Inlyta 5 mg (Axitinib)

Adult dose

1. First-line treatment of advanced renal cell carcinoma: The recommended dose of this drug is 5 mg twice daily (12 hours apart), regardless of food, in combination with pembrolizumab 200 mg administered by intravenous infusion over 30 minutes every 3 weeks, until disease progression or unacceptable toxicity occurs. When this drug is used in combination with pembrolizumab, dose escalation from the starting dose of 5 mg may be considered at intervals of 6 weeks or longer. Refer to the prescribing information for pembrolizumab for its recommended dose. 2. Second-line treatment of advanced renal cell carcinoma: When this drug is used as monotherapy, the recommended starting dose is 5 mg orally twice daily. This drug should be taken approximately 12 hours apart, regardless of food. 3. Precautions for administration: This drug should be swallowed whole with water. If the patient vomits after taking this drug or misses a dose, an additional dose should not be taken. The next prescribed dose should be taken at the usual time. 4. Dose adjustment: Dose escalation or reduction is recommended based on the safety and tolerability of each individual patient. During treatment, the dose may be increased in patients who have had no adverse reactions greater than Grade 2 (according to the Common Toxicity Criteria for Adverse Events [CTCAE]) for at least 2 consecutive weeks, maintain normal blood pressure, and are not taking antihypertensive medication. If an increase from 5 mg twice daily is recommended, the dose may be increased to 7 mg twice daily and, using the same criteria, further increased to a maximum of 10 mg twice daily. Temporary or permanent interruption of treatment with this drug and/or dose reduction may be required to manage certain adverse reactions during treatment. In general, if a Grade 3 adverse reaction occurs, the dose of this drug should be reduced by one dose level. If a Grade 4 adverse reaction occurs, treatment with this drug should be temporarily interrupted until the adverse reaction recovers to Grade 2 or lower, after which treatment should be restarted at one dose level lower. If a dose reduction from 5 mg twice daily is required, reduction to 3 mg twice daily is recommended. If further reduction is required, the dose may be reduced to 2 mg twice daily. 5. Concomitant administration with strong CYP3A4/5 inhibitors: Concomitant administration with strong CYP3A4/5 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole) should be avoided. It is recommended to select alternative concomitant medications with no or minimal potential to inhibit CYP3A4/5. Although dose adjustment of this drug has not been studied in patients receiving strong CYP3A4/5 inhibitors, if concomitant administration of a strong CYP3A4/5 inhibitor is unavoidable, it is recommended that the dose of this drug be reduced by approximately half. This reduction is expected to adjust the AUC (area under the plasma concentration-time curve) of axitinib to a range similar to that observed without concomitant administration of the inhibitor. Subsequent doses may be increased or reduced based on the safety and tolerability of each individual patient. If concomitant administration of a strong CYP3A4/5 inhibitor is discontinued, the dose of this drug should be changed to the dose used before concomitant administration of the inhibitor (after 3-5 half-lives of the inhibitor have elapsed). [See ‘5. Drug interactions’ under Precautions for Use]. 6. Hepatic impairment: No adjustment of the starting dose of this drug is required in patients with mild hepatic impairment (Child-Pugh class A). Based on pharmacokinetic data, it is recommended that the starting dose of this drug be reduced by approximately half in patients with moderate hepatic impairment (Child-Pugh class B) at baseline. Subsequent doses may be increased or reduced based on the safety and tolerability of each individual patient. This drug has not been evaluated in patients with severe hepatic impairment (Child-Pugh class C) [See ‘4. General precautions, item 11’ under Precautions for Use]. 7. Hepatotoxicity: In patients receiving this drug in combination with pembrolizumab, • If ALT or AST is elevated to 3 times or more but less than 10 times the upper limit of normal, without total bilirubin being elevated to 2 times or more the upper limit of normal, withhold both this drug and pembrolizumab until the adverse reaction recovers to Grade 0-1. Consider corticosteroid therapy. After recovery, consider restarting one of the drugs or sequentially restarting both drugs. If this drug is restarted, consider reducing the dose according to the recommended dose-adjustment guidelines. • If ALT or AST is elevated to 10 times or more the upper limit of normal, or is elevated to more than 3 times the upper limit of normal with concurrent elevation of total bilirubin to 2 times or more the upper limit of normal, permanently discontinue both this drug and pembrolizumab and consider corticosteroid therapy. Refer to the prescribing information for pembrolizumab for additional dose adjustments.

This medication may harm the fetus during pregnancy, so women who are pregnant or planning to become pregnant should avoid its use. Women of childbearing potential and their partners must use effective contraception during and up to one week after the use of this drug. Patients who have hypersensitivity to this medication should not use it. Serious adverse reactions such as heart failure, hypertension, thromboembolism, hepatotoxicity, and bleeding may occur during treatment, so regular monitoring is necessary. Especially, cardiac function and blood pressure should be checked regularly, and if any abnormal symptoms arise, immediate consultation with a healthcare professional is required. Liver function tests should also be conducted regularly to assess for liver damage. Blood tests should monitor hemoglobin, platelet, and white blood cell counts for any abnormalities. Co-administration of this medication with certain drugs (e.g., strong CYP3A4/5 inhibitors or inducers) should be avoided, and dosage adjustments may be necessary. If surgery is planned, this medication should be discontinued at least 2 days prior, and its resumption should be determined after wound healing status is checked. Symptoms such as dizziness or fatigue may appear, so caution is required while driving or operating machinery. The safety of this medication in children has not been established, and there is no need for specific dosage adjustments in the elderly. In the event of an overdose, there are no specific antidotes, so immediate discontinuation of the medication is required and symptomatic treatment should be administered. This medication should be kept out of reach of children and stored in its original container.

Cardiac arrest, pulmonary embolism, heart failure, unexplained death, myasthenia gravis, myocarditis, Fournier's gangrene, plasmacytoma, pleural effusion, pneumonia, respiratory failure, hepatotoxicity, diarrhea, acute kidney injury, dehydration, hypertension, hypothyroidism, decreased appetite, hand-foot erythema sensory neuropathy, nausea, stomatitis, mucosal inflammation, voice disturbance, rash, cough, constipation, fatigue, weakness, headache, taste disturbance, dizziness, tinnitus, hemorrhage, venous thromboembolic event, arterial thromboembolic event, hypertensive crisis, dyspnea, vomiting, abdominal pain, stomatitis, dyspepsia, upper abdominal pain, hemorrhoids, tongue pain, gastrointestinal perforation, fistula, hyperbilirubinemia, dry skin, erythema, pruritus, hair loss, arthralgia, limb pain, myalgia, proteinuria, weight loss, edema, chest discomfort, chest pain, peripheral edema, acne, vesicles, pressure ulcer, hand dermatitis, acral keratotic dermatosis, palmoplantar pustulosis, dysuria, chronic kidney disease, dysphagia, rectal pain, toothache, pulmonary arterial thrombosis, cerebral infarction, peripheral neuropathy, peripheral sensory neuropathy, perineal pain, gout, anemia, heart failure, cardiopulmonary failure, left ventricular dysfunction, right ventricular failure, reduced cardiac output, thrombocytopenia, leukopenia, hypocalcemia, hypophosphatemia, hyponatremia, hypoalbuminemia, hyperkalemia, hypercalcemia, hyperglycemia, hypoglycemia, prolonged activated partial thromboplastin time, increased hemoglobin, decreased hemoglobin, lymphocytopenia, thrombocytopenia, leukopenia, increased lipase, increased amylase, increased ALT, increased AST, hypernatremia, hypoglycemia, hypophosphatemia, increased ALP, increased serum bilirubin, reversible posterior leukoencephalopathy syndrome, pancreatitis, cholecystitis, aneurysm, arterial dissection

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is best to maintain the storage temperature between 15 to 30 degrees Celsius at room temperature. This ensures the drug's efficacy is maintained and that it can be used safely.

Appearance

Red triangular film-coated tablet

Package unit

28 tablets (14/blister X2), 56 tablets (14/blister X4)