Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132NP, Hoofddorp, The Netherlands
Moventig is indicated for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s).
For definition of inadequate response to laxative(s), see section 5.1.
The recommended dose of Moventig is 25 mg once daily.
When naloxegol therapy is initiated, it is recommended that all currently used maintenance laxative therapy should be halted, until clinical effect of naloxegol is determined.
No dose adjustment is recommended based on age (see section 5.2).
The starting dose for patients with moderate or severe renal insufficiency is 12.5 mg. If side effects impacting tolerability occur, naloxegol should be discontinued. The dose can be increased to 25 mg if 12.5 mg is well tolerated by the patient (see section 5.2). No dosage adjustment is required for patients with mild renal impairment.
No dose adjustment is required for patients with mild to moderate hepatic impairment. Safety and efficacy have not been established in patients with severe hepatic impairment (see section 5.2). Use in patients with severe hepatic impairment is not recommended.
The starting dose for patients taking moderate CYP3A4 inhibitors (e.g. diltiazem, verapamil) is 12.5 mg once daily. The dose can be increased to 25 mg if 12.5 mg is well tolerated by the patient (see section 4.5).
No dose adjustment is required for patients taking weak CYP3A4 inhibitors (e.g. alprazolam, atorvastatin (see section 4.5).
No dose adjustment is required for patients with cancer-related pain (see sections 4.3 and 4.4).
The safety and efficacy of naloxegol in children <18 years of age has not yet been established. No data are available.
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. Refer to section 6.6 for further information on administration through a nasogastric tube.
Doses of naloxegol up to 1,000 mg were administered in healthy volunteers in clinical studies. A potential CNS effect (reversal of opioid-induced miosis, as measured by pupillometry) was observed in 1 volunteer in the 250 mg group and 1 volunteer in the 1,000 mg group. In a clinical study of patients with OIC, a daily dose of 50 mg was associated with an increased incidence of intolerable gastrointestinal effects (primarily abdominal pain). No antidote is known for naloxegol and dialysis was noted to be ineffective as a means of elimination in a clinical study in patients with renal failure.
If a patient on opioid therapy receives an overdose of naloxegol, the patient should be monitored closely for potential evidence of opioid withdrawal symptoms or reversal of central analgesic effect. In cases of known or suspected overdose of naloxegol, symptomatic treatment as well as monitoring of vital functions should be performed.
The use of naloxegol in the paediatric population has not been studied.
4 years.
This medicinal product does not require any special storage conditions.
Alu/alu blister.
12.5 mg film-coated tablets: Pack sizes of 30 and 90 film-coated tablets in non-perforated blisters. Pack sizes of 30 × 1 and 90 × 1 film-coated tablets in perforated unit dose blisters.
25 mg film-coated tablets: Pack sizes of 10, 30 and 90 film-coated tablets in non-perforated blisters. Pack sizes of 10 × 1, 30 × 1, 90 × 1 and 100 × 1 film-coated tablets in perforated unit dose blisters.
Not all pack sizes may be marketed.
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
The mixture can also be administered via a nasogastric tube (CH8 or greater), in this case the tablet can be crushed to a powder and mixed with water (120 ml). It is important to flush the nasogastric tube through with water after administration of the mixture.
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