Formulation and specifications: Tablets: 1mg, 5mg
Indications:
1. For adult patients with progressive RCC who have failed prior treatment with a tyrosine kinase inhibitor or cytokine.
2. In combination with pablizumab for the first-line treatment of advanced renal clear cell carcinoma.
Key points for rational drug use:
1. The recommended starting oral dose of axitinib is 5 mg twice daily, either with food or on an empty stomach, with a time interval of approximately 12 hours between daily doses. Treatment should be continued until unacceptable toxicity occurs as long as clinical benefit is observed. If a patient vomits or misses a dose, an additional dose should not be taken and the next dose should be taken as usual.
2. Dose increases or decreases are recommended based on individual differences in patient safety and tolerability: (1) During treatment, doses may be increased in patients who meet the following criteria: tolerating at least two weeks of continuous treatment with axitinib, no grade 2 or higher adverse effects, normal blood pressure, and not receiving antihypertensive medications. When a dose increase from 5 mg twice daily is recommended, the dose of axitinib may be increased to 7 mg twice daily, and then further increased to 10 mg twice daily using the same criteria. (2) During the course of therapy, it may be necessary to suspend or permanently discontinue dosing, or to reduce the dose of axitinib. If a dose reduction from 5 mg twice daily is required, the recommended dose is 3 mg twice daily. If another dose reduction is required, the recommended dose is 2 mg twice daily.
3. Avoid combining with potent CYP3A4/5 inhibitors or inducers.
4. In combination with pablizumab for advanced renal clear cell carcinoma, the recommended dose of axitinib is 5 mg twice daily, with dose titration considered if tolerated. Please refer to the section on “Pabrolizumab” for the dosing of pabrolizumab during combination therapy.