MONTREAL--(BUSINESS WIRE)--Jubilant DraxImage Inc., dba Jubilant Radiopharma, a wholly-owned subsidiary of Jubilant Pharma Limited, is pleased to announce the clearance by the FDA to use its RUBY Rubidium Elution System™ and RUBY-FILL® (Rubidium Rb82 generator) in mobile settings. RUBY-FILL is used for cardiac PET imaging under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in patients with suspected or existing coronary artery disease.
Since the FDA approval of RUBY-FILL in 2016, Jubilant Radiopharma has partnered with health care providers across the U.S. to establish and grow cardiac PET programs. Typically, cardiac PET is performed in larger hospitals, outpatient programs and physician offices whose patient volumes can support a full time cardiac PET program. The announcement of the FDA approval for mobile use with RUBY-FILL will allow Jubilant to expand the use of cardiac PET into smaller community hospitals, in rural settings, and in areas where a full time cardiac PET program may not be warranted.
“The approval for mobile use with RUBY-FILL for cardiac PET is another example of Jubilant Radiopharma’s ongoing commitment to expand this imaging modality and increase patient access to this crucial test”, said Sergio Calvo, President, Jubilant Radiopharma, Radiopharmaceuticals Division. “Offering our customers the option to start a cardiac PET program on a part-time basis allows them to fully assess the value of initially offering the diagnostic test and making the determination how it will fit into a broader program for their patients in the future”.
Jubilant Radiopharma will have a booth at the Society of Nuclear Medicine held June 24-27, 2023 at the McCormick Convention Center in Chicago, booth 2065. Our representatives will be on hand to answer questions. Additionally, if you are interested in starting a full or part time cardiac PET program, or are interested in learning more about Jubilant Radiopharma’s “RUBY Mobile Solutions” program, please visit www.RUBY-FILL.com
About RUBY-FILL®
INDICATION (US): RUBY-FILL is a closed system used to produce rubidium (Rb82) chloride injection for intravenous use. Rubidium (Rb82) 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.
IMPORTANT SAFETY INFORMATION:
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-Full® 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)
About Jubilant Pharma Limited
Jubilant Pharma Limited (JPL), a Company incorporated under the laws of Singapore and a wholly-owned subsidiary of Jubilant Pharmova Limited, is an integrated global pharmaceutical company engaged in manufacturing and supply of Radiopharmaceuticals with a network of 46 radio-pharmacies in the US, Allergy Immunotherapy, Contract Manufacturing of Sterile Injectables and Non-sterile products and Solid Dosage Formulations through five manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies. The Company has a team of around 3,500 multicultural people across the globe and is committed to delivering value to its customers spread across over 75 countries. It is well recognized as a 'Partner of Choice' by leading pharmaceutical companies globally. For more info please visit www.jubilantpharma.com
About Jubilant Radiopharma
Jubilant Radiopharma, a division of Jubilant Pharma Ltd., is an industry-leading radiopharmaceutical business that comprises development, manufacturing and commercialization of products through Radiopharmaceuticals business and distribution through the Radiopharmacies business. Jubilant Radiopharma’s manufactured products are used in the diagnosis, treatment and monitoring of various diseases with specialization in lung, thyroid, bone and cardiac imaging products as well as in thyroid disease therapy. The division’s Radiopharmacies business is the second largest radiopharmacy network in the US with 46 pharmacies distributing nuclear medicine products to the largest national Group Purchasing Organisations (GPOs), regional health systems, stand-alone imaging centres, cardiologists and hospitals. This business has over 30 years of experience in serving the US nuclear medicine community and its current geographical reach enables it to serve over four million patients yearly. The Radiopharmacies business complements the Company’s niche Radiopharmaceuticals business and provides it with direct access to hospital networks. Jubilant Radiopharma is focused on developing, manufacturing, commercializing and distributing high quality and sustainable diagnostic and therapeutic agents for the sole purpose of “Improving Lives Through Nuclear Medicine” on a global scale.
For further information about Jubilant Radiopharma, and for full prescribing information, please visit our website: www.jubilantradiopharma.com
