【藥品庫存】 本藥品為臨時採購藥品，經院長核可後，限定特定科別、病人使用。

1. First-line treatment (in combination with avelumab or pembrolizumab) of advanced renal cell carcinoma
2. Treatment (as a single-agent) of advanced renal cell carcinoma after failure of 1 prior systemic therapy
#仿單變更2021#仿單變更2022

Antineoplastic Agent (Tyrosine Kinase Inhibitor; Vascular Endothelial Growth Factor Inhibitor)
Axitinib is a selective second-generation tyrosine kinase inhibitor which blocks angiogenesis and tumor growth by inhibiting vascular endothelial growth factor receptors (VEGFR-1, VEGFR-2, and VEGFR-3)

Absorption:
1. Bioavailability: 58%
2. Time to peak: 2.5 to 4 hours
Distribution:
1. Vd: 160 L
2. Protein binding: >99%; to albumin (primarily) and to alpha1 acid glycoprotein (AAG)
Metabolism:
Hepatic; primarily via CYP3A4/5 and to a lesser extend via CYP1A2, CYP2C19 and UGT1A1
Excretion:
1. Feces (~41%; 12% as unchanged drug); urine (~23%; as metabolites)
2. Half-life elimination: 2.5 to 6.1 hours

Hypersensitivity to axitinib or any component of the formulation.

Based on its mechanism of action and findings from animal reproduction studies, adverse effects on pregnancy would be expected.

Not recommend breastfeeding during axitinib therapy or for 2 weeks after the final axitinib dose.

1. Cardiovascular: Hypertension(BP should be well-controlled prior to treatment initiation.), aortic dissection, hemangioma<20220311>
,cardiac failure<20240419>
2. Dermatologic: skin rash
3. Endocrine & metabolic: Decreased serum bicarbonate, hyper/hypoglycemia, hyperkalemia, hyper/hyponatremia, hypoalbuminemia, hypocalcemia, hypophosphatemia, hypothyroidism
4. Gastrointestinal: Abdominal pain, constipation, diarrhea, dysgeusia, nausea, vomiting,GI perforation and fistulas<20240419>
5. Genitourinary: Proteinuria
6. Hematologic & oncologic: Decreased lymphocyte count, platelet count, white blood cell count; hemorrhage
7. Hepatic: Increased AST and ALT
8. Nervous system: Fatigue, headache, voice disorder
9. Neuromuscular & skeletal: Arthralgia, asthenia, limb pain
10. Renal: Increased SCr
11. Respiratory: Cough, dyspnea
12. Wound healing complications: Withhold axitinib treatment for over 2 days prior to elective surgery; do not administer axitinib for >2 weeks following major surgery and until adequate wound healing. <2021/7/3>
13.Thrombotic events
<20240419>

First-line combination therapy:
1. In combination with avelumab: Initial 5 mg twice daily, every 12 hours; if tolerated for 2 weeks or longer, may increase to 7 mg twice daily and then 10 mg twice daily
2. In combination with pembrolizumab: Initial 5 mg twice daily, every 12 hours; after 6 weeks (or longer), if tolerated, may increase to 7 mg twice daily and then may further increase to 10 mg twice daily
Second-line single-agent therapy:
Initial 5 mg twice daily, approximately every 12 hours; if tolerated for at least 2 consecutive weeks, may increase to 7 mg twice daily and then 10 mg twice daily

1. CrCl 15-89 mL/min: No initial dosage adjustment necessary
2. CrCl <15 mL/min: There are no dosage adjustments provided in the manufacturer's labeling; use with caution
3. End-stage renal disease: There are no dosage adjustments provided in the manufacturer's labeling; use with caution

1. Mild impairment (Child-Pugh class A): No initial axitinib dosage adjustment necessary.
2. Moderate impairment (Child-Pugh class B): Reduce axitinib starting dose by ~50%; increase or decrease subsequent doses based on individual tolerance.
3. Severe impairment (Child-Pugh class C): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).