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Frequently Asked Questions

1. What is “OIC”?

OIC stands for opioid-induced constipation. OIC can occur with initiation of opioid therapy and may persist for the duration of treatment.1,2

2. What is the mechanism of OIC?

Opioids work by binding to mu-receptors in the brain and other parts of the central nervous system to block pain signals.3 But they also bind to mu-receptors in the bowel, which may cause OIC.

3. How does MOVANTIK work to treat OIC in adult patients with chronic non‑cancer pain?

When administered at recommended dose levels, MOVANTIK functions as a PAMORA (Peripherally Acting Mu-Opioid Receptor Antagonist) in tissues such as the bowel, thereby decreasing the constipating effects of opioids.4

4. Does MOVANTIK interfere with the pain relief from opioids?

When administered at the recommended dose levels, the PEGylated structure of MOVANTIK restricts it from penetrating the blood-brain barrier, limiting potential interference with the analgesic effects of opioids.4

Alteration in analgesic dosing regimen prior to initiating MOVANTIK is not required.4

5. What is the median time to first post-dose SBM?

In the KODIAC-04 and KODIAC-05 trials, the median time to first post-dose SBM (spontaneous bowel movement) was a full day faster with MOVANTIK 25 mg than with placebo. In the two clinical studies, median time to first post-dose SBM was 6 and 12 hours with MOVANTIK 25 mg vs 36 and 37 hours for placebo.4

6. What adverse reactions were seen in the clinical trials for MOVANTIK?

The safety of MOVANTIK was investigated in 1497 patients across four clinical studies.4

The safety and efficacy of MOVANTIK was evaluated in two 12-week, replicate, randomized, double-blind placebo-controlled trials (KODIAC-04 and KODIAC-05) in patients with opioid-induced constipation (OIC) and non-cancer related pain (n=1352).4 In KODIAC-04 and KODIAC-05, the most common adverse reactions (≥3%) for MOVANTIK 25 mg vs placebo 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%).

Results from two safety and tolerability trials (one 12-week extension study, KODIAC-07 [n=302], and a 52-week, open-label safety and tolerability study of MOVANTIK vs usual care treatment, KODIAC-08 [n=844]) were similar to the KODIAC-04 and KODIAC-05 trials.4

Opioid Withdrawal

In KODIAC-04 and KODIAC-05, possible opioid withdrawal was defined as at least 3 adverse reactions potentially related to opioid withdrawal that occurred on the same day and were not all related to the GI system.4 Symptoms included, but were not limited to: hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, irritability, and yawning. Possible opioid withdrawal occurred in 3% (14/446) of patients receiving MOVANTIK 25 mg and <1% (1/444) of placebo subjects.

Consider the overall risk benefit in patients with disruptions to the blood-brain barrier.4 Monitor for symptoms of opioid withdrawal.

7. What is dosage and administration information for MOVANTIK?

 

Dosage4

  • 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
 

Administration4

  • 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
  • MOVANTIK has been shown to be efficacious in patients who have taken opioids for at least 4 weeks. Sustained exposure to opioids prior to starting MOVANTIK may increase the patient’s sensitivity to the effects of 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
 

8. Can a MOVANTIK 25-mg tablet be cut in half?

No. The MOVANTIK 25-mg tablet is not scored.4

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.

References: 1.  Panchal SJ, Müller-Schwefe P, Wurzelmann JI. Opioid-induced bowel dysfunction: prevalence, pathophysiology, and burden. Int J Clin Pract. 2007;61:1181-1187. 2. Becker G, Blum HE. Novel opioid antagonists for opioid-induced bowel dysfunction and postoperative ileus. Lancet. 2009;373:1198-1206. 3. Brock C, Olesen SS, Olesen AE, Frøkjaer JB, Andresen T, Drewes AM. Opioid-induced bowel dysfunction: pathophysiology and management. Drugs. 2012;72:1847-1865. 4. Prescribing Information for MOVANTIK. AstraZeneca Pharmaceuticals LP, Wilmington DE.