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Rubidium Rb 82

FDA Drug Information • Also known as: Ruby-Fill

Brand Names
Ruby-Fill
Route
INTRAVENOUS
Dosage Form
INJECTION, SOLUTION
Product Type
HUMAN PRESCRIPTION DRUG

⚠ Boxed Warning (Black Box)

WARNING: HIGH LEVEL RADIATION EXPOSURE WITH USE OF INCORRECT ELUENT AND FAILURE TO FOLLOW QUALITY CONTROL TESTING PROCEDURE High Level Radiation Exposure with Use of Incorrect Eluent Patients are exposed to high radiation levels when the generator is eluted with the incorrect eluent due to high Sr 82 and Sr 85 breakthrough levels [see Warnings and Precautions ( 5.1 )] Use only additive-free 0.9% Sodium Chloride Injection USP to elute the generator [see Dosage and Administration ( 2.5 )] Immediately stop the patient infusion and discontinue the use of the affected RUBY-FILL (Rb 82) generator, if the incorrect solution is used to elute the generator [see Contraindications ( 4 )]. Evaluate the patient’s radiation absorbed dose and monitor for the effects of radiation to critical organs such as bone marrow [(see Dosage and Administration ( 2.9 )] . Excess Radiation Exposure with Failure to Follow Quality Control Testing Procedure Excess radiation exposure occurs when the levels of Sr 82 or Sr 85 in the rubidium Rb 82 chloride injection exceed specified limits [see Warnings and Precautions ( 5.2 )]. The system automatically generates a record and saves the data for each generator eluate volume, including flushing and test volumes. Total cumulative eluate volumes are also recorded and saved for the life of the generator [see Dosage and Administration ( 2.5 )] . Strictly adhere to the generator quality control testing procedure, to minimize the risk of excess radiation exposure, including daily testing and additional testing at Alert Limits [see Dosage and Administration ( 2.6 )] Stop use of a generator at any of the following Expiration Limits. Expiry Limits are: o 30 L for the generator's cumulative eluate volume, or o Expiration date of the generator (60 days post-calibration) o An eluate Sr 82 level of 0.01 mcCi /mCi (kBq/MBq) Rb 82, or o An eluate Sr 85 level of 0.1 mcCi /mCi (kBq/MBq) Rb 82 [see Dosage and Administration ( 2.7 )]. WARNING: HIGH LEVEL RADIATION EXPOSURE WITH USE OF INCORRECT ELUENT AND FAILURE TO FOLLOW QUALITY CONTROL TESTING PROCEDURE Please see full prescribing information for complete boxed warning High Level Radiation Exposure with Use of Incorrect Eluent Using the incorrect eluent can cause high Strontium (Sr 82) and (Sr 85) breakthrough levels ( 5.1 ) Use only additive-free 0.9% Sodium Chloride Injection USP to elute the generator ( 2.5 ) Immediately stop the patient infusion and discontinue the use of the affected RUBY-FILL generator if the incorrect solution is used to elute the generator ( 4 ) Evaluate the patient’s radiation absorbed dose and monitor for the effects of radiation to critical organs such as bone marrow ( 2.9 ) Excess Radiation Exposure with Failure to Follow the Quality Control Testing Procedure Excess-radiation exposure occurs when the levels of Sr 82 or Sr 85 in the Rubidium Rb 82 Chloride injection exceed specific limits. ( 5.2 ) Strictly adhere to the generator quality control testing procedure ( 2.6 ) Stop using the generator if it reaches any of its Expiration Limit ( 2.7 )

Description

11 DESCRIPTION 11.1 Chemical Characteristics RUBY-FILL Rubidium Rb 82 Generator contains accelerator-produced Sr 82 adsorbed on stannic oxide in a lead-shielded column and provides a means for obtaining sterile non-pyrogenic solutions of rubidium Rb 82 chloride injection. The chemical form of Rb 82 is 82 RbCl. The amount (mCi) of Rb 82 obtained in each elution will depend on the potency of the generator. When used with the RUBY Rubidium Elution System, the generator provides ± 10% accuracy for rubidium Rb 82 chloride doses between 370 to 2220 MBq (10 to 60 mCi). When eluted at a rate of 15 to 30 mL/minute, each generator eluate at the end of elution should not contain more than 0.02 mcCi (0.74 kBq) of Sr 82 and not more than 0.2 mcCi (7.4 kBq) of Sr 85 per mCi of rubidium Rb 82 chloride injection, and not more than 1 mcg of tin per mL of eluate. 11.2 Physical Characteristics Rb 82 decays by positron emission and associated gamma emission with a physical half-life of 75 seconds. Table 5 shows the annihilation photons released following positron emission which are useful for detection and imaging studies. The decay modes of Rb 82 are: 95.5% by positron emission, resulting in the production of annihilation radiation, i.e., two 511 keV gamma rays; and 4.5% by electron capture, resulting in the emission of “prompt” gamma rays of predominantly 776.5 keV. Both decay modes lead directly to the formation of stable Kr 82. TABLE 5 Principal Radiation Emission Data Radiation Mean Percent Per Disintegration Mean Energy (keV) Annihilation photons (2) 191.01 511 (each) Gamma rays 13 to 15 776.5 The specific gamma ray constant for Rb 82 is 6.33 R cm 2 / mCi h (1.23 × 10 -12 C m 2 / kg MBq s). The first half-value layer is 0.53 cm of lead (Pb). Table 6 shows a range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb. For example, the use of a 6.15 cm thickness of Pb will attenuate the...

What Is Rubidium Rb 82 Used For?

1 INDICATIONS AND USAGE 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. RUBY-FILL is a closed system used to produce rubidium Rb 82 chloride injection for intravenous use. Rubidium Rb 82 chloride injection is a radioactive diagnostic agent 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. (1)

Dosage and Administration

2 DOSAGE AND ADMINISTRATION Use RUBY-FILL with a specific Elution System. ( 2.4)

  • Use only additive-free 0.9% Sodium Chloride Injection USP to elute the generator. ( 2.5 )
  • 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]. ( 2.2 )
  • Do not exceed a single dose of 2220 MBq (60 mCi) per rest or stress component of a procedure. (2.2)
  • Administer the single dose at a rate of 15 to 30 mL/minute through a catheter inserted into a large peripheral vein; do not exceed an infusion volume of 60 mL. ( 2.2 )
  • Use the lowest dose necessary to obtain adequate cardiac visualization and individualize the dose depending on multiple factors, including, patient weight, imaging equipment and acquisition type used to perform the procedure. ( 2.2 )
  • Start imaging acquisition 60 to 90 seconds after completion of the infusion; if a longer circulation time is anticipated, wait for 120 seconds. Acquisition may be started immediately post-injection if dynamic imaging is needed. Image acquisition is typically 3 to 7 minutes long. ( 2.3 )
  • To obtain 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. After administration of the pharmacologic stress agent, infuse the second dose of Rb 82, at the time interval according to the prescribing information of the pharmacological stress agent and complete the stress image acquisition. ( 2.3 ) 2.1 Radiation Safety - Drug Handling Rubidium Rb 82 is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure during administration [see Warnings and Precautions ( 5.3 ] ). Use only additive-free 0.9% Sodium Chloride Injection USP to elute the generator [ see Boxed Warning, Contraindications (4) , Warnings and Precautions ( 5.1 ) ]. Use waterproof gloves and effective shielding when handling rubidium Rb 82 chloride injection and the RUBY Rubidium Elution System. Use aseptic techniques in all drug handling. Visually inspect the drug for particulate matter and discoloration prior to administration whenever solution and container permit. Do not administer eluate from the generator if there is any evidence of foreign matter. 2.2 Recommended Dose and Administration Instructions The recommended weight-based dose of rubidium Rb 82 chloride to be administered per rest or stress component of a PET myocardial perfusion imaging (MPI) procedure 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). Use the lowest dose necessary to obtain adequate cardiac visualization and individualize the weight-based dose depending on multiple factors, including, patient weight, imaging equipment and acquisition type used to perform the procedure. For example, 3D imaging acquisition may require doses at the lower end of the...

    • Side Effects (Adverse Reactions)

    6 ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Jubilant DraxImage Inc., dba Jubilant Radiopharma TM at 1-888-633-5343 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following serious adverse reaction associated with the use of rubidium Rb 82 chloride was identified in clinical trials or post marketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Radiation Exposure High level radiation exposure to the bone marrow has occurred in some patients due to Sr 82 and Sr 85 breakthrough in the eluate when an incorrect solution was used to elute the rubidium Rb 82 generator [see Boxed Warning, Warnings and Precautions ( 5.1 )] . Excess radiation exposure has occurred in some patients who received rubidium Rb 82 chloride injection at clinical sites where generator eluate testing appeared insufficient [see Boxed Warning, Warnings and Precautions ( 5.2 ), Dosage and Administration ( 2.6 )] .

    Contraindications

    4 CONTRAINDICATIONS RUBY-FILL is contraindicated for use if a solution other than additive-free 0.9% Sodium Chloride Injection USP has been used to elute the generator at any time. Immediately stop the patient infusion and permanently discontinue the use of the affected RUBY-FILL generator whenever the incorrect eluent is used [ see Boxed Warning, Contraindications ( 4 ), Warnings and Precautions ( 5.1 ) ]. RUBY-FILL is contraindicated if a solution other than additive-free 0.9% Sodium Chloride Injection USP has been used to elute the generator at any time. ( 4 )

    Pregnancy and Breastfeeding

    8.1 Pregnancy Risk Summary There are no data available on the use of rubidium Rb 82 in pregnant women. Animal reproduction studies with rubidium Rb 82 chloride have not been conducted. However, all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. 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 Rb 82 and the gestational timing of exposure. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

    How Supplied

    16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied RUBY-FILL Rubidium Rb 82 Generator 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. A lead shield encases the generator. The container label provides complete assay data for each generator. Use RUBY-FILL Rubidium Rb 82 Generator only with an appropriate, properly calibrated Elution System (RUBY Rubidium Elution System) labeled for use with the generator. 16.2 Storage and Handling Store the generator at 20 to 25 ºC (68 to 77 ºF). 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. For questions about the disposal of the RUBY-FILL Rubidium Rb 82 Generator, contact Jubilant Radiopharma at 1-888-633-5343.

    About This Information

    This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

    What are side effects?

    Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

    What are drug interactions?

    Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.