Revlimid Capsule 15 mg (Lenalidomide)

Adult dosage

1. Multiple myeloma 1) Combination therapy with dexamethasone for the treatment of patients who have received at least one prior therapy Treatment should not be initiated if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <75,000/㎕. The recommended initial dose is 25mg once daily. Take a 25mg capsule on days 1~21 of each 28-day cycle. The recommended dexamethasone dose, based on a 28-day cycle, is 40mg once daily on days 1~4, 9~12, and 17~20 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 based on platelet count If decreased to <30,000/㎕: Interrupt treatment and monitor complete blood counts weekly When recovered to ≧30,000/㎕: Resume treatment at 15mg once daily For each subsequent decrease to <30,000/㎕: Interrupt treatment When recovered to ≧30,000/㎕: Resume at a dose reduced by 5mg from the dose being administered. Do not reduce the dose below 5mg once daily. ② Dose adjustment based on absolute neutrophil count (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 treatment at 25mg once daily When recovered to ≧1,000/㎕ and other toxicities have occurred: Resume treatment at 15mg once daily For each subsequent decrease to <1,000/㎕: Interrupt treatment When recovered to ≧1,000/㎕: Resume at a dose reduced by 5mg from the dose being administered. Do not reduce the dose below 5mg once daily. For neutropenia, the use of growth factors should be considered for patient management. 2) Combination therapy with dexamethasone for the treatment of newly diagnosed patients who are not eligible for transplantation Treatment should not be initiated if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <50,000/㎕. The recommended initial dose is 25mg once daily. Take a 25 mg capsule on days 1~21 of each 28-day cycle. The recommended dexamethasone dose, 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 dexamethasone dose, 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 adjustments during treatment <Dose reduction levels> This drug/Dexamethasone Initial dose: 25 mg/40 mg 1st dose reduction: 20 mg/20 mg 2nd dose reduction: 15 mg/12 mg 3rd dose reduction: 10 mg/8 mg 4th dose reduction: 5 mg/4 mg 5th dose reduction: 2.5 mg/N/A ① Dose adjustment based on 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 based on absolute neutrophil count (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 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 For each subsequent decrease to <500/㎕: Interrupt this drug and dexamethasone When recovered to ≧500/㎕: Resume at one dose level below the dose being administered For neutropenia, the use of growth factors should be considered for patient management. ③ Dose adjustment for febrile neutropenia (fever ≥38.5℃ and ANC<1,000/㎕): Interrupt treatment and monitor complete blood counts weekly. If the patient is not receiving a growth factor, use of a growth factor should be considered. On the first day of the next treatment cycle, if neutropenia was the only dose-limiting toxicity, resume treatment at the dose being administered, continuing growth factor use if necessary. Otherwise, resume treatment at one dose level below the dose being administered. If the patient is not receiving a growth factor, administer a growth factor. If the dose of this drug was reduced due to hematologic dose-limiting toxicity (dose limiting toxicity, DLT), and treatment is continued until bone marrow function improves (no dose-limiting toxicity (DLT) for at least 2 consecutive cycles, and 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 eligible for transplantation Treatment should not be initiated if the absolute neutrophil count is <1,500/㎕ and/or the platelet count is <75,000/㎕. The recommended initial dose is 10mg once daily. Take a 10 mg capsule on days 1~21 of each 28-day cycle. Through cycle 9, administer melphalan orally at a dose of 0.18mg/kg on days 1~4 of each 28-day cycle, and prednisolone orally at a dose of 2mg/kg on days 1~4 of each 28-day cycle. For patients who have completed 9 cycles or are unable to 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/Melphalan/Prednisolone Initial dose: 10 mg/0.18 mg/kg/2 mg/kg 1st dose reduction: 7.5 mg/0.14 mg/kg/1 mg/kg 2nd dose reduction: 5 mg/0.10 mg/kg/0.5 mg/kg 3rd dose reduction: 2.5 mg/N/A/0.25 mg/kg ① Dose adjustment based on 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 treatment with this drug and melphalan at doses reduced by one level For each subsequent decrease to <30,000/㎕: Interrupt this drug, melphalan, and prednisolone When recovered to ≧30,000/㎕: Resume treatment with this drug and melphalan at doses reduced by one level from the doses being administered ② Dose adjustment based on absolute neutrophil count (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 treatment at the starting dose When recovered 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 For each subsequent decrease to <500/㎕: Interrupt this drug, melphalan, and prednisolone When recovered to ≧500/㎕: Resume treatment with this drug and melphalan at doses reduced by one level from the doses being administered For neutropenia, the use of growth factors should be considered for patient management. ③ Dose adjustment for febrile neutropenia (fever ≥38.5℃ and ANC<1,000/㎕): Interrupt this 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, if neutropenia was the only dose-limiting toxicity, resume treatment at the dose being administered, continuing growth factor use if necessary. Otherwise, resume treatment at one dose level below the dose being administered. If the patient is not receiving a growth factor, administer a growth factor. 4) Combination therapy with bortezomib and dexamethasone for the treatment of newly diagnosed patients (1) Combination therapy with bortezomib and dexamethasone for the treatment of newly diagnosed patients who are not eligible for transplantation Treatment should not be initiated if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <80,000/㎕. The recommended initial dose of this drug is 25mg once daily, taken on days 1~14 of each 21-day cycle. Administer bortezomib subcutaneously 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 dexamethasone dose is 20mg once daily, taken on days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle. Patients should receive 8 cycles (a total of 24 weeks) of treatment as initial therapy. After initial therapy, take this drug 25mg once daily in combination with dexamethasone on days 1-21 of each 28-day cycle. The recommended dexamethasone dosage 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 initial dose of this drug is 25mg once daily, taken on days 1~21 of each 28-day cycle. Administer bortezomib subcutaneously 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 dexamethasone dose is 40mg once daily, taken on days 1-4 and 9-12 of each 28-day cycle. Patients should receive 6 cycles (a total of 24 weeks) of treatment as induction therapy. Dose adjustments during treatment <Dose reduction levels> Initial dose 25 mg; 1st dose reduction 20 mg; 2nd dose reduction 15 mg; 3rd dose reduction 10 mg; 4th dose reduction 5 mg; 5th dose reduction 2.5 mg ① Dose adjustment based on 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 For each subsequent decrease to <30,000/㎕: Interrupt treatment When recovered to ≧50,000/㎕: Resume at one dose level below the dose being administered ② Dose adjustment based on absolute neutrophil count (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 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 For each subsequent decrease to <500/㎕: Interrupt treatment When recovered to ≧500/㎕: Resume at one dose level below the dose being administered For neutropenia, the use of growth factors should be considered for patient management. 5) Maintenance therapy in patients with newly diagnosed disease who have undergone autologous hematopoietic stem cell transplantation Treatment should not be initiated if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <75,000/㎕. The recommended initial dose is 10mg once daily. Take a 10 mg capsule on days 1~28 of each 28-day cycle until intolerance or disease progression occurs. After 3 cycles of maintenance therapy with this drug, the dose may be increased to 15mg once daily if tolerated. Dose adjustments during treatment Starting dose (10mg)/if the dose has been increased (15mg)* 1st dose reduction: 5 mg/10 mg 2nd dose reduction: 5mg (days 1~21 of each 28-day cycle)/5 mg 3rd dose reduction: N/A/5mg (days 1~21 of each 28-day cycle) Do not reduce the dose below 5mg (days 1~21 of each 28-day cycle). *After 3 cycles of maintenance therapy with this drug, the dose may be increased to 15mg once daily if tolerated. ① Dose adjustment based on platelet count If decreased to <30,000/㎕: Interrupt treatment and monitor complete blood counts weekly When recovered to ≧30,000/㎕: Resume treatment at a dose reduced by one level For each subsequent decrease to <30,000/㎕: Interrupt treatment When recovered to ≧30,000/㎕: Resume treatment at a dose reduced by one level from the dose being administered ② Dose adjustment based on absolute neutrophil count (Absolute Neutrophil Count : ANC) If decreased to <500/㎕: Interrupt treatment and monitor complete blood counts weekly When recovered to ≧500/㎕: Resume treatment at a dose reduced by one level For each subsequent decrease to <500/㎕: Interrupt treatment When recovered to ≧500/㎕: Resume treatment at a dose reduced by one level from the dose being administered For neutropenia, the use of growth factors should be considered for patient management. 2. Myelodysplastic syndrome Treatment should not be initiated if the absolute neutrophil count is <500/㎕ and/or the platelet count is <25,000/㎕. The recommended initial dose is 10mg once daily. Take a 10 mg capsule on days 1~21 of each 28-day cycle. Dose adjustments during treatment Initial dose: 10 mg once daily on days 1~21 of each 28-day cycle 1st dose reduction: 5 mg once daily on days 1~28 of each 28-day cycle 2nd dose reduction: 2.5 mg once daily on days 1~28 of each 28-day cycle 3rd dose reduction: 2.5 mg every other day on days 1~28 of each 28-day cycle ① Dose adjustment based on platelet count If decreased to <25,000/㎕: Interrupt treatment and monitor complete blood counts weekly When recovered to ≧50,000/㎕, or recovered at least 2 times to ≧25,000/㎕~<50,000/㎕ for 7 days or longer: Resume at one dose level below the dose being administered ② Dose adjustment based on absolute neutrophil count (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, the use of growth factors should be considered for patient management. Treatment with this drug should be discontinued in patients who have not had at least a minor erythroid response within 4 months after starting treatment (demonstrated by a reduction in transfusion requirements of at least 50% or, in patients who have not received transfusions, an increase in hemoglobin level of 1g/dl). 3. Mantle cell lymphoma The recommended initial dose is 25mg once daily. Take a 25mg capsule on days 1~21 of each 28-day cycle. Dose adjustments during treatment Initial dose: 25mg once daily on days 1~21 of each 28-day cycle 1st dose reduction: 20mg once daily on days 1~21 of each 28-day cycle 2nd dose reduction: 15mg once daily on days 1~21 of each 28-day cycle 3rd dose reduction: 10mg once daily on days 1~21 of each 28-day cycle 4th dose reduction: 5mg once daily on days 1~21 of each 28-day cycle 5th dose reduction: 2.5mg once daily on days 1~21 of each 28-day cycle 5mg every other day on days 1~21 of each 28-day cycle ① Dose adjustment based on 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 For each subsequent decrease to <50,000/㎕: Interrupt treatment and monitor complete blood counts weekly When recovered to ≧60,000/㎕: Resume at one dose level below the dose being administered Do not reduce the dose below 2.5mg once daily or below 5mg every other day. ② Dose adjustment based on absolute neutrophil count (Absolute Neutrophil Count : ANC) If decreased to <1,000/㎕ for at least 7 days, or decreased to <1,000/㎕ with fever (body 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 For each subsequent decrease to <1,000/㎕ for at least 7 days, or decrease to <1,000/㎕ with fever (body temperature ≧38.5℃), or decrease 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 below 5mg every other day. For neutropenia, the use of growth factors should be considered for patient management. 4. Follicular lymphoma Treatment should not be initiated if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <50,000/㎕ (except when secondary to lymphoma infiltration of the bone marrow). The recommended initial dose is 20mg once daily. Take a 20mg capsule on days 1~21 of each 28-day cycle. Take for a maximum of 12 treatment cycles. The recommended initial rituximab dose 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 Initial dose: 20mg once daily on days 1~21 of each 28-day cycle 1st dose reduction: 15mg once daily on days 1~21 of each 28-day cycle 2nd dose reduction: 10mg once daily on days 1~21 of each 28-day cycle 3rd dose reduction: 5mg once daily on days 1~21 of each 28-day cycle For dose adjustment due to rituximab toxicity, see the relevant prescribing information. ① Dose adjustment based on platelet count If decreased to <50,000/㎕: Interrupt treatment with this drug and monitor complete blood counts weekly When recovered to ≥50,000/㎕: Resume at one dose level below the dose being administered For each subsequent decrease to <50,000/㎕: Interrupt treatment with 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 the dose below 5mg once daily. ② Dose adjustment based on absolute neutrophil count (Absolute Neutrophil Count : ANC) If decreased to <1,000/㎕ for at least 7 days, or decreased to <1,000/㎕ with fever (body temperature ≥38.5°C), or decreased to <500/㎕: Interrupt treatment with this drug and monitor complete blood counts weekly When recovered to ≥1,000/㎕: Resume at one dose level below the dose being administered For each subsequent decrease to <1,000/㎕ for at least 7 days, or decrease to <1,000/㎕ with fever (body temperature ≥38.5℃), or decrease to <500/㎕: Interrupt treatment with 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 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 be adequately hydrated orally during the first week of the first treatment cycle, or longer 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 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. Treatment with rasburicase 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. Treatment with rasburicase and hospitalization are at the physician's discretion. Once tumor lysis syndrome 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 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 (non-steroidal anti-inflammatory drugs, NSAIDs), short-term corticosteroid treatment, 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 symptomatic management according to guidance for the 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. Once 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 caused by 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, treatment should be discontinued and should not be resumed even after these reactions resolve. 7. Dose in patients with renal impairment This drug has not been studied in non-dialysis patients with creatinine clearance less than 11 mL/min or in patients with creatinine clearance less than 7 mL/min. 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 (non-dialysis patients): 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 (dialysis patients): Dose adjustment for multiple myeloma/mantle cell lymphoma 5mg once daily, administered after dialysis on dialysis days; dose adjustment for post-transplant maintenance therapy 2.5mg once daily, administered 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 syndrome Moderate renal impairment, 30 ≤ CLcr <50mL/min: Initial dose 5mg once daily (days 1 ~ 21 of each 28-day cycle); 1st dose reduction 2.5mg once daily (days 1 ~ 28 of each 28-day cycle); 2nd dose reduction 2.5mg every other day (days 1 ~ 28 of each 28-day cycle) Severe renal impairment, CLcr <30mL/min (non-dialysis patients): Initial dose 2.5mg once daily (days 1 ~ 21 of each 28-day cycle); 1st dose reduction 2.5mg every other day (days 1 ~ 28 of each 28-day cycle); 2nd dose reduction 2.5mg twice weekly (days 1 ~ 28 of each 28-day cycle) End-stage renal disease, CLcr <30mL/min (dialysis patients): Initial dose 2.5mg once daily (days 1 ~ 21 of each 28-day cycle); 1st dose reduction 2.5mg every other day (days 1 ~ 28 of each 28-day cycle); 2nd dose reduction 2.5mg twice weekly (days 1 ~ 28 of each 28-day cycle) Administer after dialysis on dialysis days Table 17. Dose in patients with renal impairment_Follicular lymphoma Moderate renal impairment, 30 ≤ CLcr < 60mL/min: 10mg once daily1,2 (days 1 ~ 21 of each 28-day cycle) 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 tolerated by the patient. 2For patients receiving an initial dose of 10mg who require dose reduction due to grade 3/4 neutropenia or thrombocytopenia, or other grade 3/4 toxicity considered related to this drug, do not reduce the dose 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 capsule. The dose may be adjusted based on clinical or laboratory test results.

This drug may cause severe birth defects or miscarriage if taken during pregnancy; therefore, it should not be taken by pregnant women. Women of childbearing potential must take two pregnancy tests before, during, and after taking this drug for a certain period, and must use at least two forms of contraception. This drug can reduce the number of white blood cells and platelets in the blood, so regular blood tests must be conducted during use, and any signs of infection or bleeding should be reported to healthcare providers immediately. Patients at risk of heart disease should be closely monitored for cardiac problems, such as myocardial infarction, while taking this drug, and risk factors should be managed. This drug may increase the risk of thrombosis; therefore, patients with a history of thrombosis or risk factors should be particularly careful, and preventive anticoagulation therapy may be recommended if necessary. This drug may affect liver function, so patients with liver disease or abnormal liver function tests should have regular liver function tests and inform their healthcare provider immediately if they experience liver damage symptoms. Patients with decreased kidney function will require dose adjustments and monitoring of kidney function. This drug may induce tumor lysis syndrome and tumor flare reactions, so cancer patients must carefully monitor symptoms, particularly during the first treatment cycle, and receive appropriate preventive measures. Patients who are prone to infections should seek prompt treatment if symptoms of infection arise, and there is a risk of reactivation of viral infections, thus requiring related tests and monitoring. This drug may cause severe skin reactions and allergic reactions, so any symptoms such as rash, itching, or difficulty breathing should be reported to healthcare providers immediately. Neurological abnormalities may appear while taking this drug, particularly symptoms of progressive multifocal leukoencephalopathy, so neurological symptoms should be closely monitored. The combination of this drug with certain immune checkpoint inhibitors may increase mortality; therefore, it should not be used together outside of clinical trials. During use, vision changes or the possibility of cataracts may occur; thus, regular eyesight examinations are necessary. Patients allergic to any ingredients contained in this drug should avoid taking it. This drug can cause various side effects, so if symptoms such as fatigue, fever, bleeding, difficulty breathing, indigestion, or neurological abnormalities occur during use, immediate consultation with healthcare providers is necessary. This drug must be taken following the guidance of a professional healthcare provider and used safely through regular examinations and monitoring.

Fetopathy, congenital malformation, miscarriage, neutropenia, thrombocytopenia, febrile reaction, bleeding, myocardial infarction, venous thromboembolism, arterial thromboembolism, secondary primary malignant neoplasm, basal cell carcinoma, squamous cell carcinoma, acute myeloid leukemia, myelodysplastic syndrome, liver failure, acute liver failure, toxic hepatitis, cytolytic hepatitis, cholestatic hepatitis, pneumonia, renal failure, pulmonary embolism, febrile neutropenia, constipation, diarrhea, muscle cramps, anemia, rash, fatigue, weakness, insomnia, decreased appetite, cough, fever, hypotension, pulmonary infection, dehydration, peripheral neuropathy, cataract, blurriness, vision decline, blindness, hearing loss, tinnitus, atrial fibrillation, bradycardia, congestive heart failure, tachycardia, heart failure, myocardial ischemia, arrhythmia, QT prolongation, atrial flutter, ventricular extrasystole, hypertension, petechiae, vasculitis, ischemia, peripheral ischemia, intracranial venous sinus thrombosis, dyspnea, epistaxis, respiratory distress, pleuritic pain, hypoxia, vocal cord dysfunction, abdominal pain, nausea, vomiting, dry mouth, stomatitis, gastrointestinal bleeding, small bowel obstruction, colitis, appendicitis, elevated alanine aminotransferase, elevated aspartate aminotransferase, hepatotoxicity, hepatocyte damage, abnormal liver function tests, hyperbilirubinemia, liver failure, urticaria, hyperhidrosis, dry skin, skin pigmentation, eczema, erythema, eosinophilia, drug rash, skin depigmentation, photosensitivity reaction, muscle weakness, bone pain, musculoskeletal pain, arthralgia, joint swelling, renal failure, hematuria, urinary retention, urinary incontinence, acquired Fanconi syndrome, erectile dysfunction, edema, influenza-like symptoms, increased serum alkaline phosphatase, elevated C-reactive protein, falls, contusion, pneumonia, septic shock, influenza, urinary tract infection, bronchitis, shingles, viral infection, atypical pneumonia, streptococcus pneumonia, Klebsiella pneumonia, pseudomembranous colitis, acute sinusitis, acute pyelonephritis, bronchopulmonary aspergillosis, Escherichia coli pneumonia, viral pneumonia, viral respiratory infection, upper respiratory infection, bacteremia, fungal pneumonia, sepsis, pneumocystis pneumonia, subcutaneous abscess, asthenia, chills, death, facial edema, overall condition deterioration, generalized edema, chest pain, 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 arterial hypertension, pulmonary edema, pulmonary congestion, pulmonary mass, bronchial obstruction, cytopenia, pancytopenia, splenomegaly, cytopenia, thrombocytopenia, febrile neutropenia, cytopenia, anal abscess, petechiae, purpura, dermatitis, urticaria, ineffectual medication, pain, peripheral edema, hiccups, reduced oral intake, anxiety, sleep disorders, vertebral compression fracture, dysuria, chest discomfort, flank pain, pustular rash, elevated serum creatinine, weight gain, decreased renal creatinine clearance, increased blood urea, conjunctival hemorrhage, borderline glaucoma, myopia, dry eyes, ocular swelling, ocular pain, retinal disorders, retinal disease, diplopia, blepharitis, periorbital edema, pericardial effusion, stress cardiomyopathy, subendocardial ischemia, cardiac arrest, Prinzmetal angina, restrictive cardiomyopathy, cardiac arrest, cervical dysplasia, vaginal discharge, vaginal bleeding, perineal rash, hyperbilirubinemia, hepatic steatosis, acute cholangitis, acute cholecystitis, bile duct stones, jaundice, adrenal insufficiency, Cushing's syndrome, inappropriate antidiuretic hormone secretion, hepatocellular carcinoma, acute leukemia, cholangiocarcinoma, malignant pleural effusion, gastric cancer, flushing, shock, ear discomfort, ear discharge, hearing loss, splenomegaly, hemolytic uremic syndrome

This drug may be sensitive to air or moisture; therefore, it should be stored in a tightly sealed container. It is recommended to maintain room temperature, that is, between 15 to 30 degrees Celsius during storage to preserve the drug's efficacy for a long time.

Appearance

Hard capsule with a beige upper part and gray lower part containing white powder

Package unit

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