muscle that are receiving poor blood flow in a technique called PET perfusion imaging.
• The half-life of the rubidium-82 is only 1.27 minutes; it is normally produced at the place of use by rubidium generators.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• whenever the incorrect eluent is used (if a solution other than additive free 0.9% Sodium Chloride Injection USP has been used to elute the generator at any time).

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Is this medicine FDA approved?

• Initial U.S. Approval: 1989

How should this medicine be used?

Recommended dosage: CardioGen-82:

• The recommended adult (70 kg) single dose of rubidium Rb 82 chloride injection is 1,480 MBq (40 mCi), with a range of 1,110 MBq to 2,220 MBq (30 mCi to 60 mCi).
• Do not exceed a single dose of 2,220 MBq (60 mCi) per rest or stress component of a procedure.

Ruby-Fill:

• The recommended weight-based dose of rubidium Rb 82 is between 10 to 30 Megabecquerels (MBq)/kg [0.27 to 0.81 millicuries (mCi)/kg].
• Do not exceed a single dose of 2220 MBq (60 mCi) per rest or stress component of a procedure.

Administration:

• Administer via intravenous infusion at a rate of 50 mL/minute (Model 510 and Model 1700), or at a rate of 20 mL/minute (Model 1700 only).
• Use only additive free 0.9% Sodium Chloride Injection USP to elute the generator.
• Use the lowest dose necessary to obtain adequate cardiac visualization. Individualize the dose depending on multiple factors, including patient weight, imaging equipment and acquisition type used to perform the procedure.
• Start imaging acquisition 60 to 90 seconds after completion of the infusion; if a longer circulation time is anticipated, wait for 120 seconds. Image acquisition is typically 5 minutes long.
• To obtain both rest and stress images, wait 10 minutes after completion of the rest image acquisition, then administer the pharmacologic stress agent in accordance with its prescribing information. Then, at a time interval after the administration of the pharmacologic stress agent that is in accordance with its prescribing information, infuse the second dose of rubidium Rb 82 chloride and complete the stress image acquisition.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As CardioGen-82 consists of strontium Sr 82 adsorbed on a hydrous stannic oxide column with an activity of 3,330 MBq to 5,550 MBq (90 millicuries to 150 millicuries) Sr 82 at calibration time.
• Ruby-Fill consists of Sr 82 adsorbed on a hydrous stannic oxide column with an activity of 3145 to 4255 MBq (85 to 115 mCi) Sr 82 at calibration time.

This medicine is available in fallowing brand namesː

• CardioGen-82; Ruby-Fill

What side effects can this medication cause?

The most common side effects of this medicine include:

• Radiation Exposure

What special precautions should I follow?

• Use only additive-free 0.9% Sodium Chloride Injection USP to elute the generator.
• Additives present in other solutions (particularly calcium ions) expose patients to high levels of radiation by causing the release of large amounts of Sr 82 and Sr 85 into the eluate regardless of the generator’s age or prior use.
• Immediately stop the patient infusion and discontinue use of the affected Ruby-Fill/CardioGen-82 generator if the incorrect eluent is used and evaluate the patient’s radiation absorbed dose and monitor for the effects of radiation to critical organs such as bone marrow.
• Excess radiation exposure occurs when the Sr 82 and Sr 85 levels in rubidium Rb 82 chloride injections exceed the specified generator eluate limits. Excess radiation exposure occurs when the Sr 82 and Sr 85 levels in rubidium Rb 82 chloride injections exceed the specified generator eluate limits.
• Pharmacologic induction of cardiovascular stress may be associated with serious adverse reactions such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction, and cerebrovascular events.
• Ensure safe handling to minimize radiation exposure to the patient and health care providers. Advise patients to void after completion of each image acquisition session and as often as possible for one hour after completion of the PET scan.
• Advise a pregnant woman of the potential risk to a fetus.
• Advise lactating women that exposure to Rb 82 chloride through breast milk can be minimized if breastfeeding is discontinued when Rb 82 chloride injection is administered. Advise lactating women not to resume breastfeeding for at least one hour after completion of rubidium Rb 82 infusion.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no data available on the use of rubidium Rb 82 chloride in pregnant women.
• If considering rubidium Rb 82 chloride injection administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from rubidium Rb 82 and the gestational timing of exposure.

Can this medicine be used in children?

• Rubidium Rb 82 chloride injection safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• RUBIDIUM CHLORIDE RB-82

Inactive ingredients:

• none

Who manufactures and distributes this medicine?

CardioGen-82 Manufactured for:

• Bracco Diagnostics Inc.
• Monroe Twp, NJ

By:

• GE Healthcare Medi-Physics, Inc.,
• South Plainfield, NJ

Ruby-Fill Manufactured by:

• Jubilant DraxImage Inc., dba Jubilant RadiopharmaTM
• 16 751 TransCanada Highway
• Kirkland, Quebec H9H 4J4 Canada

What should I know about storage and disposal of this medication?

• Store the generator at 20° to 25°C (68° to 77°F).
• Receipt, transfer, possession, storage, disposal or use of this product is subject to the radioactive material regulations and licensing requirements of the U.S. Nuclear Regulatory Commission (NRC), Agreement States or Licensing States as appropriate. Do not dispose of the generator in regular refuse systems.

• Dailymed label info on Rubidium chloride rb-82
• FDA Rubidium chloride rb-82

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