ABOUT MOVENTIG/MOA

MOVENTIG PI

Laxatives alone may not relieve OIC

Treat the underlying cause of OIC

MOVENTIG can work where laxatives don’t^1,2

MOVENTIG is indicated for the treatment of OIC in adults who have had an inadequate response to laxatives¹

Opioids bind to mu-opioid receptors in the CNS to provide pain relief³

At the same time, they also bind to mu-opioid receptors in the bowel, which can cause OIC^4,5

MOVENTIG blocks mu-opioid receptors in the bowel to prevent opioids from binding and target the underlying cause of OIC¹

Because it doesn’t cross the blood-brain barrier, MOVENTIG has no impact on opioid-mediated effects in the CNS^1,6

MOVENTIG is a PEGylated derivative of the mu-opioid
receptor antagonist, naloxone. PEGylation decreases passive permeability
and reduces penetration across the blood-brain barrier.¹

CNS, central nervous system; MOA, mechanism of action; OIC, opioid-induced constipation; P-gp, P-glycoprotein.

What is the efficacy of MOVENTIG in treating OIC?

Find Out

References 1. MOVENTIG Summary of Product Characteristics. Accessed May 2022. https://www.medicines.org.uk/emc/medicine/30483/smpc 2. Drewes AM, Munkholm P, Simrén M, et al. Definition, diagnosis and treatment strategies for opioid-induced bowel dysfunction—recommendations of the Nordic Working Group. Scand J Pain. 2016;11:111-122. doi:10.1016/j.sjpain.2016.02.003 3. Henriksen G, Willoch F. Imaging of opioid receptors in the central nervous system. Brain. 2008;131(5):1171-1196. doi: 10.1093/brain/awm255 4. Camilleri M, Drossman DA, Becker G, Webster LR, Davies AN, Mawe GM. Emerging treatments in neurogastroenterology: a multidisciplinary working group consensus statement on opioid-induced constipation. Neurogastroenterol Motil. 2014;26(10):1386-1395. doi:10.1111/nmo.12417. 5. McCarberg BH. Overview and treatment of opioid-induced constipation. Postgrad Med. 2013;125(4):7-17. doi:10.3810/pgm.2013.07.2651 6. Poulsen JL, Brock C, Olesen AE, Nilsson M, Drewes AM. Clinical potential of naloxegol in the management of opioid-induced bowel dysfunction. Exp Gastroenterol. 2014;7:345-348.

VIEW PRESCRIBING INFORMATION toggle isi

PRESCRIBING INFORMATION (prepared August 2021)

Moventig^® (naloxegol oxalate) 12.5mg and 25mg film-coated tablets

Consult Summary of Product Characteristics (SmPC) before prescribing.

Indication: Opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s) (concurrent OIC symptoms of at least moderate severity while taking at least one laxative class for a minimum of four days during the previous 2 weeks).

Dosage and administration: Recommended 25 mg once daily. Take on empty stomach at least 30 minutes prior to first meal of day or 2 hours after first meal of day. Crushed tablets can be mixed with water (120ml) and drunk immediately or administered via a nasogastric tube (CH8 or greater). Renal impairment: Moderate or severe renal impairment starting dose 12.5mg. Discontinue if side effects impact tolerability. Increase to 25mg if well tolerated. Hepatic impairment: Use in severe hepatic impairment not recommended. Moderate CYP3A4 inhibitors: Starting dose 12.5mg, can be increased to 25mg if well tolerated. Paediatric population (<18 years): Safety and efficacy not yet established.

Adverse effects: Consult SmPC for full list of side effects. Very Common: Abdominal pain, diarrhoea. Common: Nasopharyngitis, headache, flatulence, nausea, vomiting, hyperhidrosis. Uncommon: Opioid withdrawal syndrome. Not known: Hypersensitivity, Gastrointestinalperforation.

Contraindications: Hypersensitivity to active substance or any of the excipients or any other opioid antagonist. Patients with known or suspected gastrointestinal (GI) obstruction or patients at increased risk of recurrent obstruction. 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 or vascular endothelial growth factor (VEGF) inhibitor treatment. Concomitant use with strong CYP3A4 inhibitors.

Warnings and precautions: Cases of gastrointestinal 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 gastrointestinal (GI) perforation. Naloxegol must not be used in patients with known or suspected gastrointestinal obstruction or in patients at increased risk of recurrent obstruction. Use with caution in patients with any condition which might result in impaired integrity of the gastrointestinal tract wall. Advise patients to discontinue therapy and promptly report if unusually severe or persistent abdominal pain develops. Use with caution in patients with clinically important disruptions to the blood brain barrier and observe for potential CNS effects. Discontinue if interference with opioid-mediated analgesia or opioid withdrawal syndrome occurs. Use with caution in patients taking methadone. If opioid withdrawal syndrome is suspected the patient should discontinue Moventig and contact their physician. Use with caution in patients with a recent history of myocardial infarction, symptomatic congestive heart failure, overt cardiovascular (CV) disease or with a QT interval of ≥500msec. Use with caution in OIC patients with cancer-related pain. Use of naloxegol with another opioid antagonist (e.g. naltrexone, naloxone) should be avoided.

Use in pregnancy and lactation: Not recommended.

Legal category: POM.

Marketing Authorisation numbers: Moventig 12.5mg and 25mg tablets (ROI: EU/1/14/962/001-011),(GB: PL GB 50262/004&5)

Further information available on request from the Marketing Authorisation holder: Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132NP Hoofddorp, The Netherlands.

For the United Kingdom:
NHS cost: Moventig 12.5mg, 30 tablets, £55.20; Moventig 25mg, 30 tablets, £55.20.

Adverse Events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse Events should also be reported to Kyowa Kirin Ltd. on +44 (0)1896 664000, email medinfo@kyowakirin.com

For the Republic of Ireland:

Adverse Events should be reported. Information about adverse event reporting can be found at www.hpra.ie. Adverse Events should also be reported to Kyowa Kirin Ltd. on +44 (0)1896 664000, email medinfo@kyowakirin.com

OIC, opioid‐induced constipation.