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RUBY-FILL Dosage

Generic name: RUBIDIUM CHLORIDE RB-82 100mCi
Dosage form: injection, solution

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

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 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.

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 10-30 Megabecquerels (MBq)/kg [0.27-0.81 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 recommended range compared to 2D imaging.
  • Administer the single dose at a rate of 15 - 30 mL/minute through a catheter inserted into a large peripheral vein; do not exceed an infusion volume of 60 mL.
  • Instruct patients to void as soon as a study is completed and as often as possible thereafter for at least one hour.
  • The maximum available activity (delivery limit) will decrease as the generator ages [see Dosage and Administration (2.8)].

Image Acquisition Guidelines

For Rest Imaging:

  • 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 3-7 minutes.

For Stress Imaging:

  • 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 administration of the pharmacologic stress agent, administer the second dose of Rb 82 at the time interval according to the prescribing information of the pharmacological stress agent;
  • Start imaging 60-90 seconds after completion of the stress rubidium Rb 82 chloride dose infusion and acquire images for 3-7 minutes.

For Both Rest and Stress Imaging:

  • 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.
  • Acquisition may be started immediately post-injection if dynamic imaging is needed.

Elution System

  • Use RUBY-FILL Rubidium Rb 82 Generator only with an elution system specifically designed for use with the generator (RUBY Rubidium Elution System) and capable of accurate measurement and delivery of doses of rubidium Rb 82 chloride injection.
  • The generator used with the elution system provides ± 10% accuracy for rubidium Rb 82 chloride doses between 370-2220 MBq (10-60 mCi)
  • Follow instructions in the RUBY Rubidium Elution System User Manual for the set up and intravenous infusion of rubidium Rb 82 chloride injection dose.

Directions for Eluting Rubidium Rb 82 Chloride Injection

  • Allow at least 10 minutes between elutions for regeneration of Rb 82.
  • Elute with additive-free 0.9% Sodium Chloride Injection USP only. Additives (particularly calcium ions, to which strontium ions are chemically analogous), may cause the release of substantial amounts of Sr 82 and/or Sr 85 into the eluate regardless of the age or prior use of the generator.
  • The system will automatically discard the first 75 mL eluate each day the generator is first eluted.
  • The RUBY Rubidium Elution System automatically generates records and saves data of all eluate volumes (from flushing, QC testing, patient infusions), representing the cumulative volume of eluate from the generator.

Eluate Testing Protocol

  • Elute with additive-free 0.9% Sodium Chloride Injection USP only.
  • Use the ionization chamber-type dose calibrator that is integrated into the elution system (used specifically with the RUBY-FILL Rubidium Rb 82 Generator) for eluate testing.
  • Perform Mandatory Eluate Testing (i.e. Quality Control test) to determine Rb 82, Sr 82, and Sr 85 levels:
  1. Daily - Before administering rubidium Rb 82 chloride injection to the first patient each day.
  2. Repeat Every 4 patientsafter an Alert Limit has been detected.
    Alert Limits:

    • 20 L total elution volume has passed through the generator column, or
    • Sr 82 level reaches 0.004 μCi per mCi (kBq per MBq) Rb 82, or
    • Sr 85 level reaches 0.04 μCi per mCi (kBq per MBq) Rb 82.
  3. Immediately after detection of the volume alert limit (20 L).
  • The elution system will automatically indicate when alert limits have been reached and require that additional tests be performed.

When the Quality Control test is performed as described in the User Manual, the system automatically performs the following eluate testing:

Rubidium Eluate Testing:

  1. The dose calibrator is automatically set for Rb 82 within the Elution System.
  2. The Quality Control test begins by automatically initiating a generator flush using 75 mL of 0.9% Sodium Chloride Injection USP. This eluate is by default diverted towards the waste container and is ultimately discarded.
  3. After the generator flush, the system waits approximately 15.2 minutes to accomplish a complete generator recharge of 12 Rb 82 half-lives
  4. The system then elutes a calibration sample (35 mL of 0.9% Sodium Chloride Injection USP at 20 mL/min). Using the dose calibrator, the system automatically quantifies the activity of Rb 82 in the calibration sample (Rb 82 decay does not need to be corrected for because of a real-time automated measurement).

Strontium Eluate Testing (Strontium Breakthrough):

  1. Using the calibration sample obtained from the Rb 82 eluate testing, the system allows the sample to stand for 30 minutes to allow for the complete decay of Rb 82.
  2. The system measures the activity of the sample to automatically determine the total Sr 82 and Sr 85 activity.
  3. The system automatically determines the ratio (R) on the day (post calibration) 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 the Sr 85/Sr 82 ratio based on generator age using the following equation:

eq1

4. The system uses a correction factor (F) of 0.48 to compensate for the contribution of Sr-85 to the reading.

5. The system calculates the amount of Sr-82 in the sample using the following equation:

eq2

6. The system determines if Sr 82 in the eluate exceeds an Alert or Expiration Limit by dividing the μCi (or kBq) of Sr 82 by the mCi (or MBq) of Rb 82 at End of Elution (see below for further instructions based on the Sr 82 level)

eq3

7. The system determines if Sr 85 in the eluate exceeds an Alert or Expiration Limit by multiplying the result obtained in step 6 by (R) as calculated in step 3 (above).

In Empirical Units (µCi)

Example: 0.0094 x 1.48 = 0.014 μCi Sr 85/mCi Rb 82

(Sr 85 test result is below Alert and Expiration Limits)

In International Units (kBq)

Example: 0.0094 x 1.48 = 0.014 kBq Sr 85/MBq Rb 82

(Sr 85 test result is below Alert and Expiration Limits)

The system uses Table 1 to calculate the decay factor for Rb 82


TABLE 1

Physical Decay Chart: Rb 82 half-life 75 seconds

Seconds

Fraction Remaining

Seconds

Fraction Remaining

 0*

 1.00

 165

 0.218

 15

 0.871

 180

 0.190

 30

 0.758

 195

 0.165

 45

 0.660

 210

 0.144

 60

 0.574

 225

 0.125

 75

 0.500

 240

 0.109

 90

 0.435

 255

 0.095

105

 0.379

 270

 0.083

 120

 0.330

 285

 0.072

 135

 0.287

 300

 0.063

 150

 0.250

 *Elution time

The system uses Table 2 to calculate the ratio (R) of Sr 85/Sr 82.


TABLE 2

Sr 85/Sr 82 Ratio Chart (Sr 85 T1/2 = 65 days, Sr 82 T1/2 = 25 days)

 Days

 Ratio Factor

 Days

 Ratio Factor

 Days

  Ratio Factor

  0*

1.00 

21

1.43

 42

2.05 

 1

 1.02

22

1.46

43 

2.08 

 2

 1.03

 23

 1.48

 44

2.12

 3

 1.05

 24

 1.51

 45

 2.15

 4

 1.07

 25

 1.53

 46

 2.19

 5

 1.09

 26

 1.56

 47

 2.23

 6

 1.11

 27

 1.58

 48

 2.27

 7

 1.13

 28

 1.61

 49

 2.30

 8

 1.15

 29

 1.64

 50

 2.34

 9

 1.17

 30

 1.67

 51

 2.38

 10

 1.19

 31

 1.70

 52

 2.43

 11

 1.21

 32

 1.73

 53

 2.47

 12

 1.23

 33

 1.76

 54

 2.51

 13

 1.25

 34

 1.79

 55

 2.55

 14

 1.27

 35

 1.82

 56

 2.60

 15

 1.29

 36

 1.85

 57

 2.64

 16

 1.31

 37

 1.88

 58

 2.69

 17

 1.34

 38

 1.91

 59

 2.73

 18

 1.36

 39

 1.95

 60

 2.78

 19

 1.38

 40

 1.98

 20

 1.41

 41

 2.01

* Day of Calibration.

RUBY-FILL Expiration

Stop use of the RUBY-FILL Rubidium Rb 82 Generator once any one of the following Expiration Limits is reached:

  • A total elution volume of 30 L has passed through the generator column, or
  • Expiration date of the generator (60 days post-manufacturing), or
  • An eluate Sr 82 level of 0.01 μCi/mCi (kBq/MBq) Rb 82, or
  • An eluate Sr 85 level of 0.1 μCi/mCi (kBq/MBq) Rb 82.

RUBY-FILL Dose Delivery Limit

The maximum available activity (delivery limit) will decrease as the generator ages. Certain doses, including the maximum recommended dose [60 mCi (2220 MBq)], are not achievable for the entire shelf-life of the generator. Table 3 provides an estimate of the maximum available activity of Rubidium Rb 82 (Delivery Limit) as a function of generator age.

Table 3 Rubidium Rb 82 Dose Delivery Limit Based on Generator Age1

Generator Age (days) 2

Maximum Rubidium Dose

(Delivery Limit)

0-17

60 mCi (2220 MBq)

   24

50 mCi (1850 MBq)

   32

40 mCi (1480 MBq)

   42

30 mCi (1110 MBq)

   57

20 mCi ( 740 MBq)

1Estimate is based on a 100 mCi (3700 MBq) Sr 82 generator at calibration. 

2Generator age at which delivery limit is reached varies with generator activity at release.  For example, an 85 mCi (3145 MBq) generator and a 115 mCi (4255 MBq) generator will reach a delivery limit <60 mCi at ≥ 12 days and ≥ 23 days, respectively.   

Radiation Dosimetry

The estimated radiation absorbed dose coefficients for Rb 82, Sr 82, and Sr 85 from an intravenous injection of rubidium Rb 82 chloride are shown in Table 4.

Table 4
Adult absorbed dose per radioisotope activity associated with injection

Organ

82Rb1

(µGy/MBq)

82Sr2

(µGy/kBq)

85Sr2

(µGy/kBq)

Adrenals

2.4

2.9

1.4

Bone surfaces

0.42

29

2.7

Brain

0.14

2.2

0.8

Breast

0.19

1.9

0.5

Gallbladder wall

0.72

2.3

0.8

Gastrointestinal tract

Esophagus3

1.5

2.1

0.6

Stomach wall

0.83

2.1

0.6

Small intestine wall

2.0

2.6

1.1

Colon wall

1.1

9.7

1.2

(ULI wall)

1.1

6.4

1.0

(LLI wall)

1.1

14

1.4

Heart wall

4.0

2.2

0.7

Kidneys

9.3

2.5

0.7

Liver

1.0

2.2

0.7

Lungs

2.6

2.2

0.8

Muscles

0.23

2.2

0.7

Ovaries

0.50

2.8

1.2

Pancreas

2.6

2.5

0.9

Red marrow

0.38

25

2.7

Skin

0.18

1.9

0.5

Spleen

0.18

2.2

0.7

Testes

0.26

2.0

0.5

Thymus

1.5

2.1

0.6

Thyroid

0.31

2.2

0.7

Urinary bladder wall

0.18

5.9

0.8

Uterus

1.0

2.5

0.9

Remaining organs

0.31

 -

 -

Effective dose per unit activity

1.1 µSv/MBq

 6.3 µSv/kBq

1.1 µSv/kBq

1 Rb- 82 doses are averages of rest and stress dosimetry data. To calculate organ doses (µGy) from Rb- 82, multiply the dose coefficient for each organ by the administered activity in MBq. 

2 To calculate organ doses attributable to Sr-82 and Sr-85, multiply those dose coefficients by the respective strontium activities associated with the injection.

3The absorbed dose to the thymus is used as a substitute.   

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