盐酸纳呋拉啡的上市时间及作用疗效简介

Introduction: Nalfurafine Hydrochloride is a highly selective kappa (kappa)-opioid receptor agonist developed by Toray Co., Ltd. of Japan. It exerts its antipruritic effect through a new mechanism of action that is completely different from existing antihistamines or anti-allergic drugs. This article mainly talks about the launch time, action and efficacy, usage and dosage, usage precautions, etc. of nalfuraphine hydrochloride.

Time on the market

The soft capsule form of nalfurapine hydrochloride (TRK-820) has been on the market in Japan since 2009. It is mainly used to improve the itching symptoms of hemodialysis patients (only when the existing treatment effect is not satisfactory).

Subsequently, the indications of nalfuraphine hydrochloride were gradually expanded to include refractory pruritus in patients with chronic liver disease and peritoneal dialysis patients. In December 2017, Toray Corporation granted 3SBio the exclusive right to develop and commercialize TRK-820 orally disintegrating tablet formulations in China except Hong Kong, Macau and Taiwan.

In China, 3SBio’s nalfuraphine hydrochloride orally disintegrating tablets (TRK-820) were approved for marketing by the State Food and Drug Administration on July 4, 2023. It is used to treat pruritus in hemodialysis patients whose existing treatments are unsatisfactory.

Efficacy

The main effect of nalfuraphine hydrochloride is to reduce pain and itching by activating kappa-opioid receptors. The drug has proven to be an effective treatment option for hemodialysis-related pruritus in uremic patients. Nafurafine hydrochloride can not only relieve itching, but also improve the patient's quality of life by improving the patient's sleep quality and psychological state.

Usage and Dosage

Usually for adults, 2.5 μg can be used once a day. The amount can be increased according to symptoms, but the limit is 5 μg once a day. For hemodialysis patients, it is recommended to start with 2.5 μg. If the itching symptoms do not improve, the dose can be increased under the guidance of a doctor, up to a maximum of 5 μg. For peritoneal dialysis patients and patients with chronic liver disease, the starting dose is also 2.5 μg once a day. If the effect is not good, the dose can be increased to 5 μg once a day. You should follow your doctor's advice when taking it, and do not increase or decrease the dosage or stop taking it at will.

Precautions during use

If you have any adverse reactions or allergies when taking nalfuraphine hydrochloride, you should stop taking it immediately and seek medical treatment in time. Before or after taking nalfurapine hydrochloride, you should tell your doctor about any other medications you are taking or plan to take. If allergic reactions such as rash, difficulty breathing, or facial swelling occur, you should stop taking it immediately and seek medical attention.

The introduction of nalfurapine hydrochloride provides a new treatment option for hemodialysis patients, especially for those patients who are ineffective with traditional treatment methods, and is expected to significantly improve their quality of life. The design of nalfuraphine hydrochloride orally disintegrating tablets also takes into account the convenience of patients with dysphagia and can be taken without water, further improving patients' medication compliance.