Dr. Charles E Argoff is Professor of Neurology at Albany Medical College and Director of the Comprehensive Pain Center at Albany Medical Center in New York. As an expert in pain management, Dr. Argoff recognizes the impact of opioid-induced constipation (OIC) in adult patients taking opioids for chronic non-cancer pain, including patients whose pain is related to prior cancer or its treatment and who do not require frequent (eg, weekly) opioid dosage escalation.
Why is treatment for OIC important for adult patients with chronic pain related to prior cancer or its treatment?
Overall, cancer survival rates are increasing. A meta-analysis investigating the prevalence of pain reviewed literature published from September 2005 to January 2014 and showed that approximately 40 percent of patients experience pain after curative cancer treatment. Patients with chronic pain related to prior cancer or its treatment may be appropriate candidates for opioid therapy. OIC is one of the most common side effects of opioid therapy.
What is important to know about chronic pain and OIC in this patient population?
Causes of chronic pain related to prior cancer or its treatment can include tissue injury from a previous tumor or the lasting effect of interventions such as chemotherapy, radiation and surgery. These patients could require chronic pain management, which may include opioid therapy, integrated into their ongoing care.
The U.S. Food and Drug Administration (FDA) has clarified the indication of MOVANTIK® (naloxegol) tablets for the treatment of OIC in adult patients 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. This label update provides clarification that patients with chronic pain related to prior cancer or its treatment and on a stable opioid therapy are included within the previously approved patient population for the indication of MOVANTIK. Please click here for full Prescribing Information for MOVANTIK.
How do you approach treating OIC in these patients?
It’s important to understand how OIC occurs when considering treatment approaches. Opioids block pain signals by binding to mu receptors in the central nervous system (CNS), but opioids also bind to mu receptors present in the gastrointestinal (GI) tract, which can lead to constipation. In one study, 71 percent of nearly 500 patients with chronic non-cancer pain who also exhibited clinician-identified, patient-confirmed OIC reported little to no benefit from constipation treatments at baseline, including over-the-counter laxatives, prescription medications, or behavioral therapies.
HCPs may consider whether a prescription option, like MOVANTIK, is appropriate for patients experiencing OIC. When administered at recommended dose levels, MOVANTIK functions as a peripherally acting mu-opioid receptor antagonist (PAMORA) in tissues such as the GI tract, thereby decreasing the constipating effects of opioids. The CNS penetration is expected to be negligible at recommended dose levels, limiting the potential for interference with centrally mediated opioid pain relief.
What would you tell HCPs considering treatment options for OIC in adults with prior cancer?
HCPs should be aware of side effects such as OIC in patients whose chronic pain is associated with prior cancer and being treated with a stable opioid therapy. A proactive discussion about managing OIC is an important step in caring for these patients.
If patients are experiencing OIC, consider whether MOVANTIK may be an appropriate treatment option. MOVANTIK is indicated for the treatment of opioid-induced constipation (OIC) in adult patients 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. Learn more and get the full Prescribing Information by visiting MOVANTIKHCP.com.
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%)
MOVANTIK is indicated for the treatment of opioid-induced constipation (OIC) in adult patients 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.
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.
This product information is intended for US Health Care Professionals only.
MOVANTIK is a registered trademark of the AstraZeneca group of companies.
US-13879 Last Updated 8/17