Revlimid Capsule 10 mg (Lenalidomide)

Adult dosage

This medicine should be administered only to patients who have agreed to comply with the requirements specified in the Pregnancy Prevention Program (see “5. General Precautions” under Precautions for Use). In addition, this medicine should be prescribed only by physicians registered with the Pregnancy Prevention Program and dispensed only by pharmacists registered with the program. When prescribing this medicine to women of childbearing potential, negative pregnancy test results must be confirmed regularly according to the schedule specified in this program. 1. Multiple myeloma 1) Combination therapy with dexamethasone for the treatment of patients who have received at least one prior therapy Treatment should not be initiated if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <75,000/㎕. The recommended initial dose is 25mg once daily. Take 25mg capsules on Days 1 to 21 of each 28-day cycle. The recommended dose of dexamethasone is 40mg once daily on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles. After 4 cycles, administer 40mg once daily only on Days 1 to 4 of each 28-day cycle. Dose adjustments during treatment ① Dose adjustment according to platelet count Table 1. Platelet count Recommended dose If decreased to <30,000/㎕ Interrupt treatment and monitor complete blood counts weekly When recovered to ≧30,000/㎕ Resume treatment at 15mg once daily With each subsequent decrease to <30,000/㎕ Interrupt treatment When recovered to ≧30,000/㎕ Resume at a dose reduced by 5mg from the dose being taken. Do not reduce the dose below 5mg once daily. ② Dose adjustment according to absolute neutrophil count (ANC) Table 2. Absolute neutrophil count Recommended dose If decreased to <1,000/㎕ Interrupt treatment, add G-CSF, and monitor complete blood counts weekly When recovered to ≧1,000/㎕ and neutropenia is the only toxicity Resume treatment at 25mg once daily When recovered to ≧1,000/㎕ and other toxicities have occurred Resume treatment at 15mg once daily With each subsequent decrease to <1,000/㎕ Interrupt treatment When recovered to ≧1,000/㎕ Resume at a dose reduced by 5mg from the dose being taken. Do not reduce the dose below 5mg once daily. For neutropenia, use of growth factors should be considered for patient management. 2) Combination therapy with dexamethasone for the treatment of newly diagnosed patients who are not eligible for transplantation Treatment should not be initiated if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <50,000/㎕. The recommended initial dose is 25mg once daily. Take 25 mg capsules on Days 1 to 21 of each 28-day cycle. The recommended dose of dexamethasone is 40mg once daily on Days 1, 8, 15, and 22 of each 28-day cycle. For patients aged 75 years or older, the recommended dose of dexamethasone is 20mg once daily on Days 1, 8, 15, and 22 of each 28-day cycle. Continue treatment until disease progression or unacceptable toxicity occurs. Dose adjustments during treatment <Dose reduction levels> This medicine Dexamethasone Initial dose 25 mg 40 mg 1st dose reduction 20 mg 20 mg 2nd dose reduction 15 mg 12 mg 3rd dose reduction 10 mg 8 mg 4th dose reduction 5 mg 4 mg 5th dose reduction 2.5 mg N/A ① Dose adjustment according to platelet count Table 3. Platelet count Recommended dose If decreased to <25,000/㎕ Interrupt this medicine and dexamethasone and monitor complete blood counts weekly When recovered to ≧50,000/㎕ Resume at one dose level below the dose being taken ② Dose adjustment according to absolute neutrophil count (ANC) Table 4. Absolute neutrophil count Recommended dose If decreased to <500/㎕ Interrupt this medicine and dexamethasone and monitor complete blood counts weekly When recovered to ≧1,000/㎕ and neutropenia is the only toxicity Resume treatment at the starting dose When recovered to ≧500/㎕ and dose-dependent hematologic toxicity other than neutropenia has occurred Resume at one dose level below the dose being taken With each subsequent decrease to <500/㎕ Interrupt this medicine and dexamethasone When recovered to ≧500/㎕ Resume at one dose level below the dose being taken For neutropenia, use of growth factors should be considered for patient management. ③ Dose adjustment for febrile neutropenia (fever ≥38.5℃ and ANC<1,000/㎕): Interrupt treatment and monitor complete blood counts weekly. If the patient is not receiving a growth factor, use of a growth factor should be considered. On the first day of the next treatment cycle, resume treatment at the dose being taken, continuing growth factor use if needed, if neutropenia was the only dose-limiting toxicity. Otherwise, resume treatment at one dose level below the dose being taken. If the patient is not receiving a growth factor, administer a growth factor. If this medicine was reduced because of a hematologic dose-limiting toxicity (DLT), treatment may be resumed at an increased dose (up to the maximum starting dose), at the physician’s discretion, if bone marrow function improves (no DLTs for at least 2 consecutive cycles and, at the start of a new cycle at the current dose level, absolute neutrophil count ≥1,500/㎕ and platelet count ≥100,000/㎕). 3) Combination therapy with melphalan and prednisolone for the treatment of newly diagnosed patients who are not eligible for transplantation Treatment should not be initiated if the absolute neutrophil count is <1,500/㎕ and/or the platelet count is <75,000/㎕. The recommended initial dose is 10mg once daily. Take 10 mg capsules on Days 1 to 21 of each 28-day cycle. Through Cycle 9, administer oral melphalan at a dose of 0.18mg/kg on Days 1 to 4 of each 28-day cycle, and administer oral prednisolone at a dose of 2mg/kg on Days 1 to 4 of each 28-day cycle. For patients who have completed 9 cycles or who cannot complete combination therapy because of intolerance, administer this medicine alone at 10mg once daily on Days 1 to 21 of each 28-day cycle until disease progression. Dose adjustments during treatment <Dose reduction levels> This medicine Melphalan Prednisolone Initial dose 10 mg 0.18 mg/kg 2 mg/kg 1st dose reduction 7.5 mg 0.14 mg/kg 1 mg/kg 2nd dose reduction 5 mg 0.10 mg/kg 0.5 mg/kg 3rd dose reduction 2.5 mg N/A 0.25 mg/kg ① Dose adjustment according to platelet count Table 5. Platelet count Recommended dose If decreased to <25,000/㎕ Interrupt this medicine, melphalan, and prednisolone and monitor complete blood counts weekly When recovered to ≧25,000/㎕ Resume treatment with this medicine and melphalan at doses reduced by one dose level With each subsequent decrease to <30,000/㎕ Interrupt this medicine, melphalan, and prednisolone When recovered to ≧30,000/㎕ Resume treatment with this medicine and melphalan at doses reduced by one dose level from the doses being taken ② Dose adjustment according to absolute neutrophil count (ANC) Table 6. Absolute neutrophil count Recommended dose If decreased to <500/㎕ Interrupt this medicine, melphalan, and prednisolone and monitor complete blood counts weekly When recovered to ≧500/㎕ and neutropenia is the only toxicity Resume treatment at the starting dose When recovered to ≧500/㎕ and dose-dependent hematologic toxicity other than neutropenia has occurred Resume treatment with this medicine and melphalan at doses reduced by one dose level With each subsequent decrease to <500/㎕ Interrupt this medicine, melphalan, and prednisolone When recovered to ≧500/㎕ Resume treatment with this medicine and melphalan at doses reduced by one dose level from the doses being taken For neutropenia, use of growth factors should be considered for patient management. ③ Dose adjustment for febrile neutropenia (fever≥38.5℃ and ANC<1,000/㎕): Interrupt this medicine, melphalan, and prednisolone and monitor complete blood counts weekly. If the patient is not receiving a growth factor, use of a growth factor should be considered. On the first day of the next treatment cycle, resume treatment at the dose being taken, continuing growth factor use if needed, if neutropenia was the only dose-limiting toxicity. Otherwise, resume treatment at one dose level below the dose being taken. If the patient is not receiving a growth factor, administer a growth factor. 4) Combination therapy with bortezomib and dexamethasone for the treatment of newly diagnosed patients (1) Combination therapy with bortezomib and dexamethasone for the treatment of newly diagnosed patients who are not eligible for transplantation Treatment should not be initiated if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <80,000/㎕. The recommended initial dose of this medicine is 25mg once daily, taken on Days 1 to 14 of each 21-day cycle. Administer bortezomib by subcutaneous injection at a dose of 1.3mg/m2 per body surface area on Days 1, 4, 8, and 11 of each 21-day cycle. The recommended dose of dexamethasone is 20mg once daily, taken on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle. Patients should receive 8 cycles of treatment (a total of 24 weeks) as initial treatment. After initial treatment, take this medicine 25mg once daily in combination with dexamethasone on Days 1-21 of each 28-day cycle. The recommended dose and schedule of dexamethasone are 40mg once daily on Days 1, 8, 15, and 22 of each 28-day cycle. For patients aged 75 years or older, the starting dose of dexamethasone is 20mg once daily on Days 1, 8, 15, and 22 of each 28-day cycle. Treatment may be continued until disease progression or unacceptable toxicity occurs. (2) Combination induction therapy with dexamethasone and bortezomib for the treatment of newly diagnosed patients eligible for transplantation Treatment should not be initiated if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <80,000/㎕. The recommended initial dose of this medicine is 25mg once daily, taken on Days 1 to 21 of each 28-day cycle. Administer bortezomib by subcutaneous injection at a dose of 1.3mg/m2 per body surface area on Days 1, 4, 8, and 11 of each 28-day cycle. The recommended dose of dexamethasone is 40mg once daily, taken on Days 1-4 and 9-12 of each 28-day cycle. Patients should receive 6 cycles of treatment (a total of 24 weeks) as induction therapy. Dose adjustments during treatment <Dose reduction levels> This medicine Initial dose 25 mg 1st dose reduction 20 mg 2nd dose reduction 15 mg 3rd dose reduction 10 mg 4th dose reduction 5 mg 5th dose reduction 2.5 mg ① Dose adjustment according to platelet count Platelet count Recommended dose If decreased to <30,000/㎕ Interrupt treatment and monitor complete blood counts weekly When recovered to ≧50,000/㎕ Resume at one dose level below the dose being taken With each subsequent decrease to <30,000/㎕ Interrupt treatment When recovered to ≧50,000/㎕ Resume at one dose level below the dose being taken ② Dose adjustment according to absolute neutrophil count (ANC) Neutrophil count Recommended dose If decreased to <500/㎕ Interrupt treatment and monitor complete blood counts weekly When recovered to ≧1,000/㎕ and neutropenia is the only toxicity Resume treatment at the starting dose When recovered to ≧500/㎕ and dose-dependent hematologic toxicity other than neutropenia has occurred Resume at one dose level below the dose being taken With each subsequent decrease to <500/㎕ Interrupt treatment When recovered to ≧500/㎕ Resume at one dose level below the dose being taken For neutropenia, use of growth factors should be considered for patient management. *For dose adjustments of concomitant medicines, refer to the prescribing information for the respective products. 5) Maintenance therapy in patients with newly diagnosed disease who have undergone autologous hematopoietic stem cell transplantation Maintenance therapy with this medicine should be initiated in patients with no evidence of disease progression after adequate hematologic recovery following autologous hematopoietic stem cell transplantation. Treatment should not be initiated if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <75,000/㎕. The recommended initial dose is 10mg once daily. Take 10 mg capsules on Days 1 to 28 of each 28-day cycle until intolerance or disease progression occurs. After 3 cycles of maintenance therapy with this medicine, the dose may be increased to 15mg once daily if tolerated. Dose adjustments during treatment <Dose reduction levels> Starting dose (10mg) If the dose has been increased (15mg)* 1st dose reduction 5 mg 10 mg 2nd dose reduction 5mg (Days 1 to 21 of each 28-day cycle) 5 mg 3rd dose reduction N/A 5mg (Days 1 to 21 of each 28-day cycle) Do not reduce the dose below 5mg (Days 1 to 21 of each 28-day cycle). *After 3 cycles of maintenance therapy with this medicine, the dose may be increased to 15mg once daily if tolerated. ① Dose adjustment according to platelet count Table 7. Platelet count Recommended dose If decreased to <30,000/㎕ Interrupt treatment and monitor complete blood counts weekly When recovered to ≧30,000/㎕ Resume treatment at a dose reduced by one dose level With each subsequent decrease to <30,000/㎕ Interrupt treatment When recovered to ≧30,000/㎕ Resume treatment at a dose reduced by one dose level from the dose being taken ② Dose adjustment according to absolute neutrophil count (ANC) Table 8. Absolute neutrophil count Recommended dose If decreased to <500/㎕ Interrupt treatment and monitor complete blood counts weekly When recovered to ≧500/㎕ Resume treatment at a dose reduced by one dose level With each subsequent decrease to <500/㎕ Interrupt treatment When recovered to ≧500/㎕ Resume treatment at a dose reduced by one dose level from the dose being taken For neutropenia, use of growth factors should be considered for patient management. 2. Myelodysplastic syndromes Treatment should not be initiated if the absolute neutrophil count is <500/㎕ and/or the platelet count is <25,000/㎕. The recommended initial dose is 10mg once daily. Take 10 mg capsules on Days 1 to 21 of each 28-day cycle. Dose adjustments during treatment <Dose reduction levels> This medicine Initial dose 10 mg once daily on Days 1 to 21 of each 28-day cycle 1st dose reduction 5 mg once daily on Days 1 to 28 of each 28-day cycle 2nd dose reduction 2.5 mg once daily on Days 1 to 28 of each 28-day cycle 3rd dose reduction 2.5 mg every other day on Days 1 to 28 of each 28-day cycle ① Dose adjustment according to platelet count Table 9. Platelet count Recommended dose If decreased to <25,000/㎕ Interrupt treatment and monitor complete blood counts weekly When recovered to ≧50,000/㎕, or when recovered to ≧25,000/㎕ to <50,000/㎕ at least 2 times over a period of 7 days or longer Resume treatment at one dose level below the dose being taken ② Dose adjustment according to absolute neutrophil count (ANC) Table 10. Absolute neutrophil count Recommended dose If decreased to <500/㎕ Interrupt treatment and monitor complete blood counts weekly When recovered to ≧500/㎕ Resume treatment at one dose level below the dose being taken For neutropenia, use of growth factors should be considered for patient management. Treatment with this medicine should be discontinued in patients who have not achieved at least a minor erythroid response (as demonstrated by a reduction in transfusion requirements of at least 50%, or, in patients who were not transfusion-dependent, an increase in hemoglobin of 1g/dl) within 4 months after starting treatment. 3. Mantle cell lymphoma The recommended initial dose is 25mg once daily. Take 25mg capsules on Days 1 to 21 of each 28-day cycle. Dose adjustments during treatment <Dose reduction levels> This medicine Initial dose 25mg once daily on Days 1 to 21 of each 28-day cycle 1st dose reduction 20mg once daily on Days 1 to 21 of each 28-day cycle 2nd dose reduction 15mg once daily on Days 1 to 21 of each 28-day cycle 3rd dose reduction 10mg once daily on Days 1 to 21 of each 28-day cycle 4th dose reduction 5mg once daily on Days 1 to 21 of each 28-day cycle 5th dose reduction 2.5mg once daily on Days 1 to 21 of each 28-day cycle 5mg every other day on Days 1 to 21 of each 28-day cycle ① Dose adjustment according to platelet count Table 11. Platelet count Recommended dose If decreased to <50,000/㎕ Interrupt treatment and monitor complete blood counts weekly When recovered to ≧60,000/㎕ Resume at one dose level below the dose being taken With each subsequent decrease to <50,000/㎕ Interrupt treatment and monitor complete blood counts weekly When recovered to ≧60,000/㎕ Resume at one dose level below the dose being taken Do not reduce the dose below 2.5mg once daily or 5mg every other day. ② Dose adjustment according to absolute neutrophil count (ANC) Table 12. Absolute neutrophil count Recommended dose If decreased to <1,000/㎕ for at least 7 days, or if decreased to <1,000/㎕ with fever (body temperature≧38.5℃), or if decreased to <500/㎕ Interrupt treatment and monitor complete blood counts weekly When recovered to ≧1,000/㎕ Resume at one dose level below the dose being taken With each subsequent decrease to <1,000/㎕ for at least 7 days, or if decreased to <1,000/㎕ with fever (body temperature≧38.5℃), or if decreased to <500/㎕ Interrupt treatment. When recovered to ≧1,000/㎕ Resume at one dose level below the dose being taken Do not reduce the dose below 2.5mg once daily or 5mg every other day. For neutropenia, use of growth factors should be considered for patient management. 4. Follicular lymphoma Treatment should not be initiated if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <50,000/㎕ (except when this is secondary to lymphoma infiltration of the bone marrow). The recommended initial dose is 20mg once daily. Take 20mg capsules on Days 1 to 21 of each 28-day cycle. Administer for a maximum of 12 treatment cycles. The recommended initial dose of rituximab is based on 28-day cycles; in Cycle 1, administer 375 mg/m2 intravenously once weekly (Days 1, 8, 15, and 22). In Cycles 2 to 5, administer 375 mg/m2 intravenously only on Day 1 of each 28-day cycle. Dose adjustments during treatment <Dose reduction levels> This medicine Initial dose 20mg once daily on Days 1 to 21 of each 28-day cycle 1st dose reduction 15mg once daily on Days 1 to 21 of each 28-day cycle 2nd dose reduction 10mg once daily on Days 1 to 21 of each 28-day cycle 3rd dose reduction 5mg once daily on Days 1 to 21 of each 28-day cycle For dose adjustment due to rituximab toxicity, refer to the relevant prescribing information. ① Dose adjustment according to platelet count Table 13. Platelet count Recommended dose If decreased to <50,000/㎕ Interrupt this medicine and monitor complete blood counts weekly When recovered to ≥50,000/㎕ Resume at one dose level below the dose being taken With each subsequent decrease to <50,000/㎕ Interrupt this medicine and monitor complete blood counts weekly When recovered to ≥50,000/㎕ Resume at one dose level below the dose being taken Do not reduce the dose below 5mg once daily. ② Dose adjustment according to absolute neutrophil count (ANC) Table 14. Absolute neutrophil count Recommended dose If decreased to <1,000/㎕ for at least 7 days, or if decreased to <1,000/㎕ with fever (body temperature≥38.5°C), or if decreased to <500/㎕ Interrupt this medicine and monitor complete blood counts weekly When recovered to ≥1,000/㎕ Resume at one dose level below the dose being taken With each subsequent decrease to <1,000/㎕ for at least 7 days, or if decreased to <1,000/㎕ with fever (body temperature≥38.5°C), or if decreased to <500/㎕ Interrupt this medicine and monitor complete blood counts weekly When recovered to ≥1,000/㎕ Resume at one dose level below the dose being taken Do not reduce the dose below 5mg once daily. Mantle cell lymphoma or follicular lymphoma Tumor lysis syndrome (TLS) All patients should receive prophylaxis for tumor lysis syndrome (allopurinol, rasburicase, or an equivalent regimen according to institutional treatment guidelines) and should receive adequate oral hydration during the first week of the first treatment cycle or for a longer period if clinically indicated. To monitor for tumor lysis syndrome, patients should undergo a chemistry panel during the first cycle and weekly if clinically indicated. For patients with laboratory TLS or Grade 1 clinical TLS, this medicine may be continued at the same dose or, at the physician’s discretion, continued at a dose reduced by one dose level. Provide adequate intravenous hydration and appropriate medical management according to standard treatment until electrolyte abnormalities are corrected. Rasburicase treatment may be needed to reduce hyperuricemia. The decision to hospitalize the patient is at the physician’s discretion. For patients with Grade 2-4 clinical TLS, interrupt treatment with this medicine and perform a chemistry panel weekly or as clinically indicated. Provide adequate intravenous hydration and appropriate medical management according to standard treatment until electrolyte abnormalities are corrected. Rasburicase treatment and hospitalization are at the physician’s discretion. When TLS improves to Grade 0, resume treatment at one dose level lower, at the physician’s discretion. Tumor flare reaction (TFR) For patients who develop Grade 1/2 tumor flare reaction, treatment with this medicine may be continued without interruption or dose reduction, at the prescriber’s discretion. Nonsteroidal anti-inflammatory drugs (NSAIDs), a limited course of corticosteroids, and/or narcotic analgesics may be administered at the prescriber’s discretion. For patients who develop Grade 3/4 tumor flare reaction, interrupt treatment with this medicine and initiate treatment with NSAIDs, corticosteroids, and/or narcotic analgesics. When the reaction resolves to Grade 1 or lower, resume treatment at the same dose for the remainder of the cycle. Patients may be managed for symptoms according to the guidance for treatment of Grade 1/2 tumor flare reaction. 5. Dose adjustment for other Grade 3/4 toxicities If other Grade 3/4 toxicities associated with this medicine occur, interrupt treatment. Once the toxicity has resolved to Grade 2 or lower, resume treatment at a dose one level below the dose being taken, at the prescriber’s discretion. 6. This medicine should not be administered to patients with a history of Grade 4 rash caused by thalidomide. For Grade 2-3 skin rash, interruption or discontinuation of this medicine should be considered. If angioedema, an anaphylactic reaction, Grade 4 rash, exfoliative or bullous rash occurs, or Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) is suspected, treatment should be discontinued and should not be resumed even after the reaction resolves. 7. Dose in patients with renal impairment This medicine is excreted through the kidneys; therefore, toxicity may be greater in patients with renal impairment. Since elderly patients are more likely to have renal impairment, use caution when selecting the dose and carefully monitor renal function. The initial dose in patients with renal impairment is as follows. This medicine has not been studied in non-dialysis patients with creatinine clearance below 11 mL/min or in patients with creatinine clearance below 7 mL/min. Table 15. Initial dose in patients with renal impairment—multiple myeloma or mantle cell lymphoma Category Renal function (Cockcroft-Gault CLcr) Dose adjustment for multiple myeloma/mantle cell lymphoma Dose adjustment for post-transplant maintenance therapy Moderate renal impairment 30 ≤ CLcr <50mL/min 10mg once daily* 5mg once daily Severe renal impairment CLcr <30mL/min (non-dialysis patients) 7.5mg once daily or 15mg every other day 2.5mg once daily End-stage renal disease CLcr <30mL/min (dialysis patients) 5mg once daily Administer after dialysis on dialysis days 2.5mg once daily Administer after dialysis on dialysis days *After the second treatment cycle, the dose may be increased to 15mg once daily if the patient has not responded to treatment and tolerates the treatment. Table 16. Initial dose in patients with renal impairment—myelodysplastic syndromes Category Renal function (Cockcroft-Gault CLcr) Dose adjustment for myelodysplastic syndromes Initial dose 1st dose reduction 2nd dose reduction Moderate renal impairment 30 ≤ CLcr <50mL/min 5mg once daily (Days 1 to 21 of each 28-day cycle) 2.5mg once daily (Days 1 to 28 of each 28-day cycle) 2.5mg every other day (Days 1 to 28 of each 28-day cycle) Severe renal impairment CLcr <30mL/min (non-dialysis patients) 2.5mg once daily (Days 1 to 21 of each 28-day cycle) 2.5mg every other day (Days 1 to 28 of each 28-day cycle) 2.5mg twice weekly (Days 1 to 28 of each 28-day cycle) End-stage renal disease CLcr <30mL/min (dialysis patients) 2.5mg once daily (Days 1 to 21 of each 28-day cycle) 2.5mg every other day (Days 1 to 28 of each 28-day cycle) 2.5mg twice weekly (Days 1 to 28 of each 28-day cycle) Administer after dialysis on dialysis days Administer after dialysis on dialysis days Administer after dialysis on dialysis days Table 17. Dose in patients with renal impairment—follicular lymphoma Category Renal function (Cockcroft-Gault CLcr) Dose adjustment for follicular lymphoma (Days 1 to 21 of each 28-day cycle) Moderate renal impairment 30 ≤ CLcr < 60mL/min 10mg once daily1,2 Severe renal impairment CLcr < 30mL/min (non-dialysis patients) 5 mg once daily End-stage renal disease CLcr < 30mL/min (dialysis patients) 5 mg once daily, administered after dialysis on dialysis days ¹After the second treatment cycle, the dose may be increased to 15mg once daily if the patient tolerates treatment. 2For patients receiving an initial dose of 10mg who require dose reduction due to Grade 3/4 neutropenia or thrombocytopenia, or another Grade 3/4 toxicity considered related to this medicine, do not reduce the dose below 5mg every other day or 2.5mg once daily. After starting treatment with this medicine, dose adjustment in patients with renal impairment should be performed according to the individual patient’s tolerability, as described above. 8. Take with water. Do not crush, chew, or open the capsules. The dose may be adjusted based on clinical or laboratory test results.

This drug can cause severe birth defects or miscarriage if taken during pregnancy; therefore, it should never be used by pregnant women. Women of childbearing potential must undergo two pregnancy tests before starting this medication and must use appropriate contraception during and after treatment. This drug can reduce the number of cells in the blood, so regular blood tests to check white blood cell and platelet counts are required. Depending on blood test results, the medication may need to be discontinued or the dosage adjusted, and any symptoms of infection or bleeding should be reported to healthcare professionals immediately. Patients at risk for heart disease should be closely monitored for cardiac issues such as myocardial infarction while taking this medication. This drug may increase the risk of thrombosis; therefore, patients with a history of thrombosis or risk factors should take preventive measures and seek treatment immediately if symptoms appear. Liver function may be affected; thus, regular liver function tests should be conducted, and patients with a history of liver disease should be especially cautious. Patients with impaired kidney function need to adjust the dosage, and the condition should be monitored through kidney function tests. Special attention is required at the beginning of treatment or during dosage increases due to the risk of rapid tumor growth or tumor lysis syndrome. There is a risk that infection susceptibility may increase, so any symptoms of infection should be reported immediately to healthcare professionals for appropriate treatment. There is also a risk of reactivation of viral infections, so patients with a history of shingles or hepatitis B must be thoroughly monitored before and after treatment. Severe skin reactions or allergies may occur, so if symptoms such as skin rash, difficulty breathing occur, treatment should be stopped immediately and consulted with healthcare professionals. This medication may affect the immune system and potentially lead to serious neurological diseases such as progressive multifocal leukoencephalopathy, so immediate assessment is required if neurological symptoms occur. Co-administration with other specific medications may increase mortality, so dosing should only occur after consulting healthcare professionals. Prolonged use may lead to eye diseases such as cataracts, necessitating regular eye examinations. This medication can cause various side effects, so patients should closely monitor their condition and consult a physician or pharmacist immediately if any abnormal symptoms occur.

Skeletal deformities, congenital malformations, miscarriage, neutropenia, thrombocytopenia, febrile reactions, bleeding, myocardial infarction, venous thromboembolism, arterial thromboembolism, secondary primary malignant tumors, acute myeloid leukemia, myelodysplastic syndrome, liver failure, acute liver failure, toxic hepatitis, cellular lysis hepatitis, cholestatic hepatitis, vasogenic edema, anaphylactic reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash syndrome with eosinophilia and systemic symptoms, pulmonary hypertension, tumor lysis syndrome, infections, pneumonia, septic shock, influenza, lung infections, bronchitis, urinary tract infections, basal cell carcinoma, squamous cell skin cancer, skin squamous cell carcinoma, fever, fatigue, constipation, diarrhea, muscle cramps, anemia, rash, weakness, insomnia, decreased appetite, cough, fever, myalgia, peripheral neuropathy, paresthesia, dizziness, tremors, dysgeusia, headache, stroke, syncope, neuralgia, ataxia, impaired balance, intracranial hemorrhage, transient ischemic attack, cerebral ischemia, cataract, blurring, visual impairment, blindness, hearing loss, tinnitus, atrial fibrillation, bradycardia, congestive heart failure, tachycardia, heart failure, myocardial ischemia, arrhythmia, QT prolongation, atrial flutter, ventricular extrasystole, hypotension, hypertension, petechial hemorrhage, vasculitis, ischemia, peripheral ischemia, intracranial venous sinus thrombosis, dyspnea, epistaxis, respiratory distress, pleuritic pain, hypoxia, speech disorders, abdominal pain, nausea, vomiting, dyspepsia, dry mouth, stomatitis, gastrointestinal bleeding, small bowel obstruction, colitis, appendicitis, elevated alanine aminotransferase, elevated aspartate aminotransferase, hepatotoxicity, hepatocellular injury, hyperbilirubinemia, abnormal liver function tests, urticaria, hyperhidrosis, dry skin, skin pigmentation, eczema, erythema, drug rash, skin lightening, phototoxic reactions, muscle weakness, bone pain, musculoskeletal pain and discomfort, limb pain, myalgia, arthralgia, joint swelling, renal failure, renal tubular necrosis, hematuria, urinary retention, urinary incontinence, acquired Fanconi syndrome, erectile dysfunction, fatigue, edema, influenza-like symptoms, increased serum alkaline phosphatase, increased C-reactive protein, falls, contusions, pneumococcal pneumonia, septic shock, staphylococcal sepsis, peripheral sensory neuropathy, hematoma, pulmonary embolism, pleural effusion, interstitial pneumonia, aspiration pneumonia, acute respiratory distress syndrome, bronchiectasis, pneumothorax, chronic obstructive pulmonary disease, congestion, tachypnea, oropharyngeal pain, mediastinal emphysema, pulmonary arterial hypertension, pulmonary edema, pulmonary congestion, pulmonary tumor, obstructive bronchitis, hiccups, peripheral motor neuropathy, dementia, hypertrophic muscle cramps, neuropathic pain, speech disorders, epilepsy, intracranial mass, chronic polyneuropathy, cauda equina syndrome, head discomfort, hemiplegia, seizures, neuritis, uremic encephalopathy, cognitive impairment, paraesthesia syndrome, third cranial nerve palsy, Parkinson's disease, postherpetic neuralgia, action tremor, hyperkalemia, hypercalcemia, hypoalbuminemia, hypoglycemia, hyperphosphatemia, diabetic ketoacidosis, metabolic acidosis, iron deficiency, delirium, agitation, bipolar disorder, altered mental status, attention deficit disorder, shock, pericardial effusion, stress-induced cardiomyopathy, subendocardial ischemia, cardiac arrest, Prinzmetal angina, restrictive cardiomyopathy, vertebral compression fracture, rib fracture, femoral neck fracture, radiation pneumonitis, spinal injury, vertebral fracture, forearm fracture, thoracic vertebra fracture, acute kidney injury, dysuria, nitrogenemia, end-stage renal disease, polyuria, nocturia, abnormal urination, urethral discharge, mucosal inflammation, swelling, multiple organ failure, multi-organ dysfunction, heat sensation, injection site pain, blisters, petechial hemorrhage, skin hyperpigmentation, papular scaly rash, chronic pigmented purpura, exfoliative dermatitis, spots, purpura, contact dermatitis, alopecia, skin reactions, skin lesions, skin peeling, subcutaneous hemorrhage, jaw pain, osteoporosis, joint stiffness, bone resorption, limb discomfort, rhabdomyolysis, chest wall mass, pustular rash, gingivitis, increased serum creatinine, weight gain, decreased renal creatinine clearance, increased blood urea, increased serum lactate dehydrogenase, conjunctival hemorrhage, borderline glaucoma, myopia, dry eyes, eyelid swelling, eye pain, retinal disorders, retinopathy, diplopia, blepharitis, periorbital edema, pericardial effusion, stress-induced cardiomyopathy, subendocardial ischemia, cardiac arrest, restrictive cardiomyopathy, benign prostatic hyperplasia, female genital fistula, cervical dysplasia, vaginal discharge, vaginal bleeding, perineal rash, hyperbilirubinemia, hepatic impairment, hepatic steatosis, acute cholangitis, acute cholecystitis, bile duct stones, jaundice, adrenal insufficiency, Cushing's syndrome, inappropriate antidiuretic hormone secretion, hepatocellular carcinoma, acute leukemia, bile duct carcinoma, malignant pleural effusion, gastric cancer, flushing, shock, ear discomfort, ear pus, hearing impairment, splenomegaly, hemolytic uremic syndrome

This medication should be stored in a tightly sealed container to prevent air or moisture from entering. It is best to keep it at room temperature between 15 and 30 degrees Celsius.

Appearance

A hard capsule with a white powder inside, with a greenish-blue upper part and a light yellow lower part.

Package unit

7 capsules per pack