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Getting started with MOVANTIK

Treat at the source with MOVANTIK—One 25-mg tablet, once a day1

MOVANTIK 25 mg Dosing and Administration

Dosage1

  • The recommended dose of MOVANTIK is 25 mg once daily in the morning
  • Reduce the dosage to 12.5 mg once daily for patients who are not able to tolerate the 25-mg dose
  • The starting dosage for patients with creatinine clearance (CLcr) <60 mL/min (ie, patients with moderate, severe, or end-stage renal impairment) is 12.5 mg once daily. If this dosage is well tolerated but OIC symptoms continue, the dosage may be increased to 25 mg once daily taking into consideration the potential for markedly increased exposures in some patients with renal impairment and the increased risk of adverse reactions with higher exposures
  • Avoid concomitant use of MOVANTIK with moderate CYP3A4 inhibitor drugs (eg, diltiazem, erythromycin, verapamil). If concurrent use is unavoidable, reduce the MOVANTIK dosage to 12.5 mg once daily and monitor for adverse reactions
 

Administration1

  • Discontinue all maintenance laxative therapy prior to initiation of MOVANTIK. Laxative(s) can be used as needed if there is a suboptimal response to MOVANTIK after three days
  • Alteration in analgesic dosing regimen prior to initiating MOVANTIK is not required
  • Patients receiving opioids for less than 4 weeks may be less responsive to MOVANTIK
  • Take MOVANTIK on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal
  • For patients who are unable to swallow the MOVANTIK tablet whole, the tablet can be crushed to a powder, mixed with 4 ounces (120 mL) of water and drunk immediately. The glass should be refilled with 4 ounces (120 mL) of water, stirred and the contents drunk
  • MOVANTIK can also be administered via a nasogastric (NG) tube, please see the Prescribing Information for full details
  • Avoid consumption of grapefruit or grapefruit juice during treatment with MOVANTIK
  • Discontinue MOVANTIK if treatment with the opioid pain medication is also discontinued
 

 

IMPORTANT SAFETY INFORMATION ABOUT MOVANTIK

  • MOVANTIK® (naloxegol) is contraindicated in:
    • Patients with known or suspected gastrointestinal (GI) obstruction and patients at increased risk of recurrent obstruction, due to the potential for GI perforation
    • Patients receiving strong CYP3A4 inhibitors (eg, clarithromycin, ketoconazole) because these medications can significantly increase exposure to naloxegol which may precipitate opioid withdrawal symptoms
    • Patients with a known serious or severe hypersensitivity reaction to MOVANTIK or any of its excipients
  • Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, irritability, and yawning, occurred in patients treated with MOVANTIK. Patients receiving methadone as therapy for their pain condition were observed in the clinical trials to have a higher frequency of GI adverse reactions that may have been related to opioid withdrawal than patients receiving other opioids. Patients with disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal or reduced analgesia. These patients (eg, multiple sclerosis, recent brain injury, Alzheimer’s disease, and uncontrolled epilepsy) were not enrolled in the clinical studies. Take into account the overall risk-benefit profile when using MOVANTIK in such patients. Monitor for symptoms of opioid withdrawal when using MOVANTIK in such patients
  • Severe abdominal pain and/or diarrhea have been reported, generally within a few days of initiation of MOVANTIK. Monitor and discontinue if severe symptoms occur. Consider restarting MOVANTIK at 12.5 mg once daily
  • Cases of GI perforation have been reported with the use of another peripherally acting opioid antagonist in patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract. Monitor for severe, persistent, or worsening abdominal pain; discontinue if this symptom develops
  • Avoid concomitant use of moderate CYP3A4 inhibitors (eg, diltiazem, erythromycin, verapamil) because they may increase the risk of adverse reactions. Use of strong CYP3A4 inducers (eg, rifampin, carbamazepine, St. John’s Wort) is not recommended because they may decrease the efficacy of MOVANTIK. Avoid concomitant use of MOVANTIK with another opioid antagonist due to the increased risk of opioid withdrawal
  • The use of MOVANTIK during pregnancy may precipitate opioid withdrawal in a fetus due to the immature fetal blood-brain barrier. MOVANTIK should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Due to the potential for serious adverse reactions, including opioid withdrawal, in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother
  • The most common adverse reactions with MOVANTIK as compared to placebo in clinical trials were: abdominal pain (21% vs 7%), diarrhea (9% vs 5%), nausea (8% vs 5%), flatulence (6% vs 3%), vomiting (5% vs 4%), headache (4% vs 3%), and hyperhidrosis (3% vs <1%)

INDICATION

MOVANTIK is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.

Please click here for full Prescribing Information and Medication Guide.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1‑800‑FDA‑1088.

Reference: 1. Prescribing Information for MOVANTIK. AstraZeneca Pharmaceuticals LP, Wilmington, DE.