![]() Remove the cap from the Vial 2 (buffer vial), swab the top of the vial with alcohol to disinfect the surface, and allow the stopper to dry. Pierce the Vial 1 septum with a sterile needle connected to a 0.22 micron sterile vented filter (not supplied) to maintain atmospheric pressure within the vial during the reconstitution process. Remove the cap from Vial 1 (reaction vial), swab the top of the vial with alcohol to disinfect the surface, and allow the stopper to dry.į. The Ga 68 chloride is sterile as eluted from the GalliaPharm generator.Į. Other gamma emitting radionuclides should be ≤ 0.001%. Test periodically (weekly) the Ga 68 chloride eluate for Ge 68 breakthrough by suitable method. NETSPOT DRUG GENERATORUse 0.1N sterile HCl supplied by the generator manufacturer. Prepare a syringe containing 5 mL of 0.1 N sterile HCl, to be used for elution of the GalliaPharm Set the temperature of the shielded dry bath to 203 ☏ (95 ☌), and wait for the temperature to reach the set point and stabilize.ĭ. Use suitable shielding to reduce radiation exposure.Ĭ. Prepare Ga 68 dotatate for intravenous injection according to the following aseptic procedure (see above diagram):Ī. Of Ge 68 potentially present in generator eluate. The accessory cartridge reduces the amount Vial 2 (buffer vial) contains: 60 mg formic acid 56.5 mg sodium hydroxide and water for injection.Īccessory cartridge contains: 660 mg porous silica. Vial 1 (reaction vial with lyophilized powder) contains: 40 mcg dotatate, 5 mcg 1,10-phenanthroline Has been established only when using a Ga 68 chloride solution eluted from the GalliaPharm generator. The safety and efficacy of the Ga 68 DOTATATE injection drug product prepared from the NETSPOT kit GalliaPharm Ge 68/Ga 68 generator (“GalliaPharm generator”) is not supplied with the NETSPOT kit. Ziegler GalliaPharm Germanium 68/Gallium 68 (Ge 68/Ga 68) generator. (3) ] which allows for direct preparation of Ga 68 DOTATATE injection with the eluate from an Eckert & The NETSPOT kit is supplied as 2 vials and an accessory cartridge [see Dosage Forms and Strengths Here is an example of three generators linked to an accessory cartridgeĭrug Preparation (link to entire package insert).Following an elution of 68Ga of 60 mCi, how long would you have to wait to get an additional 45 mCi?.T1/2 of 68Ge is 271 days and the T1/2 of 68Ga is 68 minutes.Via a cyclotron 68Ge is made: 68Zn(p,n) 68Ga.Currently only DOTATATE has been approved by the FDG (June 2016) A new 68Ga imaging agent can be labeled to DOTATATE, DOTATOC, or DOTANOC.We will first explore the imaging of, with PET and then continue with therapy and treatment. While we are familiar with the use of MIBG and Octreotide PET imaging and therapy has now entered the nuclear arena to evaluate and treat neuroendocrine tumors (NET). All rights reserved.Neuroendocrine Tumors - Diagnostic and Treatment Even though NETs have historically been considered as rare tumors (orphan disease), their incidence has grown more than 500 percent over the last 3 decades. and the European Union is approximately 47,300 patients/year. The estimated incidence of NETs for the combined populations of the U.S. in two forms: as a kit for reconstitution using a Ga 68 generator, and as Netspot Injection, a ready-to-use dose delivered from a local radiopharmacy in selected metropolitan areas. The product will be available in the U.S. Gallium Ga 68 dotatate received Orphan Drug Designation from both the FDA and European Medicines Agency (EMA) in March 2014.įollowing approval, Netspot will be made available to the U.S. It is the first approved drug using Ga 68 as a positron emitter. Netspot is the new market name for Somakit-TATE (a kit for the preparation of gallium Ga 68 dotatate injection) in the U.S. Netspot received approval following a Priority Review from the FDA. The FDA has approved Netspot (Somakit-TATE) for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. ![]()
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