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Symproic Generic Name & Formulations
Legal Class
Rx
General Description
Naldemedine 0.2mg; tabs.
Pharmacological Class
Opioid antagonist (peripheral).
How Supplied
Tabs—90
Manufacturer
Generic Availability
NO
Symproic Indications
Indications
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.
Symproic Dosage and Administration
Adult
Take with or without food. 0.2mg once daily. Discontinue if opioid pain therapy is also discontinued.
Children
Not established.
Symproic Contraindications
Contraindications
Known or suspected GI obstruction. Patients at increased risk of recurrent obstruction.
Symproic Boxed Warnings
Not Applicable
Symproic Warnings/Precautions
Warnings/Precautions
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).
Symproic Pharmacokinetics
See Literature
Symproic Interactions
Interactions
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.
Symproic Adverse Reactions
Adverse Reactions
Abdominal pain, diarrhea, nausea, vomiting, gastroenteritis; opioid withdrawal.
Symproic Clinical Trials
See Literature
Symproic Note
Not Applicable
Symproic Patient Counseling
See Literature
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