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Intrathecal Pump Use & Drug Delivery
How to Prime the Synchromed® II Naïve Pump
Step 1: Prepare
- The first time the pump is used with PRIALT, it must be primed with undiluted PRIALT.1
- Use only undiluted PRIALT 25 mcg/mL (20 mL vial) formulation for naïve pump priming.1
- Using a 5-mL syringe, remove 2 mL from the vial of undiluted 25 mcg/mL PRIALT.1
- Set aside the remaining 18 mL in the vial.1
Step 2: Rinse
- Rinse the internal surfaces of the pump with 2 mL of undiluted PRIALT.1
- Discard the used 2 mL solution after rinsing.1
- Repeat the rinse procedure two more times for a total of three rinses.1
Step 3: Fill
- Fill the naïve pump after priming with the appropriate volume of PRIALT.1
- Initiate PRIALT dosing at a delivery rate of no higher than 2.4 mcg/day or 0.1 mcg/hour.1
PACC Guidelines recommends a starting dose for continuous intrathecal delivery of 0.5-1.2 mcg/day–consistent with the PRIALT prescribing information.2
How to Refill the Synchromed® II Pump
The Initial Pump Refill1
- Discard the remaining PRIALT in the pump.
- The Synchromed® II Pump should be refilled using a new vial of PRIALT within 14 days of the initial pump fill to help ensure appropriate dose administration.*
*In a naïve pump, PRIALT is lost due to two factors that do not occur upon subsequent refills: absorption on internal surfaces such as titanium, and by dilution in the residual space of the device.
All Subsequent Refills1
Fill the pump at least every:
- 40 days if PRIALT is diluted
- 84 days if PRIALT is undiluted
REFERENCES:
- PRIALT® (ziconotide) solution, intrathecal infusion [package insert]. Lake Forest, IL; TerSera Therapeutics.
- Deer TR, Prager J, Levy R, et al. Polyanalgesic Consensus Conference 2012: recommendations for the management of pain by intrathecal (intraspinal) drug delivery: report of an interdisciplinary expert panel. Neuromodulation. 2012;15(5):436-464
- 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;1-36. doi:10.1111/ner.12538
- Bolash R, et al. Intrathecal Pain Pumps: Indications, Patient Selection, Techniques, and Outcomes. Neurosurg Clin N Am 25 (2014) 735–742
- Pope JE, Deer TR, Bruel BM, Falowski S. Clinical Uses of Intrathecal Therapy and Its Placement in the Pain Care Algorithm. Pain Pract. 2016