Generic name: RUBIDIUM CHLORIDE RB-82 150mCi
Dosage form: injection, solution
Medically reviewed by Drugs.com. Last updated on Oct 1, 2019.
Use CardioGen-82 only with an infusion system specifically designed for use with the generator and capable of accurate measurement and delivery of doses of rubidium Rb 82 chloride injection. Follow instructions in the Infusion System User’s Guide for the set up and intravenous infusion of rubidium Rb 82 chloride injection dose(s).
Rubidium Rb 82 Chloride Injection Dosage
- Do not exceed a single dose of 2220 MBq (60 mCi).
- Use the lowest dose necessary to obtain adequate cardiac visualization consistent with the dosing goal of as low as reasonably achievable (ALARA).
- Individualize the dose by considering factors such as body size, and the imaging equipment and technique.
- Administer the single dose at 50 mL/minute through a catheter inserted into a large peripheral vein; do not to exceed a total infusion volume of 100 mL.
- Administer a single (“rest”) rubidium Rb 82 chloride dose;
- Start imaging 60-90 seconds after completion of the infusion of the rest dose and acquire images for 5 minutes; if a longer circulation time is anticipated (e.g., in a patient with severe left ventricular dysfunction), start imaging 120 seconds after the rest dose.
- Begin the study 10 minutes after completion of the resting dose infusion, to allow for sufficient Rb 82 decay;
- Administer a pharmacologic stress agent in accordance with its prescribing information;
- After an interval of 3 minutes, infuse a single (“stress”) rubidium Rb 82 chloride dose;
- Start imaging 60-90 seconds after completion of the stress Rb 82 chloride dose infusion and acquire images for 5 minutes; if a longer circulation time is anticipated start imaging 120 sec after the stress dose.
Radiation Safety-Drug Handling
- Use only additive-free 0.9 %Sodium Chloride Injection USP to elute the generator [see Boxed Warning, Contraindications (4), and Warnings and Precautions (5.1)].
- Limit the use of radiopharmaceuticals to physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.
- Wear waterproof gloves and effective shielding when handling rubidium Rb 82 chloride injection and the infusion system.
- Observe 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.
Directions for Eluting Rubidium Rb 82 Chloride Injection
- Use only additive-free 0.9 % Sodium Chloride Injection USP to elute the generator [see Boxed Warning, Contraindications (4), and Warnings and Precautions (5.1)].
- Prepare the 0.9 % Sodium Chloride Injection USP for use with the Saline Tag
- Prepare the intravenous port in accordance with the DOSAGE AND ADMINISTRATION section of the approved prescribing information of the 0.9 % Sodium Chloride Injection USP.
- The intravenous administration port of the sodium chloride container must be penetrated only one time.
- Strap the saline tag provided with the CardioGen-82 Infusion System on the additive-free 0.9% Sodium Chloride Injection USP container and install on the CardioGen-82 Infusion System.
- Once the container port closure is penetrated, it should remain installed on the CardioGen-82 Infusion System for its entire period of use. A maximum of 12 hours from the initial port closure penetration is permitted, after which the bag must be replaced for the next patient.
- Allow at least 10 minutes between elutions for regeneration of Rb 82.
- Discard the first 50 mL eluate each day the generator is first eluted. Employ proper safety precautions since the eluate contains radioactivity.
- Maintain an on-going record of all eluate volumes (washing, testing, dosing volumes), including a summary of the cumulative volume of eluate from the generator.
Eluate Testing Protocol
- Use an ionization chamber-type dose calibrator for eluate testing.
- Daily, before administering rubidium Rb 82 chloride injection to any patient, perform an eluate testing to determine Rb 82, Sr 82, and Sr 85 levels
- Perform additional daily eluate tests after detecting any of the following Alert Limits:
- 14 L total elution volume has passed through the generator column, or
- Sr 82 level reaches 0.002 μCi per mCi Rb 82, or
- Sr 85 level reaches 0.02 μCi per mCi Rb 82.
- Perform the additional daily eluate tests at time points determined by the day’s elution volume; tests are performed every 750 mL.
- For example, if an Alert Limit were reached and the clinical site eluted less than 750 mL from the generator during the day, then no additional eluate tests would have been performed that day.
- If the same clinical site the next day eluted 1,500 mL from the generator, then the site would have performed three tests that day: 1) the required daily test that precedes any patient dosing, 2) a test at the 750 mL elution point, and 3) a test at the 1,500 mL elution point.
- If a generator’s Alert Limit is reached, the clinical site performs the additional daily tests (at intervals of 750 mL) each subsequent day the generator is used. The additional tests are necessary to promptly detect excessive Sr 82 and/or Sr 85 in eluates.
- Set a dose calibrator for Rb 82 as recommended by the manufacturer or use the Co-60 setting and divide the reading obtained by 0.548. Obtain the reading from the instrument in millicuries.
- Elute the generator with 50 mL of Sodium Chloride Injection USP and discard the eluate (first elution).
- Allow at least 10 minutes for the regeneration of Rb 82, then elute the generator with 50 mL of Sodium Chloride Injection USP at a rate of 50 mL/min and collect the eluate in a stoppered glass vial (plastic containers are not suitable). Note the exact time of end of elution (E.O.E.).
- Using the dose calibrator, determine the activity of Rb 82 and note the time of the reading. Correct the reading for decay to the E.O.E. using the appropriate decay factor for Rb 82 (see Table 1).
Note: If the reading is taken 2 ½ minutes after end of elution, multiply the dose calibrator reading by 4 to correct for decay.
Strontium Eluate Level Testing:
- Using the sample obtained for the Rb 82 activity determination, allow the sample to stand for at least one hour to allow for the complete decay of Rb 82.
- Measure the activity of the sample in a dose calibrator at the setting recommended by the manufacturer for Rb 82 and/or Sr 82. As an alternative, use the Co-60 setting and the reading obtained divided by 0.548. Set the instrument to read in microcuries and record the reading in the display.
- Calculate the ratio (R) of Sr 85/Sr 82 on the day (postcalibration) of the measurement using the ratio of Sr 85/Sr 82 on the day of calibration provided on the generator label and the Sr 85/Sr 82 Ratio Factor from Table 2. Determine R using the following equation:
R = [Sr 85] / [Sr 82] on calibration date X Ratio Factor on the day (post-calibration) of measurement
- Use a correction factor (F) of 0.478 to compensate for the contribution of Sr 85 to the reading.
- Calculate the amount of Sr 82 in the sample using the following equation:
Sr 82 (μCi) = dose calibration reading (μCi) / [1 + (R) (F)]
Example: dose calibrator reading (μCi) = 0.8; Sr 85/Sr 82 ratio (R) =1.48; correction factor (F) = 0.478.
Sr 82 (μCi) = 0.8 / [1 + (1.48)(0.478)] = 0.47
- Determine if Sr 82 in the eluate exceeds an Alert or Expiration Limit by dividing the μCi of Sr 82 by the mCi of Rb 82 at End of Elution (see below for further instructions based on the Sr 82 level)
Example: 0.47 μCi of Sr 82; 50 mCi of Rb 82 E.O.E.
0.47 μCi Sr 82 / 50 mCi Rb 82 = 0.0094 μCi/mCi Rb 82 (is above Alert Limit of 0.002; additional daily eluate testing must be performed)
- Determine if Sr 85 in the eluate exceeds an Alert or Expiration Limit by multiplying the result obtained in step 10 by (R) as calculated in step 7 (above).
Example: 0.0094 x 1.48 = 0.014 μCi Sr 85/mCi Rb 82 (test result is below Alert and Expiration Limits)
Physical Decay Chart: Rb 82 half-life 75 seconds
|*Day of calibration|
Sr 85/Sr 82 Ratio Chart (Sr 85 T ½ = 65 days, Sr 82 ½ = 25 days)
|Days||Ratio Factor||Days||Ratio Factor||Days||Ratio Factor|
- A total elution volume of 17 L has passed through the generator column, or
- 42 days post calibration date, or
- An eluate Sr 82 level of 0.01 μCi /mCi Rb 82, or
- An eluate Sr 85 level of 0.1 μCi /mCi Rb 82.
|aRb 82 doses are averages of rest and stress dosimetry data (see Senthamizhchelvan et al. 1,2). To calculate organ doses (mrem) from Rb 82, multiply the dose coefficient for each organ by the administered activity in mCi.
bSr 82 and Sr 85 doses are calculated using software package DCAL and ICRP dose coefficients. To calculate organ doses (mrem) attributable to Sr 82, and Sr 85, multiply the dose coefficients by the calculated amounts of strontium in μCi.3
cTo convert to SI units, insert the dose coefficient into the formula in parentheses, e.g. for adrenals 7.56 mrem/mCi = 7.56 μSv/37 MBq = 2.04 x 10-13 Sv/Bq.
dCalculated from ICRP 66
eCalculated from ICRP 60
fStress phase only
|Table 3 Adult Absorbed Radiation Dose Coefficient|
(Average for Rest and Stress)
|Bone – Osteogenic cells||1.86||---||---|
|Gall Bladder Wall||3.17||8.47||2.82|
|Lower Large Intestine Wall||2.84||51.8||5.14|
|Upper Large Intestine||5.94||23.7||3.62|
|Urinary Bladder Wall||1.61||21.9||2.90|
|Total Body||1.77||Not Calculated||Not Calculated|
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