Renalid Tablet (Lenalidomide)

Adult dosage

This drug 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). This drug may be prescribed only by physicians enrolled in the Risk Management Program and dispensed only by pharmacists enrolled in the program. When prescribed to women of childbearing potential, negative pregnancy test results must be confirmed continuously according to the schedule specified in this program. 1. Multiple myeloma 1) Combination therapy with dexamethasone for the treatment of patients who have received one or more prior therapies Treatment should not be initiated if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <75,000/㎕. The recommended starting dose is 25mg once daily. Take 25mg on days 1~21 of each 28-day cycle. The recommended dose of dexamethasone, based on a 28-day cycle, is 40mg once daily on days 1~4, 9~12, and 17~20 during the first 4 cycles. After cycle 4, 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 If decreased to <30,000/㎕, interrupt treatment and monitor complete blood counts weekly When recovered to ≧30,000/㎕, resume at 15mg once daily Thereafter, if 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 below 5mg daily. ② Dose adjustment according to absolute neutrophil count (ANC) If decreased to <1,000/㎕, interrupt treatment, add G-CSF, and monitor complete blood counts weekly When recovered to ≧1,000/㎕ and neutropenia is the only toxicity, resume at 25mg once daily When recovered to ≧1,000/㎕ and other toxicities have occurred, resume at 15mg once daily Thereafter, if 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 below 5mg daily. For neutropenia, use of growth factors should be considered for patient management. 2) Combination therapy with dexamethasone for the treatment of newly diagnosed patients who are not candidates for transplantation Treatment should not be initiated if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <50,000/㎕. The recommended starting dose is 25mg once daily. Take 25 mg on days 1~21 of each 28-day cycle. The recommended dose of dexamethasone, based on a 28-day cycle, is 40mg 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 20mg once daily on days 1, 8, 15, and 22. Continue treatment until disease progression or unacceptable toxicity occurs. Dose adjustment during treatment <Dose reduction levels> This drug / dexamethasone Starting 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 If decreased to <25,000/㎕, interrupt this drug and dexamethasone and monitor complete blood counts weekly When recovered to ≧50,000/㎕, resume at one dose level below the dose being administered ② Dose adjustment according to absolute neutrophil count (ANC) If decreased to <500/㎕, interrupt this drug and dexamethasone and monitor complete blood counts weekly When recovered to ≧1,000/㎕ and neutropenia is the only toxicity, resume at the starting dose When recovered to ≧500/㎕ and dose-dependent hematologic toxicities other than neutropenia have occurred, resume at one dose level below the dose being administered Thereafter, if decreased to <500/㎕, interrupt this drug 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 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, resume treatment at the dose being administered if neutropenia is the only dose-limiting toxicity, continuing the growth factor if necessary. 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 drug has been dose-reduced due to a hematologic dose-limiting toxicity (dose limiting toxicity, DLT), and treatment continues with improved bone marrow function (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 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 not candidates for transplantation Treatment should not be initiated if the absolute neutrophil count is <1,500/㎕ and/or the platelet count is <75,000/㎕. The recommended starting dose is 10mg once daily. Take 10 mg 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, take this drug alone at 10mg once daily on days 1~21 of each 28-day cycle until disease progression. Dose adjustment during treatment <Dose reduction levels> This drug / melphalan / prednisolone Starting 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 If decreased to <25,000/㎕, interrupt this drug, melphalan, and prednisolone and monitor complete blood counts weekly When recovered to ≧25,000/㎕, resume with this drug and melphalan at doses reduced by one level Thereafter, if decreased to <30,000/㎕, interrupt this drug, melphalan, and prednisolone When recovered to ≧30,000/㎕, resume with this drug and melphalan at doses reduced by one level from the doses being administered ② Dose adjustment according to absolute neutrophil count (ANC) If decreased to <500/㎕, interrupt this drug, melphalan, and prednisolone and monitor complete blood counts weekly When recovered to ≧500/㎕ and neutropenia is the only toxicity, resume at the starting dose When recovered to ≧500/㎕ and dose-dependent hematologic toxicities other than neutropenia have occurred, resume with this drug and melphalan at doses reduced by one level Thereafter, if decreased to <500/㎕, interrupt this drug, melphalan, and prednisolone When recovered to ≧500/㎕, resume 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 this drug, 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, resume treatment at the dose being administered if neutropenia is the only dose-limiting toxicity, continuing the growth factor if necessary. 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 candidates for transplantation Treatment should not be initiated if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <80,000/㎕. The recommended starting dose of this 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 treatment for 8 cycles (a total of 24 weeks) as initial therapy. After initial therapy, take this drug 25mg once daily in combination with dexamethasone on days 1-21 of each 28-day cycle. The recommended dose and administration 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 who are candidates for transplantation Treatment should not be initiated if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <80,000/㎕. The recommended starting dose of this 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 treatment for 6 cycles (a total of 24 weeks) as induction therapy. Dose adjustment 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 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 administered Thereafter, if decreased to <30,000/㎕, interrupt treatment When recovered to ≧50,000/㎕, resume at one dose level below the dose being administered ② Dose adjustment according to absolute neutrophil count (ANC) If decreased to <500/㎕, interrupt treatment and monitor complete blood counts weekly When recovered to ≧1,000/㎕ and neutropenia is the only toxicity, resume at the starting dose When recovered to ≧500/㎕ and dose-dependent hematologic toxicities other than neutropenia have occurred, resume at one dose level below the dose being administered Thereafter, if 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. *Refer to the prescribing information for the concomitant drug for dose adjustments. 5) Maintenance therapy in patients with newly diagnosed disease who have undergone autologous hematopoietic stem cell transplantation Maintenance therapy with this drug should be initiated in patients without 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, taking 10 mg on days 1~28 of each 28-day cycle until intolerance 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 adjustment during treatment <Dose reduction levels> Starting dose (10mg): first dose reduction 5 mg; second dose reduction 5mg (days 1~21 of each 28-day cycle) 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 each 28-day cycle) Do not reduce below 5mg (days 1~21 of each 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 decreased to <30,000/㎕, interrupt treatment and monitor complete blood counts weekly When recovered to ≧30,000/㎕, resume at a dose reduced by one level Thereafter, if decreased to <30,000/㎕, interrupt treatment When recovered to ≧30,000/㎕, resume at a dose reduced by one level from the dose being administered ② Dose adjustment according to absolute neutrophil count (ANC) If decreased to <500/㎕, interrupt treatment and monitor complete blood counts weekly When recovered to ≧500/㎕, resume at a dose reduced by one level Thereafter, if decreased to <500/㎕, interrupt treatment When recovered 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 on days 1~21 of each 28-day cycle. Dose adjustment during treatment <Dose reduction levels> Starting 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 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 7 days or longer, resume at one dose level below the dose being administered ② Dose adjustment according to absolute neutrophil count (ANC) 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 administered For neutropenia, use of growth factors should be considered for patient management. Treatment with this drug should be discontinued in patients who do not have at least a minor erythroid response within 4 months after starting treatment (demonstrated by at least a 50% reduction in transfusion requirements or, 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 on days 1~21 of each 28-day cycle. Dose adjustment during treatment <Dose reduction levels> Starting 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 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 administered Thereafter, 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 administered Do not reduce below 2.5mg daily or 5mg every other day. ② Dose adjustment according to absolute neutrophil count (ANC) If decreased to <1,000/㎕ for at least 7 days, or decreased to <1,000/㎕ with fever (temperature≧38.5℃), or 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 administered Thereafter, if decreased to <1,000/㎕ for at least 7 days, or decreased to <1,000/㎕ with fever (temperature≧38.5℃), or decreased to <500/㎕, interrupt treatment. When recovered to ≧1,000/㎕, resume at one dose level below the dose being administered Do not reduce below 2.5mg 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 on days 1~21 of each 28-day cycle. Take for a maximum of 12 treatment cycles. The recommended starting dose of rituximab, based on a 28-day cycle, is 375 mg/m2 intravenously once weekly during cycle 1 (days 1, 8, 15, and 22). During cycles 2~5, administer 375 mg/m2 intravenously only on day 1 of each 28-day cycle. Dose adjustment during treatment <Dose reduction levels> Starting 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 If decreased to <50,000/㎕, interrupt this drug and monitor complete blood counts weekly When recovered to ≥50,000/㎕, resume at one dose level below the dose being administered Thereafter, if decreased to <50,000/㎕, interrupt this drug and monitor complete blood counts weekly When recovered to ≥50,000/㎕, resume at one dose level below the dose being administered Do not reduce below 5mg daily. ② Dose adjustment according to absolute neutrophil count (ANC) If decreased to <1,000/㎕ for at least 7 days, or decreased to <1,000/㎕ with fever (temperature≥38.5°C), or decreased to <500/㎕, interrupt this drug and monitor complete blood counts weekly When recovered to ≥1,000/㎕, resume at one dose level below the dose being administered Thereafter, if decreased to <1,000/㎕ for at least 7 days, or decreased to <1,000/㎕ with fever (temperature≥38.5°C), or decreased to <500/㎕, interrupt this drug and monitor complete blood counts weekly When recovered to ≥1,000/㎕, resume at one dose level below the dose being administered Do not reduce below 5mg daily. Mantle cell lymphoma or follicular lymphoma Tumor lysis syndrome (TLS) All patients should receive tumor lysis syndrome prophylaxis (allopurinol, rasburicase, or an equivalent regimen according to institutional treatment guidelines) and adequate oral hydration during the first week of the first treatment cycle or for a longer period if clinically indicated. To monitor for tumor lysis syndrome, patients should undergo a chemistry panel during the first cycle and weekly if clinically indicated. 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 the electrolyte abnormalities are corrected. Rasburicase treatment may be required 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 indicated. Provide adequate intravenous hydration and appropriate medical management according to standard treatment until the 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 one level lower at the physician’s discretion. Tumor flare reaction (TFR) For patients who develop a grade 1/2 tumor flare reaction, this drug 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. For patients who develop a 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. The patient’s symptoms may be managed 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 associated with this drug occur, interrupt treatment and, when the toxicity improves to grade 2 or lower, resume treatment at a dose reduced by one level from 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. Treatment should be discontinued if angioedema, anaphylactic reactions, grade 4 rash, exfoliative or bullous rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) is suspected, and treatment should not be resumed even after these reactions resolve. 7. Dose in patients with renal impairment Because this drug is excreted through the kidneys, toxicity may be greater in patients with renal impairment. As renal impairment is more common in elderly patients, care is needed when selecting a dose, and renal function should be monitored carefully. The initial dose for patients with renal impairment is as follows. This drug has not been studied in non-dialysis patients with creatinine clearance <11 mL/min or in patients with creatinine clearance <7 mL/min. Table 17. 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 maintenance therapy after transplantation 5mg once daily Severe renal impairment: CLcr <30mL/min (non-dialysis patients); dose adjustment for multiple myeloma/mantle cell lymphoma 7.5mg once daily or 15mg every other day; dose adjustment for maintenance therapy after transplantation 2.5mg once daily End-stage renal disease: CLcr <30mL/min (dialysis patients); dose adjustment for multiple myeloma/mantle cell lymphoma 5mg once daily, administer after dialysis on dialysis days; dose adjustment for maintenance therapy after transplantation 2.5mg once daily, administer after dialysis on dialysis days *After the second treatment cycle, the dose may be increased to 15mg once daily if the patient has not responded to treatment and is tolerating it. Table 18. Initial dose in patients with renal impairment_myelodysplastic syndromes 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 (non-dialysis patients); 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 (dialysis patients); 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) Administer after dialysis on dialysis days Table 19. 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 (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 treatment. 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 to be related to this drug, do not reduce below 5mg every other day or 2.5mg once daily. 3Patients with severe and end-stage renal impairment were excluded from clinical trials. After starting treatment with this drug, 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 medicine. The dose may be adjusted based on clinical or laboratory test results.

This medication must not be used during pregnancy due to the risk of severe congenital malformations in the fetus. Women of childbearing potential should undergo multiple pregnancy tests before and during use of this medication and must implement effective contraception during and for a period after treatment. This medication can only be prescribed and dispensed by physicians and pharmacists registered in a special management program, and patients must strictly adhere to this program. During treatment, blood levels of white blood cells and platelets should be monitored frequently to detect infections or bleeding risks early and take appropriate measures. Patients at risk for cardiovascular disease require careful monitoring for potential cardiovascular complications such as myocardial infarction. The risk of thrombosis is increased; thus, patients with a history of thrombosis or risk factors should take necessary preventive measures. Long-term use of this medicine may increase the risk of secondary cancers, necessitating regular cancer screenings and physician monitoring. Liver function abnormalities may occur, so regular liver function tests are necessary, and patients with a history of liver disease should be particularly cautious. Patients with impaired kidney function require dosage adjustment and routine kidney function testing. Patients with high tumor burden or increased risk of infection need meticulous observation and appropriate preventive measures during treatment. This medication can cause serious skin reactions and allergic reactions, so symptoms such as rash, difficulty breathing, or swelling should be reported to healthcare personnel immediately. During treatment, signs of pulmonary hypertension and other cardiopulmonary disease should be monitored closely. This medication should not be administered to patients with certain genetic disorders and should not be used in cases of hypersensitivity. During treatment, various side effects may arise, and if symptoms such as fatigue, fever, bleeding, difficulty breathing, and neurological symptoms occur, the physician should be consulted immediately.

Skeletal dysplasia, congenital malformations, miscarriage, neutropenia, thrombocytopenia, febrile reactions, bleeding, myocardial infarction, venous thromboembolism, arterial thromboembolism, secondary primary malignant tumors, acute myeloid leukemia, myelodysplastic syndrome, solid tumors, Hodgkin's lymphoma, liver failure, acute liver failure, toxic hepatitis, cytolytic hepatitis, cholestatic hepatitis, pneumonia, renal failure, vascular edema, anaphylactic reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash syndrome accompanied by eosinophilia and systemic symptoms, pulmonary hypertension, tumor flare response, tumor lysis syndrome, infections, shingles, reactivation of hepatitis B virus, progressive multifocal leukoencephalopathy, cataracts, fatigue, constipation, diarrhea, muscle cramps, anemia, rash, decreased appetite, cough, fever, malaise, insomnia, back pain, bronchitis, nasopharyngitis, upper respiratory infection, pulmonary embolism, pneumonia, febrile neutropenia, leukopenia, lymphopenia, pancytopenia, hemolytic anemia, hypersensitivity reactions, 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 sense of balance, intracranial hemorrhage, transient ischemic attack, cerebral ischemia, cataracts, blurred vision, vision loss, blindness, hearing loss, tinnitus, atrial fibrillation, bradycardia, congestive heart failure, tachycardia, heart failure, myocardial ischemia, arrhythmia, QT prolongation, atrial flutter, ectopic ventricular contraction, hypotension, hypertension, petechiae, vasculitis, ischemia, peripheral ischemia, intracranial venous sinus thrombosis, dyspnea, epistaxis, respiratory distress, pleuritic pain, hypoxia, dysphonia, abdominal pain, nausea, vomiting, dyspepsia, dry mouth, stomatitis, gastrointestinal bleeding, small bowel obstruction, colitis, appendicitis, increased alanine aminotransferase, increased aspartate aminotransferase, hepatotoxicity, hepatocyte damage, hyperbilirubinemia, liver failure, urticaria, diaphoresis, dry skin, skin pigmentation, eczema, erythema, drug rash accompanied by eosinophilia and systemic reactions, drug rash, skin depigmentation, photosensitivity reaction, muscle weakness, bone pain, musculoskeletal and connective tissue pain and discomfort, limb pain, myalgia, 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, bruising, pneumonia, septic shock, influenza, pulmonary embolism, 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 nodule, obstructive bronchitis, respiratory abnormalities, pleuritic pain, hiccups, peripheral motor neuropathy, dementia, hypertrophic cardiomyopathy, neuralgic pain, dysarthria, epilepsy, intracranial mass, chronic polyneuropathy, cauda equina syndrome, feeling of discomfort in the head, hemiplegia, seizures, neuritis, uremic encephalopathy, cognitive impairment, jaw numbness syndrome, third cranial nerve palsy, Parkinson's disease, postherpetic neuralgia, action tremor, hyperkalemia, hypercalcemia, hypoalbuminemia, hyperphosphatemia, diabetic ketoacidosis, metabolic acidosis, iron deficiency, delirium, agitation, bipolar disorder, changes in mental status, attention deficit disorder, rib fractures, limb injuries, upper extremity fractures, spinal fractures, femoral neck fractures, femur fractures, radiation pneumonia, bone fragment formation, laceration, traumatic fractures, lumbar fractures, ligament sprains, spinal cord injury, dental fractures, forearm fractures, thoracic spine fractures, acute kidney injury, dysuria, end-stage renal disease, frequent urination, nocturia, urinary abnormalities, urethral discharge, mucosal inflammation, swelling, multiple organ failure, multi-organ dysfunction, heat sensation, infusion site pain, blisters, petechiae, excessive skin pigmentation, papulosquamous rash, chronic hyperpigmentation of the skin, exfoliative dermatitis, macules, purpura, contact dermatitis, hair loss, skin reactions, skin lesions, skin peeling, subcutaneous bleeding, jaw pain, osteoporosis, spondylolisthesis, joint stiffness, bone resorption, limb discomfort, rhabdomyolysis, chest wall mass, pustular rash, gingivitis, tympanitis, increased serum creatinine, weight gain, decreased renal creatinine clearance, increased serum alkaline phosphatase, increased international normalized ratio, positive influenza A virus test, increased serum urea nitrogen, increased serum lactate dehydrogenase, conjunctival hemorrhage, borderline glaucoma, myopia, dry eyes, eyelid swelling, eye pain, retinal disorders, retinopathy, diplopia, blepharitis, periocular edema, pericardial effusion, stress-induced cardiomyopathy, subendocardial ischemia, cardiac arrest, restrictive cardiomyopathy, cervical dysplasia, vaginal discharge, vaginal bleeding, perineal rash, hyperbilirubinemia, fatty liver, acute cholangitis, acute cholecystitis, biliary stones, jaundice, adrenal insufficiency, Cushing's syndrome, inappropriate secretion of antidiuretic hormone, hepatocellular carcinoma, cholangiocarcinoma, malignant pleural effusion, gastric cancer, flushing, shock, ear discomfort, ear discharge, hearing loss, splenomegaly, hemolytic uremic syndrome, candidemia

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, and it is safe to store at room temperature between 1 to 30 degrees Celsius. Storing it this way maintains the drug's efficacy and prevents degradation.

Appearance

[25mg, 20mg, 15mg, 10mg] This medication is a light yellow, oblong film-coated tablet. [7.5mg, 5mg, 2.5mg] This medication is a light yellow, round film-coated tablet.

Package unit

2.5mg, 5mg, 7.5mg, 10mg, 15mg, 20mg, 25mg : 21 tablets (7 tablets/PTP×3), 7 tablets (7 tablets/PTP×1)