Nucynta ER

Drug - Nucynta ER (tapentadol extended release) [Janssen]

June 2016

Therapeutic area - 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

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

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

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

Dosing	Oxycodone total daily dose	Morphine daily dose range	Nucynta ER dose range
Strengths available	10, 15, 20, 30, 40, 60, 80 mg	15, 30, 60, 100 mg	50, 100, 150, 200, 250 mg
Dosing frequency	Twice daily	Twice daily	Twice daily
Expected equianalgesic dosing Represents total daily dose.	20 mg 30 mg 40 mg 60 mg 80 mg 100 mg	30 - 40 mg 45 - 60 mg 60 - 80 mg 90 - 120 mg 120 - 160 mg 150 - 200 mg	100 mg 150 mg 200 mg 300 mg 400 mg 500 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.

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411