in the mother, who is being treated with a concurrent opioid. Naloxegol use is therefore not recommended during pregnancy.
Breast-feeding
It is unknown whether naloxegol is excreted in human milk. Available toxicological data in rats have shown naloxegol excreted in milk (see section 5.3).
At therapeutic doses, most opioids (e.g. morphine, meperidine, methadone) are excreted into breast milk in minimal amounts. There is a theoretical possibility that naloxegol could provoke opioid withdrawal in a breast-fed neonate whose mother is taking an opioid receptor agonist. Therefore, use in breast-feeding mothers is not recommended.
Fertility
The effect of naloxegol on fertility in humans has not been studied. Naloxegol was found to have no effect on fertility of male and female rats at oral doses up to 1,000 mg/kg per day (greater than 1,000 times the human therapeutic exposure (AUC) at the recommended human dose of 25 mg/day).
4.7 Effects on ability to drive and use machines
Moventig has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
Summary of the safety profile
In the pooled data from clinical trials the most commonly reported adverse reactions with naloxegol (≥ 5%) are: abdominal pain, diarrhoea, nausea, headache and flatulence. The majority of 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).
Table 1 Adverse reactions by System Organ Class (SOC) and frequency
System Organ Classification
Very Common
Common
Uncommon
Rare
Not known
Infections and Infestations
Nasopharyngitis
Nervous system disorders
Headache
Opioid withdrawal syndrome
Gastrointestinal disorders
Abdominal paina, diarrhoea
Flatulence, nausea, vomiting
Skin and subcutaneous tissue disorders
Hyperhidrosis
Immune system disorders
Hypersensitivity
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:
United Kingdom
Yellow Card Sch
