Lenalidomide Capsule 15 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” under 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 a woman of childbearing potential, negative pregnancy test results must be confirmed continuously according to the schedule specified in this program. 1. Multiple myeloma 1) In combination 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 a 25 mg capsule 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 on Days 1–4 of each 28-day cycle only. 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 If recovered to ≧30,000/㎕ Resume treatment at 15mg once daily If subsequently decreased to <30,000/㎕ Interrupt treatment If recovered to ≧30,000㎕ Resume at a dose reduced by 5mg from the dose being administered. Do not reduce the dose to less than 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 If recovered to ≧1,000/㎕ and neutropenia is the only toxicity Resume treatment at 25mg once daily If recovered to ≧1,000/㎕ and other toxicities are present Resume treatment at 15mg once daily If subsequently decreased to <1,000/㎕ Interrupt treatment If recovered to ≧1,000/㎕ Resume at a dose reduced by 5mg from the dose being administered. Do not reduce the dose to less than 5mg once daily. For neutropenia, the use of growth factors should be considered for patient management. 2) In combination with dexamethasone for the treatment of newly diagnosed patients who are ineligible 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 a 25 mg capsule 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 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 If 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 medicine and dexamethasone and monitor complete blood counts weekly If recovered to ≧1,000/㎕ and neutropenia is the only toxicity Resume treatment at the starting dose If recovered to ≧500/㎕ and dose-dependent hematologic toxicity other than neutropenia occurs Resume at one dose level below the dose being administered If subsequently decreased to <500/㎕ Interrupt this medicine and dexamethasone If recovered to ≧500/㎕ Resume at one dose level below the dose being administered For neutropenia, the 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, its use should be considered. On the first day of the next treatment cycle, resume treatment at the dose being administered if neutropenia is the only dose-limiting toxicity, continuing growth factor use if necessary. Otherwise, resume treatment at one dose level below the dose being administered. If the patient is not receiving a growth factor, administer one. If this medicine has been dose-reduced due to hematologic dose-limiting toxicity (DLT), once bone marrow function improves (no DLT for at least 2 consecutive cycles and, at the start of a new cycle at the current dose level, an absolute neutrophil count ≥1,500/㎕ and platelet count ≥100,000㎕), treatment may be resumed at an increased dose of this medicine at the physician’s discretion (up to the maximum starting dose). 3) In combination with melphalan and prednisolone for the treatment of newly diagnosed patients who are ineligible 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 a 10 mg capsule 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 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 cannot complete combination therapy because of intolerance, take 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 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 If recovered to ≧25,000㎕ Resume treatment with this medicine and melphalan at one dose level below the dose being administered If subsequently decreased to <30,000/㎕ Interrupt this medicine, melphalan, and prednisolone If recovered to ≧30,000㎕ Resume treatment with this medicine and melphalan at one dose level below the dose being administered 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 If recovered to ≧500/㎕ and neutropenia is the only toxicity Resume treatment at the starting dose If recovered to ≧500/㎕ and dose-dependent hematologic toxicity other than neutropenia occurs Resume treatment with this medicine and melphalan at one dose level below the dose being administered If subsequently decreased to <500/㎕ Interrupt this medicine, melphalan, and prednisolone If recovered to ≧500/㎕ Resume treatment with this medicine and melphalan at one dose level below the dose being administered For neutropenia, the 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, its use should be considered. On the first day of the next treatment cycle, resume treatment at the dose being administered if neutropenia is the only dose-limiting toxicity, continuing growth factor use if necessary. Otherwise, resume treatment at one dose level below the dose being administered. If the patient is not receiving a growth factor, administer one. 4) In combination with bortezomib and dexamethasone for the treatment of newly diagnosed patients (1) In combination with bortezomib and dexamethasone for the treatment of newly diagnosed patients who are ineligible 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 1–14 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 in total) of treatment as initial therapy. After initial treatment, take 25mg of this medicine once daily in combination with dexamethasone on Days 1–21 of each 28-day cycle. The recommended dosage regimen 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 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 therapy in combination with dexamethasone and bortezomib for the treatment of newly diagnosed patients who are 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 1–21 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 in total) of treatment as induction therapy. Dose adjustment 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 Table 7. Platelet count Recommended dose If decreased to <30,000/㎕ Interrupt treatment and monitor complete blood counts weekly If recovered to ≧50,000㎕ Resume at one dose level below the dose being administered If subsequently decreased to <30,000/㎕ Interrupt treatment If recovered to ≧50,000㎕ Resume treatment at one dose 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 If recovered to ≧1,000/㎕ and neutropenia is the only toxicity Resume treatment at the starting dose If recovered to ≧500/㎕ and dose-dependent hematologic toxicity other than neutropenia occurs Resume at one dose level below the dose being administered If subsequently decreased to <500/㎕ Interrupt treatment If recovered to ≧500/㎕ Resume at one dose level below the dose being administered For neutropenia, the 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 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 a 10 mg capsule 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 If recovered to ≧30,000㎕ Resume treatment at one dose level below the dose being administered If subsequently decreased to <30,000/㎕ Interrupt treatment If 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 If recovered to ≧500/㎕ Resume treatment at one dose level below the dose being administered If subsequently decreased to <500/㎕ Interrupt treatment If recovered to ≧500/㎕ Resume treatment at one dose level below the dose being administered For neutropenia, the 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 a 10 mg capsule on Days 1–21 of each 28-day cycle. Dose adjustment during treatment <Dose reduction levels> This medicine 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 If recovered to ≧50,000/㎕, or if recovered to ≧25,000/㎕ to <50,000/㎕ at least twice for 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 If recovered to ≧500/㎕ Resume at one dose level below the dose being administered For neutropenia, the use of growth factors should be considered for patient management. Treatment with this medicine should be discontinued in patients who have not had at least a minor erythroid response within 4 months after starting treatment (demonstrated by at least a 50% reduction in transfusion requirements or, if not transfused, an increase in hemoglobin level of 1g/dl). 3. Mantle cell lymphoma The recommended initial dose is 25mg once daily. Take a 25mg capsule on Days 1–21 of each 28-day cycle. Dose adjustment during treatment <Dose reduction levels> This medicine 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 If recovered to ≧60,000/㎕ Resume at one dose level below the dose being administered If subsequently decreased to <50,000/㎕ Interrupt treatment and monitor complete blood counts weekly If recovered to ≧60,000/㎕ Resume at one dose level below the dose being administered Do not reduce the dose to less than 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 If recovered to ≧1,000/㎕ Resume at one dose level below the dose being administered 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. If recovered to ≧1,000/㎕ Resume at one dose level below the dose being administered Do not reduce the dose to less than 2.5mg once daily or 5mg every other day. For neutropenia, the 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 in cases secondary to lymphoma infiltration of the bone marrow). The recommended initial dose is 20mg once daily. Take a 20mg capsule on Days 1–21 of each 28-day cycle. Take for up to 12 treatment cycles. The recommended initial dose of rituximab, based on a 28-day cycle, is 375 mg/m2 intravenously once weekly during Cycle 1 (Days 1, 8, 15, and 22). During Cycles 2–5, administer 375 mg/m2 intravenously on Day 1 only of each 28-day cycle. Dose adjustment during treatment <Dose reduction levels> This medicine 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 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 If recovered to ≥50,000/㎕ Resume at one dose level below the dose being administered If subsequently decreased to <50,000/㎕ Interrupt this medicine and monitor complete blood counts weekly If recovered to ≥50,000/㎕ Resume at one dose level below the dose being administered Do not reduce the dose to less than 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 If recovered to ≥1,000/㎕ Resume at one dose level below the dose being administered 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 If recovered to ≥1,000/㎕ Resume at one dose level below the dose being administered Do not reduce the dose to less than 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 adequate oral hydration during the first week of the first treatment cycle or for longer if clinically necessary. To monitor for tumor lysis syndrome, patients should undergo a chemistry panel during the first cycle and weekly if clinically necessary. 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 level. Provide adequate intravenous hydration and appropriate medical management according to standard treatment until electrolyte abnormalities are corrected. Treatment with rasburicase may be necessary to reduce hyperuricemia. Hospitalization is at the physician’s discretion. For patients with Grade 2–4 clinical TLS, discontinue this medicine 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. Once TLS improves to Grade 0, resume treatment at a dose one level lower at the physician’s discretion. Tumor flare reaction (TFR) In patients who develop Grade 1/2 tumor flare reaction, this medicine 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 opioid analgesics may be administered. In patients who develop Grade 3/4 tumor flare reaction, discontinue this medicine and initiate treatment with NSAIDs, corticosteroids, and/or opioid 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 treating 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. If the toxicity improves to Grade 2 or lower, resume treatment at a dose one level lower than the dose being administered, 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, 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, discontinue treatment and do not resume it even after these reactions have resolved. 7. Dose in patients with renal impairment This medicine is excreted through the kidneys, so toxicity may be greater in patients with renal impairment. As renal impairment is more common in older patients, use caution when selecting the dose and carefully monitor renal function. The initial dose for patients with renal impairment is as follows. Patients with creatinine clearance less than 11 mL/min who are not on dialysis 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 maintenance therapy after transplantation 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 it. Table 18. 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 1–21 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, if the dose is reduced because of 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. 3Patients with severe renal impairment and end-stage renal disease were excluded from clinical trials. After starting treatment with this medicine, dose adjustment in patients with renal impairment should be made according to each patient’s tolerability, as described above. 8. Take with water. Do not crush, chew, or open the capsule. The dose may be adjusted based on clinical or laboratory test results.

This medication can cause serious fetal malformations if used during pregnancy; therefore, women of childbearing potential must undergo two pregnancy tests before taking the medication and must use two effective contraceptive methods to avoid pregnancy during treatment and up to four weeks after therapy. Only physicians and pharmacists registered in a special risk management program can prescribe and dispense this medication, and patients must strictly adhere to the program's regulations. During treatment, blood tests must be conducted regularly, as there may be significant decreases in white blood cell and platelet counts, and any signs of infection or bleeding must be reported to a doctor immediately. The risk of cardiovascular events, such as myocardial infarction, may increase; therefore, patients with cardiovascular risk factors should be monitored carefully and efforts should be made to minimize these risks. There is an increased risk of thrombosis (clots in blood vessels), so if symptoms of thrombosis (e.g., shortness of breath, chest pain, limb swelling) occur, immediate treatment is required, and preventive anticoagulation treatment may be administered. This drug may increase the risk of secondary malignancies, hence regular cancer screenings and monitoring by a physician are necessary before and during treatment. Patients with liver dysfunction may face a risk of liver toxicity; regular liver function tests should be conducted, and dosage adjustments may be necessary if liver impairment is present. Patients with reduced kidney function should be monitored closely, as the drug's elimination may be delayed, increasing the risk of side effects. Tumor lysis syndrome and tumor flare reactions may occur, so careful monitoring and preventive measures are required during the early stages of treatment, especially for patients with a high tumor burden. During treatment, the risk of infections is heightened; any symptoms of infections (such as cough or fever) should be reported to healthcare personnel immediately, and there is a risk of reactivation of viral infections, necessitating appropriate testing and management. Severe skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) can occur, so if there are any skin rashes or allergic symptoms, the medication should be discontinued immediately and a doctor consulted. Pulmonary hypertension and other cardiopulmonary disorders may develop, so heart and lung status should be evaluated before and after treatment, and any symptoms should be reported to healthcare personnel immediately. Pregnant women, women of childbearing potential, patients allergic to this drug or its components, and those with certain hereditary lactose intolerance should not use this drug. This drug has a variety of side effects, including fatigue, diarrhea, constipation, rash, blood count abnormalities, infections, neurological issues, cardiovascular problems, etc.; if any abnormal symptoms occur, immediate consultation with healthcare professionals is necessary. Particularly, leukopenia and thrombocytopenia are common, so regular blood tests are essential, and precautions for severe infections or bleeding risks should be taken. During treatment, it is crucial to regularly monitor health status per physician's instructions and report any adverse reactions promptly.

Limb dysplasia, congenital deformities, miscarriage, neutropenia, thrombocytopenia, febrile reactions, hemorrhage, myocardial infarction, venous thromboembolism, arterial thromboembolism, secondary primary malignant tumors, acute myeloid leukemia, myelodysplastic syndrome, basal cell carcinoma, squamous cell carcinoma, acute liver failure, toxic hepatitis, cytolytic hepatitis, cholestatic hepatitis, abnormal liver function, vascular edema, anaphylactic reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash syndrome with eosinophilia and systemic symptoms, 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, pneumonia, renal failure, weakness, insomnia, decreased appetite, cough, fever, peripheral neuropathy, paresthesia, dizziness, tremor, taste disorder, headache, stroke, syncope, neuralgia, ataxia, impaired sense of balance, 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, petechial hemorrhage, vasculitis, ischemia, peripheral ischemia, intracranial venous thrombosis, dyspnea, epistaxis, respiratory distress, pleuritic pain, hypoxia, speech disorders, abdominal pain, nausea, vomiting, dyspepsia, dry mouth, stomatitis, gastrointestinal bleeding, small bowel obstruction, gastrointestinal hemorrhage, dysphagia, colitis, appendicitis, alanine aminotransferase increase, aspartate aminotransferase increase, hepatotoxicity, hepatocyte damage, hyperbilirubinemia, liver failure, urticaria, hyperhidrosis, skin dryness, skin pigmentation, eczema, erythema, drug rash, skin depigmentation, photosensitivity, muscle weakness, bone pain, musculoskeletal pain, limb pain, myalgia, arthralgia, joint swelling, renal failure, hematuria, urinary retention, urinary incontinence, acquired Fanconi syndrome, erectile dysfunction, edema, influenza-like symptoms, elevated serum alkaline phosphatase, increased C-reactive protein, falls, contusion, pneumonia, septicemia, urinary tract infection, sinusitis, plasmacytoma, lung infection, bronchitis, pharyngitis, otitis media, squamous cell carcinoma of the skin, febrile neutropenia, leukopenia, lymphocytopenia, hypokalemia, hyperglycemia, hypoglycemia, hypocalcemia, hyponatremia, dehydration, diabetes, hypophosphatemia, hyperuricemia, depression, insomnia, decreased libido, cerebral infarction, mood changes, hallucinations, papulosquamous rash, alopecia, oral pain, toothache, oral ulcers, chronic gastritis, gastritis, dental caries, hemorrhoids, ascites, ischemic colitis, colonic ulcers, colonic perforation, colonic polyps, epigastric discomfort, erosive esophagitis, esophagitis, gastric ulcers, gingival swelling, hemorrhagic diverticulum, intestinal obstruction, intestinal obstruction syndrome, rectal pain, periodontal disease, anal erosions, bloody stools, pleural effusion, asthma, rhinitis, hemoptysis, acute respiratory distress syndrome, bronchiectasis, pneumothorax, chronic obstructive pulmonary disease, nasal congestion, tachypnea, oropharyngeal pain, mediastinal emphysema, pulmonary arterial hypertension, pulmonary edema, pulmonary congestion, lung masses, obstructive bronchitis, respiratory abnormalities, pleuritic pain, hiccups, dementia, myotonic seizures, neuritis, speech disorders, epilepsy, intracranial tumors, chronic polyneuropathy, Marfan syndrome, head discomfort, hemiplegia, seizures, neuropathy, uremic encephalopathy, cognitive impairment, chin numbness syndrome, third cranial nerve palsy, Parkinson's disease, postherpetic neuralgia, action tremor, hyperkalemia, hypercalcemia, hypoalbuminemia, iron deficiency, delirium, anxiety, attention deficit disorder, rib fractures, limb injuries, upper limb fractures, femoral neck fractures, femoral fractures, radiation pneumonitis, bone fragment formation, laceration, traumatic fractures, lumbar fractures, ligament sprains, dental fractures, forearm fractures, thoracic vertebrae fractures, urethral discomfort, end-stage kidney disease, polyuria, nocturia, urinary abnormalities, urethral discharge, mucosal inflammation, swelling, heat sensation, injection site pain, blisters, petechial hemorrhage, chronic pigmented macules, exfoliative dermatitis, macules, purpura, contact dermatitis, skin reactions, skin peeling, subcutaneous hemorrhage, jaw pain, osteoporosis, spondylolisthesis, joint stiffness, bone resorption, limb discomfort, rhabdomyolysis, chest wall tumors, elevated serum creatinine, weight gain, decreased renal creatinine clearance, elevated blood urea nitrogen, conjunctival hemorrhage, borderline glaucoma, myopia, eyelid edema, eye pain, retinal disorders, retinal diseases, diplopia, blepharitis, periorbital edema, pericardial effusion, stress-induced cardiomyopathy, subendocardial ischemia, cardiac arrest, restrictive cardiomyopathy, adrenal insufficiency, Cushing's syndrome, inappropriate antidiuretic hormone secretion, cervical dysplasia, vaginal discharge, vaginal bleeding, perineal rash, hyperbilirubinemia, shock, ear discomfort, ear discharge, hearing impairment, splenomegaly, hemolytic uremic syndrome

This medication is sensitive to air and moisture; therefore, it must be stored in a tightly sealed container. It is important to maintain a storage temperature between 15 and 30 degrees Celsius to preserve the medication's efficacy for a longer duration.

Appearance

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

Package unit

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