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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:

  1. PRIALT® (ziconotide) solution, intrathecal infusion [package insert]. Lake Forest, IL; TerSera Therapeutics.
  2. 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
  3. 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
  4. Bolash R, et al. Intrathecal Pain Pumps: Indications, Patient Selection, Techniques, and Outcomes. Neurosurg Clin N Am 25 (2014) 735–742
  5. Pope JE, Deer TR, Bruel BM, Falowski S. Clinical Uses of Intrathecal Therapy and Its Placement in the Pain Care Algorithm. Pain Pract. 2016