Naldemedine (Symproic®)

SELF ADMINISTRATION

Indications for Prior Authorization:

  • Treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g. weekly) opioid dosage escalation

Prior Authorization Criteria:

  • Patient is at least 18 years old, AND
  • OIC use is not due to cancer-related pain, AND
  • Patient does not have a gastrointestinal obstruction or is at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation, AND
  • Will not be used concomitantly with strong CYP3A inducers, AND
  • Will not be used concomitantly with other opioid antagonists, AND
  • Patient has tried and failed a stool softener plus a stimulant laxative and at least one other class of laxative

Dosing:

  • 0.2mg once daily with or without food
  • Severe hepatic impairment: avoid use
  • Alteration of analgesic dosing regimen prior to initiating Symproic is not required
  • Discontinue Symproic if treatment with the opioid pain medication is also discontinued

Approval:

  • One year

Last review date: December 17, 2018