Donafenib(甲苯磺酸多纳非尼片)

Introduction of Donafenib

Donafenib Tosylate Tablets is China’s first domestic deuterated anti-tumor drug and the first domestic first-line targeted drug for liver cancer. It is supported by the Major New Drug Creation Program, and holds a number of core patents at home and abroad with the longest validity period up to 2032.

Indications

This product is indicated for the treatment of patients with unresectable hepatocellular carcinoma who have not received prior systemic therapy.

Overview

Dosage and Administration

Recommended Dosage and Administration

This product should be used under the guidance of a physician with experience in relevant clinical practice.

The recommended dosage is 0.2g (2×0.1g) administered twice daily, taken orally on an empty stomach with warm boiled water.

It is recommended to take the medicine at the same time each day. If a dose is missed, do not make up the missed dose and take the next dose at the regular scheduled time.

Treatment Duration

Continue administration until the patient no longer derives clinical benefit or experiences intolerable toxic reactions.

Contraindications

Hypersensitivity to any component of this product is a contraindication. This product is also contraindicated in patients with active bleeding, active peptic ulcer, medically uncontrolled hypertension and severe hepatic insufficiency.

Lactating women are contraindicated to use this product.

Adverse Reactions

The most common adverse reactions include: hand-foot skin reaction, diarrhea, decreased platelet count, hypertension, elevated aspartate aminotransferase, alopecia, rash and proteinuria.

Common Grade 3 and above adverse reactions include: hypertension and hand-foot skin reaction.

Special Populations

Women and Men of Childbearing Potential

Fertility

There are no available data on the effects of this product on human fertility. However, results from animal studies in rats have shown that this product impairs the fertility of both male and female rats.

Contraception

Women and men of childbearing potential receiving Donafenib treatment should adopt reliable contraceptive measures during the treatment period and within 2 weeks after the last dose of Donafenib.

Pregnancy

There are no available clinical data on the use of Donafenib in pregnant women. Animal studies have demonstrated that Donafenib administration to rats and rabbits causes embryotoxicity, fetotoxicity and teratogenicity.

Patients who are women of childbearing potential should be informed of the potential harm to the fetus associated with this product. Donafenib should be avoided during pregnancy unless clearly necessary, and only after the potential therapeutic benefits and fetal risks have been fully evaluated.

Lactation

It is unknown whether Donafenib and/or its metabolites are excreted in human milk. Since many drugs are excreted in human milk and the potential risks to breastfed infants cannot be excluded, breastfeeding must be discontinued during treatment with this product.

Pediatric Use

There are no available clinical data on the use of this product in patients under 18 years of age, and its safety and efficacy have not been established.

Geriatric Use

There are no dedicated clinical study data for geriatric patients, and clinical data on the use of this product in patients over 75 years of age are limited. It is recommended to use this product with caution and adjust the dosage as appropriate under the guidance of a physician, based on the patient's clinical condition and laboratory parameters.

For more detailed drug information, please consult the official package leaflet.

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