Axilieva Tablet

Axitinib is a kinase inhibitor indicated: - 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 RCC. - as a single agent, for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy. First-Line Advanced Renal Cell Carcinoma Axitinib in combination with avelumab is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC). Axitinib in combination with pembrolizumab is indicated for the first-line treatment of patients with advanced RCC. Second-Line Advanced Renal Cell Carcinoma Axitinib as a single agent is indicated for the treatment of advanced RCC after failure of one prior systemic therapy.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

• Hypertension: Hypertension including hypertensive crisis has been observed. Blood pressure should be well-controlled prior to initiating Axitinib. Monitor for hypertension and treat as needed. Withhold and then dose reduce Axitinib or permanently discontinue based on severity of hypertension. - Arterial and Venous Thromboembolic Events: Arterial and venous thrombotic events have been observed and can be fatal. Use with caution in patients who are at increased risk for these events. Permanently discontinue Axitinib if an arterial thromboembolic event occurs during treatment. Withhold Axitinib and then resume at same dose or permanently discontinue based on severity of VTE. - Hemorrhage: Hemorrhagic events, including fatal events, have been reported. Axitinib has not been studied in patients with evidence of untreated brain metastasis or recent active gastrointestinal bleeding and should not be used in those patients. Withhold and then dose reduce Axitinib or discontinue based on severity and persistence of hemorrhage. - Cardiac Failure: Cardiac failure has been observed and can be fatal. Monitor for signs or symptoms of cardiac failure throughout treatment with Axitinib. Management of cardiac failure may require dose reduction, dose interruption or permanent discontinuation of Axitinib. - 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. - Hypothyroidism: Hypothyroidism requiring thyroid hormone replacement has been reported. Monitor thyroid function before initiation of, and periodically throughout, treatment with Axitinib. - Impaired Wound Healing: Withhold Axitinib for at least 2 days prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. Resume Axitinib at a reduced dose or discontinue based on severity and persistence of the impaired wound healing. The safety of resumption of Axitinib after resolution of wound healing complications has not been established. - Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS has been observed. Permanently discontinue Axitinib if signs or symptoms of RPLS occur. - Proteinuria: Monitor for proteinuria before initiation of, and periodically throughout, treatment with Axitinib. For moderate to severe proteinuria, withhold and then dose reduce Axitinib. - Hepatotoxicity: Liver enzyme elevation has occurred during treatment with Axitinib as a single agent. Monitor ALT, AST and bilirubin before initiation of, and periodically throughout, treatment with Axitinib. When used in combination with avelumab or pembrolizumab, higher frequencies of Grade 3 and 4 ALT and AST elevation may occur. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following clinically significant adverse reactions are discussed elsewhere in the labeling: - Hypertension - Arterial thromboembolic events - Venous thromboembolic events - Hemorrhage - Cardiac failure - Gastrointestinal perforation and fistula formation - Thyroid dysfunction - Reversible posterior leukoencephalopathy syndrome - Proteinuria - Hepatotoxicity - Hepatic impairment Most common adverse reactions (≥20%) are: Axitinib in combination with avelumab: diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain, and headache. Axitinib in combination with pembrolizumab: diarrhea, fatigue/asthenia, hypertension, hepatotoxicity, hypothyroidism, decreased appetite, palmar-plantar erythrodysesthesia, nausea, stomatitis/mucosal inflammation, dysphonia, rash, cough, and constipation. Axitinib as a single agent: diarrhea, hypertension, fatigue, decreased appetite, nausea, dysphonia, palmar-plantar erythrodysesthesia (hand-foot) syndrome, weight decreased, vomiting, asthenia, and constipation. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of Axitinib has been evaluated in combination with avelumab in JAVELIN Renal 101 and pembrolizumab in KEYNOTE-426 for the first-line treatment of patients with advanced RCC. The data described reflect exposure to Axitinib in combination with avelumab in 434 patients and pembrolizumab in 429 patients. The safety of Axitinib has been evaluated in 715 patients in second-line monotherapy studies, which included 537 patients with advanced RCC. The data described reflect exposure to Axitinib in 359 patients with advanced RCC who participated in a randomized clinical study versus sorafenib. First-Line Advanced RCC Axitinib in Combination with Avelumab The safety of Axitinib in combination with avelumab was evaluated in JAVELIN Renal 101. Patients with autoimmune disease other than type I diabetes mellitus, vitiligo, psoriasis, or thyroid disorders not requiring immunosuppressive treatment were excluded. Patients received Axitinib 5 mg twice daily (N=434) in combination with avelumab 10 mg/kg every 2 weeks administered or sunitinib 50 mg once daily for 4 weeks followed by 2 weeks off (N=439). Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.