Initial Use of PRIALT in a Naïve Pump6,14
The initial concentration of PRIALT is reduced over time in the IT pump, which may affect the dose and potentially impact safety and efficacy.
Reasons for this concentration reduction include:
- Adsorption on internal device surfaces, such as titanium
- Dilution of ziconotide solution into the residual space of pump reservoir
Example of Concentration on Initial Fill and Refill With Undiluted 25-mcg/mL PRIALT in SynchroMed® II Pump14
A naïve pump must be rinsed 3 times with 2 mL of undiluted 25-mcg/mL PRIALT.
Important Safety Information
Elevation of Serum Creatine Kinase
In clinical trials, serum creatine kinase (CK) levels above the upper limit of normal (ULN) were reported in 40% of patients, with 11% of patients having CK levels >3 times ULN. Incidences were higher during the first 2 months of treatment. Serum CK should be monitored periodically. If these symptoms continue and CK levels remain elevated or continue to rise, reduce the dose or discontinue the use of PRIALT.
Please see full Prescribing Information, including BOXED Warning, and click here for additional Important Safety Information.