traindications
Hypersensitivity
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or any other opioid antagonist.
Gastrointestinal obstruction
Patients with known or suspected gastrointestinal (GI) obstruction or in patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation (see section 4.4).
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 gastrointestinal tract or peritoneum
• recurrent or advanced ovarian cancer
• vascular endothelial growth factor (VEGF) inhibitor treatment.
Strong CYP3A4 inhibitors
Concomitant use with strong CYP3A4 inhibitors (e.g. clarithromycin, ketoconazole, itraconazole or telithromycin; protease inhibitors such as ritonavir, indinavir or saquinavir; grapefruit juice when consumed in large quantities), see section 4.5.
4.4 Special warnings and precautions for use
Conditions with increased potential for gastrointestinal perforation
Rare cases of gastrointestinal perforation have been reported in the post-marketed use of peripherally acting mu-opioid receptor antagonists in patients with advanced medical illness. Caution with regards to the use of naloxegol should be exercised in patients with any condition which might result in impaired integrity of the gastrointestinal tract wall (e.g. severe peptic ulcer disease, Crohn's Disease, active or recurrent diverticulitis, infiltrative gastrointestinal tract malignancies or peritoneal metastases). The overall benefit-risk profile for each patient should be taken into account. Patients are 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. Patients with clinically important disruptions to the blood-brain barrier (e.g. primary brain malignancies, CNS metastases or other inflammatory conditions, active multiple sclerosis, advanced Alzheimer's disease etc.) 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 trials to have a higher frequency of gastrointestinal 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 me |
