盐酸纳呋拉啡是什么药？

It is a selective kappa opioid receptor agonist used for the treatment of hemodialysis-related uremic pruritus. Other indications for the drug include pruritus in patients with chronic liver disease and pruritus in peritoneal dialysis patients.

Nalfuraphine hydrochloride marketing information

In 2009, nalfuraphine soft capsules were launched in Japan for the treatment of hemodialysis-related pruritus in uremic patients.

In 2015 and 2017, nalfurapine was approved in Japan for the treatment of pruritus in patients with chronic liver disease and pruritus in peritoneal dialysis patients.

In 2018, Chinese biopharmaceutical company 3SBio signed an exclusive license agreement with Japan's Toray to develop and commercialize this product in mainland China.

The effects of nalfuraphine hydrochloride

Nalfuraphine has a strong G protein bias. Animal experiment results show that it does not cause irritability, sedation and other effects at analgesic doses, and does not produce hallucinations in clinical practice. Therefore, nalfuraphine is positioned as an analgesic and antipruritic agent with low side effects. Clinical trials have shown that nalfurapine has severe sedative effects at analgesic doses, but this side effect can be avoided at low doses (antipruritic doses).

Efficacy of nalfurapine hydrochloride

A meta-analysis included two randomized controls, a total of 144 patients with uremic pruritus (UP), who were given intravenous injection of nalfurapine or placebo for 2 to 4 weeks after each dialysis.

The results showed that compared with placebo, nalfurapine significantly reduced the most severe itching (P=0.0212, responders had at least a 50% reduction in the most severe itching VAS at baseline), itching intensity (P=0.041 0), and sleep disturbance (P=0.000 3. The number of days with good night sleep in the nalfurafine group increased from 1.7 nights/week at baseline to 3.4 nights/week and 4.3 nights/week in weeks 1 and 2, respectively).

Nalfuraphine has been shown to be effective and safe in the treatment of severe itching.

In phase III of a randomized controlled trial, 337 patients with refractory hemodialysis pruritus were treated with oral administration of 2.5 μg or 5 ug of nalfurorphine (once/d) and placebo for 14 days. Compared with the placebo group, the decrease in VAS of the two doses of nalfurapine group reached a significant level, and the most common adverse reaction was sleep disorder.

An open study reported that 211 patients with refractory hemodialysis UP were treated with oral administration of nalfuraphine (5 μg, once/d) for 52 weeks, and long-term suppression of pruritus without significant safety issues.

Dosage, dosage and side effects of nalfuraphine hydrochloride

1. Dosage and usage

(1) Recommended daily dose for adults: Generally, adults should take 2.5 μg of nalfuraphine hydrochloride per day (calculated as nalfuraphine hydrochloride). This dose should be taken by mouth after dinner or before bed to ensure the medication is working before bedtime.

(2) Dose adjustment: If symptoms require, the dose can be increased according to the situation. However, the increased dose should be limited to once daily, up to a maximum of 5 μg.

(3) Precautions for use: When increasing the dose, be sure to do so under the guidance of a doctor to ensure safe and rational use of the drug. Follow the recommended dosage and timing to avoid the possible risks of overdose or improper use.

For more information about nalfuraphine hydrochloride, please refer to: This article details the usage and dosage of nalfuraphine hydrochloride, as well as information on drug interactions.

2. Side effects

Common side effects of nalfurafine include dizziness, drowsiness, confusion, nausea, weight loss, itching, rash, etc. The following are common side effects treatment measures:

(1) Dizziness: take appropriate rest and avoid strenuous exercise or standing for long periods of time.

(2) Drowsiness: Arrange work and rest time reasonably and avoid driving or operating dangerous machinery.

(3) Confusion: Stop activities immediately, keep quiet and rest, and seek medical treatment if necessary.

(4) Nausea: Eat small meals frequently, avoid greasy food, and try taking anti-nausea drugs.

(5) Weight loss: Pay attention to nutritional intake, eat a balanced diet, and consult a nutritionist if necessary.

(6) Itching: Avoid irritating the skin, use mild skin care products, and seek medical attention if severe.

(7) Skin rash: Keep the skin clean and dry, avoid using irritating drugs, and seek medical treatment if necessary.

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