Axitinib instructions

1. Indications

Axitinibis a kinase inhibitor:

•In combination with avelumab, it is used for the first-line treatment of patients with advanced renal cell carcinoma(RCC).

•In combination with pembrolizumab, it is used for the first-line treatment of patients with advanced renal cancer.

•As a single agent for the treatment of advanced renal cell carcinoma(RCC) after failure of one prior systemic therapy.

2. Dosage and usage

•Axitinib 5 mg orally twice daily and avelumab 800 mg every 2 weeks.

• Axitinib 5 mg orally twice daily, pembrolizumab 200 mg every 3 weeks, or pembrolizumab 400 mg every 6 weeks.

•Axitinibas a single agent, starting at 5 mg taken orally twice daily.

•Dosage adjustments can be based on individual safety and tolerability.

•With or without food, take approximately 12 hours apart.

•Axitinib should be swallowed whole with a glass of water.

•If you need stronger strengthCYP3A4/5Inhibitors, reduce theaxitinibdose by approximately one-half.

•In patients with moderate hepatic impairment, reduce the starting dose by approximately one-half.

Three. Dosage form and strength

1mg and 5mg tablets.

Four. Contraindications

None

Five. Warnings and Precautions

1.Hypertension may occur, hypertension, including hypertensive crisis, has been observed. Blood pressure should be well controlled before starting axitinib. Monitor hypertension and treat as needed,Depending on the severity of hypertension, withhold medication and then immediately reduce dose or permanently discontinue.

2.Arterial and venous thromboembolic events may occur, Arterial and venous thromboembolic events have been observed and may be fatal. Use with caution in patients at increased risk for these events. If an arterial thromboembolic event occurs during treatment, permanently discontinue axitinib. Depending on the severity of VTE, withhold axitinib and then resume the same dose or permanently discontinue.

3.Bleeding and bleeding events, including fatal events, may occur. Axitinib has not been studied in patients with untreated brain metastases or evidence of recent active gastrointestinal bleeding and should not be used in these patients. Depending on the severity and duration of bleeding, withhold the medication and then reduce or discontinue the medication immediately.

4.Heart failure may occur, Heart failure has been observed and may be fatal. Monitor for signs or symptoms of heart failure throughout treatment with axitinib, management of heart failure may require dose reduction, dose interruption, or permanent discontinuation of axitinib.

5.Gastrointestinal perforation and fistula formation, Gastrointestinal perforation and fistula, including death, have occurred. Use with caution in patients at risk for gastrointestinal perforation or fistula.

6.Hypothyroidism, hypothyroidism requiring thyroid hormone replacement has been reported. Monitor thyroid function before initiatingaxitinibtreatment and periodically throughout treatment.

7.Poor wound healing，择期手术前至少2天停用阿昔替尼。 Do not administer this medication for at least 2 weeks after major surgery until the wound has completely healed.根据受损伤口愈合的严重程度和持久性，减少剂量或停止阿昔替尼。 Resume after resolution of wound healing complicationsThe safety of axitinibhas not been established.

8.可逆性后部白质脑病综合征(RPLS)，已经观察到RPLS。如果出现RPLS症状或体征，请永久停止阿昔替尼。

9.Proteinuria, Monitor for proteinuria before initiatingaxitinibtherapy and periodically throughout treatment.对于中度至重度蛋白尿，应暂停用药，然后减量静脉注射。

10.肝毒性:在用阿昔替尼作为单一药物治疗期间，出现肝酶升高。 MonitorALT, ASTand bilirubin before initiatingaxitinibtreatment and periodically throughout treatment.当与avelumab或pembrolizumab联合使用时，可能出现更高频率的3 grade and 4 grade ALT and AST were elevated. Consider monitoring liver enzymes more frequently. Discontinue INLYTA and avelumab or pembrolizumab as needed, initiate corticosteroid therapy as needed, and permanently discontinue the combination due to severe or life-threatening hepatotoxicity.

6. adverse reactions

最常见的不良反应(≥20%)有:

Axitinib in combination with avelumab :Diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar red blood cell paresthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain, and headache.

阿昔替尼与pembrolizumab联合用药:Diarrhea, fatigue/Asthenia, hypertension, hepatotoxicity, hypothyroidism, decreased appetite, palmoplantar red blood cell paresthesias, nausea, stomatitis/Mucosal inflammation, dysphonia, rash, cough and constipation.

Axitinib As a single agent:Diarrhea, hypertension, fatigue, decreased appetite, nausea, dysphonia, hand-foot paresthesia syndrome, weight loss, vomiting, asthenia, and constipation.

7. drug interactions

•Avoid strongCYP3A4/5inhibitors. If unavoidable, reduceaxitinibdose.

•Avoid strongCYP3A4/5inducers

There are generic drugs in Bangladesh, and the retail price of Bikang Pharmaceutical in Bangladesh is about 5mg 60 tablets1800 yuan. If you want to get more high-quality information, you can contact Yaode, and Yaode will do its best to learn more about high-quality overseas drugs for you.

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