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Rizmoic is a brand name for Naldemedine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Rizmoic is indicated for the treatment of opioid-induced constipation (OIC) in adult patients who have previously been treated with a laxative.
Verbatim from this product's EMA label. Tap a section to expand.
Posology 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. 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.
2). 4). Hepatic impairment No dose adjustment is required in patients with mild or moderate hepatic impairment. 2). Paediatric population The safety and efficacy of naldemedine in children and adolescents aged below 18 years have not yet been established.
No data are available. 3 Method of administration Oral use. 2).
1%). The majority of these gastrointestinal adverse reactions were of mild to moderate severity and resolved without 6 discontinuation of naldemedine treatment. One serious case of abdominal pain and one serious case of nausea were reported in patients with chronic non-cancer pain and OIC.
9%). The majority of these gastrointestinal adverse reactions were of mild to moderate severity and resolved with treatment. Two serious cases of diarrhoea were reported in patients with cancer and OIC. Tabulated list of adverse reactions The adverse reactions with naldemedine 200 microgram tablets in patients with chronic non-cancer pain and OIC and in patients with cancer and OIC reported in clinical studies are presented in the tables according to the MedDRA system organ classification.
The frequency categories are defined using the following convention: 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 (frequency cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table 1. Adverse reactions presented by System Organ Class and frequency in patients with chronic non-cancer pain and opioid-induced constipation System organ class Common Uncommon Rare Unknown Immune system disorders Hypersensitivitya Gastrointestinal disorders Diarrhoea Abdominal painb Nausea Vomiting Gastrointestinal perforation General disorders and administration site conditions Opioid withdrawal syndrome aOne serious report of hypersensitivity reaction was observed in clinical studies with naldemedine.
The patient recovered following discontinuation from the study bMedDRA Preferred Terms: abdominal pain, abdominal pain upper, abdominal pain lower and abdominal discomfort Table 2. 6% (1/155) of patients with cancer and OIC taking naldemedine 200 micrograms compared to 0% (0/152) of patients taking placebo.
g. diverticular disease and underlying malignancies of the gastrointestinal tract or peritoneal metastases). 3). g. peptic ulcer disease, Ogilvie’s syndrome, malignancy of the GI tract, Crohn’s disease). The overall benefit risk for each patient should be taken into account.
Patients should be monitored for the development of severe, persistent or worsening abdominal pain. 3). g. abdominal pain, vomiting and diarrhoea) have been reported with Rizmoic. Patients should be advised to report severe, persistent or worsening symptoms to their physician.
8). Opioid withdrawal syndrome Opioid withdrawal syndrome is a cluster of three or more of the following signs or symptoms: dysphoric mood, nausea or vomiting, muscle aches, lacrimation or rhinorrhea, pupillary dilation or piloerection or sweating, diarrhoea, yawning, fever or insomnia.
Opioid withdrawal syndrome typically develops within minutes to several days following administration of an opioid antagonist. Caution should be exercised with regards to opioid withdrawal. Patients should be advised to discontinue naldemedine and to contact their physician if opioid withdrawal occurs.
8). , primary brain malignancies, central nervous system (CNS) metastases or other inflammatory conditions, active multiple sclerosis and advanced Alzheimer’s disease) may be at increased risk of opioid withdrawal or reduced analgesia.
The overall benefit-risk of naldemedine should be considered in these patients with close monitoring for symptoms of opioid withdrawal. 4 Patients with cardiovascular conditions Naldemedine was not studied in the clinical trial programme in patients who had a recent history of myocardial infarction, stroke or transient ischaemic attack within 3 months of screening.
These patients should be clinically monitored when taking Rizmoic. A QTc study performed with naldemedine in healthy volunteers did not indicate any prolongation of the QT interval. Patients with cardiovascular disease risk factors were not excluded from the naldemedine clinical trial programme, with BMI ≥ 30 kg/m2, and a medical history of hypertension and/or dyslipidaemia being the most commonly reported risk factors.
1. 4).
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4). Gastrointestinal disorders Abdominal pain, diarrhoea, nausea and vomiting were the most commonly reported adverse reactions in clinical studies with patients with chronic non-cancer pain and OIC and with patients with cancer and OIC.
The majority of these gastrointestinal adverse reactions were mild to moderate severity and resolved with treatment. 5% and 0% respectively for patients with cancer and OIC. 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 the national reporting system listed in Appendix V.
2). Severe hepatic impairment Naldemedine has not been studied in patients with severe hepatic impairment. 2). Opioid pain medicinal products 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.
g. buprenorphine). Caution should be exercised when treating these patients. g. grapefruit juice, itraconazole, ketoconazole, ritonavir, indinavir, saquinavir, telithromycin and clarithromycin) leads to an increase in naldemedine exposure and may increase the risk of adverse reactions.
Concomitant use with strong CYP3A inhibitors should be avoided. g. St. John’s wort (Hypericum perforatum), rifampicin, carbamazepine, phenobarbital and phenytoin) leads to a decrease in naldemedine exposure and may reduce the efficacy of naldemedine.
5). g. 5). Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”.