Naloxegol is an active pharmaceutical ingredient in the Peripheral Opioid Receptor Antagonists group (A06AH). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
CAOfficial regulatory label· revised March 22, 2025[1]
AND CLINICAL USE ........................................................................... 3 CONTRAINDICATIONS ................................................................................................. 3 WARNINGS AND PRECAUTIONS ...............................................................................
4 ADVERSE REACTIONS ................................................................................................. 6 DRUG INTERACTIONS ...............................................................................................
11 DOSAGE AND ADMINISTRATION ........................................................................... 13 OVERDOSAGE .............................................................................................................. 15 ACTION AND CLINICAL PHARMACOLOGY ..........................................................
15 STORAGE AND STABILITY ....................................................................................... 18 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................... 18 PART II: SCIENTIFIC INFORMATION .............................................................................
EUEuropean Union· EMA
1 product
Uses
EUOfficial regulatory label· revised April 11, 2025[2]
Moventig is indicated for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s). 1.
How to take
EU
Drug interactions
Known interactions involving Naloxegol. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]Health Canada (DPD) · 02442167 · revised March 22, 2025
[2]European Medicines Agency · EMEA/H/C/002810 · revised April 11, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
27 PART III: CONSUMER INFORMATION............................................................................ 5 mg and 25 mg None. For a complete listing of nonmedicinal ingredients see DOSAGE FORMS, COMPOSITION AND PACKAGING. INDICATIONS AND CLINICAL USE MOVANTIK (naloxegol oxalate) is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with non-cancer pain who have had an inadequate response to laxative(s).
Pediatrics (<18 years of age):
The safety and efficacy of MOVANTIK in pediatric patients below 18 years of age has not been established and is not indicated for use in this patient population. CONTRAINDICATIONS MOVANTIK (naloxegol oxalate) is contraindicated in: Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container, or to any other opioid antagonist.
For a complete listing of ingredients, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the Product Monograph. MOVANTIK® (naloxegol) Product Monograph Page 4 of 30 Patients with known or suspected gastrointestinal obstruction or in patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation (see WARNINGS AND PRECAUTIONS, Gastrointestinal).
, ketoconazole, voriconazole, clarithromycin, protease inhibitors such as ritonavir), due to significant increase in exposure to naloxegol (see DRUG INTERACTIONS).
WARNINGS AND PRECAUTIONS General Opioid withdrawal syndrome:
Cases of opioid withdrawal syndrome have been reported in patients treated with MOVANTIK. Opioid withdrawal syndrome is a cluster of three or more of the following signs or symptoms: hyperhidrosis, dysphoric mood, nausea or vomiting, muscle aches, lacrimation or rhinnorrhea, pupillary dilation or piloerection or sweating, diarrhea, yawning, fever or insomnia.
If opioid withdrawal syndrome is suspected the patient should discontinue MOVANTIK and contact their healthcare professional (see Neurologic).
Concurrent methadone use:
Patients receiving methadone for their pain in clinical trials had a higher frequency of gastrointestinal adverse events (such as abdominal pain and diarrhea) than patients not receiving methadone and, in a few cases, symptoms suggestive of opioid withdrawal when receiving MOVANTIK 25 mg were observed.
, rifampin, carbamazepine, phenytoin, St. John’s wort) can significantly reduce exposure to naloxegol and should generally be avoided (see DRUG INTERACTIONS). g. diltiazem, verapamil, erythromycin) should be avoided with MOVANTIK, since the systemic exposure to naloxegol is increased.
, opioid withdrawal syndrome and/or reversal of analgesia). See DRUG INTERACTIONS; DOSAGE AND ADMINISTRATION, Special Populations. Concomitant consumption of grapefruit (a CYP3A4 inhibitor) or grapefruit juice while taking MOVANTIK should be avoided.
Concomitant use of strong CYP3A4 inhibitors is contraindicated (see CONTRAINDICATIONS and DRUG INTERACTIONS).
Cardiovascular Patients with cardiovascular conditions:
MOVANTIK was not studied in the clinical trial program in patients who had a recent history of myocardial infarction within 6 MOVANTIK® (naloxegol) Product Monograph Page 5 of 30 months, symptomatic congestive heart failure, overt cardiovascular disease or patients with a QT interval of 500msec.
MOVANTIK should be used with caution in these patients. A QTc study performed […]
Posology The recommended dose of Moventig is 25 mg once daily. Moventig may be used with or without laxatives. Moventig treatment must be withdrawn when systemic opioid therapy is stopped. 2). 5 mg. If side effects impacting tolerability occur, naloxegol should be discontinued.
2). 3 No dosage adjustment is required for patients with mild renal impairment. Hepatic impairment No dose adjustment is required for patients with mild to moderate hepatic impairment. 2). Use in patients with severe hepatic impairment is not recommended.
g. 5 mg once daily. 5). g. 5). 3). Paediatric population The safety and efficacy of naloxegol in children <18 years of age has not yet been established. No data are available. Method of administration Oral use. It is recommended that Moventig is taken in the morning, for patient convenience to avoid bowel movements in the middle of the night.
Moventig should be taken on an empty stomach at least 30 minutes prior to the first meal of the day or 2 hours after the first meal of the day. For patients who are unable to swallow the tablet whole, the tablet can be crushed to a powder and mixed in half a glass of water (120 ml) and drunk immediately.
The glass should be rinsed with a further half glass of water (120 ml) and the contents drunk. 6 for further information on administration through a nasogastric tube.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised April 11, 2025[2]
Summary of the safety profile In pooled data from Clinical Studies the most commonly reported adverse reactions with naloxegol (≥ 5%) are: abdominal pain, diarrhoea, nausea, headache and flatulence. Most gastrointestinal adverse reactions were graded as mild to moderate, occurred early in treatment and resolved with continued treatment.
They were often reported as having a component of cramping discomfort. Tabulated list of adverse reactions Adverse reactions are classified according to frequency and System Organ Class. Frequency categories are defined according to the following conventions: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
4) 8 System Organ Classification Very Common Common Uncommon Rare Not known Skin and subcutaneous tissue disorders Hyperhidrosis Note: Selection of ADRs and their frequencies based on the 25 mg dose a Reflects MedDRA Preferred Terms of: “abdominal pain”, “abdominal pain upper”, “abdominal pain lower” and “gastrointestinal pain”.
Description of selected adverse reactions Opioid withdrawal syndrome Naloxegol at therapeutic doses has minimal uptake across the blood brain barrier. In some patients, however, a constellation of symptoms has been reported, which resembles the syndrome of central opioid withdrawal.
Most such reports were observed shortly after initial administration with the medicinal product and were mild or moderate in intensity. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
EUOfficial regulatory label· Warnings and precautions· revised April 11, 2025[2]
Conditions with increased potential for gastrointestinal perforation Cases of gastrointestinal (GI) perforation have been reported in the post-marketing setting, including fatal cases when naloxegol was used in patients who were at an increased risk of GI perforation.
3). g. severe peptic ulcer disease, Crohn’s Disease, active or recurrent diverticulitis, infiltrative GI tract malignancies or peritoneal metastases). The overall benefit-risk profile for each patient should be taken into account. Patients should be advised to discontinue therapy with naloxegol and promptly notify their physician if they develop unusually severe or persistent abdominal pain.
Clinically important disruptions of the blood-brain barrier Naloxegol is a peripherally acting mu-opioid receptor antagonist with restricted access to the central nervous system (CNS). The blood brain barrier integrity is important for minimizing naloxegol uptake into the CNS.
g. ) were not included in Clinical Studies and may be at risk for naloxegol entry into the CNS. Naloxegol should be prescribed with caution in such patients taking into account their individual benefit-risk balance with observation for potential CNS effects, such as symptoms of opioid withdrawal and/or interference with opioid-mediated analgesia.
If evidence for opioid-mediated interference with analgesia or opioid withdrawal syndrome occurs, patients should be instructed to discontinue Moventig and contact their physician. Concurrent methadone use Patients taking methadone as primary therapy for their pain condition were observed in Clinical Studies to have a higher frequency of GI adverse reactions (such as abdominal pain and diarrhoea) than patients not receiving methadone.
In a few cases, symptoms suggestive of opioid withdrawal when taking naloxegol 25 mg were observed in patients taking methadone for their pain condition. This was observed in a higher proportion of patients taking methadone than those not taking methadone.
Patients taking methadone for treatment of opioid addiction were not included in the clinical development programme and use of naloxegol in these patients should be approached with caution. Gastrointestinal adverse reactions Reports of severe abdominal pain and diarrhoea have been observed in Clinical Studies with a 25 mg dose, typically occurring shortly after initiation of treatment.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised April 11, 2025[2]
1 or any other opioid antagonist. 4). Conditions in patients with cancer pain • Patients with underlying cancer who are at heightened risk of GI perforation, such as those with: • underlying malignancies of GI tract or peritoneum • recurrent or advanced ovarian cancer • vascular endothelial growth factor (VEGF) inhibitor treatment.
g. 5.
This is not medical advice. Consult a qualified healthcare professional.
9%, respectively). Patients should be advised to promptly report severe, persistent or worsening symptoms to their physician. 5mg in patients experiencing severe GI adverse events depending upon the response and tolerability of individual patients.
Opioid withdrawal syndrome Cases of opioid withdrawal syndrome have been reported in the naloxegol clinical programme (DSM-5). Opioid withdrawal syndrome is a cluster of three or more of the following signs or symptoms: dysphoric mood, nausea, vomiting, muscle aches, lacrimation, rhinorrhoea, pupillary dilation, piloerection, sweating, diarrhoea, yawning, fever or insomnia.
Opioid withdrawal syndrome typically develops within minutes to several days following administration of an opioid antagonist. If opioid withdrawal syndrome is suspected the patient should discontinue Moventig and contact their physician.
1). Moventig should be used with caution in these patients. 1). g. carbamazepine, rifampin, St. 5). 3 and