RUBY-FILL
Details
- Status
- Prescription
- First Approved
- 2016-09-30
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
RUBY-FILL Approval History
What RUBY-FILL Treats
1 indicationsRUBY-FILL is approved for 1 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Coronary Artery Disease
RUBY-FILL Boxed 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 ...
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 EXPOSU
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Trial Timeline
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
RUBY-FILL FDA Label Details
ProIndications & Usage
FDA Label (PDF)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) im...
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 8...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.