Navigation

Ampules and Refill Kit

Ampules and Concentrations

Lioresal® Intrathecal is supplied in single-use ampules:1

  • 0.05 mg/1 ml (50 mcg/mL; NDC 70257-562-55)
  • 10 mg/20 mL (500 mcg/mL; NDC 70257-560-01)
  • 10 mg/5 mL (2000 mcg/mL; NDC 70257-561-02)
  • 40 mg/20 mL (2000 mcg/mL; 1 ampule: NDC 70257-563-01; 2 ampules: NDC 70257-563-02)
  • Conforms to within +/−5% of package-listed concentration2
  • The only intrathecal baclofen to undergo dynamic drug testing in catheters representative of the entire portfolio of those approved for use with the Medtronic SynchroMed® II pump

For the screening dose, there is 1 ampule containing 0.05 mg/1 mL (50 mcg/mL; NDC 70257-562-55). The additional concentrations for pump reservoir refill allow for individualized dosing.1

Lioresal® Intrathecal does not require refrigeration.1

For patients who require concentrations other than 500 mcg/mL or 2000 mcg/mL, Lioresal® Intrathecal must be diluted.1

Why +/-5% Matters

“For patients receiving ITB, viability in either stability or concentration could make titrating to an effective dose difficult and could result in unintended life-threatening withdrawal or overdose.”2—Moberg-Wolffe E., Arch Phys Med Rehabil, 2009

The Ampule Difference

Lioresal® Intrathecal has long been provided in glass ampules, which offer quality and allow for maintenance of sterility. They have been a leading choice of drug manufacturers for well over 100 years, ensuring the highest quality product is delivered to the patient.

  • Provide improved opportunities for aseptic technique and maintenance of sterile field
  • Minimize drug contact with constituents
  • Minimize risk from leachables and extractables
  • Minimize the potential introduction of particulate matter due to puncture-free design

Refilling the Medtronic SynchroMed® II pump with Lioresal® Intrathecal

With Lioresal® Intrathecal, the pump system needs to be periodically refilled to provide long-term therapy and prevent withdrawal.1

Lioresal® Intrathecal Refill Kit

Reservoir refilling must be performed by fully trained and qualified personnel following the directions provided by the pump manufacturer. Extreme caution must be used when filling an FDA-approved implantable pump, following strict aseptic technique and ensuring refill directly into the reservoir and not the catheter access port.1

 

Designed with the safety of both provider and patient in mind


Importantly, supplying Lioresal® Intrathecal in glass ampules can help providers maintain a sterile field. The use of the FILTER STRAW® by Braun with the Lioresal® Intrathecal ampule provides additional distance to help maintain sterility.

The SynchroMed® II pump system is designed to allow for refills every few weeks or months, depending on the needs of the patient based on Lioresal® Intrathecal concentration and daily dose. Lioresal® Intrathecal is stable in the pump reservoir for up to 180 days.4 The pump has an alarm that will sound when the reservoir of Lioresal® is running low.3,4 Patients and caregivers should be made aware of what the pump alarms sound like, and if they hear an alarm, they should contact the appropriate healthcare provider immediately.1,3

Reservoir refills are sterile, procedures that need to be scheduled, and it is important that patients keep their scheduled refill appointments. It is critically important that patients adhere to their refill schedule to prevent abrupt withdrawal syndrome.1,3,4

Refill Considerations

Changes in Lioresal® Intrathecal concentrations are often made during pump refills. Experts suggest drug concentrations be increased to lengthen the time between pump refills. Increasing the concentration of baclofen will decrease the volume of drug delivered, which occurs at a decreased flow rate. If the patient does not respond as well to the higher concentration, experts recommend increasing the total daily dose until the desired therapeutic effect is achieved.3

To change drug concentrations, a bridge bolus must be performed so that the old drug concentration is infused at a rate necessary to clear the pump tubing and catheter of the residual drug in the previous concentration.3

Following pump implantation, and for each adjustment of the dosing rate of the pump and/or concentration of Lioresal® Intrathecal, the patient should be monitored closely until it is certain the patient’s response to the infusion is acceptable and reasonably stable.

  1. Lioresal® Intrathecal (baclofen injection) for intrathecal injection [prescribing information]. Saol Therapeutics, Roswell, Georgia; January 2019.
  2. Moberg-Wolff E. Potential clinical impact of compounded versus noncompounded intrathecal baclofen. Arch Phys Med Rehabil. 2009;90(11):1815-1820.
  3. Boster AL, Adair RL, Gooch JL, et al. Best practices for intrathecal baclofen therapy: dosing and long-term management. Neuromodulation. 2016;19(6):623-631.
  4. Francisco GE, Saulino M. Chapter 19: Intrathecal baclofen for spasticity. In: Brashear A, Elovic E, eds. Spasticity: Diagnosis and Management. 2nd ed. New York, NY: Demos Medical Publishing, LLC, 2016.

Important Safety Information for Lioresal® Intrathecal (baclofen injection)

Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure and death.

Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal. Special attention should be given to patients at apparent risk (e.g. spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen). Consult the technical manual of the implantable infusion system for additional postimplant clinician and patient information (see WARNINGS).

Indications and Usage

Contraindications

Select Warnings and Precautions

Adverse Reactions

Common Adverse Reactions

Serious Adverse Reactions

Postmarketing Experience

Use in Specific Populations

For more information, including BOX WARNING, refer to Lioresal® Intrathecal (baclofen injection) prescribing information.