Generic Name and Formulations:
Naldemedine 0.2mg; tabs.
Indications for SYMPROIC:
Opioid-induced constipation in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (eg, weekly) opioid dosage escalation.
Take with or without food. 0.2mg once daily. Discontinue if opioid pain therapy is also discontinued.
Known or suspected GI obstruction. Patients at increased risk of recurrent obstruction.
Risk of GI perforation in those with conditions associated with reduction in structural integrity of the GI tract wall (eg, peptic ulcer disease, Ogilvie’s syndrome, diverticular disease, infiltrative GI tract malignancies, or peritoneal metastases). Monitor for abdominal pain; discontinue if severe, persistent, or worsening symptoms occur. Monitor for symptoms of opioid withdrawal (esp. patients having disruptions to the blood brain barrier). Severe hepatic impairment (Child-Pugh Class C): avoid. Pregnancy. Nursing mothers: not recommended (during and for 3 days after final dose).
Opioid antagonist (peripheral).
Avoid concomitant strong CYP3A inducers (eg, rifampin, carbamazepine, phenytoin, St. John’s Wort) or other opioid antagonists. Potentiated by moderate (eg, fluconazole, atazanavir, aprepitant, diltiazem, erythromycin) and strong CYP3A inhibitors (eg, itraconazole, ketoconazole, clarithromycin, ritonavir, saquinavir), or P-gp inhibitors (eg, amiodarone, captopril, cyclosporine, quercetin, quinidine, verapamil); monitor.
Abdominal pain, diarrhea, nausea, vomiting, gastroenteritis; opioid withdrawal.
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