1. Indications and Usage
According to the drug instructions of the drug regulatory authority, donafenib mesylate tablets are indicated for patients with unresectable hepatocellular carcinoma who have not received systemic treatment before, as well as for patients with advanced, locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer.
2. Dosage and Administration
Recommended Dosage: The recommended dose is 0.2 g (2 × 0.1 g tablets) taken orally twice daily.
Administration: The tablets should be taken on an empty stomach with warm water. It is recommended to take the medication at the same time each day.
Missed Dose: If a dose is missed, do not supplement it. Take the next dose at the regular time.
Dose Modifications: Treatment should continue until there is no clinical benefit or intolerable toxicity. Dose interruptions, reductions, or permanent discontinuation should follow the principle of first interrupting treatment and then reducing the dose.
3. Mechanism of Action
Donafenib is a small molecule multi-target tyrosine kinase inhibitor. It primarily inhibits vascular endothelial growth factor receptors (VEGFR) and fibroblast growth factor receptors (FGFR), thereby blocking tumor angiogenesis. Additionally, it inhibits downstream signaling pathways to suppress tumor cell proliferation.
4. Safety and Warnings
Hand-Foot Skin Reaction: This is the most common adverse reaction. Symptomatic support and dose adjustments are required for Grade 3 reactions.
Hypertension: Blood pressure should be well-controlled before treatment. Regular monitoring is necessary during treatment. Dose adjustment is required if Grade 3 hypertension persists despite optimal antihypertensive therapy.
Hepatotoxicity: Liver function should be monitored regularly. For Grade 3 or higher abnormalities, treatment should be interrupted, the dose reduced, or therapy permanently stopped, along with active hepatoprotective treatment.
Hemorrhage: Monitor for bleeding risks. For Grade 3 or higher upper gastrointestinal bleeding, the drug should be temporarily or permanently stopped.
QTc Prolongation: Monitor ECG and electrolytes (magnesium, potassium, calcium) regularly.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: The most common adverse reactions (incidence ≥20%) include hand-foot skin reaction, diarrhea, thrombocytopenia, hypertension, elevated aspartate aminotransferase (AST), alopecia, rash, and proteinuria.
Clinical Research: In the pivotal Phase III clinical trial (ZGDH3) for hepatocellular carcinoma, the Donafenib group showed a significant improvement in overall survival compared to Sorafenib.
6. Drug Interactions
CYP3A4 Inhibitors: Since Donafenib is mainly metabolized by CYP3A4 in the liver, the use of calcium channel blockers that inhibit the CYP3A4 metabolic pathway should be avoided to prevent increased adverse reactions due to drug accumulation.
Anticoagulants: When used with anticoagulants like warfarin, prothrombin time (APTT) and international normalized ratio (INR) should be monitored regularly.
7. Pharmaceutical Information
Composition: The active ingredient is Donafenib Tosylate.
Appearance: Red, round, film-coated tablets.
Storage: Store at controlled room temperature in the original packaging.
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