RUBY-FILL 100 mCi/1
Rubidium Rb 82 · INJECTION, SOLUTION · Jubilant DraxImage Inc., dba Jubilant Radiopharma
RUBY-FILL is a injection, solution containing rubidium rb 82 at 100 mCi/1, taken intravenous. Manufactured by Jubilant DraxImage Inc., dba Jubilant Radiopharma.
Key Facts
- Brand Name
- RUBY-FILL
- Generic Name
- Rubidium Rb 82
- NDC Code (Product)
65174-021- Manufacturer
- Jubilant DraxImage Inc., dba Jubilant Radiopharma
- Strength
- 100 mCi/1
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA202153
- Marketing Start
- 09/30/2016
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
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 & 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…
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 )
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 )] .
Frequently Asked Questions
What is RUBY-FILL used for?
RUBY-FILL contains Rubidium Rb 82. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is RUBY-FILL a controlled substance?
RUBY-FILL is not classified as a controlled substance by the DEA.
What is the generic name for RUBY-FILL?
The generic name for RUBY-FILL is Rubidium Rb 82. There are no other listed brand versions of Rubidium Rb 82.
What is the NDC code for RUBY-FILL 100 mCi/1?
The NDC (National Drug Code) for RUBY-FILL 100 mCi/1 is 65174-021, listed by Jubilant DraxImage Inc., dba Jubilant Radiopharma.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)