Transcript Use of the Personal Therapy Manager With Prialt

Use of the Personal Therapy Manager With
Prialt® (Ziconotide Intrathecal Infusion) for
Patient-controlled Analgesia:
Case Series
Gladstone C. McDowell, II, MD
Integrated Pain Solutions, Columbus, Ohio
Personal Therapy Manager (PTM) and
Prialt® (ziconotide intrathecal infusion)
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PTM
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Patient-activated delivery of physician-programmed
supplemental dose of intrathecal (IT) medication as needed
Ziconotide
IT analgesic for chronic severe pain1
 Inhibits N-type calcium channels, believed to reduce signaling
along the spinal pain pathways2
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We have used the PTM in patients receiving continuous
infusion of IT ziconotide (monotherapy or combination)
1. PRIALT® (ziconotide intrathecal infusion) [package insert]. 2008.
2. McGivern JG. Neuropsychiatr Dis Treat. 2007;3(1):69-85.
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PTM is Contraindicated for Use With Ziconotide
“Contraindications
… Do not prescribe or use the Personal Therapy Manager for
administration of an intrathecal infusion of ziconotide, because
ziconotide has a defined titration scheme.”1
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However,
Bolus trials are routinely used to test effectiveness of
ziconotide for individuals2-4
 Ziconotide overdose does not lead to respiratory
depression or death5
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Formal study is needed to define usage criteria to
ensure efficacy and safety and minimize side effects
1. Personal Therapy Manager for Synchromed II [Product Insert]. 2007.
2. Baumgartl WH. (poster) 10th Annual Meeting of NANS; 2006.
3. Rosenblum SM. (Abstract A1566) ASA Annual Meeting; 2008.
4. Grigsby E, et al. (Abstract 14) ASRA 2010 Annual Pain Meeting and Workshops; 2010.
5. Charapata S and Ellis D. Pain Medicine. 2002;3(2):189-190.
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Dosing considerations
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PTM with ziconotide monotherapy
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PTM with ziconotide in combination with opioid
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Simpler, safer than combination therapy
Calculate programmed dose based on ziconotide infusion
dose (minding opioid overdose)
Bolus doses equivalent to ~10% of daily continuous dose
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Ziconotide bolus dose range, 0.15 to 0.25 mcg
Intervals of 1−2 hours (cancer patients) to 4−6 hours
(nonmalignant disease patients)
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Tolerability and Pain Relief
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This treatment strategy was well tolerated
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No severe adverse effects
A few patients experienced nausea or dizziness with PTM
doses that exceeded 60% of their simple continuous
ziconotide dose
The addition of PTM increased patient satisfaction and
decreased office visits
 Patient compliance was related directly to proper and
adequate education regarding the utility and beneficial
effects of the PTM device
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PTM Cases
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Ziconotide monotherapy, 3 patients:
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1 patient with arachnoiditis
1 patient with rheumatoid arthritis and osteoarthritis
1 patient with chronic pancreatitis
Ziconotide + hydromorphone, 11 patients:
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4 patients with metastatic breast cancer
1 patient with large anal cancer
1 patient with metastatic pancreatic cancer
3 patients with lumbar postlaminectomy syndrome
1 patient with diabetic peripheral neuropathy
1 patient with interstitial cystitis and lumbar postlaminectomy
syndrome
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Ziconotide (IT) Monotherapy Cases (1)
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Arachnoiditis
Simple continuous dose
Ziconotide 14.983 mcg/d
PTM dose
Ziconotide 0.25 mcg q4h
Status
Pain 4/10, maintains active lifestyle
Minimal contact, generally seen only for pump refills
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Rheumatoid arthritis and osteoarthritis
Simple continuous dose
Ziconotide 4.8 mcg/d
PTM dose
Ziconotide 0.20 mcg q3h
Status
(Oral) oxymorphone ER 5 mg q12h
Pain 4–5/10, more functional
Seen only for pump refills
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Ziconotide (IT) Monotherapy Cases (2)
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Chronic pancreatitis (failed SCS)
Simple continuous dose
Ziconotide 1.5 mcg/d
PTM dose
Ziconotide 0.15 mcg q2h
Status
Pain 5/10, functional
Phone calls reduced, seen only for pump refills and titration
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Combination Therapy Cases (1)
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Metastatic breast cancer – lumbar spine metastases
Simple continuous dose
Ziconotide 6.701 mcg/d + hydromorphone 6.7 mg/d
PTM dose
Ziconotide 0.25 mcg + hydromorphone 0.25 mg q8h
Status
Pain 6/10, now fully ambulatory and more active
Minimal unscheduled contact, generally seen only for pump refills
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Metastatic breast cancer – thoracic/lumbar spine, bilateral
femur, and extensive pelvis metastases with fractures
Simple continuous dose
Ziconotide 14.408 mcg/d + hydromorphone 3.0 mg/d
PTM dose
Ziconotide 0.10 mcg + hydromorphone 0.02 mg q3h
Status
Pain remains high, but she is functional despite continued tumor spread
No hospital admissions or ER visits, seen monthly for pump refills and
occasional dose increases
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Combination Therapy Cases (2)
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Metastatic pancreatic cancer – L5 metastasis
Simple continuous dose
Ziconotide 1.0 mcg/d + hydromorphone 1.5 mg/d
PTM dose
Ziconotide 0.10 mcg + hydromorphone 0.15 mg q8h
Status
Pain 1/10 within 1 month, rare PTM use, doses reduced by 5%
Minimal phone contact, receiving home pump refills
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Lumbar post-laminectomy syndrome (failed SCS)
Simple continuous dose
Ziconotide 3.994 mcg/d + hydromorphone 1.33 mg/d
PTM dose
Ziconotide 0.20 mcg + hydromorphone 0.067 mg q3h
Status
Pain 4–5/10, young patient remains active
Generally seen only for pump refills
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Combination Therapy Cases (3)
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Diabetic peripheral neuropathy
Simple continuous dose
Ziconotide 6.0 mcg/d
Hydromorphone 1.2 mg/d
PTM dose
Ziconotide 0.25 mcg q3h
Hydromorphone 0.05 mg q3h
Status
More active, less neuropathy pain, less frequent anxiety flares
Minimal unscheduled contact, generally seen only for pump refills
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Conclusions
The PTM can be used with ziconotide monotherapy or
with ziconotide in combination with an opioid with
acceptable tolerability and improved pain relief
outcomes
 Individualization of therapy and communication with
patient are essential for successful PTM use
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Formal study is needed to provide evidence for
1) Efficacy, safety, tolerability
2) Dosing parameters
3) Guidelines for physicians
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