Revlimid Capsule 10mg (Lenalidomide)

Adult dosage

This medicine should be administered only to patients who agree to comply with the requirements specified in the Pregnancy Prevention Program (see “5. General Precautions” under Precautions for Use). In addition, this medicine should be prescribed only by physicians enrolled in the Pregnancy Prevention Program and dispensed only by pharmacists enrolled in the program. When prescribed to women of childbearing potential, negative pregnancy test results must be confirmed on an ongoing basis according to the schedule specified in this program. 1. Multiple myeloma 1) Combination therapy with dexamethasone for the treatment of patients who have received at least one prior therapy Treatment should not be initiated if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <75,000/㎕. The recommended initial dose is 25mg once daily. Take the 25mg capsule on days 1~21 of each 28-day cycle. The recommended dose of dexamethasone is 40mg once daily on days 1~4, 9~12, and 17~20 of each 28-day cycle for the first 4 cycles. After 4 cycles, administer 40mg 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 treatment at 15mg once daily For each subsequent decrease to <30,000/㎕ Interrupt treatment When recovered to ≧30,000/㎕ Resume at a dose reduced by 5mg from the dose being taken. Do not reduce the dose below 5mg once daily. ② Dose adjustment according to absolute neutrophil count (ANC) Table 2. Absolute neutrophil count Recommended dose If decreased to <1,000/㎕ Interrupt treatment, add G-CSF, and monitor complete blood counts weekly When recovered to ≧1,000/㎕ and neutropenia is the only toxicity Resume treatment at 25mg once daily When recovered to ≧1,000/㎕ and other toxicities have occurred Resume treatment at 15mg once daily For each subsequent decrease to <1,000/㎕ Interrupt treatment When recovered to ≧1,000/㎕ Resume at a dose reduced by 5mg from the dose being taken. Do not reduce the dose below 5mg once daily. For neutropenia, use of growth factors should be considered for patient management. 2) Combination therapy with dexamethasone for the treatment of newly diagnosed patients who are not eligible for transplantation Treatment should not be initiated if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <50,000/㎕. The recommended initial dose is 25mg once daily. Take the 25 mg capsule on days 1~21 of each 28-day cycle. The recommended dose of dexamethasone is 40mg once daily on days 1, 8, 15, and 22 of each 28-day cycle. For patients aged 75 years or older, the recommended dose of dexamethasone is 20mg once daily on days 1, 8, 15, and 22 of each 28-day cycle. Continue treatment until disease progression or unacceptable toxicity occurs. Dose adjustment during treatment <Dose reduction steps> This medicine Dexamethasone Initial dose 25 mg 40 mg First dose reduction 20 mg 20 mg Second dose reduction 15 mg 12 mg Third dose reduction 10 mg 8 mg Fourth dose reduction 5 mg 4 mg Fifth dose reduction 2.5 mg N/A ① Dose adjustment according to platelet count Table 3. Platelet count Recommended dose If decreased to <25,000/㎕ Interrupt this medicine and dexamethasone and monitor complete blood counts weekly When recovered to ≧50,000/㎕ Resume at one dose level below the dose being taken ② Dose adjustment according to absolute neutrophil count (ANC) Table 4. Absolute neutrophil count Recommended dose If decreased to <500/㎕ Interrupt this medicine and dexamethasone and monitor complete blood counts weekly When recovered to ≧1,000/㎕ and neutropenia is the only toxicity Resume treatment at the starting dose When recovered to ≧500/㎕ and dose-dependent hematologic toxicity other than neutropenia has occurred Resume at one dose level below the dose being taken For each subsequent decrease to <500/㎕ Interrupt this medicine and dexamethasone When recovered to ≧500/㎕ Resume at one dose level below the dose being taken For neutropenia, use of growth factors should be considered for patient management. ③ Dose adjustment for febrile neutropenia (fever ≥38.5℃ and ANC<1,000/㎕): Interrupt treatment and monitor complete blood counts weekly. If the patient is not receiving a growth factor, use of a growth factor should be considered. On the first day of the next treatment cycle, if neutropenia is the only dose-limiting toxicity, resume treatment at the dose being taken, continuing growth factor use 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 the dose of this medicine has been reduced because of a hematologic dose-limiting toxicity (DLT), and treatment is continued until bone marrow function improves (no DLT for at least 2 consecutive cycles, and an absolute neutrophil count ≥1,500/㎕ and platelet count ≥100,000/㎕ at the start of a new cycle at the current dose level), treatment may be resumed at an increased dose of this medicine, 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 the 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 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 because of 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 steps> This medicine Melphalan Prednisolone Initial dose 10 mg 0.18 mg/kg 2 mg/kg First dose reduction 7.5 mg 0.14 mg/kg 1 mg/kg Second dose reduction 5 mg 0.10 mg/kg 0.5 mg/kg Third dose reduction 2.5 mg N/A 0.25 mg/kg ① Dose adjustment according to platelet count Table 5. Platelet count Recommended dose If decreased to <25,000/㎕ Interrupt this medicine, melphalan, and prednisolone and monitor complete blood counts weekly When recovered to ≧25,000/㎕ Resume treatment with this medicine and melphalan at one dose level below the doses being taken For each subsequent decrease to <30,000/㎕ Interrupt this medicine, melphalan, and prednisolone When recovered to ≧30,000/㎕ Resume treatment with this medicine and melphalan at one dose level below the doses being taken ② Dose adjustment according to absolute neutrophil count (ANC) Table 6. Absolute neutrophil count Recommended dose If decreased to <500/㎕ Interrupt this medicine, melphalan, and prednisolone and monitor complete blood counts weekly When recovered to ≧500/㎕ and neutropenia is the only toxicity Resume treatment at the starting dose When recovered to ≧500/㎕ and dose-dependent hematologic toxicity other than neutropenia has occurred Resume treatment with this medicine and melphalan at one dose level below the doses being taken For each subsequent decrease to <500/㎕ Interrupt this medicine, melphalan, and prednisolone When recovered to ≧500/㎕ Resume treatment with 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 growth factor use 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 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 1~14 of each 21-day cycle. Administer bortezomib by subcutaneous injection at a dose of 1.3mg/m2 per body surface area on days 1, 4, 8, and 11 of each 21-day cycle. The recommended dose of dexamethasone is 20mg once daily, taken on days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle. Patients should receive 8 cycles (a total of 24 weeks) of treatment as initial therapy. After initial treatment, take this medicine 25mg once daily in combination with dexamethasone on days 1-21 of each 28-day cycle. The recommended dose 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 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 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/m2 per body surface area on days 1, 4, 8, and 11 of each 28-day cycle. The recommended dose of dexamethasone is 40mg once daily, taken on days 1-4 and 9-12 of each 28-day cycle. Patients should receive 6 cycles (a total of 24 weeks) of treatment as induction therapy. Dose adjustment during treatment <Dose reduction steps> This medicine Initial dose 25 mg First dose reduction 20 mg Second dose reduction 15 mg Third dose reduction 10 mg Fourth dose reduction 5 mg Fifth dose reduction 2.5 mg ① Dose adjustment according to platelet count Platelet count Recommended dose If decreased to <30,000/㎕ Interrupt treatment and monitor complete blood counts weekly When recovered to ≧50,000/㎕ Resume at one dose level below the dose being taken For each subsequent decrease to <30,000/㎕ Interrupt treatment When recovered to ≧50,000/㎕ Resume at one dose level below the dose being taken ② Dose adjustment according to absolute neutrophil count (ANC) Neutrophil count Recommended dose If decreased to <500/㎕ Interrupt treatment and monitor complete blood counts weekly When recovered to ≧1,000/㎕ and neutropenia is the only toxicity Resume treatment at the starting dose When recovered to ≧500/㎕ and dose-dependent hematologic toxicity other than neutropenia has occurred Resume at one dose level below the dose being taken For each subsequent decrease to <500/㎕ Interrupt treatment When recovered to ≧500/㎕ Resume at one dose level below the dose being taken For neutropenia, use of growth factors should be considered for patient management. *For dose adjustment of concomitant medicines, refer to the prescribing information for the respective products. 5) Maintenance therapy in patients with newly diagnosed disease who have undergone autologous hematopoietic stem cell transplantation Maintenance therapy with this medicine should be initiated in patients with no evidence of disease progression after adequate hematologic recovery following autologous hematopoietic stem cell transplantation. Treatment should not be initiated if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <75,000/㎕. The recommended initial dose is 10mg once daily. Take the 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 steps> Starting dose (10mg) If the dose has been increased (15mg)* First dose reduction 5 mg 10 mg Second dose reduction 5mg (days 1~21 of a 28-day cycle) 5 mg Third dose reduction N/A 5mg (days 1~21 of a 28-day cycle) Do not reduce the dose below 5mg (days 1~21 of a 28-day cycle). *After 3 cycles of maintenance therapy with this medicine, the dose may be increased to 15mg once daily if tolerated. ① Dose adjustment according to platelet count Table 7. Platelet count Recommended dose If decreased to <30,000/㎕ Interrupt treatment and monitor complete blood counts weekly When recovered to ≧30,000/㎕ Resume at one dose level below the dose being taken For each subsequent decrease 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 8. 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 each subsequent decrease to <500/㎕ Interrupt treatment When recovered to ≧500/㎕ Resume at one dose level below the dose being taken For neutropenia, use of growth factors should be considered for patient management. 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 the 10 mg capsule on days 1~21 of each 28-day cycle. Dose adjustment during treatment <Dose reduction steps> This medicine Initial dose 10 mg once daily on days 1~21 of each 28-day cycle First dose reduction 5 mg once daily on days 1~28 of each 28-day cycle Second dose reduction 2.5 mg once daily on days 1~28 of each 28-day cycle Third 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 9. Platelet count Recommended dose If decreased to <25,000/㎕ Interrupt treatment and monitor complete blood counts weekly When recovered to ≧50,000/㎕ or when recovered to ≧25,000/㎕~<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 10. 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 have not had at least a minor erythroid response within 4 months after starting treatment (demonstrated by a reduction in transfusion requirements of at least 50%, or, in patients who have not received transfusions, an increase in hemoglobin level of 1g/dl). 3. Mantle cell lymphoma The recommended initial dose is 25mg once daily. Take the 25mg capsule on days 1~21 of each 28-day cycle. Dose adjustment during treatment <Dose reduction steps> This medicine Initial dose 25mg once daily on days 1~21 of each 28-day cycle First dose reduction 20mg once daily on days 1~21 of each 28-day cycle Second dose reduction 15mg once daily on days 1~21 of each 28-day cycle Third dose reduction 10mg once daily on days 1~21 of each 28-day cycle Fourth dose reduction 5mg once daily on days 1~21 of each 28-day cycle Fifth 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 11. Platelet count Recommended dose If decreased to <50,000/㎕ Interrupt treatment and monitor complete blood counts weekly When recovered to ≧60,000/㎕ Resume at one dose level below the dose being taken For each subsequent decrease to <50,000/㎕ Interrupt treatment and monitor complete blood counts weekly When recovered to ≧60,000/㎕ Resume at one dose level below the dose being taken Do not reduce the dose below 2.5mg once daily or 5mg every other day. ② Dose adjustment according to absolute neutrophil count (ANC) Table 12. Absolute neutrophil count Recommended dose If decreased to <1,000/㎕ for at least 7 days, or if decreased to <1,000/㎕ with fever (body temperature≧38.5℃), or if decreased to <500/㎕ Interrupt treatment and monitor complete blood counts weekly When recovered to ≧1,000/㎕ Resume at one dose level below the dose being taken For each subsequent decrease to <1,000/㎕ for at least 7 days, or if decreased to <1,000/㎕ with fever (body temperature≧38.5℃), or if decreased to <500/㎕ Interrupt treatment. When recovered to ≧1,000/㎕ Resume at one dose level below the dose being taken Do not reduce the dose below 2.5mg once daily or 5mg every other day. For neutropenia, use of growth factors should be considered for patient management. 4. Follicular lymphoma Treatment should not be initiated if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <50,000/㎕ (except when secondary to lymphoma involving the bone marrow). The recommended initial dose is 20mg once daily. Take the 20mg capsule on days 1~21 of each 28-day cycle. Take for a maximum of 12 treatment cycles. The recommended initial dose of rituximab is based on a 28-day cycle and is 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 adjustment during treatment <Dose reduction steps> This medicine Initial dose 20mg once daily on days 1~21 of each 28-day cycle First dose reduction 15mg once daily on days 1~21 of each 28-day cycle Second dose reduction 10mg once daily on days 1~21 of each 28-day cycle Third 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 13. Platelet count Recommended dose If decreased to <50,000/㎕ Interrupt treatment with this medicine and monitor complete blood counts weekly When recovered to ≥50,000/㎕ Resume at one dose level below the dose being taken For each subsequent decrease to <50,000/㎕ Interrupt treatment with this medicine and monitor complete blood counts weekly When recovered to ≥50,000/㎕ Resume at one dose level below the dose being taken Do not reduce the dose below 5mg once daily. ② Dose adjustment according to absolute neutrophil count (ANC) Table 14. Absolute neutrophil count Recommended dose If decreased to <1,000/㎕ for at least 7 days, or if decreased to <1,000/㎕ with fever (body temperature≥38.5°C), or if decreased to <500/㎕ Interrupt treatment with this medicine and monitor complete blood counts weekly When recovered to ≥1,000/㎕ Resume at one dose level below the dose being taken For each subsequent decrease to <1,000/㎕ for at least 7 days, or if decreased to <1,000/㎕ with fever (body temperature≥38.5°C), or if decreased to <500/㎕ Interrupt treatment with 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 be given adequate oral hydration during the first week of the first treatment cycle, or for a longer period if clinically indicated. To monitor for tumor lysis syndrome, patients should have a chemistry panel performed during the first cycle and weekly thereafter if clinically indicated. In patients with laboratory TLS or grade 1 clinical TLS, this medicine may be continued at the same dose or, at the physician’s discretion, continued at a dose reduced by one dose level. Provide adequate intravenous hydration and appropriate medical management according to standard treatment until electrolyte abnormalities are corrected. Rasburicase treatment may be needed to reduce hyperuricemia. Hospitalization is at the physician’s discretion. In patients with grade 2-4 clinical TLS, interrupt treatment with this medicine and perform a chemistry panel weekly or as clinically indicated. Provide adequate intravenous hydration and appropriate medical management according to standard treatment until electrolyte abnormalities are corrected. Rasburicase treatment and hospitalization are at the physician’s discretion. When TLS improves to grade 0, resume treatment at a dose one level lower, at the physician’s discretion. Tumor flare reaction (TFR) In patients who develop a 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 a 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 for symptoms according to the guidance for treatment of grade 1/2 tumor flare reactions. 5. Dose adjustment for other grade 3/4 toxicities If other grade 3/4 toxicities related to this medicine occur, interrupt treatment. Once the toxicity improves to grade 2 or lower, resume treatment at a dose one level below the dose being taken, at the prescriber’s discretion. 6. This medicine should not be administered to patients with a history of grade 4 rash caused by thalidomide. For grade 2-3 skin rash, interruption or discontinuation of this medicine should be considered. If angioedema, 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, so toxicity may be greater in patients with renal impairment. Since older patients are more likely to have renal impairment, caution is needed when selecting a dose and renal function should be monitored carefully. The initial doses for patients with renal impairment are as follows. Patients who are not on dialysis and have a creatinine clearance below 11 mL/min, and patients with a creatinine clearance below 7 mL/min, have not been studied. Table 15. Initial dose in patients with renal impairment—multiple myeloma or mantle cell lymphoma Category Renal function (Cockcroft-Gault CLcr) Dose adjustment for multiple myeloma/mantle cell lymphoma Dose adjustment for post-transplant maintenance therapy Moderate renal impairment 30 ≤ CLcr <50mL/min 10mg once daily* 5mg once daily Severe renal impairment CLcr <30mL/min (non-dialysis 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 does not respond to treatment and tolerates it. Table 16. Initial dose in patients with renal impairment—myelodysplastic syndromes Category Renal function (Cockcroft-Gault CLcr) Dose adjustment for myelodysplastic syndromes Initial dose First dose reduction Second 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 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 17. 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 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 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 toxicities 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 performed according to each 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 severe birth defects or miscarriage if taken during pregnancy; therefore, women of childbearing potential must take a pregnancy test twice before taking the drug and ensure effective contraception for a certain period before and after treatment. This drug can reduce white blood cell and platelet counts in the blood, so regular blood tests should be conducted during treatment, and if symptoms such as fever or bleeding occur, medical personnel should be informed immediately. Patients with a risk of heart disease may experience cardiovascular problems such as myocardial infarction; therefore, patients with risk factors should be monitored closely and risk factors minimized. There is an increased risk of thrombosis, meaning blood clots can form, thus patients with risk factors for thrombosis need extra caution and should seek immediate treatment if symptoms of thrombosis appear. This medication can affect liver function, so patients with liver disease or suspected liver function abnormalities should have their liver function tested regularly, and if liver function abnormalities are severe, dose adjustment or discontinuation may be necessary. For patients with compromised kidney function, this drug may be difficult to excrete, increasing the risk of side effects, requiring careful assessment of kidney function and dose adjustments. Patients with a high tumor burden may experience tumor flare reactions or tumor lysis syndrome, necessitating special caution and appropriate preventive measures during initial treatment. The risk of infection may be increased, so timely treatment should be sought if infection symptoms develop, and there is a risk of reactivation of viral infections; thus, patients with a history of herpes zoster or hepatitis B should be carefully monitored before and after treatment. This drug can cause serious skin reactions; thus, if rashes or allergic symptoms occur, it should be discontinued immediately, and medical personnel should be consulted. During treatment, there may be a risk of cataracts, so it is advisable to regularly check visual function. This drug should not be administered to patients with certain genetic metabolic disorders (e.g., galactose intolerance), and those with hypersensitivity should avoid taking it. Various side effects may occur during treatment, so it is essential to closely monitor symptoms such as fatigue, fever, muscle cramps, digestive disorders, and abnormal blood counts, and report any unusual symptoms to medical personnel immediately.

Teratogenicity, congenital malformation, miscarriage, neutropenia, thrombocytopenia, febrile reaction, hemorrhagic symptoms, myocardial infarction, venous thromboembolism, arterial thromboembolism, secondary primary malignancy, acute myeloid leukemia, myelodysplastic syndrome, basal cell carcinoma, squamous cell carcinoma, liver failure, toxic hepatitis, cytolytic hepatitis, cholestatic hepatitis, liver dysfunction, vascular edema, anaphylactic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash syndrome with eosinophilia and systemic symptoms, pulmonary hypertension, tumor lysis syndrome, infection, pneumonia, renal failure, weakness, fever, insomnia, decreased appetite, cough, rash, fatigue, constipation, diarrhea, muscle cramps, anemia, leukopenia, lymphopenia, pancytopenia, hemolytic anemia, hypercoagulability, 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, ataxia, impaired balance, intracranial hemorrhage, transient ischemic attack, cerebral ischemia, cataract, blurred vision, vision loss, blindness, hearing loss, tinnitus, atrial fibrillation, bradycardia, congestive heart failure, tachycardia, heart failure, myocardial ischemia, arrhythmia, QT prolongation, atrial flutter, ventricular extrasystole, hypotension, hypertension, petechiae, vasculitis, ischemia, peripheral ischemia, intracranial venous thrombosis, dyspnea, epistaxis, respiratory distress, pleuritic pain, hypoxia, dysphonia, abdominal pain, nausea, vomiting, indigestion, dry mouth, stomatitis, gastrointestinal bleeding, intestinal obstruction, colitis, appendicitis, alanine aminotransferase elevation, aspartate aminotransferase elevation, hepatotoxicity, hepatocellular injury, hyperbilirubinemia, liver failure, rash, pruritus, urticaria, hyperhidrosis, dry skin, skin pigmentation, eczema, erythema, drug rash with eosinophilia and systemic symptoms, skin depigmentation, photosensitivity, muscle weakness, bone pain, musculoskeletal and connective tissue pain, limb pain, myalgia, arthralgia, joint swelling, renal failure, hematuria, urinary retention, urinary incontinence, acquired Fanconi syndrome, erectile dysfunction, fatigue, edema, influenza-like symptoms, chest pain, somnolence, increased serum alkaline phosphatase level, C-reactive protein elevation, falls, contusion, pneumonia, septic shock, influenza, urinary tract infection, bronchitis, herpes zoster, urosepsis, viral infection, sinusitis, atypical pneumonia, streptococcus pneumonia, Klebsiella pneumonia, pseudomembranous colitis, acute sinusitis, acute pyelonephritis, bronchopulmonary aspergillosis, Escherichia coli pneumonia, viral pneumonia, viral respiratory infection, upper respiratory tract infection, bacteremia, fungal pneumonia, sepsis, pneumocystis pneumonia, subcutaneous abscess, pain, peripheral edema, chills, multiple organ failure, multi-organ dysfunction, facial edema, overall deterioration, generalized edema, chest pain, pleural effusion, interstitial pneumonia, aspiration pneumonia, acute respiratory distress syndrome, bronchiectasis, pneumothorax, chronic obstructive pulmonary disease, congestion, tachypnea, oropharyngeal pain, mediastinal emphysema, pulmonary hypertension, pulmonary edema, pulmonary congestion, pulmonary mass, bronchial obstruction, respiratory abnormalities, pleuritic pain, papulosquamous eruption, hair loss, skin reaction, skin desquamation, subcutaneous hemorrhage, jaw pain, osteoporosis, cervical spondylolisthesis, joint stiffness, bone resorption, limb discomfort, rhabdomyolysis, chest wall mass, increased serum creatinine, weight gain, decreased renal creatinine clearance, increased blood urea, conjunctival hemorrhage, borderline glaucoma, myopia, dry eyes, eyelid swelling, eye pain, retinal disorders, retinal disease, 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, hepatic steatosis, acute cholangitis, acute cholecystitis, choledocholithiasis, jaundice, flushing, shock, ear discomfort, ear discharge, hearing loss, splenomegaly, hemolytic uremic syndrome

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, it is advisable to keep it at room temperature between 15 and 30 degrees Celsius to maintain its effectiveness.

Appearance

A hard capsule with a yellow upper part and a gray lower part containing white powder.

Package unit

21 capsules per box [(7 capsules/blister x 3)], 7 capsules per box [(7 capsules/blister x 1)]