纳地美定(Naldemedine)的不良反应有什么？

The main adverse reactions of (Naldemedine) include gastrointestinal perforation and opioid withdrawal. Patients need to pay special attention when using it.

About Naldemedine

Naldemedine (trade name Symproic) is a peripherally acting opioid receptor antagonist (PAMORAs) that acts on the peripheral nervous system and relieves opioid-induced constipation by antagonizing opioid receptors in the gastrointestinal tract. Its molecular structure limits its ability to cross the blood-brain barrier and enter the central nervous system. Naldemedine was approved in the United States and Japan in March 2017 for the treatment of opioid-induced constipation (OIC) with chronic non-cancer pain in adults.

Adverse reactions in Naldemedine trials

Because clinical trials are conducted under a variety of different conditions, the incidence observed in the clinical trials of one drug cannot be directly compared with the incidence in the clinical trials of another drug, nor does it reflect the incidence observed in practice.

The data described below reflect SYMPROIC exposure for 1,163 patients in clinical trials, including 487 patients exposed for more than 6 months and 203 patients exposed for more than 12 months.

The following safety data come from 3 double-blind, placebo-controlled trials in patients with OIC and chronic non-cancer pain: 2 12-week studies (Studies 1 and 2) and 1 52-week study (Study 3).

In Studies 1 and 2, patients receiving laxatives were asked to discontinue laxatives prior to study enrollment. During the study period, all patients were limited to salvage treatment with bisacodyl. In Study 3, approximately 60% of patients in both treatment groups received the laxative regimen at baseline; patients were allowed to continue using the laxative regimen throughout the study. The safety profile of SYMPROIC relative to placebo was similar regardless of whether a laxative was used.

Tables 1 and 2 list common adverse reactions that occurred in at least 2% of patients treated with SYMPROIC and occurred at a higher rate than placebo. Table 1 shows the pooled 12-week data from Studies 1 and 2. Table 2 shows the 12-week data from Study 3.

Table 1: Common adverse reactions in patients with OIC and chronic non-cancer pain (12-week data from Studies 1 and 2)

Table 2: Common adverse reactions in patients with OIC and chronic non-cancer pain (12-week data from Study 3)

Adverse reactions up to 12 months in Study 3 were similar to those listed in Tables 1 and 2 (Diarrhea in SYMPROIC and placebo groups: 11% vs. 5%, abdominal pain: 8% vs. 3%, nausea: 8% vs. 6%).

Opioid Withdrawal

In Studies 1, 2, and 3, adverse effects consistent with opioid withdrawal were based on investigator assessment and were based on the occurrence of at least 3 adverse events potentially related to opioid withdrawal that occurred on the same day or within a single day.

Possible adverse effects of opioid withdrawal may include non-gastrointestinal (GI) symptoms (such as sweating, hot flashes or flushes, chills, tremor, tachycardia, anxiety, agitation, yawning, rhinorrhea, increased tearing, sneezing, chills, and fever), GI symptoms (such as vomiting, diarrhea, or abdominal pain), or GI and non-GI symptoms.

In combined studies 1 and 2, the incidence of opioid withdrawal adverse reactions was 1% (8/542) in the SYMPROIC group and 1% (3/546) in the placebo group. In Study 3 (52-week data), the incidence was 3% (20/621) in the SYMPROIC group and 1% (9/619) in the placebo group. Most SYMPROIC-treated subjects experienced GI only or both GI and non-GI symptoms at approximately equal rates.

Measures for handling adverse reactions of Naldemedine

1. Tearing (perforation) of the stomach or intestinal wall: Severe stomach pain may be a sign of a serious disease. If you have persistent stomach pain, stop taking SYMPROIC immediately and get emergency medical help.

2. Opioid withdrawal. You may experience opioid withdrawal symptoms during treatment with SYMPROIC, including sweating, chills, watering, warmth or feeling of warmth in the face (flushing), sneezing, fever, feeling of coldness, abdominal pain, diarrhea, nausea, and vomiting. If you develop any of these symptoms, tell your healthcare provider.

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