Lenalidomide Capsule 5 mg (Lenalidomide)

Adult dosage

This drug should be administered only to patients who agree to comply with the requirements specified in the Risk Management Program (see “5. General Precautions” under Precautions for Use). In addition, this drug should be prescribed only by physicians enrolled in the Risk Management Program and dispensed only by pharmacists enrolled in the program. When prescribing this drug to women of childbearing potential, negative pregnancy test results must be confirmed continuously according to the schedule specified in the program. 1. Multiple myeloma 1) Combination therapy with dexamethasone for the treatment of patients who have received one or more prior therapies 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 25 mg capsules on days 1~21 of each 28-day cycle. The recommended dose of dexamethasone is 40 mg once daily on days 1~4, 9~12, and 17~20 during the first 4 cycles of each 28-day cycle. After 4 cycles, administer 40 mg once daily only on days 1~4 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 Thereafter, if decreased to <30,000/㎕ Interrupt treatment When recovered to ≧30,000㎕ Resume at a dose reduced by 5mg from the dose being administered. Do not reduce below 5mg once daily. ② Dose adjustment according to absolute neutrophil count (ANC) Table 2. 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 toxicity has occurred Resume treatment at 15mg once daily Thereafter, if decreased to <1,000/㎕ Interrupt treatment When recovered to ≧1,000/㎕ Resume at a dose reduced by 5mg from the dose being administered. Do not reduce 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 1~21 of each 28-day cycle. The recommended dose of dexamethasone is 40 mg 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 20 mg 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 drug 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 drug and dexamethasone and monitor complete blood counts weekly When recovered to ≧50,000㎕ Resume at one dose level below the dose being administered ② Dose adjustment according to absolute neutrophil count (ANC) Table 4. Neutrophil count Recommended dose If decreased to <500/㎕ Interrupt this drug 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 administered Thereafter, if decreased to <500/㎕ Interrupt this drug and dexamethasone When recovered to ≧500/㎕ Resume at one dose level below the dose being administered 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, if neutropenia is the only dose-limiting toxicity, resume treatment at the dose being administered, continuing use of a growth factor if necessary. Otherwise, resume treatment at one dose level below the dose being administered. If the patient is not receiving a growth factor, administer a growth factor. If this drug was dose-reduced due to a hematologic dose-limiting toxicity (DLT), after continuing treatment and improvement in bone marrow function (no DLT for at least 2 consecutive cycles, and absolute neutrophil count ≥1,500/㎕ and platelet count ≥100,000㎕ at the start of a new cycle at the current dose level), treatment with this drug may be resumed at an increased dose, at the physician’s discretion (up to the maximum starting dose). 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 1~21 of each 28-day cycle. Through cycle 9, administer melphalan orally at a dose of 0.18mg/kg on days 1~4 of each 28-day cycle, and administer prednisolone orally at a dose of 2mg/kg on days 1~4 of each 28-day cycle. For patients who have completed 9 cycles or who cannot complete combination therapy because of intolerance, administer this drug alone at 10mg once daily on days 1~21 of each 28-day cycle until disease progression. Dose adjustments during treatment <Dose reduction levels> This drug 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 drug, melphalan, and prednisolone and monitor complete blood counts weekly When recovered to ≧25,000㎕ Resume treatment with this drug and melphalan at one dose level below the previous doses Thereafter, if decreased to <30,000/㎕ Interrupt this drug, melphalan, and prednisolone When recovered to ≧30,000㎕ Resume treatment with this drug and melphalan at one dose level below the doses being administered ② Dose adjustment according to absolute neutrophil count (ANC) Table 6. Neutrophil count Recommended dose If decreased to <500/㎕ Interrupt this drug, 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 drug and melphalan at one dose level below the previous doses Thereafter, if decreased to <500/㎕ Interrupt this drug, melphalan, and prednisolone When recovered to ≧500/㎕ Resume treatment with this drug and melphalan at one dose level below the doses being administered 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 with this drug, 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, if neutropenia is the only dose-limiting toxicity, resume treatment at the dose being administered, continuing use of a growth factor if necessary. Otherwise, resume treatment at one dose level below the dose being administered. 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 drug is 25mg once daily, taken on days 1~14 of each 21-day cycle. Administer bortezomib by subcutaneous injection at a dose of 1.3mg/㎡ of 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 (24 weeks total) of treatment as initial therapy. After initial therapy, take this drug 25mg once daily in combination with dexamethasone on days 1-21 of each 28-day cycle. The recommended dexamethasone dose and regimen is 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 continue until disease progression or unacceptable toxicity occurs. (2) Induction combination 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 drug is 25mg once daily, taken on days 1~21 of each 28-day cycle. Administer bortezomib by subcutaneous injection at a dose of 1.3mg/㎡ of 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 (24 weeks total) of treatment as induction therapy. Dose adjustments during treatment <Dose reduction levels> This drug 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 Table 7. 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 administered Thereafter, if decreased to <30,000/㎕ Interrupt treatment When recovered to ≧50,000㎕ Resume treatment at a dose one level below the dose being administered 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 ≧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 administered Thereafter, if decreased to <500/㎕ Interrupt treatment When recovered to ≧500/㎕ Resume at one dose level below the dose being administered For neutropenia, use of growth factors should be considered for patient management. *For dose adjustments of concomitant medications, refer to the prescribing information for the respective product. 5) Maintenance therapy in patients with newly diagnosed disease who have undergone autologous hematopoietic stem cell transplantation Maintenance therapy with this drug should be initiated after adequate hematologic recovery following autologous hematopoietic stem cell transplantation in patients with no evidence of disease progression. 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 1~28 of each 28-day cycle until intolerance or disease progression occurs. After 3 cycles of maintenance therapy with this drug, 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 1~21 of each 28-day cycle) 5 mg 3rd dose reduction N/A 5mg (days 1~21 of each 28-day cycle) Do not reduce below 5mg (days 1~21 of each 28-day cycle). *After 3 cycles of maintenance therapy with this drug, the dose may be increased to 15mg once daily if tolerated. ① Dose adjustment according to platelet count Table 9. 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 one dose level below the previous dose Thereafter, if decreased to <30,000/㎕ Interrupt treatment When recovered to ≧30,000㎕ Resume treatment at one dose level below the dose being administered ② Dose adjustment according to absolute neutrophil count (ANC) Table 10. 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 previous dose Thereafter, if decreased to <500/㎕ Interrupt treatment When recovered to ≧500/㎕ Resume treatment at one dose level below the dose being administered 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 1~21 of each 28-day cycle. Dose adjustments during treatment <Dose reduction levels> This drug Initial dose 10 mg once daily on days 1~21 of each 28-day cycle 1st dose reduction 5 mg once daily on days 1~28 of each 28-day cycle 2nd dose reduction 2.5 mg once daily on days 1~28 of each 28-day cycle 3rd dose reduction 2.5 mg every other day on days 1~28 of each 28-day cycle ① Dose adjustment according to platelet count Table 11. 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/㎕~<50,000/㎕ at least twice over 7 days or longer Resume at one dose level below the dose being administered ② Dose adjustment according to absolute neutrophil count (ANC) Table 12. Absolute neutrophil count Recommended dose If decreased to <500/㎕ Interrupt treatment and monitor complete blood counts weekly When recovered to ≧500/㎕ Resume at one dose level below the dose being administered For neutropenia, use of growth factors should be considered for patient management. Discontinue treatment with this drug in patients who have not achieved at least a minor erythroid response (demonstrated by a reduction of at least 50% in transfusion requirements or, in patients who were not receiving transfusions, 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 1~21 of each 28-day cycle. Dose adjustments during treatment <Dose reduction levels> This drug Initial dose 25mg once daily on days 1~21 of each 28-day cycle 1st dose reduction 20mg once daily on days 1~21 of each 28-day cycle 2nd dose reduction 15mg once daily on days 1~21 of each 28-day cycle 3rd dose reduction 10mg once daily on days 1~21 of each 28-day cycle 4th dose reduction 5mg once daily on days 1~21 of each 28-day cycle 5th dose reduction 2.5mg once daily on days 1~21 of each 28-day cycle 5mg every other day on days 1~21 of each 28-day cycle ① Dose adjustment according to platelet count Table 13. 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 administered Thereafter, 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 administered Do not reduce below 2.5mg once daily or 5mg every other day. 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 (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 administered Thereafter, if decreased to <1,000/㎕ for at least 7 days, or if decreased to <1,000/㎕ with fever (temperature ≧38.5℃), or if decreased to <500/㎕ Interrupt treatment. When recovered to ≧1,000/㎕ Resume at one dose level below the dose being administered Do not reduce 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 secondary to lymphoma infiltration of the bone marrow). The recommended initial dose is 20mg once daily. Take 20mg capsules on days 1~21 of each 28-day cycle. Take for up to 12 treatment cycles. The recommended initial dose of rituximab is based on a 28-day cycle, with 375 mg/m2 administered intravenously weekly during cycle 1 (days 1, 8, 15, and 22). During cycles 2~5, administer 375 mg/m2 intravenously only on day 1 of each 28-day cycle. Dose adjustments during treatment <Dose reduction levels> This drug Initial dose 20mg once daily on days 1~21 of each 28-day cycle 1st dose reduction 15mg once daily on days 1~21 of each 28-day cycle 2nd dose reduction 10mg once daily on days 1~21 of each 28-day cycle 3rd dose reduction 5mg once daily on days 1~21 of each 28-day cycle For dose adjustments due to rituximab toxicity, refer to the relevant prescribing information. ① Dose adjustment according to platelet count Table 15. Platelet count Recommended dose If decreased to <50,000/㎕ Interrupt treatment with this drug and monitor complete blood counts weekly When recovered to ≥50,000/㎕ Resume at one dose level below the dose being administered Thereafter, if decreased to <50,000/㎕ Interrupt treatment with this drug and monitor complete blood counts weekly When recovered to ≥50,000/㎕ Resume at one dose level below the dose being administered Do not reduce below 5mg once daily. ② Dose adjustment according to absolute neutrophil count (ANC) Table 16. Absolute neutrophil count Recommended dose If decreased to <1,000/㎕ for at least 7 days or if decreased to <1,000/㎕ with fever (temperature≥38.5°C), or if decreased to <500/㎕ Interrupt treatment with this drug and monitor complete blood counts weekly When recovered to ≥1,000/㎕ Resume at one dose level below the dose being administered Thereafter, if decreased to <1,000/㎕ for at least 7 days, or if decreased to <1,000/㎕ with fever (temperature≥38.5°C), or if decreased to <500/㎕ Interrupt treatment with this drug and monitor complete blood counts weekly When recovered to ≥1,000/㎕ Resume at one dose level below the dose being administered Do not reduce 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 necessary. To monitor for tumor lysis syndrome, patients should undergo a chemistry panel during the first cycle and weekly when clinically necessary. For patients with laboratory TLS or grade 1 clinical TLS, this drug may be continued at the same dose or, at the physician’s discretion, continued at a dose reduced by one level. Provide adequate intravenous hydration and appropriate medical management according to standard treatment until electrolyte abnormalities are corrected. Rasburicase treatment may be required to reduce hyperuricemia. The decision to hospitalize the patient is at the physician’s discretion. For patients with grade 2-4 clinical TLS, discontinue this drug and perform a chemistry panel weekly or as clinically necessary. 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 drug may be continued without interruption or dose reduction at the prescriber’s discretion. At the prescriber’s discretion, non-steroidal anti-inflammatory drugs (NSAIDs), a limited course of corticosteroids, and/or narcotic analgesics may be administered. For patients who develop grade 3/4 tumor flare reaction, interrupt treatment with this drug 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 symptomatically according to the guidance for treatment of grade 1/2 tumor flare reaction. 5. Dose adjustment for other grade 3/4 toxicities If grade 3/4 toxicity associated with this drug occurs, interrupt treatment and, once the toxicity has resolved to grade 2 or lower, resume treatment at a dose one level below the dose being administered, at the prescriber’s discretion. 6. This drug should not be administered to patients with a history of grade 4 rash due to thalidomide. For grade 2-3 skin rash, interruption or discontinuation of this drug should be considered. If angioedema, 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 must be discontinued and should not be resumed even after these reactions have resolved. 7. Dose in patients with renal impairment Because this drug is excreted by the kidneys, toxicity may be more pronounced in patients with renal impairment. Since renal impairment is more common in older patients, caution is required when selecting the dose, and careful monitoring of renal function is necessary. The initial dose in patients with renal impairment is as follows. The drug has not been studied in nondialysis patients with creatinine clearance below 11 mL/min or in patients with creatinine clearance below 7 mL/min. Table 17. Initial dose in patients with renal impairment (days 1 ~ 21 of each 28-day cycle)_multiple myeloma or mantle cell lymphoma Category Renal function (Cockcroft-Gault CLcr) Dose adjustment in multiple myeloma/mantle cell lymphoma Dose adjustment in post-transplant maintenance therapy Moderate renal impairment 30 ≤ CLcr <50mL/min 10mg once daily* 5mg once daily Severe renal impairment CLcr <30mL/min (nondialysis patient) 7.5mg once daily or 15mg every other day 2.5mg once daily End-stage renal disease CLcr <30mL/min (dialysis patient) 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 drug. Table 18. Initial dose in patients with renal impairment_myelodysplastic syndromes Category Renal function (Cockcroft-Gault CLcr) Dose adjustment in myelodysplastic syndromes Initial dose 1st dose reduction 2nd dose reduction Moderate renal impairment 30 ≤ CLcr <50mL/min 5mg once daily (days 1 ~ 21 of each 28-day cycle) 2.5mg once daily (days 1 ~ 28 of each 28-day cycle) 2.5mg every other day (days 1 ~ 28 of each 28-day cycle) Severe renal impairment CLcr <30mL/min (nondialysis patient) 2.5mg once daily (days 1 ~ 21 of each 28-day cycle) 2.5mg every other day (days 1 ~ 28 of each 28-day cycle) 2.5mg twice weekly (days 1 ~ 28 of each 28-day cycle) End-stage renal disease CLcr <30mL/min (dialysis patient) 2.5mg once daily (days 1 ~ 21 of each 28-day cycle) 2.5mg every other day (days 1 ~ 28 of each 28-day cycle) 2.5mg twice weekly (days 1 ~ 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 19. Dose in patients with renal impairment_follicular lymphoma Category Renal function (Cockcroft-Gault CLcr) Dose adjustment in follicular lymphoma (days 1 ~ 21 of each 28-day cycle) Moderate renal impairment 30 ≤ CLcr < 60mL/min 10mg once daily1,2 Severe renal impairment CLcr < 30mL/min (nondialysis patient) No data3 End-stage renal disease CLcr < 30mL/min (dialysis patient) No data3 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 drug, do not reduce below 5mg every other day or 2.5mg once daily. 3Patients with severe renal impairment and end-stage renal disease were excluded from clinical trials. After initiating treatment with this drug, dose adjustment in patients with renal impairment should be based on 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 according to clinical or laboratory test results.

This drug can cause serious birth defects or miscarriage if used during pregnancy; therefore, women of childbearing age must take two pregnancy tests before taking this medication. During and for four weeks after taking this medication, sexual intercourse should be avoided or two or more effective contraceptive methods should be used. This drug can only be prescribed and dispensed by doctors and pharmacists registered in a special risk management program, and patients must strictly adhere to this program. Blood cell counts of white blood cells and platelets may decrease, so regular blood tests are necessary. Patients should immediately inform healthcare professionals if any symptoms of infection or bleeding appear. There may be cardiovascular issues such as myocardial infarction; therefore, patients with risk factors for cardiovascular disease should be observed very carefully. There is a high risk of thrombosis, so patients with risk factors for thromboembolism require continuous monitoring and preventive measures. Liver function abnormalities may occur during treatment, so patients with liver disease or abnormal liver function test results should have periodic liver function tests. Patients with decreased renal function may experience increased drug concentrations, necessitating dosage adjustments and renal monitoring. Tumor flare reactions or tumor lysis syndrome may occur, so special caution is required during initial treatment. The risk of infections may increase, making patients more susceptible to pneumonia and other respiratory infections, so any signs of infection should be reported to healthcare professionals immediately for treatment. Patients with a history of herpes zoster or hepatitis B virus infection may have a risk of reactivation; thus, the viral status should be confirmed prior to treatment, and careful monitoring is necessary during treatment. This drug may cause serious skin reactions or allergic reactions; therefore, if symptoms such as rash or breathing difficulties occur, the medication should be discontinued immediately and healthcare professionals should be consulted. Pulmonary hypertension and other cardiopulmonary diseases may arise, so cardiopulmonary status should be assessed before and during treatment, and prompt action should be taken if any abnormal symptoms occur. Pregnant women or those who may become pregnant, and patients who are allergic to this drug or its ingredients should not use this medication. This drug contains lactose, so patients with lactose intolerance should not use it. Various side effects may occur during treatment, so if symptoms such as fatigue, diarrhea, constipation, rash, muscle cramps, blood count abnormalities, etc., appear, patients should discuss with healthcare professionals. Notably, leukopenia, thrombocytopenia, and anemia are common and regular blood tests are essential. Various adverse reactions including cardiovascular, neurological, liver function abnormalities, infections, and skin reactions have been reported, so close monitoring is necessary. All adverse reactions occurring during treatment should be reported to healthcare professionals immediately to receive appropriate care.

Skeletal deformity, congenital malformation, miscarriage, neutropenia, thrombocytopenia, febrile reaction, bleeding, myocardial infarction, venous thromboembolism, arterial thromboembolism, secondary primary malignant neoplasm, acute myeloid leukemia, myelodysplastic syndrome, solid tumors, liver failure, toxic hepatitis, cytolytic hepatitis, cholestatic hepatitis, abnormal liver function, vascular edema, anaphylactic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms, pulmonary hypertension, tumor lysis syndrome, infection, herpes zoster reactivation, hepatitis B virus reactivation, progressive multifocal leukoencephalopathy, cataract, fatigue, constipation, diarrhea, muscle cramps, anemia, rash, pneumonia, renal failure, weakness, insomnia, loss of appetite, cough, fever, peripheral neuropathy, paresthesia, dizziness, tremor, dysgeusia, headache, stroke, syncope, neuralgia, ataxia, impaired balance, intracranial hemorrhage, transient ischemic attack, cerebral ischemia, cataract, blurriness, visual impairment, blindness, hearing loss, tinnitus, atrial fibrillation, bradycardia, congestive heart failure, tachycardia, heart failure, myocardial ischemia, arrhythmia, QT prolongation, atrial flutter, ventricular ectopy, hypotension, hypertension, petechiae, vasculitis, dyspnea, epistaxis, respiratory distress, pleuritic pain, hypoxia, voice disorder, abdominal pain, nausea, vomiting, dyspepsia, dry mouth, stomatitis, gastrointestinal bleeding, small bowel obstruction, colitis, appendicitis, increased alanine aminotransferase, increased aspartate aminotransferase, hepatotoxicity, hepatocellular injury, hyperbilirubinemia, urticaria, hyperhidrosis, dry skin, skin pigmentation, eczema, erythema, drug rash, skin depigmentation, photosensitivity reaction, muscle weakness, bone pain, musculoskeletal pain, arthralgia, joint swelling, renal failure, hematuria, urinary retention, urinary incontinence, acquired Fanconi syndrome, erectile dysfunction, edema, influenza-like symptoms, increased serum alkaline phosphatase, increased C-reactive protein, falls, contusions, pulmonary embolism, pulmonary infection, bronchitis, upper respiratory infection, bacterial infection, viral infection, fungal infection, sepsis, pneumonia, urinary tract infection, sinusitis, basal cell carcinoma, squamous cell carcinoma, T-cell acute leukemia, hemolytic anemia, hypercoagulation, coagulation disorders, hypersensitivity reactions, hypothyroidism, hypokalemia, hyperglycemia, hypoglycemia, hypocalcemia, hyponatremia, dehydration, weight loss, diabetes, hypophosphatemia, hyperuricemia, hypomagnesemia, hypercalcemia, depression, insomnia, decreased libido, cerebral infarction, mood changes, hallucinations, fatigue, chills, papulosquamous rash, hair loss, skin reactions, skin peeling, subcutaneous bleeding, jaw pain, osteoporosis, spondylolisthesis, arthrogryposis, bone lysis, rhabdomyolysis, chest wall mass, pustular rash, gingivitis, otitis media, dry eyes, hemorrhoids, sensory loss, depression, urethral dysfunction, erectile dysfunction, hiccups, chest discomfort, vertebral compression fracture, rib fracture, femoral neck fracture, radiation pneumonitis, spinal cord injury, vertebral fracture, forearm fracture, thoracic fracture, increased serum creatinine, weight gain, decreased renal creatinine clearance, increased blood urea, conjunctival hemorrhage, borderline glaucoma, myopia, eyelid swelling, eye pain, retinal disorders, retinal disease, diplopia, blepharitis, periorbital edema, pericardial effusion, stress-induced cardiomyopathy, subendocardial ischemia, cardiac arrest, restrictive cardiomyopathy, Cushing's syndrome, inappropriate antidiuretic hormone secretion, cervical dysplasia, vaginal discharge, vaginal bleeding, perineal rash, hyperbilirubinemia, adrenal insufficiency, shock, ear discomfort, ear discharge, hearing impairment, splenomegaly, hemolytic uremic syndrome, candidemia

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is recommended to maintain a storage temperature between 15 degrees and 30 degrees Celsius.

Appearance

A hard capsule product with a white or pale yellow powder inside, with the upper and lower parts in white

Package unit

7 capsules (7 capsules/PTP x 1), 21 capsules (7 capsules/PTP x 3)