Axitinib/Axitinib (Axitinib) 2024 detailed instructions

1. Indications and Usage

Axitinib/Axitinibis a kinase inhibitor:

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

•In combination with pembrolizumab for the first-line treatment of patients with advanced kidney 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/Axitinib 5 mgorally twice daily, avelumab 800 mgonce every 2 weeks.

•Axitinib/Axitinib 5 mgorally twice daily, pembrolizumabevery3weeks200 mgor 400 mg every6weeks.

•Axitinib/AxitinibAs a single agent, the starting dose is 5 mg taken orally twice daily.

•Dosage may be adjusted based on individual safety and tolerability.

•Whether eating or not, the interval is aboutTake once every 12 hours.

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

•If a strong CYP3A4/5 inhibitor is required, reduce the axitinib/axitinib dose by approximately one-half.

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

Three. Dosage form and strength

1mg and 5mg tablets

Four. Contraindications

No.

Five. adverse reactions

The most common adverse reactions (≥20%) are:

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.

Axitinibcombination with pembrolizumab:Diarrhea, fatigue/Weakness fatigue, hypertension, hepatotoxicity, hypothyroidism, decreased appetite, palmar-red blood cell paresthesia, 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, fatigue, and constipation.

6. Things to note

1.Hypertension:Hypertension including hypertensive crisis has been observed. StartAxitinibBlood pressure should be controlled before taking any medication. Monitor high blood pressure and treat as needed. Depending on the severity of hypertension, withhold the medication and then immediately reduce the dose or permanently discontinue the medication.

2.Arterial and Venous Thromboembolic Events: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. Withholdaxitinibtreatment and then resume treatment at the same dose or permanently discontinue treatment based onVTEseverity.

3.Hemorrhage:Bleeding events, including death, have been reported. Axitinibhas 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:Heart failure has been observed and may be fatal. Monitor for signs or symptoms of heart failure duringaxitinibtreatment. Management of heart failure may require dose reduction, dose interruption, or permanent discontinuation of axitinib.

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

6.Hypothyroidism:There are reports that hypothyroidism requires thyroid hormone replacement therapy. Monitor thyroid function before initiating treatment with axitinib and periodically during treatment.

7.Impaired wound healing: Discontinue axitinib at least before elective surgery. Do not administer this medication for at least 2 weeks after major surgery until the wound has completely healed. Depending on the severity and persistence of impaired wound healing, reduce the dose of INLYTA or discontinue axitinib. Resume after resolution of wound healing complicationsThe safety of axitinibhas not been established.

8.Reversible posterior leukoencephalopathy syndrome (RPLS), observedRPLS. If signs or symptoms of RPLS occur, permanently discontinue axitinib.

9.Proteinuria:Monitor proteinuria before axitinibtreatment is initiated and periodically during treatment. For moderate to severe proteinuria, the drug should be discontinued and the dose should be reduced.

10.Hepatotoxicity: Elevated liver enzymes occurred during axitinib monotherapy. MonitorALT, AST and bilirubin before initiating axitinibtreatment and periodically during treatment. A higher frequency of 3 may occur when used in combination with avelumab or pembrolizumab 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.

11.Usage in patients with hepatic impairment:If used in patients with moderate hepatic impairment, the starting dose of axitinib should be reduced. Axitinib has not been studied in patients with severe hepatic impairment.

12.Major cardiovascular adverse events (INLYTAcombinationavelumab), optimizing the management of cardiovascular risk factors. For grade 3-4 events, permanently discontinue coadministration of axitinib and avelumab.

13.Embryonic-Fetal Toxicity:Axitinibcan cause fetal harm. Inform patients of the potential risk to the fetus and use effective contraception.

7. drug interactions

Avoid the use of strongCYP3A4/5inhibitors. If unavoidable, reduceaxitinib dose.

Avoid the use of strongCYP3A4/5 inducers.

8. Used by specific groups of people

Lactation period:It is recommended not to breastfeed.

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