Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Shionogi B.V., Kingsfordweg 151, 1043GR Amsterdam, The Netherlands
Rizmoic is indicated for the treatment of opioid-induced constipation (OIC) in adult patients who have previously been treated with a laxative.
The recommended dose of naldemedine is 200 micrograms (one tablet) daily. Rizmoic may be used with or without laxative(s). It may be taken at any time of the day but it is recommended to be taken at the same time every day.
Alteration of the analgesic dosing regimen prior to initiating Rizmoic is not required. Rizmoic must be discontinued if treatment with the opioid pain medicinal product is discontinued.
No dose adjustment is required in patients older than 65 years of age (see section 5.2). Due to the limited therapeutic experience in patients 75 years old and older, naldemedine therapy should be initiated with caution in this age group.
No dose adjustment is required in patients with renal impairment (see section 5.2). Due to the limited therapeutic experience, patients with severe renal impairment should be clinically monitored when initiating therapy with naldemedine.
No dose adjustment is required in patients with mild or moderate hepatic impairment. Use in patients with severe hepatic impairment is not recommended (see sections 4.4 and 5.2).
There is limited experience in patients treated with opioid pain medicinal product(s) at daily doses of more than the equivalent of 400 mg of morphine. There is no experience in patients treated for constipation induced by partial opioid mu-agonists (e.g. buprenorphine).
The safety and efficacy of naldemedine in children and adolescents aged below 18 years have not yet been established. No data are available.
Oral use.
Rizmoic should be taken once daily, with or without food (see section 5.2).
A single dose of naldemedine up to 100 mg and multiple doses of up to 30 mg/day for 10 days were administered to healthy volunteers in clinical studies. Dose-dependent increases in gastrointestinal-related adverse reactions, including abdominal pain, diarrhoea, and nausea, were observed. These were mild or moderate in severity and resolved.
A single dose of naldemedine (0.01 mg to 3 mg) and multiple doses of 0.4 mg/day have been administered to patients with OIC in clinical studies. A patient who took a single dose of naldemedine 1 mg experienced severe drug withdrawal syndrome, including nausea and stomach cramping and was given esomeprazole and ondansetron for nausea and midazolam hydrochloride for stomach cramping. The symptoms resolved. In clinical studies, patients with OIC who were administered 0.4 mg/day (twice the recommended dose) over 4 weeks had an increased incidence of GI-related adverse drug reactions including diarrhoea and abdominal pain frequently within 1-2 days after initial dosing.
There is no specific antidote for naldemedine. Naldemedine is not removed from the body by haemodialysis. In the event of an overdose, patients should be closely monitored for potential signs and symptoms of opioid withdrawal syndrome (see section 4.4) and provided with appropriate supportive care.
3 years.
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light and moisture.
Aluminium/aluminium blister containing 7, 10 or 14 film-coated tablets.
Pack sizes of 7, 10, 28, 30, 84 or 100 film-coated tablets.
Not all pack sizes may be marketed.
No special requirements.
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