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Importance of Titration
Start Low and Go Slow
- PACC Guidelines recommends a starting dose for continuous intrathecal delivery of 0.5-1.2 mcg/day–consistent with the PRIALT prescribing information.
- Initiate dosing at no more than 2.4 mcg/day (0.1 mcg/hour).
- The lowest initial starting dose of PRIALT that can be delivered through the Medtronic SynchroMed® II pump without dilution is 1.2 mcg/day.
- The lowest flow rate is 0.048 mL/day.
- Titrate gradually by no more than 2.4 mcg/day and no more than two to three times per week. Lower and less frequent dose increases may be used.
- The daily dose should not exceed 19.2 mcg/day (0.8 mcg/hour).
- Ongoing patient assessment is key to managing outcomes
- Adjust the dose according to:
- Pain severity.
- Patient response to therapy.
- Occurrence of adverse events.
Finding the appropriate dose for your patient may take time. Be sure to counsel your patient and set expectations regarding the titration process. Ongoing communication with your patient regarding their therapy and PRIALT use is essential to finding an appropriate dose.
*PACC, founded 2000, offers guidance on IT therapy to help improve efficacy and patient safety. PACC was initiated by the International Neuromodulation Society (INS) and was partially funded via an unrestricted grant from product sponsor. No corporate entities had any direct input into the contents of the manuscripts or the conclusions of the collaborators.1
- Deer TR, Pope JE, Hayek S, et al. The Polyanalgesic Consensus Conference (PACC): Recommendations on intrathecal drug infusion systems best practices and guidelines. Neuromodulation. 2017; 2: 16.
- PRIALT® (ziconotide) solution, intrathecal infusion [package insert]. Lake Forest, IL; TerSera Therapeutics.
- Rauck RL, Wallace MS, Leong MS, et al; Ziconotide 301 Study Group. A randomized, double‐blind, placebo‐controlled study of intrathecal ziconotide in adults with severe chronic pain. J Pain Symptom Manage. 2006; 5:403-404.
- Targeted drug delivery: SynchroMed II infusion pump performance data. Medtronic for Healthcare Professionals Website. http://www.medtronic.com/us-en/healthcare-professionals/products/neurological/drug-infusion-systems/synchromed-ii.html Updated July 31, 2012. Accessed July 13, 2018.