What is Moventig - naloxegol used for and what is it used for?
Moventig is a medicine used in adults for the treatment of constipation caused by pain medication, called opioids. It is used in patients in whom treatment with laxatives has not given results. Moventig contains the active ingredient naloxegol.
How is Moventig - naloxegol used?
Moventig is available as tablets (12.5 and 25 mg). The recommended dose is one 25 mg tablet per day. For patients with moderate or severe renal insufficiency or who are taking other medicines that may increase the effects of Moventig, a lower starting dose of 12.5 mg can be prescribed. Before starting treatment with Moventig you must stop taking laxatives. The medicine can only be obtained with a prescription.
How does Moventig - naloxegol work?
Opioids relieve pain by binding to "opioid receptors" in the brain and spinal cord. However, these receptors are also found in the intestine and when opioids bind to receptors in the gastrointestinal tract, reduce bowel movement and can cause constipation. The active substance in Moventig, naloxegol, is a peripheral antagonist of mu opioid receptors. This means that it binds to a specific type of opioid receptor called the "opioid mu receptor" and prevents opioids from binding to these receptors. Naloxegol is a derivative of naloxone, a known substance used to block the action of opioids. Naloxegol enters the central nervous system in a limited way compared to naloxone, ie it can block the mu opioid receptors in the intestine, but less in the brain. By blocking the receptors in the intestinal tract, Moventig reduces constipation due to opioids, without interfering with the analgesic effects.
What benefit has Moventig - naloxegol shown during the studies?
In two main studies, Moventig was effective in treating constipation in adult patients with inadequate response to laxatives. The studies involved 1 352 adults with constipation caused by opioids used for the treatment of pain unrelated to cancer, half of whom had an inadequate response to laxatives (720). Patients were given Moventig (12.5 and 25 mg dose) or placebo (a dummy treatment) for 12 weeks. Treatment response was based on an improvement in the number of spontaneous evacuations per week that had to be maintained for most of the duration of the study. Analyzing together the results of the two studies, 48% (115 out of 241) of adult patients with a previous inadequate response to laxatives to which they were administered 25 mg of Moventig responded to treatment, compared to 30% (72 of 239) of adults treated with placebo. Among adult patients who took 12.5 mg of Moventig and who had an inadequate response to laxatives, 43% (102 of 240) responded to treatment.
What is the risk associated with Moventig - naloxegol?
The most common side effects of Moventig (which may affect more than 5 people in 100) are abdominal pain (stomach ache), diarrhea, nausea (feeling sick), headache and flatulence. In most cases, gastrointestinal adverse reactions have been classified as mild to moderate, have arisen at the start of treatment and improved with continued therapy. Moventig should not be administered to patients with gastrointestinal obstruction or at a high risk of gastrointestinal obstruction (intestinal blockage) or to patients with cancer who are at an increased risk of gastrointestinal perforation (a hole in the intestine wall). Furthermore, it should not be used together with certain medicines that affect the way Moventig is absorbed by the body. For the full list of reported side effects and restrictions regarding Moventig, see the package leaflet.
Why has Moventig - naloxegol been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Moventig's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP considers that Moventig has shown a clinically relevant benefit when used in adult patients with an inadequate response to previous treatments with laxatives. Although no studies have been conducted on patients with related cancer pain, based on the mechanism of action of this medicine the benefits for such patients are not expected to be different, but safety needs to be closely monitored. In terms of safety, side effects are acceptable or manageable.
What measures are being taken to ensure the safe and effective use of Moventig - naloxegol?
A risk management plan has been developed to ensure that Moventig is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and the package leaflet for Moventig, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
Other information on Moventig - naloxegol
On 8 December 2014, the European Commission issued a marketing authorization for Moventig, valid throughout the European Union. For more information about treatment with Moventig, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 12-2014.
