Download MHCP Enrolled Providers – Pharmacies Fee-for

MHCP Enrolled Providers – Pharmacies
Fee-for-Service PA Criteria Sheet – Nucynta ER
(June 2016)
Drug
Therapeutic Area
Nucynta ER (tapentadol extended release) [Janssen]
Pain - Long Acting Opioids
Approval Criteria
 Patient has a patient-specific pain management plan and a copy of that plan accompanying the PA request which has
been updated in the past 12 months AND
 Patient has tried and failed sustained release morphine at equivalent dosing* OR have a documented intolerance to
preferred long-acting morphine (generic morphine ER) AND
 Patient does NOT have or is not suspected of having a paralytic ileus AND
 Patient does NOT have severe respiratory depression or severe bronchial asthma
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Exclusion Criteria
 Patient has impaired pulmonary function (significant respiratory depression, acute or severe bronchial asthma or
hypercapnia in unmonitored settings or the absence of resuscitative equipment) OR
 Paralytic ileus OR
 Concurrent use of monoamine oxidase (MAO) inhibitors or use within the last 14 days
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Quantity Limits
The starting dose of Nucynta ER for all patients is 50 mg twice daily. Patients should be titrated to adequate pain control with
increases of 50 mg at a minimum of twice daily every three days. The dose should be titrated within the therapeutic range of 100
mg to 250 mg twice daily. The maximum daily dosage of Nucynta ER is 500 mg daily.
Conversion from Nucynta IR to Nucynta ER: Divide the equivalent total daily dose of Nucynta IR into two equal doses of Nucynta
ER separated by 12 hours. (e.g. 50 mg of Nucynta IT four times daily converts to 100 mg Nucynta ER twice daily).
 Quantity Limit = 68 tablets; allow max total daily dose of 500 mg Nucynta ER
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Background information
Tapentadol extended-release (Nucynta ER) is an opioid analgesic indicated for the management of moderate to severe chronic
pain in adults when a continuous, around-the clock opioid analgesic is needed for an extended period of time and the treatment of
neuropathic pain associated with diabetic peripheral neuropathy.
Notable Drug Interactions
Nucynta ER should not be taken by patients who have received a monoamine oxidase inhibitor (MAOI) in the last 14 days.
Nucynta ER should also be used with caution with selective serotonin receptor inhibitors (SSRIs), selective norepinephrine
receptor inhibitors (SNRIs), triptans and any other drugs that may affect serotonergic neurotransmitter systems due to the
risk of serotonin syndrome.
Expected Equivalent Dosing
Nucynta ER dose range
Oxycodone total daily dose
Morphine daily dose range
50, 100, 150, 200, 250 mg
10, 15, 20, 30, 40, 60, 80mg 15, 30, 60, 100 mg
Twice daily
Twice daily
Twice daily
100 mg
20 mg
30 - 40 mg
150 mg
30 mg
45 - 60 mg
200 mg
40 mg
60 - 80 mg
Represents total daily dose.
300 mg
60 mg
90 - 120 mg
400 mg
80 mg
120 - 160 mg
500 mg
100 mg
150 - 200 mg
These recommendations are guides only. Individual patients require doses to be adjusted. Expected equianalgesic doses for
Nucynta ER are based on limited clinical support from the manufacturer using a 5:1 ratio of Nucynta ER to oxycodone.
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MHCP Provider Call Center 651-431-2700 or 800-366-5411
Strengths available
Dosing frequency
Expected equianalgesic
dosing