Lenalidomide Capsule 25 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 may be prescribed only by physicians registered in the Risk Management Program and dispensed only by pharmacists registered in the program. When prescribing this medicine to a woman of childbearing potential, continuously confirm negative pregnancy test results 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 during 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 count weekly When recovered to ≧30,000/㎕ Resume treatment 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 administered. Do not reduce the dose below 5mg once daily. ② Dose adjustment according to absolute neutrophil count (Absolute Neutrophil Count: ANC) Table 2. Neutrophil count Recommended dose If decreased to <1,000/㎕ Interrupt treatment, add G-CSF, and monitor complete blood count weekly When recovered to ≧1,000/㎕ and neutropenia is the only toxicity Resume treatment at 25mg once daily When recovered to ≧1,000/㎕ and other toxicity has occurred Resume treatment at 15mg once daily If subsequently decreased to <1,000/㎕ Interrupt treatment When recovered to ≧1,000/㎕ Resume at a dose reduced by 5mg from the dose being administered. Do not reduce 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 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 worsens 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 count weekly When recovered to ≧50,000㎕ Resume at one dose level below the dose being administered ② Dose adjustment according to absolute neutrophil count (Absolute Neutrophil Count: ANC) Table 4. Neutrophil count Recommended dose If decreased to <500/㎕ Interrupt this medicine and dexamethasone and monitor complete blood count weekly When recovered to ≧1,000/㎕ and neutropenia is the only toxicity Resume treatment at the starting dose When recovered to ≧500/㎕ and dose-dependent hematologic toxicity other than neutropenia has occurred Resume at one dose level below the dose being administered If subsequently decreased to <500/㎕ Interrupt this medicine and dexamethasone When recovered to ≧500/㎕ Resume at one dose level below the dose being administered For neutropenia, use of growth factors should be considered for patient management. ③ Dose adjustment for febrile neutropenia (fever ≥38.5℃ and ANC<1,000/㎕): Interrupt treatment and monitor complete blood count weekly. If the patient is not receiving a growth factor, use of a growth factor should be considered. On the first day of the next treatment cycle, resume treatment at the dose being administered, continuing growth factor use if necessary, if neutropenia is the only dose-limiting toxicity. Otherwise, resume treatment at one dose level below the dose being administered. If the patient is not receiving a growth factor, administer a growth factor. If this medicine was dose-reduced due to hematologic dose-limiting toxicity (DLT), treatment may be resumed at an increased 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 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 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 cannot 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 worsens. 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 count weekly When recovered to ≧25,000㎕ Resume treatment with this medicine and melphalan at one dose level below the doses being administered If subsequently decreased 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 administered ② Dose adjustment according to absolute neutrophil count (Absolute Neutrophil Count: ANC) Table 6. Neutrophil count Recommended dose If decreased to <500/㎕ Interrupt this medicine, melphalan, and prednisolone and monitor complete blood count 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 administered If subsequently decreased 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 administered For neutropenia, use of growth factors should be considered for patient management. ③ Dose adjustment for febrile neutropenia (fever ≥38.5℃ and ANC<1,000/㎕): Interrupt this medicine, melphalan, and prednisolone and monitor complete blood count weekly. If the patient is not receiving a growth factor, use of a growth factor should be considered. On the first day of the next treatment cycle, resume treatment at the dose being administered, continuing growth factor use if necessary, if neutropenia is the only dose-limiting toxicity. Otherwise, resume treatment at one dose level below the dose being administered. If the patient is not receiving a growth factor, administer a growth factor. 4) Combination therapy with bortezomib and dexamethasone for the treatment of newly diagnosed patients (1) Combination therapy with bortezomib and dexamethasone for the treatment of newly diagnosed patients who are not eligible for transplantation Treatment should not be initiated if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <80,000/㎕. The recommended 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 (24 weeks total) of treatment as initial therapy. After initial therapy, take 25mg of this medicine with dexamethasone once daily on days 1-21 of each 28-day cycle. The recommended dexamethasone dosage regimen is 40mg once daily on days 1, 8, 15, and 22 of each 28-day cycle. For patients aged 75 years or older, the starting dose of dexamethasone is 20mg once daily on days 1, 8, 15, and 22 of each 28-day cycle. Treatment may continue until disease progression or unacceptable toxicity occurs. (2) Induction combination therapy with dexamethasone and bortezomib for the treatment of newly diagnosed patients 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 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 (24 weeks total) 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 count weekly When recovered to ≧50,000㎕ Resume at one dose level below the dose being administered If subsequently decreased to <30,000/㎕ Interrupt treatment When recovered to ≧50,000㎕ Resume treatment at one dose level below the dose being administered ② Dose adjustment according to absolute neutrophil count (Absolute Neutrophil Count: ANC) Table 8. Absolute neutrophil count Recommended dose If decreased to <500/㎕ Interrupt treatment and monitor complete blood count weekly When recovered to ≧1,000/㎕ and neutropenia is the only toxicity Resume treatment at the starting dose When recovered to ≧500/㎕ and dose-dependent hematologic toxicity other than neutropenia has occurred Resume at one dose level below the dose being administered If subsequently decreased to <500/㎕ Interrupt treatment When recovered to ≧500/㎕ Resume at one dose level below the dose being administered For neutropenia, use of growth factors should be considered for patient management. *For dose adjustment of concomitant medicines, refer to the prescribing information for the relevant product. 5) Maintenance therapy for 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 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 a 28-day cycle) 5 mg 3rd 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 9. Platelet count Recommended dose If decreased to <30,000/㎕ Interrupt treatment and monitor complete blood count weekly When recovered to ≧30,000㎕ Resume treatment at one dose level below the dose being administered If subsequently decreased to <30,000/㎕ Interrupt treatment When recovered to ≧30,000㎕ Resume treatment at one dose level below the dose being administered ② Dose adjustment according to absolute neutrophil count (Absolute Neutrophil Count: ANC) Table 10. Neutrophil count Recommended dose If decreased to <500/㎕ Interrupt treatment and monitor complete blood count weekly When recovered to ≧500/㎕ Resume treatment at one dose level below the dose being administered If subsequently decreased to <500/㎕ Interrupt treatment When recovered to ≧500/㎕ Resume treatment at one dose level below the dose being administered For neutropenia, use of growth factors should be considered for patient management. 2. Myelodysplastic syndromes Treatment should not be initiated if the absolute neutrophil count is <500/㎕ and/or the platelet count is <25,000/㎕. The recommended 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 count weekly When recovered to ≧50,000/㎕, or When recovered to ≧25,000/㎕~<50,000/㎕ at least 2 times over 7 days or more Resume at one dose level below the dose being administered ② Dose adjustment according to absolute neutrophil count (Absolute Neutrophil Count: ANC) Table 12. Absolute neutrophil count Recommended dose If decreased to <500/㎕ Interrupt treatment and monitor complete blood count weekly When recovered to ≧500/㎕ Resume at one dose level below the dose being administered For neutropenia, use of growth factors should be considered for patient management. Discontinue treatment with this medicine 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, if no transfusions were given, a 1g/dl increase in hemoglobin level). 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 count weekly When 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 count weekly When recovered to ≧60,000/㎕ Resume at one dose level below the dose being administered Do not reduce the dose below 2.5mg once daily or 5mg every other day. ② Dose adjustment according to absolute neutrophil count (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 count weekly When 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. When recovered to ≧1,000/㎕ Resume at one dose level below the dose being administered 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 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 is based on a 28-day cycle. During cycle 1, administer 375 mg/m2 intravenously once weekly (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 count weekly When 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 count weekly When recovered to ≥50,000/㎕ Resume at one dose level below the dose being administered Do not reduce the dose below 5mg once daily. ② Dose adjustment according to absolute neutrophil count (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 count weekly When 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 count weekly When recovered to ≥1,000/㎕ Resume at one dose level below the dose being administered Do not reduce the dose below 5mg once daily. Mantle cell lymphoma or follicular lymphoma Tumor lysis syndrome (Tumor lysis syndrome, TLS) All patients should receive prophylaxis for tumor lysis syndrome (allopurinol, rasburicase, or an equivalent regimen in accordance with institutional treatment guidelines) and should receive adequate oral hydration during the first week of the first treatment cycle or for a longer period if clinically necessary. To monitor for tumor lysis syndrome, patients should have a chemistry panel performed weekly during the first cycle and as 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 practice until electrolyte abnormalities are corrected. Treatment with rasburicase may be necessary 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 necessary. Provide adequate intravenous hydration and appropriate medical management according to standard practice until electrolyte abnormalities are corrected. Treatment with rasburicase and hospitalization are at the physician’s discretion. Once TLS improves to grade 0, resume treatment at one dose level lower, at the physician’s discretion. Tumor flare reaction (tumor flare reaction, TFR) For 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. 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 a grade 3/4 tumor flare reaction, interrupt this medicine and initiate treatment with non-steroidal anti-inflammatory drugs, 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 guidance for treating grade 1/2 tumor flare reactions. 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 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, an anaphylactic reaction, grade 4 rash, exfoliative or bullous rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, or a drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) is suspected, discontinue treatment and do not resume treatment even after the reaction has resolved. 7. Dose in patients with renal impairment This medicine is excreted through the kidneys, and toxicity may be more pronounced in patients with renal impairment. Because renal impairment is more common in elderly patients, use caution when selecting the dose and carefully monitor renal function. The initial dose for patients with renal impairment is as follows. This medicine has not been studied in non-dialysis patients with creatinine clearance below 11 mL/min or in patients with creatinine clearance below 7 mL/min. Table 17. Initial dose in patients with renal impairment (days 1 ~ 21 of each 28-day cycle)_multiple myeloma or mantle cell lymphoma Category Renal function (Cockcroft-Gault CLcr) Dose adjustment in multiple myeloma/mantle cell lymphoma Dose adjustment in post-transplant maintenance therapy Moderate renal impairment 30 ≤ CLcr <50mL/min 10mg once daily* 5mg once daily Severe renal impairment CLcr <30mL/min (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 does not respond to treatment and tolerates it. Table 18. Initial dose in patients with renal impairment_myelodysplastic syndromes Category Renal function (Cockcroft-Gault CLcr) Dose adjustment in 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 in follicular lymphoma (days 1 ~ 21 of each 28-day cycle) Moderate renal impairment 30 ≤ CLcr < 60mL/min 10mg once daily1,2 Severe renal impairment CLcr < 30mL/min (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, 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 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 based on the individual patient’s tolerability, as described above. 8. Take with water. Do not crush, chew, or open the capsules. The dose may be adjusted based on clinical or laboratory test results.

This medication can cause serious birth defects if taken during pregnancy, so women of childbearing potential must have at least two pregnancy tests before starting and use effective contraception during and for a certain period after treatment. This medication may reduce the number of white blood cells and platelets in the blood, increasing the risk of infections or bleeding. Regular blood tests to monitor blood cell counts are essential. Patients with a risk of cardiovascular disease or thrombosis may be at increased risk of myocardial infarction or thromboembolism while taking this medication; precautions should be taken to minimize risks and monitor carefully. This medication can affect liver and kidney function, so patients with liver or kidney impairment should have their dose adjusted and undergo regular liver and kidney function tests. Tumor lysis syndrome and tumor flare reactions may occur, so especially patients with a high tumor burden need careful observation and preventive measures when initiating treatment or increasing doses. This medication may impact the immune system, increasing the risk of infections. Patients should report any symptoms of infection to healthcare providers immediately and should take precautions against infections. Hypersensitivity reactions, severe skin reactions (such as Stevens-Johnson syndrome, toxic epidermal necrolysis), and anaphylaxis have been reported. If these symptoms occur, treatment must be stopped immediately, and medical attention should be sought. This medication should not be administered to patients with certain genetic disorders (e.g., galactose intolerance), and consultation with healthcare providers is required before use. Regular health assessments during or after treatment are necessary. Any unusual symptoms should be reported to healthcare providers immediately.

Skeletal dysplasia, congenital malformation, miscarriage, neutropenia, thrombocytopenia, febrile reaction, bleeding, myocardial infarction, venous thromboembolism, arterial thromboembolism, secondary primary malignant tumors, acute myeloid leukemia, myelodysplastic syndrome, liver failure, toxic hepatitis, cytolytic hepatitis, cholestatic hepatitis, liver function abnormalities, vascular edema, anaphylactic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS 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, pneumonia, renal failure, weakness, insomnia, decreased appetite, cough, fever, back pain, asthenia, upper respiratory infection, bacterial infection, viral infection, fungal infection, rhinitis, pharyngitis, bronchitis, sinusitis, soft tissue infection, sepsis, lung infection, urinary tract infection, sinusitis, basal cell carcinoma, squamous cell carcinoma, T-cell acute leukemia, thrombocytopenia, leukopenia, lymphopenia, pancytopenia, hemolytic anemia, hypercoagulability, coagulopathy, hypersensitivity, hypothyroidism, hypokalemia, hyperglycemia, hypoglycemia, hypocalcemia, hyponatremia, dehydration, weight loss, diabetes, hypophosphatemia, hyperuricemia, hypercalcemia, depression, insomnia, decreased libido, peripheral neuropathy, paresthesia, dizziness, tremor, dysgeusia, headache, stroke, syncope, neuralgia, ataxia, impaired sense of balance, intracranial hemorrhage, transient ischemic attack, cerebral ischemia, cataract, blurred vision, visual impairment, blindness, hearing loss, tinnitus, atrial fibrillation, bradycardia, congestive heart failure, tachycardia, heart failure, myocardial ischemia, arrhythmia, QT prolongation, atrial flutter, premature ventricular contractions, hypotension, hypertension, petechiae, vasculitis, ischemia, peripheral ischemia, intracranial venous thrombosis, dyspnea, nosebleed, breathing difficulties, pleuritic pain, hypoxia, voice disorders, abdominal pain, nausea, vomiting, dyspepsia, dry mouth, stomatitis, gastrointestinal bleeding, small bowel obstruction, colitis, appendicitis, alanine aminotransferase elevation, aspartate aminotransferase elevation, hepatocyte damage, hyperbilirubinemia, urticaria, hyperhidrosis, dry skin, skin hyperpigmentation, eczema, erythema, skin depigmentation, photosensitivity, muscle weakness, bone pain, musculoskeletal pain, arthralgia, limb pain, myalgia, joint swelling, renal failure, hematuria, urinary retention, urinary incontinence, acquired Fanconi syndrome, erectile dysfunction, edema, influenza-like symptoms, increased serum alkaline phosphatase, increased C-reactive protein, falls, contusions, pulmonary embolism, hypocalcemia, hypomagnesemia, hyperuricemia, hypercalcemia, fatigue, chills, hiccups, anxiety, sleep disorders, abdominal discomfort, oral pain, dental pain, oral ulceration, chronic gastritis, gastritis, dental caries, hemorrhoids, ascites, ischemic colitis, colon ulcer, colon perforation, colon polyp, epigastric discomfort, erosive esophagitis, esophagitis, gastric ulcer, gum swelling, hemorrhagic diverticulitis, intestinal obstruction, intestinal occlusion, rectal pain, periodontal disease, anal erosion, hematochezia, pleural effusion, asthma, rhinorrhea, 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, pulmonary mass, obstructive bronchitis, respiratory abnormalities, pleuritic pain, peripheral motor neuropathy, dementia, hypertrophic cardiomyopathy, neuropathic pain, speech disorders, epilepsy, intracranial mass, chronic polyneuropathy, Charcot-Marie-Tooth syndrome, head discomfort, hemiplegia, seizures, neuritis, uremic encephalopathy, cognitive impairment, burning mouth syndrome, oculomotor nerve palsy, Parkinson's disease, postherpetic neuralgia, action tremor, hyperkalemia, hypoalbuminemia, iron deficiency, delirium, restlessness, attention deficit disorder, vertebral compression fracture, rib fracture, femoral neck fracture, radiation pneumonitis, spinal cord injury, vertebral fractures, forearm fracture, thoracic vertebra fracture, urethral discomfort, end-stage renal disease, polyuria, nocturia, abnormal urination, urethral discharge, mucosal inflammation, swelling, multiple organ failure, multiorgan dysfunction, death, warmth sensation, injection site pain, blister, petechiae, skin hyperpigmentation, papular scaly rash, chronic pigmented purpura, exfoliative dermatitis, macule, purpura, contact dermatitis, hair loss, skin reaction, skin lesions, skin peeling, subcutaneous bleeding, jaw pain, osteoporosis, joint stiffness, bone resorption, limb discomfort, rhabdomyolysis, chest wall mass, pustular rash, gingivitis, elevated serum creatinine, weight gain, decreased renal creatinine clearance, increased blood urea, conjunctival hemorrhage, borderline glaucoma, myopia, eye swelling, eye pain, retinal disorders, retinopathy, double vision, blepharitis, periorbital edema, cardiac effusion, stress-induced cardiomyopathy, subendocardial ischemia, cardiac arrest, Prinzmetal angina, restrictive cardiomyopathy, cervical dysplasia, vaginal discharge, vaginal bleeding, perineal rash, hyperbilirubinemia, Cushing's syndrome, inappropriate secretion of antidiuretic hormone, benign prostatic hyperplasia, female genital fistula, flushing, shock, ear discomfort, ear pus, hearing loss, hemolytic uremic syndrome, acquired hemophilia, candidemia

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, it is best stored at room temperature between 15°C and 30°C. Proper storage will help maintain the drug's effectiveness over time.

Appearance

A hard capsule containing white or off-white powder in the upper and lower parts.

Package unit

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