Naldemedine(纳地美定)的副作用？

What are the side effects of Naldemedine?

Naldemedine can be used to treat constipation caused by the use of opioid analgesics in patients with non-cancer pain, and improve the pain relief experience of cancer patients using opioids. Although the treatment effect is significant, it also has side effects, which are relatively serious. It is a tear (perforation) in the stomach or intestinal wall. You need to stop taking the drug in time and contact a doctor for treatment. In addition, it may also cause opioid withdrawal symptoms, including sweating, chills, tearing, sneezing, fever, abdominal pain, diarrhea, facial warmth or hot feeling (flushing), cold feeling, nausea, vomiting, etc. If you experience these opioid withdrawal symptoms, contact your doctor for help.

What is the safety profile of Naldemedine in trials?

Naldemedine was effective in treating opioid-induced constipation in chronic pain patients in the COMPOSE-1 and COMPOSE-2 trials. In terms of safety, the incidence of treatment-related adverse events in the Naldemedine group (COMPOSE-1, 49%; COMPOSE-2, 50%) was similar to that in the placebo group (45% and 48%, respectively).

Treatment-related events were more common in the Naldemedine group than in the placebo group, primarily due to higher rates of diarrhea and abdominal pain in the Naldemedine group.

In COMPOSE-1, 2 of 271 patients in the Naldemedine group and 1 of 272 patients in the placebo group experienced opioid withdrawal. Opiate withdrawal was not reported in COMPOSE-2. Pain scores were generally stable across both trials.

Although Naldemedine has serious side effects, once-daily dosage is relatively well tolerated. Naldemedine was developed by Japan's Shionogi Pharmaceutical Co., Ltd. and was approved for marketing by the U.S. FDA in 2017. It has attracted the attention of many patients and is a new treatment option for patients with chronic non-cancer pain and opioid constipation. It is recommended that patients take medication under the guidance of a doctor and receive symptomatic treatment.

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