Lenalocapsule 20 mg (Lenalidomide)

Adult dosage

This medicine should be administered only to patients who agree to comply with the requirements specified in the Risk Management Program (see “5. General Precautions” in Precautions for Use). In addition, this medicine should be prescribed only by physicians enrolled in the Risk Management Program and dispensed only by pharmacists enrolled in the program. When prescribed to women of childbearing potential, negative pregnancy test results must be confirmed continuously according to the schedule specified in this 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 starting dose is 25mg once daily. Take 25 mg capsules on Days 1~21 of each 28-day cycle. The recommended dose of dexamethasone, based on a 28-day cycle, is 40 mg once daily on Days 1~4, 9~12, and 17~20 for the first 4 cycles. After 4 cycles, administer 40 mg once daily only on Days 1~4 of each 28-day cycle. Dose adjustment 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 at 15mg once daily If subsequently decreased 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. 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 at 25mg once daily When recovered to ≧1,000/㎕ and other toxicities have occurred Resume at 15mg once daily If subsequently decreased 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 candidates 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 starting dose is 25mg once daily. Take 25 mg capsules on Days 1~21 of each 28-day cycle. The recommended dose of dexamethasone, based on a 28-day cycle, is 40 mg once daily on Days 1, 8, 15, and 22. For patients aged 75 years or older, the recommended dose of dexamethasone, based on a 28-day cycle, is 20 mg once daily on Days 1, 8, 15, and 22. Continue treatment until disease progression or unacceptable toxicity occurs. Dose adjustment during treatment <Dose reduction levels> This medicine Dexamethasone Starting 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. 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 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 If subsequently decreased 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, if neutropenia is the only dose-limiting toxicity, resume treatment at the dose being taken, continuing use of a growth factor if needed. 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 dose-reduced due to hematologic dose-limiting toxicity (DLT), treatment may be resumed at a higher dose, at the physician’s discretion (up to the maximum starting dose), if bone marrow function improves during continued treatment (no DLT 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 candidates 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 starting 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 are unable to complete combination therapy due to intolerance, administer this medicine alone at 10mg once daily on Days 1~21 of each 28-day cycle until disease progression. Dose adjustment during treatment <Dose reduction levels> This medicine Melphalan Prednisolone Starting 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 this medicine and melphalan at one dose level below the doses being taken If subsequently decreased to <30,000/㎕ Interrupt this medicine, melphalan, and prednisolone When recovered to ≧30,000㎕ Resume this medicine and melphalan at one dose level below the doses being taken ② Dose adjustment according to absolute neutrophil count (ANC) Table 6. 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 at the starting dose When recovered to ≧500/㎕ and dose-dependent hematologic toxicity other than neutropenia has occurred Resume this medicine and melphalan at one dose level below the doses being taken If subsequently decreased to <500/㎕ Interrupt this medicine, melphalan, and prednisolone When recovered to ≧500/㎕ Resume this medicine and melphalan at one dose level below 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, if neutropenia is the only dose-limiting toxicity, resume treatment at the dose being taken, continuing use of a growth factor if needed. 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 candidates 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 starting dose of this medicine 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 (a total of 24 weeks) of treatment as initial therapy. After initial therapy, take this medicine 25mg once daily in combination with dexamethasone on Days 1-21 of each 28-day cycle. The recommended dosage regimen for 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 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 who are candidates 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 starting dose of this medicine 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 (a total of 24 weeks) of treatment as induction therapy. Dose adjustment during treatment <Dose reduction levels> This medicine Starting 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 taken If subsequently decreased to <30,000/㎕ Interrupt treatment When recovered to ≧50,000㎕ Resume treatment at one dose level below 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 ≧1,000/㎕ and neutropenia is the only toxicity Resume 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 If subsequently decreased 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 adjustment of concomitant medicines, refer to the prescribing information for the respective products. 5) Maintenance therapy for newly diagnosed patients 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 starting 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 medicine, the dose may be increased to 15mg once daily if tolerated. Dose adjustment 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 the dose below 5mg (Days 1~21 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 9. Platelet count Recommended dose If decreased to <30,000/㎕ Interrupt treatment and monitor complete blood counts weekly When recovered to ≧30,000㎕ Resume at one dose level below the dose being taken If subsequently decreased to <30,000/㎕ Interrupt treatment When recovered to ≧30,000㎕ Resume at one dose level below the dose being taken 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 at one dose level below the dose being taken If subsequently decreased 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. 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 starting dose is 10mg once daily. Take 10 mg capsules on Days 1~21 of each 28-day cycle. Dose adjustment during treatment <Dose reduction levels> This medicine Starting 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/㎕ to <50,000/㎕ at least 2 times over a period of 7 days or longer Resume at one dose level below the dose being taken 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 taken For neutropenia, use of growth factors should be considered for patient management. Treatment with this medicine should be discontinued in patients who do not have at least a minor erythroid response within 4 months after starting treatment (demonstrated by at least a 50% reduction in transfusion requirements or, in patients who were not receiving transfusions, a hemoglobin increase of 1g/dl). 3. Mantle cell lymphoma The recommended starting dose is 25mg once daily. Take 25mg capsules on Days 1~21 of each 28-day cycle. Dose adjustment during treatment <Dose reduction levels> This medicine Starting 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 taken If subsequently 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 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 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 taken If subsequently 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 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/㎕ (excluding cases secondary to lymphoma infiltration of the bone marrow). The recommended starting dose is 20mg once daily. Take 20mg capsules on Days 1~21 of each 28-day cycle. Take for a maximum of 12 treatment cycles. The recommended starting dose of rituximab, based on a 28-day cycle, is 375 mg/m2 administered intravenously once 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 adjustment during treatment <Dose reduction levels> This medicine Starting 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 adjustment 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 this medicine and monitor complete blood counts weekly When recovered to ≥50,000/㎕ Resume at one dose level below the dose being taken If subsequently 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 Do not reduce the dose 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 this medicine and monitor complete blood counts weekly When recovered to ≥1,000/㎕ Resume at one dose level below the dose being taken If subsequently 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 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 longer if clinically indicated. To monitor for tumor lysis syndrome, patients should have a chemistry panel performed weekly during the first cycle and as 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 required to reduce hyperuricemia. The decision to hospitalize the patient is at the physician’s discretion. For patients with Grade 2-4 clinical TLS, interrupt 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. The decision to administer rasburicase and hospitalize the patient is 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, this medicine may be continued without interruption or dose reduction, at the prescriber’s discretion. Non-steroidal 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 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 receive symptom management 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 related to this medicine occurs, interrupt treatment. When the toxicity improves to Grade 2 or lower, resume treatment at one dose 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 due to thalidomide. For Grade 2-3 skin rash, interruption or discontinuation of this medicine 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 should be discontinued and should not be resumed even after these reactions resolve. 7. Dosage in patients with renal impairment This medicine is excreted through the kidneys; therefore, toxicity may be greater in patients with renal impairment. Since renal impairment is more common in elderly patients, caution is needed when selecting a dose, and careful monitoring of renal function is necessary. The initial doses for patients with renal impairment are as follows. Patients who are not on dialysis with creatinine clearance less than 11 mL/min and patients with creatinine clearance less than 7 mL/min have not been studied. 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 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 is tolerating it. Table 18. Initial dose in patients with renal impairment_myelodysplastic syndromes Category Renal function (Cockcroft-Gault CLcr) Dose adjustment for myelodysplastic syndromes Starting 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 (non-dialysis patients) 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 patients) 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 for 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 (non-dialysis patients) No data3 End-stage renal disease CLcr < 30mL/min (dialysis patients) No data3 ¹After the second treatment cycle, the dose may be increased to 15mg once daily if the patient tolerates it. 2For patients receiving an initial dose of 10mg who require dose reduction due to Grade 3/4 neutropenia or thrombocytopenia, or other Grade 3/4 toxicity considered related to this medicine, do not reduce the dose below 5mg every other day or 2.5mg once daily. 3Patients with severe and end-stage renal impairment were excluded from clinical trials. After initiating 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 fetal malformations or miscarriage if taken during pregnancy, so it should not be taken by pregnant women or women who may become pregnant. Women of childbearing potential must have two pregnancy tests before taking this drug and must ensure strict contraception during and for a period after taking it. This drug can reduce the number of white blood cells and platelets in the blood, so regular blood tests should be conducted during treatment, and any signs of infection or bleeding should be reported immediately to the healthcare provider. Patients at risk of heart disease or thrombosis should carefully monitor their cardiac and vascular status while using this drug, and it is important to take preventive measures against thrombosis. This drug can affect liver function, so patients with liver diseases or impaired liver function should regularly undergo liver function tests, and dosage adjustments may be necessary as needed. Patients with high tumor burden or certain lymphomas may experience tumor flare reactions or tumor lysis syndrome; therefore, careful monitoring and preventive measures are necessary. The risk of infections may increase, so prompt treatment is essential if any signs of infection appear, and patients with viral infections should be continuously monitored for viral reactivation. There may be severe allergic reactions such as skin rash, difficulty breathing, and swelling during the use of this drug, so if such symptoms occur, treatment should be stopped immediately, and the healthcare provider should be consulted. Furthermore, since this drug is excreted through the kidneys, patients with impaired kidney function require dosage adjustments and monitoring of kidney function. Co-administration of this drug with other immunosuppressants or specific anticancer agents may increase the risk of mortality; therefore, it should only be used under professional guidance. During treatment, side effects such as fatigue, muscle cramps, digestive disorders, neutropenia, thrombocytopenia, rash, weakness, insomnia, decreased appetite, cough, fever, pain in the back, muscle pain, joint pain, peripheral neuropathy, headache, dizziness, taste disturbance, drowsiness, hearing impairment, tinnitus, atrial fibrillation, bradycardia, congestive heart failure, tachycardia, myocardial ischemia, arrhythmia, QT prolongation, atrial flutter, ventricular ectopy, hypotension, hypertension, petechiae, vasculitis, and nosebleed may commonly occur; any unusual symptoms should be reported to the healthcare provider.

Dysmelia, Congenital deformity, Abortion, Neutropenia, Thrombocytopenia, Febrile reaction, Hemorrhage, Myocardial infarction, Venous thromboembolism, Arterial thromboembolism, Secondary primary malignant tumor, Basal cell carcinoma, Squamous cell carcinoma, Acute myeloid leukemia, Myelodysplastic syndrome, Liver failure, Toxic hepatitis, Cytolytic hepatitis, Cholestatic hepatitis, Pneumonia, Renal failure, Angioedema, Anaphylactic reaction, Stevens-Johnson syndrome, Toxic epidermal necrolysis, Drug rash syndrome, Pulmonary hypertension, Tumor lysis syndrome, Infection, Reactivation of herpes zoster, Reactivation of hepatitis B virus, Progressive multifocal leukoencephalopathy, Cataract, Fatigue, Constipation, Diarrhea, Muscle cramps, Anemia, Rash, Weakness, Insomnia, Decreased appetite, Cough, Fever, Myalgia, Arthralgia, Thrombocytopenia, Leukopenia, Lymphopenia, Pancytopenia, Hemolytic anemia, Hypersensitivity reaction, Hypothyroidism, Hypokalemia, Hyperglycemia, Hypoglycemia, Hypocalcemia, Hyponatremia, Dehydration, Weight loss, Depression, Insomnia, Decreased libido, Peripheral neuropathy, Paresthesia, Dizziness, Tremor, Dysgeusia, Headache, Stroke, Syncope, Neuralgia, Visual impairment, Hearing loss, Tinnitus, Atrial fibrillation, Bradycardia, Congestive heart failure, Tachycardia, Heart failure, Myocardial ischemia, Arrhythmia, QT prolongation, Atrial flutter, Ventricular ectopic beats, Hypotension, Hypertension, Petechial hemorrhage, Vasculitis, Ischemia, Peripheral ischemia, Intracranial venous sinus thrombosis, Dyspnea, Epistaxis, Respiratory distress, Pleuritic pain, Hypoxemia, Dysphonia, Abdominal pain, Nausea, Vomiting, Dyspepsia, Dry mouth, Stomatitis, Gastrointestinal bleeding, Small bowel obstruction, Colitis, Appendicitis, Increased alanine aminotransferase, Increased aspartate aminotransferase, Hepatocellular damage, Hyperbilirubinemia, Urticaria, Hyperhidrosis, Dry skin, Skin hyperpigmentation, Eczema, Erythema, Skin depigmentation, Photosensitivity reaction, Muscle weakness, Bone pain, Limb pain, 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, Contusion, Pulmonary embolism, Pneumonia, Sepsis, Bronchitis, Rhinitis, Soft tissue infection, Urinary tract infection, Sinusitis, Basal cell carcinoma, Squamous cell skin carcinoma, T-cell acute leukemia, Tumor lysis syndrome, Febrile neutropenia, Pancytopenia, Autoimmune hemolytic anemia, Hirsutism, Blindness, Ocular hypertension, Gastrointestinal bleeding, Tongue pain, Lethargy, Cerebral infarction, Mood changes, Hallucination, Rash, Skin hyperpigmentation, Hyperthyroidism, Solid organ transplant rejection, Acute graft-versus-host disease, Viral infection, Interstitial pneumonia, Pulmonary arterial hypertension, Acquired hemophilia, Candidemia

This drug may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is advisable to maintain the storage temperature between 15 and 30 degrees Celsius. This helps to preserve the drug's effectiveness.

Appearance

A hard capsule with a greenish upper and blue lower part containing a white or yellowish powder.

Package unit

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