Generic Name and Formulations:
Naloxegol 12.5mg, 25mg; tabs.
Indications for MOVANTIK:
Opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including chronic pain related to prior cancer or its treatment in patients who do not require frequent opioid dosage escalation.
Discontinue all laxative therapy prior to initiation; may use as needed if suboptimal response after 3 days. Discontinue if opioid pain therapy is also discontinued. Swallow whole. Take on an empty stomach. 25mg once daily in the AM; may reduce to 12.5mg once daily if unable to tolerate. If unable to swallow tab whole: may crush and mix with 4oz of water and drink immediately; refill glass with additional 4oz of water, stir and drink. Also, may give via NG tube (see full labeling). Moderate, severe, or end-stage renal impairment (CrCl <60mL/min): 12.5mg once daily; may increase to 25 mg once daily if well tolerated and symptoms continue. Concomitant moderate CYP3A4 inhibitors: if unavoidable, reduce naloxegol to 12.5mg once daily; monitor.
Known or suspected GI obstruction. Patients at increased risk of recurrent obstruction. Concomitant strong CYP3A4 inhibitors (eg, clarithromycin, itraconazole, ketoconazole).
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 and/or diarrhea; discontinue if severe symptoms occur (consider restarting at 12.5mg once daily, if appropriate). Monitor for symptoms of opioid withdrawal (esp. patients receiving methadone or having disruptions to the blood brain barrier). Severe hepatic impairment (Child-Pugh Class C); avoid. Pregnancy (Cat.C). Nursing mothers: not recommended.
See Contraindications. Avoid concomitant moderate CYP3A4 inhibitors (eg, diltiazem, erythromycin, verapamil): if unavoidable, reduce dose (see Adults). Avoid concomitant other opioid antagonists, grapefruit, or grapefruit juice. Concomitant strong CYP3A4 inducers (eg, rifampin, carbamazepine, St. John’s Wort): not recommended.
Opioid antagonist (peripheral).
Abdominal pain, diarrhea, nausea, flatulence, vomiting, headache, hyperhidrosis.
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