INDICATIONS AND USAGE（适应症）

First-Line Advanced Renal Cell Carcinoma

INLYTA in combination with avelumab is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

INLYTA in combination with pembrolizumab is indicated for the first-line treatment of patients with advanced renal cell carcinoma.

Second-Line Advanced Renal Cell Carcinoma

INLYTA as a single agent is indicated for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy.

DOSAGE（服用剂量）

First-Line Advanced RCC

The recommended dose of INLYTA is 5 mg orally taken twice daily (12 hours apart) with or without food in combination with avelumab 800 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. When INLYTA is used in combination with avelumab, dose escalation of INLYTA above the initial 5 mg dose may be considered at intervals of two weeks or longer. Review the Full Prescribing Information for recommended avelumab dosing information.

The recommended dose of INLYTA is 5 mg orally twice daily (12 hours apart) with or without food in combination with pembrolizumab 200 mg every 3 weeks or 400 mg every 6 weeks administered as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity. When INLYTA is used in combination with pembrolizumab, dose escalation of INLYTA above the initial 5 mg dose may be considered at intervals of six weeks or longer. Review the Full Prescribing Information for recommended pembrolizumab dosing information.

Second-Line Advanced RCC

When INLYTA is used as a single agent, the recommended starting oral dose is 5 mg twice daily. Administer INLYTA doses approximately 12 hours apart with or without food.

Important Administration Instructions

Advise patients to swallow INLYTA whole with a full glass of water. If the patient vomits or misses a dose, an additional dose should not be taken. Advise the patient to take the next prescribed dose at the usual time.

ADVERSE REACTIONS（不良反应）

Hypertension and hypertensive crisis

Arterial thromboembolic events

Venous thromboembolic events

Hemorrhage

Cardiac failure

Gastrointestinal perforation and fistula formation

Thyroid dysfunction

Reversible posterior leukoencephalopathy syndrome

Proteinuria

Hepatotoxicity

Hepatic impairment

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/8a903e31-936e-4ed7-8a59-59f32374f338/spl-doc?hl=axitinib

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