Moventig

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 Moventig treatment must be withdrawn when systemic opioid therapy is stopped. 2). 5 mg.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.

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.

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.

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.