Revlimid Capsule 25 mg (Lenalidomide)

Adult dosage

This medicine should be administered only to patients who have agreed to comply with the requirements specified in the Pregnancy Prevention Program (see “5. General Precautions” under Precautions for Use). In addition, this medicine should be prescribed only by physicians registered in the Pregnancy Prevention Program and dispensed only by pharmacists registered 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 previous therapies Treatment should not be started 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 25mg capsules 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 for the first 4 cycles. After 4 cycles, administer 40mg once daily only on days 1~4 of each 28-day cycle. Dose modification during treatment ① Dose modification according to platelet count Table 1. Platelet count Recommended dose If decreased to <30,000/㎕ Interrupt treatment and monitor complete blood counts weekly When recovered to ≧30,000/㎕ Resume treatment at 15mg once daily For each subsequent decrease to <30,000/㎕ Interrupt treatment When recovered to ≧30,000/㎕ Resume at a dose reduced by 5mg from the dose being taken. Do not reduce the dose below 5mg once daily. ② Dose modification according to absolute neutrophil count (ANC) Table 2. Absolute neutrophil count Recommended dose If decreased to <1,000/㎕ Interrupt treatment, add G-CSF, and monitor complete blood counts weekly When recovered to ≧1,000/㎕ and neutropenia is the only toxicity Resume treatment at 25mg once daily When recovered to ≧1,000/㎕ and other toxicities have occurred Resume treatment at 15mg once daily For each subsequent decrease to <1,000/㎕ Interrupt treatment When recovered to ≧1,000/㎕ Resume at a dose reduced by 5mg from the dose being taken. Do not reduce the dose below 5mg once daily. For neutropenia, use of growth factors should be considered for patient management. 2) Combination therapy with dexamethasone for the treatment of newly diagnosed patients who are not eligible for transplantation Treatment should not be started 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 25 mg capsules 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 worsens or unacceptable toxicity occurs. Dose modification during treatment <Dose reduction levels> This medicine 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 modification according to platelet count Table 3. Platelet count Recommended dose If decreased to <25,000/㎕ Interrupt this medicine and dexamethasone and monitor complete blood counts weekly When recovered to ≧50,000/㎕ Resume at one dose level below the dose being taken ② Dose modification according to absolute neutrophil count (ANC) Table 4. Absolute neutrophil count Recommended dose If decreased to <500/㎕ Interrupt this medicine and dexamethasone and monitor complete blood counts weekly When recovered to ≧1,000/㎕ and neutropenia is the only toxicity Resume treatment at the starting dose When recovered to ≧500/㎕ and dose-dependent hematologic toxicity other than neutropenia has occurred Resume at one dose level below the dose being taken For each subsequent decrease to <500/㎕ Interrupt this medicine and dexamethasone When recovered to ≧500/㎕ Resume at one dose level below the dose being taken For neutropenia, use of growth factors should be considered for patient management. ③ Dose modification 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 taken, continuing the growth factor if necessary, if neutropenia is the only dose-limiting toxicity. Otherwise, resume treatment at one dose level below the dose being taken. If the patient is not receiving a growth factor, administer a growth factor. If this medicine was reduced because of a hematologic dose-limiting toxicity (DLT), treatment may be resumed at an increased dose (up to the maximum starting dose), at the physician’s discretion, if bone marrow function improves during continued treatment (no 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). 3) Combination therapy with melphalan and prednisolone for the treatment of newly diagnosed patients who are not eligible for transplantation Treatment should not be started 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 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 prednisolone orally at a dose of 2mg/kg on days 1~4 of each 28-day cycle. For patients who have completed 9 cycles or are unable to complete combination therapy because of intolerance, take this medicine alone at 10mg once daily on days 1~21 of each 28-day cycle until disease worsens. Dose modification during treatment <Dose reduction levels> This medicine 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 modification according to platelet count Table 5. Platelet count Recommended dose If decreased to <25,000/㎕ Interrupt this medicine, melphalan, and prednisolone and monitor complete blood counts weekly When recovered to ≧25,000/㎕ Resume treatment with this medicine and melphalan at one dose level lower For each subsequent decrease to <30,000/㎕ Interrupt this medicine, melphalan, and prednisolone When recovered to ≧30,000/㎕ Resume treatment with this medicine and melphalan at one dose level below the dose being taken ② Dose modification according to absolute neutrophil count (ANC) Table 6. Absolute neutrophil count Recommended dose If decreased to <500/㎕ Interrupt this medicine, melphalan, and prednisolone and monitor complete blood counts weekly When recovered to ≧500/㎕ and neutropenia is the only toxicity Resume treatment at the starting dose When recovered to ≧500/㎕ and dose-dependent hematologic toxicity other than neutropenia has occurred Resume treatment with this medicine and melphalan at one dose level lower For each subsequent decrease to <500/㎕ Interrupt this medicine, melphalan, and prednisolone When recovered to ≧500/㎕ Resume treatment with this medicine and melphalan at one dose level below the dose being taken For neutropenia, use of growth factors should be considered for patient management. ③ Dose modification for febrile neutropenia (fever ≥38.5℃ and ANC<1,000/㎕): Interrupt this medicine, melphalan, and prednisolone and monitor complete blood counts weekly. If the patient is not receiving a growth factor, use of a growth factor should be considered. On the first day of the next treatment cycle, resume treatment at the dose being taken, continuing the growth factor if necessary, if neutropenia is the only dose-limiting toxicity. Otherwise, resume treatment at one dose level below the dose being taken. If the patient is not receiving a growth factor, administer a growth factor. 4) Combination therapy with bortezomib and dexamethasone for the treatment of newly diagnosed patients (1) Combination therapy with bortezomib and dexamethasone for the treatment of newly diagnosed patients who are not eligible for transplantation Treatment should not be started if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <80,000/㎕. The recommended initial dose of this medicine is 25mg once daily, taken on days 1~14 of each 21-day cycle. Administer bortezomib by subcutaneous injection at a dose of 1.3mg/m2 per body surface area on days 1, 4, 8, and 11 of each 21-day cycle. The recommended dose of dexamethasone is 20mg once daily, taken on days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle. Patients should be treated for 8 cycles (a total of 24 weeks) as initial therapy. After initial treatment, take this medicine 25mg once daily in combination with dexamethasone on days 1-21 of each 28-day cycle. The recommended 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 started if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <80,000/㎕. The recommended initial dose of this medicine is 25mg once daily, taken on days 1~21 of each 28-day cycle. Administer bortezomib by subcutaneous injection at a dose of 1.3mg/m2 per body surface area on days 1, 4, 8, and 11 of each 28-day cycle. The recommended dose of dexamethasone is 40mg once daily, taken on days 1-4 and 9-12 of each 28-day cycle. Patients should be treated for 6 cycles (a total of 24 weeks) as induction therapy. Dose modification during treatment <Dose reduction levels> This medicine 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 modification according to platelet count Platelet count Recommended dose If decreased to <30,000/㎕ Interrupt treatment and monitor complete blood counts weekly When recovered to ≧50,000/㎕ Resume at one dose level below the dose being taken For each subsequent decrease to <30,000/㎕ Interrupt treatment When recovered to ≧50,000/㎕ Resume at one dose level below the dose being taken ② Dose modification according to absolute neutrophil count (ANC) Neutrophil count Recommended dose If decreased to <500/㎕ Interrupt treatment and monitor complete blood counts weekly When recovered to ≧1,000/㎕ and neutropenia is the only toxicity Resume treatment at the starting dose When recovered to ≧500/㎕ and dose-dependent hematologic toxicity other than neutropenia has occurred Resume at one dose level below the dose being taken For each subsequent decrease to <500/㎕ Interrupt treatment When recovered to ≧500/㎕ Resume at one dose level below the dose being taken For neutropenia, use of growth factors should be considered for patient management. *For dose modification of concomitant medicines, refer to the prescribing information for the respective products. 5) Maintenance therapy in patients newly diagnosed and receiving autologous hematopoietic stem cell transplantation Maintenance therapy with this medicine should be initiated after adequate hematologic recovery following autologous hematopoietic stem cell transplantation in patients with no evidence of disease progression. Treatment should not be started 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 10 mg capsules on days 1~28 of each 28-day cycle until intolerance or disease progression occurs. After 3 cycles of maintenance therapy with this medicine, the dose may be increased to 15mg once daily if tolerated. Dose modification during treatment <Dose reduction levels> Starting dose (10mg) If the dose has been increased (15mg)* 1st dose reduction 5 mg 10 mg 2nd dose reduction 5mg (days 1~21 of a 28-day cycle) 5 mg 3rd dose reduction N/A 5mg (days 1~21 of a 28-day cycle) Do not reduce below 5mg (days 1~21 of a 28-day cycle). *After 3 cycles of maintenance therapy with this medicine, the dose may be increased to 15mg once daily if tolerated. ① Dose modification according to platelet count Table 7. Platelet count Recommended dose If decreased to <30,000/㎕ Interrupt treatment and monitor complete blood counts weekly When recovered to ≧30,000/㎕ Resume treatment at one dose level below the dose being taken For each subsequent decrease to <30,000/㎕ Interrupt treatment When recovered to ≧30,000/㎕ Resume treatment at one dose level below the dose being taken ② Dose modification according to absolute neutrophil count (ANC) Table 8. Absolute neutrophil count Recommended dose If decreased to <500/㎕ Interrupt treatment and monitor complete blood counts weekly When recovered to ≧500/㎕ Resume treatment at one dose level below the dose being taken For each subsequent decrease to <500/㎕ Interrupt treatment When recovered to ≧500/㎕ Resume treatment at one dose level below the dose being taken For neutropenia, use of growth factors should be considered for patient management. 2. Myelodysplastic syndromes Treatment should not be started if the absolute neutrophil count is <500/㎕ and/or the platelet count is <25,000/㎕. The recommended initial dose is 10mg once daily. Take 10 mg capsules on days 1~21 of each 28-day cycle. Dose modification during treatment <Dose reduction levels> This medicine 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 modification according to platelet count Table 9. Platelet count Recommended dose If decreased to <25,000/㎕ Interrupt treatment and monitor complete blood counts weekly When recovered to ≧50,000/㎕ or when recovered to ≧25,000/㎕ to <50,000/㎕ at least twice over 7 days or longer Resume treatment at one dose level below the dose being taken ② Dose modification according to absolute neutrophil count (ANC) Table 10. Absolute neutrophil count Recommended dose If decreased to <500/㎕ Interrupt treatment and monitor complete blood counts weekly When recovered to ≧500/㎕ Resume treatment at one dose level below the dose being taken For neutropenia, use of growth factors should be considered for patient management. Treatment with this medicine should be discontinued in patients who 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, an increase in hemoglobin of 1g/dl). 3. Mantle cell lymphoma The recommended initial dose is 25mg once daily. Take 25mg capsules on days 1~21 of each 28-day cycle. Dose modification during treatment <Dose reduction levels> This medicine 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 modification according to platelet count Table 11. Platelet count Recommended dose If decreased to <50,000/㎕ Interrupt treatment and monitor complete blood counts weekly When recovered to ≧60,000/㎕ Resume at one dose level below the dose being taken For each subsequent decrease to <50,000/㎕ Interrupt treatment and monitor complete blood counts weekly When recovered to ≧60,000/㎕ Resume at one dose level below the dose being taken Do not reduce the dose below 2.5mg once daily or 5mg every other day. ② Dose modification according to absolute neutrophil count (ANC) Table 12. Absolute neutrophil count Recommended dose If decreased to <1,000/㎕ for at least 7 days or if decreased to <1,000/㎕ with fever (temperature ≧38.5℃) or if decreased to <500/㎕ Interrupt treatment and monitor complete blood counts weekly When recovered to ≧1,000/㎕ Resume at one dose level below the dose being taken For each subsequent decrease to <1,000/㎕ for at least 7 days or if decreased to <1,000/㎕ with fever (temperature ≧38.5℃) or if decreased to <500/㎕ Interrupt treatment. When recovered to ≧1,000/㎕ Resume at one dose level below the dose being taken Do not reduce the dose below 2.5mg once daily or 5mg every other day. For neutropenia, use of growth factors should be considered for patient management. 4. Follicular lymphoma Treatment should not be started if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <50,000/㎕ (except when secondary to lymphoma involvement of the bone marrow). The recommended initial dose is 20mg once daily. Take 20mg capsules on days 1~21 of each 28-day cycle. Take for up to 12 treatment cycles. The recommended initial dose of rituximab is based on a 28-day cycle. During cycle 1, administer 375 mg/m2 intravenously once weekly (days 1, 8, 15, and 22). During cycles 2~5, administer 375 mg/m2 intravenously only on day 1 of each 28-day cycle. Dose modification during treatment <Dose reduction levels> This medicine 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 modification due to rituximab toxicity, refer to the relevant prescribing information. ① Dose modification according to platelet count Table 13. Platelet count Recommended dose If decreased to <50,000/㎕ Interrupt this medicine and monitor complete blood counts weekly When recovered to ≥50,000/㎕ Resume at one dose level below the dose being taken For each subsequent decrease to <50,000/㎕ Interrupt this medicine and monitor complete blood counts weekly When recovered to ≥50,000/㎕ Resume at one dose level below the dose being taken Do not reduce the dose below 5mg once daily. ② Dose modification according to absolute neutrophil count (ANC) Table 14. Absolute neutrophil count Recommended dose If decreased to <1,000/㎕ for at least 7 days or if decreased to <1,000/㎕ with fever (temperature ≥38.5°C) or if decreased to <500/㎕ Interrupt this medicine and monitor complete blood counts weekly When recovered to ≥1,000/㎕ Resume at one dose level below the dose being taken For each subsequent decrease to <1,000/㎕ for at least 7 days or if decreased to <1,000/㎕ with fever (temperature ≥38.5°C) or if decreased to <500/㎕ Interrupt this medicine and monitor complete blood counts weekly When recovered to ≥1,000/㎕ Resume at one dose level below the dose being taken Do not reduce the dose below 5mg once daily. Mantle cell lymphoma or follicular lymphoma Tumor lysis syndrome (TLS) All patients should receive prophylaxis for tumor lysis syndrome (allopurinol, rasburicase, or an equivalent regimen according to institutional treatment guidelines) and should receive adequate oral hydration during the first week of the first treatment cycle, or for longer if clinically necessary. To monitor for tumor lysis syndrome, patients should have a chemistry panel performed during the first cycle and weekly thereafter if clinically necessary. For patients with laboratory TLS or grade 1 clinical TLS, this medicine may be continued at the same dose or, at the physician’s discretion, continued at a dose reduced by one dose level. Provide adequate intravenous hydration and appropriate medical management according to standard treatment until electrolyte abnormalities are corrected. Rasburicase treatment may be necessary to reduce hyperuricemia. Hospitalization is at the physician’s discretion. For patients with grade 2-4 clinical TLS, interrupt treatment with this medicine 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 TLS 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 medicine may be continued without interruption or dose reduction at the prescribing physician’s discretion. Non-steroidal anti-inflammatory drugs (NSAIDs), a limited course of corticosteroids, and/or narcotic analgesics may be administered at the prescribing physician’s discretion. For patients who develop a grade 3/4 tumor flare reaction, interrupt treatment with this medicine and initiate treatment with non-steroidal anti-inflammatory drugs, corticosteroids, and/or narcotic analgesics. When the reaction resolves to grade 1 or lower, resume treatment at the same dose for the remainder of the cycle. Patients may receive symptom management according to the guidance for treating grade 1/2 tumor flare reactions. 5. Dose modification for other grade 3/4 toxicities If other grade 3/4 toxicities associated with this medicine occur, interrupt treatment. When the toxicity improves to grade 2 or lower, resume treatment at a dose one level below the dose being taken, at the prescribing physician’s discretion. 6. This medicine should not be administered to patients with a history of grade 4 rash caused by thalidomide. Consider interruption or discontinuation of this medicine for grade 2-3 skin rash. 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; treatment should not be resumed even after these reactions resolve. 7. Dose in patients with renal impairment Because this medicine is excreted through the kidneys, toxicity may be greater in patients with renal impairment. Since elderly patients are more likely to have renal impairment, caution is required when selecting the dose, and renal function should be monitored carefully. Initial doses for patients with renal impairment are as follows. This medicine has not been studied in nondialysis patients with creatinine clearance less than 11 mL/min or patients with creatinine clearance less than 7 mL/min. Table 15. Initial dose in patients with renal impairment—multiple myeloma or mantle cell lymphoma Category Renal function (Cockcroft-Gault CLcr) Dose modification for multiple myeloma/mantle cell lymphoma Dose modification for maintenance therapy after transplantation Moderate renal impairment 30 ≤ CLcr <50mL/min 10mg once daily* 5mg once daily Severe renal impairment CLcr <30mL/min (nondialysis patient) 7.5mg once daily or 15mg every other day 2.5mg once daily End-stage renal disease CLcr <30mL/min (dialysis patient) 5mg once daily Administer after dialysis on dialysis days 2.5mg once daily Administer after dialysis on dialysis days *After the second treatment cycle, the dose may be increased to 15mg once daily if the patient has not responded to treatment and tolerates it. Table 16. Initial dose in patients with renal impairment—myelodysplastic syndromes Category Renal function (Cockcroft-Gault CLcr) Dose modification for myelodysplastic syndromes Initial dose 1st dose reduction 2nd dose reduction Moderate renal impairment 30 ≤ CLcr <50mL/min 5mg once daily (days 1 ~ 21 of each 28-day cycle) 2.5mg once daily (days 1 ~ 28 of each 28-day cycle) 2.5mg every other day (days 1 ~ 28 of each 28-day cycle) Severe renal impairment CLcr <30mL/min (nondialysis patient) 2.5mg once daily (days 1 ~ 21 of each 28-day cycle) 2.5mg every other day (days 1 ~ 28 of each 28-day cycle) 2.5mg twice weekly (days 1 ~ 28 of each 28-day cycle) End-stage renal disease CLcr <30mL/min (dialysis patient) 2.5mg once daily (days 1 ~ 21 of each 28-day cycle) 2.5mg every other day (days 1 ~ 28 of each 28-day cycle) 2.5mg twice weekly (days 1 ~ 28 of each 28-day cycle) Administer after dialysis on dialysis days Administer after dialysis on dialysis days Administer after dialysis on dialysis days Table 17. Dose in patients with renal impairment—follicular lymphoma Category Renal function (Cockcroft-Gault CLcr) Dose modification for follicular lymphoma (days 1 ~ 21 of each 28-day cycle) Moderate renal impairment 30 ≤ CLcr < 60mL/min 10mg once daily1,2 Severe renal impairment CLcr < 30mL/min (nondialysis patient) No data3 End-stage renal disease CLcr < 30mL/min (dialysis patient) No data3 ¹After the second treatment cycle, the dose may be increased to 15mg once daily if the patient tolerates it. 2For patients receiving an initial dose of 10mg, if dose reduction is required because of grade 3/4 neutropenia or thrombocytopenia, or another grade 3/4 toxicity considered related to this medicine, do not reduce the dose below 5mg every other day or 2.5mg once daily. 3Patients with severe renal impairment and end-stage renal disease were excluded from clinical trials. After starting treatment with this medicine, dose modification 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 medication must not be taken during pregnancy, as it can cause serious birth defects in the fetus. Women of childbearing potential must undergo two pregnancy tests before using this medication and must use at least two forms of contraception during and after treatment. This drug can reduce the number of white blood cells and platelets in the blood, requiring regular blood tests. If blood counts fall very low, it may be necessary to temporarily suspend or adjust the dosage. Patients with heart issues, particularly those at increased risk of myocardial infarction, should be closely monitored. There is an increased risk of thrombosis—blood clots forming and blocking blood vessels. Patients with risk factors for thrombosis require more stringent management and preventive measures. During the use of this drug, there may be liver function abnormalities; therefore, liver health should be periodically monitored. Patients with impaired kidney function should have their dosage adjusted and kidney function regularly monitored. This medication can cause serious side effects, such as tumor lysis syndrome and tumor flare reactions, necessitating careful monitoring and necessary preventive measures during initial treatment. There is an increased risk of infections, so any symptoms of infection must be promptly reported to healthcare providers. This drug poses a risk of severe skin reactions, anaphylaxis, pulmonary hypertension, etc., and treatment should be discontinued immediately if any adverse symptoms arise, seeking medical attention. This medication should not be used in patients with certain genetic disorders, especially those with lactose intolerance. Furthermore, when used in conjunction with other immunosuppressants or specific chemotherapy agents, there is an elevated risk of increased mortality, thus requiring careful use under expert guidance. While taking this medication, various side effects such as fatigue, muscle cramps, gastrointestinal disturbances, neurological abnormalities, and blood disorders may occur; close monitoring of symptoms is essential. Regular blood tests, liver function tests, and cardiac and renal function tests should be conducted to ensure safety while on this medication. Both the patient and their family or caregivers should be aware of potential adverse symptoms that may arise during treatment and be able to promptly report any issues to healthcare providers.

Dysmelia, congenital malformation, miscarriage, neutropenia, thrombocytopenia, febrile reaction, bleeding, myocardial infarction, venous thromboembolism, arterial thromboembolism, secondary primary malignant tumors, acute myeloid leukemia, myelodysplastic syndrome, basal cell carcinoma, squamous cell carcinoma, liver failure, acute liver failure, toxic hepatitis, cytolytic hepatitis, cholestatic hepatitis, abnormal liver function tests, angioedema, anaphylactic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash syndrome with eosinophilia and systemic symptoms, pulmonary hypertension, tumor lysis syndrome, pneumonia, renal failure, diarrhea, fatigue, back pain, weakness, insomnia, rash, appetite loss, cough, fever, muscle cramps, anemia, leukopenia, lymphopenia, pancytopenia, hemolytic anemia, hypercoagulation, hypersensitivity, hypothyroidism, hypokalemia, hyperglycemia, hypoglycemia, hypocalcemia, hyponatremia, dehydration, weight loss, diabetes, hypophosphatemia, hyperuricemia, hypomagnesemia, depression, insomnia, decreased libido, peripheral neuropathy, paresthesia, dizziness, tremor, taste distortion, headache, stroke, syncope, neuralgia, ataxia, intracranial hemorrhage, transient ischemic attack, cerebral ischemia, cataract, blurred vision, visual impairment, blindness, hearing loss, tinnitus, atrial fibrillation, bradycardia, congestive heart failure, tachycardia, heart failure, myocardial ischemia, arrhythmia, QT prolongation, atrial flutter, ventricular extrasystole, hypotension, hypertension, petechiae, vasculitis, ischemia, peripheral ischemia, cerebral venous sinus thrombosis, dyspnea, epistaxis, respiratory distress, pleuritic pain, hypoxia, dysphonia, abdominal pain, nausea, vomiting, indigestion, dry mouth, stomatitis, gastrointestinal bleeding, small bowel obstruction, colitis, appendicitis, alanine aminotransferase increase, aspartate aminotransferase increase, hepatotoxicity, hepatocellular injury, hyperbilirubinemia, urticaria, hyperhidrosis, dry skin, skin pigmentation, eczema, erythema, drug rash, skin depigmentation, photosensitivity, muscle weakness, bone pain, musculoskeletal and connective tissue pain, arthralgia, renal failure, tubular necrosis, hematuria, urinary retention, incontinence, acquired Fanconi syndrome, erectile dysfunction, fatigue, edema, weakness, influenza-like symptoms, increased serum alkaline phosphatase, increased C-reactive protein, falls, contusion, pulmonary embolism, pneumonia, sepsis, influenza, bronchitis, rhinitis, soft tissue infection, pulmonary infection, urinary tract infection, sinusitis, basal cell carcinoma, squamous cell carcinoma, T-cell acute leukemia, tumor lysis syndrome, thrombocytopenia, leukopenia, lymphopenia, febrile neutropenia, pancytopenia, hemolysis, autoimmune hemolytic anemia, hypercoagulation, hyperthyroidism, solid organ transplant rejection, acute graft-versus-host disease, viral infection, progressive multifocal leukoencephalopathy, interstitial pneumonia, pulmonary arterial hypertension, acquired hemophilia, candidemia

Store this medication in a tightly closed container to protect it from air and moisture exposure. It is best to keep it at room temperature, away from direct sunlight, ideally between 15 to 30 degrees Celsius.

Appearance

White hard capsule with white powder inside

Package unit

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