纳地美定(Naldemedine)2024年多少钱一盒?

The price of Naldemedine in 2024

Currently known prices of the Japanese version of Naldemedine The influence of various factors is not fixed, but it is roughly as follows:

The price of 0.2mg*50 tablets is about 3790$ per box;

The price of 0.2mg*14 tablets is about 1260$ per box.

Indications for Naldemedine

Naldemedine is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain associated with prior cancer or its treatment, who do not require frequent (e.g., weekly) opioid dose increases.

Dosage of Naldemedine

The recommended dose of Naldemedine is 0.2 mg, taken once a day, with or without food.

There is no need to change the analgesic regimen before symptoms develop.

Patients who receive opioids for less than 4 weeks may have a weaker response to symptoms.

Discontinue Naldemedine symptomatic treatment if opioid pain medication is also discontinued.

Therapeutic Efficacy of Naldemedine

The long-term safety of the peripherally acting μ-opioid receptor antagonist Naldemedine was evaluated in a 52-week, randomized, double-blind Phase 3 study in patients with opioid-induced constipation and chronic non-cancer pain.

Eligible adults were randomized in a 1:1 ratio to receive 0.2 mg orally once daily (623 people) or placebo (623 people).

A similar proportion of patients reported treatment-emergent AEs (Naldemedine 68.4% vs. placebo 72.1%) and treatment-emergent AEs leading to study discontinuation (Naldemedine 6.3% vs. placebo 5.8%). Naldemedine (11.0%) vs. placebo (5.3%; difference: 5.6% [2.6-8.6]). There were no significant differences between groups in opioid withdrawal or pain intensity.

Naldemedine provided sustained and significant improvements in bowel movement frequency, constipation-related symptoms, and quality of life (compared to placebo at all time points). Naldemedine was generally well tolerated through 52 weeks and did not interfere with opioid-mediated analgesia or Causes opioid withdrawal. Compared with placebo, Naldemedine significantly increases bowel movements, improves symptoms of opioid-induced constipation, and improves patients' quality of life.

Naldemedine use in specific populations

There are currently no available data on the use of Naldemedine in pregnant women. Naldemedine should be used during pregnancy only if the potential benefits justify the potential risks.

Due to the potential for serious, including opioid withdrawal in the breastfed infant, decisions should be made to discontinue breastfeeding or discontinue the drug if necessary to minimize the risk to the breastfed infant. If Naldemedine is discontinued due to drug exposure, it is recommended that women resume breastfeeding 3 days after the last dose of Naldemedine.

The safety and effectiveness of Naldemedine in pediatric patients have not been established.

Naldemedine should be avoided in patients with severe hepatic impairment. No dose adjustment is required in patients with mild or moderate hepatic impairment.Recommended related hot articles:

References

Webster LR, Nalamachu S, Morlion B, Reddy J, Baba Y, Yamada T, Arjona Ferreira JC. Long-term use of naldemedine in the treatment of opioid-induced constipation in patients with chronic noncancer pain: a randomized, double-blind, placebo-controlled phase 3 study. Pain. 2018 May;159(5):987-994. doi: 10.1097/j.pain.0000000000001174. PMID: 29419653; PMCID: PMC5916485.