Revlimid Capsule 25 mg (Lenalidomide)

Adult dosage

1. Multiple myeloma 1) Combination therapy with dexamethasone for 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 starting dose is 25mg once daily. Take 25mg capsules 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 adjustments during treatment ① Dose adjustment according to platelet count If the count decreases to <30,000/㎕, interrupt treatment and monitor the complete blood count weekly When the count recovers to ≧30,000/㎕, resume treatment at 15mg once daily If the count subsequently decreases to <30,000/㎕, interrupt treatment When the count recovers 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) If the count decreases to <1,000/㎕, interrupt treatment, administer additional G-CSF, and monitor the complete blood count weekly When the count recovers to ≧1,000/㎕ and neutropenia is the only toxicity, resume treatment at 25mg once daily When the count recovers to ≧1,000/㎕ and other toxicities have occurred, resume treatment at 15mg once daily If the count subsequently decreases to <1,000/㎕, interrupt treatment When the count recovers 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 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 starting dose is 25mg once daily. Take 25 mg capsules 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 adjustments during treatment <Dose reduction levels> This drug: starting 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 Dexamethasone: starting dose 40 mg, first dose reduction 20 mg, second dose reduction 12 mg, third dose reduction 8 mg, fourth dose reduction 4 mg, fifth dose reduction N/A ① Dose adjustment according to platelet count If the count decreases to <25,000/㎕, interrupt administration of this drug and dexamethasone and monitor the complete blood count weekly When the count recovers 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) If the count decreases to <500/㎕, interrupt administration of this drug and dexamethasone and monitor the complete blood count weekly When the count recovers to ≧1,000/㎕ and neutropenia is the only toxicity, resume treatment at the starting dose When the count recovers to ≧500/㎕ and dose-dependent hematologic toxicity other than neutropenia has occurred, resume at one dose level below the dose being administered If the count subsequently decreases to <500/㎕, interrupt administration of this drug and dexamethasone When the count recovers 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 the complete blood count weekly. If the patient has not been receiving a growth factor, use of a growth factor should be considered. At the start of the next treatment cycle, if neutropenia is the only dose-limiting toxicity, resume treatment at the dose being administered, continuing use of a growth factor if necessary. Otherwise, resume treatment at one dose level below the dose being administered. If the patient has not been receiving a growth factor, administer a growth factor. If the dose of this drug has been reduced due to hematologic dose-limiting toxicity (dose limiting toxicity, DLT), and bone marrow function improves during continued treatment (no dose-limiting toxicity (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/㎕), treatment may be resumed with an increased dose of this drug 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 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 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 due to tolerability, administer this drug alone at 10mg once daily on days 1~21 of each 28-day cycle until disease progression. Dose adjustments during treatment <Dose reduction levels> This drug: starting dose 10 mg, first dose reduction 7.5 mg, second dose reduction 5 mg, third dose reduction 2.5 mg Melphalan: starting dose 0.18 mg/kg, first dose reduction 0.14 mg/kg, second dose reduction 0.10 mg/kg, third dose reduction N/A Prednisolone: starting dose 2 mg/kg, first dose reduction 1 mg/kg, second dose reduction 0.5 mg/kg, third dose reduction 0.25 mg/kg ① Dose adjustment according to platelet count If the count decreases to <25,000/㎕, interrupt administration of this drug, melphalan, and prednisolone and monitor the complete blood count weekly When the count recovers to ≧25,000/㎕, resume treatment with this drug and melphalan at doses reduced by one level If the count subsequently decreases to <30,000/㎕, interrupt administration of this drug, melphalan, and prednisolone When the count recovers to ≧30,000/㎕, resume treatment with this drug and melphalan at doses reduced by one level from the doses being administered ② Dose adjustment according to absolute neutrophil count (Absolute Neutrophil Count: ANC) If the count decreases to <500/㎕, interrupt administration of this drug, melphalan, and prednisolone and monitor the complete blood count weekly When the count recovers to ≧500/㎕ and neutropenia is the only toxicity, resume treatment at the starting dose When the count recovers to ≧500/㎕ and dose-dependent hematologic toxicity other than neutropenia has occurred, resume treatment with this drug and melphalan at doses reduced by one level If the count subsequently decreases to <500/㎕, interrupt administration of this drug, melphalan, and prednisolone When the count recovers to ≧500/㎕, resume treatment with this drug and melphalan at doses reduced by one level from 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 administration of this drug, melphalan, and prednisolone and monitor the complete blood count weekly. If the patient has not been receiving a growth factor, use of a growth factor should be considered. At the start of the next treatment cycle, if neutropenia is the only dose-limiting toxicity, resume treatment at the dose being administered, continuing use of a growth factor if necessary. Otherwise, resume treatment at one dose level below the dose being administered. If the patient has not been 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 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 starting dose of this drug is 25mg once daily, taken on days 1~14 of each 21-day cycle. Administer bortezomib by subcutaneous injection at a dose of 1.3mg/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 (24 weeks total) of treatment as initial therapy. After initial treatment, take 25mg of this drug once daily in combination with dexamethasone on days 1-21 of each 28-day cycle. The recommended dosage regimen for dexamethasone is 40mg once daily on days 1, 8, 15, and 22 of each 28-day cycle. For patients aged 75 years or older, the starting dose of dexamethasone is 20mg once daily on days 1, 8, 15, and 22 of each 28-day cycle. Treatment may continue until disease progression or unacceptable toxicity occurs. (2) Induction combination therapy with dexamethasone and bortezomib for the treatment of newly diagnosed patients 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 drug is 25mg once daily, taken on days 1~21 of each 28-day cycle. Administer bortezomib by subcutaneous injection at a dose of 1.3mg/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 (24 weeks total) of treatment as induction therapy. Dose adjustments during treatment <Dose reduction levels> This drug: starting 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 If the count decreases to <30,000/㎕, interrupt treatment and monitor the complete blood count weekly When the count recovers to ≧50,000/㎕, resume at one dose level below the dose being administered If the count subsequently decreases to <30,000/㎕, interrupt treatment When the count recovers 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) If the count decreases to <500/㎕, interrupt treatment and monitor the complete blood count weekly When the count recovers to ≧1,000/㎕ and neutropenia is the only toxicity, resume treatment at the starting dose When the count recovers to ≧500/㎕ and dose-dependent hematologic toxicity other than neutropenia has occurred, resume at one dose level below the dose being administered If the count subsequently decreases to <500/㎕, interrupt treatment When the count recovers to ≧500/㎕, resume at one dose level below the dose being administered For neutropenia, use of growth factors should be considered for patient management. *Refer to the prescribing information for the concomitant drug for dose adjustments. 5) Maintenance therapy in newly diagnosed patients who have undergone autologous hematopoietic stem cell transplantation Maintenance therapy with this drug 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 intolerable toxicity or disease progression occurs. After 3 cycles of maintenance therapy with this drug, the dose may be increased to 15mg once daily if tolerated. Dose adjustments during treatment <Dose reduction levels> Starting dose (10mg): first dose reduction 5 mg, second dose reduction 5mg (days 1~21 of a 28-day cycle), third dose reduction N/A If the dose has been increased (15mg)*: first dose reduction 10 mg, second dose reduction 5 mg, third dose reduction 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 drug, the dose may be increased to 15mg once daily if tolerated. ① Dose adjustment according to platelet count If the count decreases to <30,000/㎕, interrupt treatment and monitor the complete blood count weekly When the count recovers to ≧30,000/㎕, resume at a dose reduced by one level If the count subsequently decreases to <30,000/㎕, interrupt treatment When the count recovers to ≧30,000/㎕, resume at a dose reduced by one level from the dose being administered ② Dose adjustment according to absolute neutrophil count (Absolute Neutrophil Count: ANC) If the count decreases to <500/㎕, interrupt treatment and monitor the complete blood count weekly When the count recovers to ≧500/㎕, resume at a dose reduced by one level If the count subsequently decreases to <500/㎕, interrupt treatment When the count recovers to ≧500/㎕, resume at a dose reduced by one level from 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 adjustments during treatment <Dose reduction levels> Starting dose of this drug: 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 If the count decreases to <25,000/㎕, interrupt treatment and monitor the complete blood count weekly When the count recovers to ≧50,000/㎕, or recovers to ≧25,000/㎕~<50,000/㎕ at least 2 times over a period of at least 7 days, resume at one dose level below the dose being administered ② Dose adjustment according to absolute neutrophil count (Absolute Neutrophil Count: ANC) If the count decreases to <500/㎕, interrupt treatment and monitor the complete blood count weekly When the count recovers to ≧500/㎕, resume at one dose level below the dose being administered For neutropenia, use of growth factors should be considered for patient management. Discontinue treatment with this drug in patients who have not achieved at least a minor erythroid response within 4 months after starting treatment, as demonstrated by at least a 50% reduction in transfusion requirements or, in patients who were not transfusion-dependent, a hemoglobin increase of 1g/dl. 3. Mantle cell lymphoma The recommended starting dose is 25mg once daily. Take 25mg capsules on days 1~21 of each 28-day cycle. Dose adjustments during treatment <Dose reduction levels> Starting dose of this drug: 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 If the count decreases to <50,000/㎕, interrupt treatment and monitor the complete blood count weekly When the count recovers to ≧60,000/㎕, resume at one dose level below the dose being administered If the count subsequently decreases to <50,000/㎕, interrupt treatment and monitor the complete blood count weekly When the count recovers 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) If the count decreases to <1,000/㎕ for at least 7 days, or decreases to <1,000/㎕ with fever (temperature≧38.5℃), or decreases to <500/㎕, interrupt treatment and monitor the complete blood count weekly When the count recovers to ≧1,000/㎕, resume at one dose level below the dose being administered If the count subsequently decreases to <1,000/㎕ for at least 7 days, or decreases to <1,000/㎕ with fever (temperature≧38.5℃), or decreases to <500/㎕, interrupt treatment. When the count recovers 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 infiltration of the bone marrow). The recommended starting dose is 20mg once daily. Take 20mg capsules on days 1~21 of each 28-day cycle. Take for a maximum of 12 treatment cycles. The recommended starting dose of rituximab is based on a 28-day cycle: administer 375 mg/m2 intravenously weekly during cycle 1 (days 1, 8, 15, and 22). During cycles 2~5, administer 375 mg/m2 intravenously only on day 1 of each 28-day cycle. Dose adjustments during treatment <Dose reduction levels> Starting dose of this drug: 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 Refer to the relevant prescribing information for dose adjustments due to rituximab toxicity. ① Dose adjustment according to platelet count If the count decreases to <50,000/㎕, interrupt treatment with this drug and monitor the complete blood count weekly When the count recovers to ≥50,000/㎕, resume at one dose level below the dose being administered If the count subsequently decreases to <50,000/㎕, interrupt treatment with this drug and monitor the complete blood count weekly When the count recovers 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) If the count decreases to <1,000/㎕ for at least 7 days, or decreases to <1,000/㎕ with fever (temperature≥38.5°C), or decreases to <500/㎕, interrupt treatment with this drug and monitor the complete blood count weekly When the count recovers to ≥1,000/㎕, resume at one dose level below the dose being administered If the count subsequently decreases to <1,000/㎕ for at least 7 days, or decreases to <1,000/㎕ with fever (temperature≥38.5°C), or decreases to <500/㎕, interrupt treatment with this drug and monitor the complete blood count weekly When the count recovers 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 according to institutional treatment guidelines) and should receive adequate oral hydration during the first week of the first treatment cycle, or for a longer period if clinically necessary. To monitor for tumor lysis syndrome, patients should undergo a chemistry panel during the first cycle and weekly if clinically necessary. For patients with laboratory tumor lysis syndrome (laboratory TLS) or grade 1 clinical tumor lysis syndrome (clinical TLS), this drug may be continued at the same dose or, at the physician's discretion, continued at a dose reduced by one level. Provide adequate intravenous hydration and appropriate medical management according to standard treatment until electrolyte abnormalities are corrected. Rasburicase treatment may be needed to reduce hyperuricemia. Hospitalization is at the physician's discretion. For patients with grade 2-4 clinical tumor lysis syndrome, discontinue this drug and perform a chemistry panel weekly or as clinically necessary. Provide adequate intravenous hydration and appropriate medical management according to standard treatment until electrolyte abnormalities are corrected. Rasburicase treatment and hospitalization are at the physician's discretion. When tumor lysis syndrome improves to grade 0, resume treatment at a dose reduced by one level at the physician's discretion. Tumor flare reaction (tumor flare reaction, TFR) For patients who develop grade 1/2 tumor flare reaction, treatment with this drug may continue without interruption or dose reduction at the prescriber's discretion. At the prescriber's discretion, non-steroidal anti-inflammatory drugs (non-steroidal anti-inflammatory drugs, NSAIDs), corticosteroids for a limited period, and/or opioid analgesics may be administered. For patients who develop grade 3/4 tumor flare reaction, discontinue this drug and initiate treatment with non-steroidal anti-inflammatory drugs, 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 receive symptom management according to guidance for treatment of grade 1/2 tumor flare reaction. 5. Dose adjustment for other grade 3/4 toxicities If other grade 3/4 toxicities related to this drug occur, interrupt treatment. Once the toxicity improves to grade 2 or lower, resume treatment at a dose one level below the dose being administered, at the prescriber's discretion. 6. This drug should not be administered to patients with a history of grade 4 rash due to thalidomide. For grade 2-3 skin rash, interruption or discontinuation of this drug should be considered. If angioedema, anaphylactic reaction, grade 4 rash, exfoliative or bullous rash occurs, or Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) is suspected, discontinue treatment and do not resume treatment even after the reaction resolves. 7. Dosage in patients with renal impairment Because this drug is excreted through the kidneys, toxicity may be more pronounced in patients with renal impairment. Renal impairment is more common in elderly patients; caution is required when selecting a dose, and renal function should be monitored carefully. The initial doses for patients with renal impairment are as follows. Patients with a creatinine clearance of less than 11 mL/min who are not on dialysis and patients with a creatinine clearance of less than 7 mL/min have not been studied. Table 15. Initial dose in patients with renal impairment_Multiple myeloma or mantle cell lymphoma Moderate renal impairment: 30 ≤ CLcr <50mL/min, dose adjustment for multiple myeloma/mantle cell lymphoma 10mg once daily*, dose adjustment for post-transplant maintenance therapy 5mg once daily Severe renal impairment: CLcr <30mL/min (patients not on dialysis), dose adjustment for multiple myeloma/mantle cell lymphoma 7.5mg once daily or 15mg every other day, dose adjustment for post-transplant maintenance therapy 2.5mg once daily End-stage renal disease: CLcr <30mL/min (patients on dialysis), dose adjustment for multiple myeloma/mantle cell lymphoma 5mg once daily; administer after dialysis on dialysis days, dose adjustment for post-transplant maintenance therapy 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 16. Initial dose in patients with renal impairment_Myelodysplastic syndromes Moderate renal impairment: 30 ≤ CLcr <50mL/min, starting dose 5mg once daily (days 1 ~ 21 of each 28-day cycle), first dose reduction 2.5mg once daily (days 1 ~ 28 of each 28-day cycle), second dose reduction 2.5mg every other day (days 1 ~ 28 of each 28-day cycle) Severe renal impairment: CLcr <30mL/min (patients not on dialysis), starting dose 2.5mg once daily (days 1 ~ 21 of each 28-day cycle), first dose reduction 2.5mg every other day (days 1 ~ 28 of each 28-day cycle), second dose reduction 2.5mg twice weekly (days 1 ~ 28 of each 28-day cycle) End-stage renal disease: CLcr <30mL/min (patients on dialysis), starting dose 2.5mg once daily (days 1 ~ 21 of each 28-day cycle), first dose reduction 2.5mg every other day (days 1 ~ 28 of each 28-day cycle), second dose reduction 2.5mg twice weekly (days 1 ~ 28 of each 28-day cycle) On dialysis days, administer after dialysis Table 17. Dose in patients with renal impairment_Follicular lymphoma Moderate renal impairment: 30 ≤ CLcr < 60mL/min, dose adjustment for follicular lymphoma (days 1 ~ 21 of each 28-day cycle) 10mg once daily1,2 Severe renal impairment: CLcr < 30mL/min (patients not on dialysis), 5mg once daily End-stage renal disease: CLcr < 30mL/min (patients on dialysis), 5mg once daily; administer after dialysis on dialysis days 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 due to grade 3/4 neutropenia or thrombocytopenia, or another grade 3/4 toxicity considered related to this drug, do not reduce the dose below 5mg every other day or 2.5mg once daily. After starting treatment with this drug, dose adjustment in patients with renal impairment should be performed according to the individual patient's tolerability, as described above. 8. Take with water. Do not crush, chew, or open the capsule. The administered dose may be adjusted based on clinical or laboratory test results.

This medication should not be taken during pregnancy as it may pose serious risks of fetal malformations or miscarriage. Women of childbearing potential must undergo two pregnancy tests before taking this medication and must use adequate contraception before, during, and after treatment. This drug can reduce levels of white blood cells and platelets in the blood, so regular blood tests are required, and any signs of infection or bleeding must be reported immediately to a healthcare provider. Patients at risk of cardiovascular disease should be closely monitored for cardiovascular problems such as myocardial infarction during the use of this medication. There may be an increased risk of thrombosis; therefore, patients with a history of thrombosis or risk factors should take special precautions and preventive measures. This medication may affect liver function; thus, regular liver function tests are required for patients with liver disease or abnormal liver function findings. Patients with reduced kidney function require dosage adjustments and continual monitoring of kidney function. Patients with a high tumor burden may experience tumor lysis syndrome or tumor flare reactions, necessitating special precautions and monitoring at the start of treatment or when adjusting dosages. The risk of infection may increase; hence, rapid consultation with healthcare providers is crucial if symptoms like fever or cough occur. There is a risk of reactivation of viral infections; patients with a history of viral infections such as hepatitis B require careful monitoring and management before and after treatment. This medication can evoke severe skin reactions or allergic responses; therefore, treatment should be immediately stopped and the healthcare provider informed if symptoms like rash or breathing difficulty arise. Neurological symptoms or cognitive and behavioral changes may occur during treatment, requiring immediate consultation with healthcare professionals if such symptoms appear. This medication should not be administered to patients with specific genetic metabolic disorders, and those with a history of hypersensitivity should also avoid it. Various side effects may occur during the treatment process, so regular health status checks and prompt consultation with healthcare providers for any abnormal symptoms are important.

Skeletal dysplasia, congenital malformation, miscarriage, neutropenia, thrombocytopenia, febrile reaction, bleeding, myocardial infarction, venous thromboembolism, arterial thromboembolism, secondary primary malignant tumor, acute myeloid leukemia, myelodysplastic syndrome, liver failure, toxic hepatitis, cytolytic hepatitis, cholestatic hepatitis, pneumonia, renal failure, vascular edema, anaphylactic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash syndrome with eosinophilia and systemic symptoms, pulmonary hypertension, tumor lysis syndrome, infection, viral reactivation, progressive multifocal leukoencephalopathy, cataract, fatigue, constipation, diarrhea, muscle cramps, anemia, rash, decreased appetite, cough, fever, weakness, insomnia, back pain, lethargy, hypotension, lung infection, dehydration, hypokalemia, hyperglycemia, hypoglycemia, hypocalcemia, hyponatremia, diabetes, hypophosphatemia, hyperuricemia, depression, insomnia, decreased libido, peripheral neuropathy, abnormal sensation, dizziness, tremor, taste disorder, headache, stroke, fainting, neuralgia, ataxia, impaired sense of balance, intracranial hemorrhage, transient ischemic attack, cerebral ischemia, visual impairment, blindness, hearing loss, tinnitus, atrial fibrillation, bradycardia, congestive heart failure, tachycardia, heart failure, myocardial ischemia, arrhythmia, QT prolongation, atrial flutter, ventricular ectopic contractions, hypertension, petechiae, vasculitis, ischemia, peripheral ischemia, intracranial venous sinus thrombosis, shortness of breath, nosebleed, respiratory distress, pleuritic pain, hypoxemia, voice disorder, abdominal pain, nausea, vomiting, dyspepsia, dry mouth, stomatitis, gastrointestinal bleeding, small bowel obstruction, colitis, appendicitis, elevated alanine aminotransferase, elevated aspartate aminotransferase, hepatotoxicity, hepatocyte injury, hyperbilirubinemia, liver failure, urticaria, hyperhidrosis, dry skin, skin hyperpigmentation, eczema, erythema, drug rash, skin depigmentation, photosensitivity reaction, muscle weakness, bone pain, musculoskeletal and connective tissue pain, arthralgia, joint swelling, renal failure, hematuria, urinary retention, urinary incontinence, acquired Fanconi syndrome, erectile dysfunction, edema, influenza-like symptoms, chest pain, drowsiness, increased serum alkaline phosphatase, increased C-reactive protein, falls, contusions, pneumonia, septic shock, influenza, pulmonary embolism, pleural effusion, interstitial pneumonia, pulmonary arterial hypertension, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug adverse reaction with eosinophilia and systemic reaction, acquired hemophilia, candidemia

This medication must be stored in a tightly closed container to protect it from air and moisture. Additionally, it is important to store it at room temperature between 15 to 30 degrees Celsius to maintain its efficacy.

Appearance

A white hard capsule containing white powder.

Package unit

7 capsules/pack