Renaloma Capsule 10 mg (Lenalidomide)

Adult dosage

This medicine should be administered only to patients who agree to comply with the requirements specified in the Risk Management Program (see “5. General Precautions” under Precautions for Use). In addition, this medicine should be prescribed only by physicians registered in the Risk Management Program and dispensed only by pharmacists registered in the program. When prescribed to a woman of childbearing potential, negative pregnancy test results must be confirmed continuously according to the schedule specified in the program. 1. Multiple myeloma 1) In combination with dexamethasone for the treatment of patients who have received at least one prior therapy Treatment must 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 the 25 mg capsules on Days 1–21 of each 28-day cycle. The recommended dose of dexamethasone is 40 mg once daily on Days 1–4, 9–12, and 17–20 of each 28-day cycle for the first 4 cycles. After 4 cycles, administer 40 mg once daily only on Days 1–4 of each 28-day cycle. Dose adjustments during treatment ① Dose adjustment based on 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 If subsequently decreased to <30,000/㎕ Interrupt treatment When recovered to ≧30,000㎕ Resume at a dose reduced by 5mg from the dose being administered. Do not reduce below 5mg once daily. ② Dose adjustment based on absolute neutrophil count (ANC) Table 2. 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 If subsequently decreased to <1,000/㎕ Interrupt treatment When recovered to ≧1,000/㎕ Resume at a dose reduced by 5mg from the dose being administered. Do not reduce below 5mg once daily. For neutropenia, use of growth factors should be considered for patient management. 2) In combination with dexamethasone for the treatment of newly diagnosed patients who are ineligible for transplantation Treatment must 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 the 25 mg capsules on Days 1–21 of each 28-day cycle. The recommended dose of dexamethasone is 40 mg once daily on Days 1, 8, 15, and 22 of each 28-day cycle. For patients aged 75 years or older, the recommended dose of dexamethasone is 20 mg once daily on Days 1, 8, 15, and 22 of each 28-day cycle. Continue treatment until disease progression or unacceptable toxicity occurs. Dose adjustments during treatment <Dose reduction levels> This medicine Dexamethasone Starting dose 25 mg 40 mg 1st dose reduction 20 mg 20 mg 2nd dose reduction 15 mg 12 mg 3rd dose reduction 10 mg 8 mg 4th dose reduction 5 mg 4 mg 5th dose reduction 2.5 mg N/A ① Dose adjustment based on 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 administered ② Dose adjustment based on absolute neutrophil count (ANC) Table 4. 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 administered If subsequently decreased to <500/㎕ Interrupt this medicine and dexamethasone When recovered to ≧500/㎕ Resume at one dose level below the dose being administered For neutropenia, use of growth factors should be considered for patient management. ③ Dose adjustment for febrile neutropenia (fever ≥38.5℃ and ANC<1,000/㎕): Interrupt treatment and monitor complete blood 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 is 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 this medicine was reduced due to a hematologic dose-limiting toxicity (DLT), treatment may be resumed at an increased dose, at the physician’s discretion (up to the starting dose), if bone marrow function improves (no DLT for at least 2 consecutive cycles and, at the start of a new cycle at the current dose level, absolute neutrophil count ≥1,500/㎕ and platelet count ≥100,000㎕). 3) In combination with melphalan and prednisolone for the treatment of newly diagnosed patients who are ineligible for transplantation Treatment must 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 the 10 mg capsules on Days 1–21 of each 28-day cycle. Through Cycle 9, administer melphalan orally at a dose of 0.18mg/kg on Days 1–4 of each 28-day cycle, and administer prednisolone orally at a dose of 2mg/kg on Days 1–4 of each 28-day cycle. For patients who have completed 9 cycles or cannot complete combination therapy due to tolerability, take this medicine 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 medicine Melphalan Prednisolone Starting dose 10 mg 0.18 mg/kg 2 mg/kg 1st dose reduction 7.5 mg 0.14 mg/kg 1 mg/kg 2nd dose reduction 5 mg 0.10 mg/kg 0.5 mg/kg 3rd dose reduction 2.5 mg N/A 0.25 mg/kg ① Dose adjustment based on 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 this medicine and melphalan at one dose level below the doses being administered If subsequently decreased to <30,000/㎕ Interrupt this medicine, melphalan, and prednisolone When recovered to ≧30,000㎕ Resume this medicine and melphalan at one dose level below the doses being administered ② Dose adjustment based on absolute neutrophil count (ANC) Table 6. 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 this medicine and melphalan at one dose level below the doses being administered If subsequently decreased to <500/㎕ Interrupt this medicine, melphalan, and prednisolone When recovered to ≧500/㎕ Resume this medicine and melphalan at one dose level below the doses being administered For neutropenia, use of growth factors should be considered for patient management. ③ Dose adjustment for febrile neutropenia (fever ≥38.5℃ and ANC<1,000/㎕): Interrupt this medicine, melphalan, and prednisolone and monitor complete blood 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 is 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) In combination with bortezomib and dexamethasone for the treatment of newly diagnosed patients (1) In combination with bortezomib and dexamethasone for the treatment of newly diagnosed patients who are ineligible for transplantation Treatment must not be initiated if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <80,000/㎕. The recommended starting dose of this medicine is 25mg once daily, taken on Days 1–14 of each 21-day cycle. Administer bortezomib by subcutaneous injection at a dose of 1.3mg/㎡ of body surface area on Days 1, 4, 8, and 11 of each 21-day cycle. The recommended dose of dexamethasone is 20mg once daily, taken on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle. Patients should receive 8 cycles (a total of 24 weeks) of treatment 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 dose of dexamethasone is 40mg once daily on Days 1, 8, 15, and 22 of each 28-day cycle. For patients aged 75 years or older, the 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 therapy in combination with dexamethasone and bortezomib for the treatment of newly diagnosed patients who are eligible for transplantation Treatment must not be initiated if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <80,000/㎕. The recommended starting dose of this medicine is 25mg once daily, taken on Days 1–21 of each 28-day cycle. Administer bortezomib by subcutaneous injection at a dose of 1.3mg/㎡ of body surface area on Days 1, 4, 8, and 11 of each 28-day cycle. The recommended dose of dexamethasone is 40mg once daily, taken on Days 1–4 and 9–12 of each 28-day cycle. Patients should receive 6 cycles (a total of 24 weeks) of treatment as induction therapy. Dose adjustments during treatment <Dose reduction levels> This medicine Starting dose 25 mg 1st dose reduction 20 mg 2nd dose reduction 15 mg 3rd dose reduction 10 mg 4th dose reduction 5 mg 5th dose reduction 2.5 mg ① Dose adjustment based on platelet count Table 7. 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 administered If subsequently decreased to <30,000/㎕ Interrupt treatment When recovered to ≧50,000㎕ Resume treatment at one dose level below the dose being administered ② Dose adjustment based on 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 ≧1,000/㎕ and neutropenia is the only toxicity Resume treatment at the starting dose When recovered to ≧500/㎕ and dose-dependent hematologic toxicity other than neutropenia has occurred Resume at one dose level below the dose being administered If subsequently decreased to <500/㎕ Interrupt treatment When recovered to ≧500/㎕ Resume at one dose level below the dose being administered For neutropenia, use of growth factors should be considered for patient management. *For dose adjustments of concomitant medicines, refer to the prescribing information for the relevant product. 5) Maintenance therapy in patients with newly diagnosed disease who have undergone autologous hematopoietic stem cell transplantation Maintenance therapy with this medicine should be initiated in patients with no evidence of disease progression after adequate hematologic recovery following autologous hematopoietic stem cell transplantation. Treatment must not be initiated if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <75,000/㎕. The recommended starting dose is 10mg once daily. Take the 10 mg capsules on Days 1–28 of each 28-day cycle until the medicine is not tolerated 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 adjustments 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 each 28-day cycle) 5 mg 3rd dose reduction N/A 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 medicine, the dose may be increased to 15mg once daily if tolerated. ① Dose adjustment based on platelet count Table 9. 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 administered If subsequently decreased to <30,000/㎕ Interrupt treatment When recovered to ≧30,000㎕ Resume treatment at one dose level below the dose being administered ② Dose adjustment based on absolute neutrophil count (ANC) Table 10. 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 administered If subsequently decreased to <500/㎕ Interrupt treatment When recovered to ≧500/㎕ Resume treatment at one dose level below the dose being administered For neutropenia, use of growth factors should be considered for patient management. 2. Myelodysplastic syndromes Treatment must 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 the 10 mg capsules on Days 1–21 of each 28-day cycle. Dose adjustments during treatment <Dose reduction levels> This medicine Starting dose 10 mg once daily on Days 1–21 of each 28-day cycle 1st dose reduction 5 mg once daily on Days 1–28 of each 28-day cycle 2nd dose reduction 2.5 mg once daily on Days 1–28 of each 28-day cycle 3rd dose reduction 2.5 mg every other day on Days 1–28 of each 28-day cycle ① Dose adjustment based on platelet count Table 11. 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 a period of 7 days or longer Resume at one dose level below the dose being administered ② Dose adjustment based on absolute neutrophil count (ANC) Table 12. Absolute neutrophil count Recommended dose 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 medicine should be discontinued in patients who have no erythroid response of at least mild severity within 4 months after starting treatment (demonstrated by at least a 50% reduction in transfusion requirements or, in patients who have not received transfusions, a 1g/dl increase in hemoglobin level). 3. Mantle cell lymphoma The recommended starting dose is 25mg once daily. Take the 25mg capsules on Days 1–21 of each 28-day cycle. Dose adjustments during treatment <Dose reduction levels> This medicine Starting dose 25mg once daily on Days 1–21 of each 28-day cycle 1st dose reduction 20mg once daily on Days 1–21 of each 28-day cycle 2nd dose reduction 15mg once daily on Days 1–21 of each 28-day cycle 3rd dose reduction 10mg once daily on Days 1–21 of each 28-day cycle 4th dose reduction 5mg once daily on Days 1–21 of each 28-day cycle 5th dose reduction 2.5mg once daily on Days 1–21 of each 28-day cycle 5mg every other day on Days 1–21 of each 28-day cycle ① Dose adjustment based on platelet count Table 13. 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 administered If subsequently 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 once daily or 5mg every other day. ② Dose adjustment based on absolute neutrophil count (ANC) Table 14. Absolute neutrophil count Recommended dose If decreased to <1,000/㎕ for at least 7 days or if decreased to <1,000/㎕ with fever (temperature ≧38.5℃) or if decreased to <500/㎕ Interrupt treatment and monitor complete blood counts weekly When recovered to ≧1,000/㎕ Resume at one dose level below the dose being administered If subsequently decreased to <1,000/㎕ for at least 7 days or if decreased to <1,000/㎕ with fever (temperature ≧38.5℃) or if decreased to <500/㎕ Interrupt treatment. When recovered to ≧1,000/㎕ Resume at one dose level below the dose being administered Do not reduce 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 must not be initiated if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <50,000/㎕ (except when secondary to lymphoma involving the bone marrow). The recommended starting dose is 20mg once daily. Take the 20mg capsules on Days 1–21 of each 28-day cycle. Take for up to 12 treatment cycles. The recommended starting dose of rituximab is based on 28-day cycles: administer 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 adjustments during treatment <Dose reduction levels> This medicine Starting dose 20mg once daily on Days 1–21 of each 28-day cycle 1st dose reduction 15mg once daily on Days 1–21 of each 28-day cycle 2nd dose reduction 10mg once daily on Days 1–21 of each 28-day cycle 3rd dose reduction 5mg once daily on Days 1–21 of each 28-day cycle For dose adjustment due to rituximab toxicity, refer to the relevant prescribing information. ① Dose adjustment based on platelet count Table 15. 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 administered If subsequently 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 administered Do not reduce below 5mg once daily. ② Dose adjustment based on absolute neutrophil count (ANC) Table 16. Absolute neutrophil count Recommended dose If decreased to <1,000/㎕ for at least 7 days or if decreased to <1,000/㎕ with fever (temperature ≥38.5°C) or if decreased to <500/㎕ Interrupt this medicine and monitor complete blood counts weekly When recovered to ≥1,000/㎕ Resume at one dose level below the dose being administered If subsequently decreased to <1,000/㎕ for at least 7 days or if decreased to <1,000/㎕ with fever (temperature ≥38.5°C) or if decreased to <500/㎕ Interrupt this medicine and monitor complete blood counts weekly When recovered to ≥1,000/㎕ Resume at one dose level below the dose being administered Do not reduce 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 be adequately hydrated orally during the first week of the first treatment cycle or for a longer period if clinically necessary. To monitor for tumor lysis syndrome, patients should undergo a chemistry panel during the first cycle and weekly 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 level. Provide adequate intravenous hydration and appropriate medical management according to standard treatment until electrolyte abnormalities are corrected. Rasburicase treatment may be needed to reduce hyperuricemia. The decision to hospitalize the patient 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 reduced by one level at the physician’s discretion. Tumor flare reaction (TFR) For patients who develop Grade 1/2 tumor flare reaction, this medicine 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 Grade 3/4 tumor flare reaction, interrupt treatment with this medicine and initiate treatment with non-steroidal anti-inflammatory drugs, corticosteroids, and/or opioid analgesics. When the reaction resolves to Grade 1 or lower, resume treatment at the same dose for the remainder of the cycle. Patients may receive symptom management according to guidance for treating Grade 1/2 tumor flare reaction. 5. Dose adjustment for other Grade 3/4 toxicities If Grade 3/4 toxicity related to this medicine occurs, interrupt treatment. When the toxicity resolves to Grade 2 or lower, resume treatment at a dose one level below the dose being administered, at the prescriber’s discretion. 6. This medicine must not be administered to patients with a history of Grade 4 rash caused by thalidomide. For Grade 2–3 skin rash, interruption or discontinuation of this medicine should be considered. If angioedema, 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 must 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 more pronounced in patients with renal impairment. Since older patients are more likely to have impaired renal function, care should be taken when selecting a dose and renal function should be monitored carefully. The initial dose for patients with renal impairment is as follows. It has not been studied in non-dialysis patients with creatinine clearance less than 11 mL/min or patients with creatinine clearance less than 7 mL/min. Table 17. Initial dose in patients with renal impairment (Days 1–21 of each 28-day cycle)_multiple myeloma or mantle cell lymphoma Classification Renal function (Cockcroft-Gault CLcr) Dose adjustment for multiple myeloma/mantle cell lymphoma Dose adjustment for maintenance therapy after transplantation Moderate renal impairment 30 ≤ CLcr <50mL/min 10mg once daily* 5mg once daily Severe renal impairment CLcr <30mL/min (non-dialysis patients) 7.5mg once daily or 15mg every other day 2.5mg once daily End-stage renal disease CLcr <30mL/min (dialysis patients) 5mg once daily Administer after dialysis on dialysis days 2.5mg once daily Administer after dialysis on dialysis days *After the second treatment cycle, the dose may be increased to 15mg once daily if the patient does not respond to treatment and tolerates it. Table 18. Initial dose in patients with renal impairment_myelodysplastic syndromes Classification Renal function (Cockcroft-Gault CLcr) Dose adjustment for myelodysplastic syndromes Starting dose 1st dose reduction 2nd dose reduction Moderate renal impairment 30 ≤ CLcr <50mL/min 5mg once daily (Days 1–21 of each 28-day cycle) 2.5mg once daily (Days 1–28 of each 28-day cycle) 2.5mg every other day (Days 1–28 of each 28-day cycle) Severe renal impairment CLcr <30mL/min (non-dialysis patients) 2.5mg once daily (Days 1–21 of each 28-day cycle) 2.5mg every other day (Days 1–28 of each 28-day cycle) 2.5mg twice weekly (Days 1–28 of each 28-day cycle) End-stage renal disease CLcr <30mL/min (dialysis patients) 2.5mg once daily (Days 1–21 of each 28-day cycle) 2.5mg every other day (Days 1–28 of each 28-day cycle) 2.5mg twice weekly (Days 1–28 of each 28-day cycle) Administer after dialysis on dialysis days Administer after dialysis on dialysis days Administer after dialysis on dialysis days Table 19. Dose in patients with renal impairment_follicular lymphoma Classification Renal function (Cockcroft-Gault CLcr) Dose adjustment 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 (non-dialysis patients) No data3 End-stage renal disease CLcr < 30mL/min (dialysis patients) No data3 ¹After the second treatment cycle, the dose may be increased to 15mg once daily if the patient tolerates it. 2For patients starting at 10mg, if the dose is reduced due to Grade 3/4 neutropenia or thrombocytopenia or another Grade 3/4 toxicity considered related to this medicine, do not reduce 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 initiating treatment with this medicine, dose adjustments in patients with renal impairment should be made according to the tolerability of each individual patient, as described above. 8. Take with water. Do not crush, chew, or open the capsules. The administered dose may be adjusted based on clinical or laboratory test results.

This medication can cause serious birth defects or miscarriages if taken during pregnancy. Therefore, it must not be used by pregnant women or women who may become pregnant. Women who are capable of becoming pregnant must undergo two pregnancy tests before taking this medication and should avoid sexual intercourse or use two or more contraceptive methods during and for a period after taking the medication. This medication may reduce white blood cell and platelet counts; regular blood tests are necessary during usage, and medical assistance should be sought immediately if infection or bleeding symptoms occur. Patients with a risk of heart disease may experience cardiovascular problems such as myocardial infarction, so risk factors should be managed and closely monitored. The risk of thrombosis may increase; thus, those with previous thrombosis or risk factors should take special precautions and seek immediate treatment if symptoms arise. This medication may increase the risk of certain malignancies, so cancer occurrences should be routinely checked before and during administration. It can affect liver function; therefore, patients with a history of liver disease or suspected liver dysfunction should undergo regular liver function tests. Patients with kidney dysfunction may need dosage adjustments, and kidney function should be checked periodically. Tumor flare reactions or tumor lysis syndrome may occur, necessitating special care and preventive measures for high-risk patients at the start of treatment. Vulnerability to infections may increase; therefore, seek appropriate medical treatment immediately if infection symptoms occur. This medication can cause serious allergic reactions or severe skin reactions; if symptoms such as rash, shortness of breath, or facial swelling occur, discontinue use and seek medical attention immediately. Cardiopulmonary diseases such as pulmonary hypertension may develop, so the cardiopulmonary status should be thoroughly assessed before and during treatment. This medication is contraindicated for patients with certain genetic disorders and should not be used in case of hypersensitivity. Various side effects may occur during usage, so if experiencing unusual symptoms such as fatigue, fever, muscle pain, dyspepsia, or neurological abnormalities, consult healthcare professionals. Only doctors and pharmacists registered in a professional risk management program can prescribe and dispense this medication, and patients must adhere to the guidelines of the program.

Skeletal dysplasia, congenital malformation, miscarriage, neutropenia, thrombocytopenia, febrile reaction, bleeding, myocardial infarction, venous thromboembolism, arterial thromboembolism, secondary primary malignancy, acute myeloid leukemia, myelodysplastic syndrome, skin cancer, liver failure, toxic hepatitis, cytolytic hepatitis, cholestatic hepatitis, pneumonia, renal failure, vascular edema, anaphylactic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug eruption syndrome with eosinophilia and systemic symptoms, pulmonary hypertension, tumor lysis reaction, tumor lysis syndrome, infection, viral reactivation, progressive multifocal leukoencephalopathy, cataract, fatigue, constipation, diarrhea, muscle cramps, anemia, rash, decreased appetite, cough, fever, weakness, insomnia, myalgia, arthralgia, thrombocytopenia, leukopenia, lymphopenia, pancytopenia, hemolytic anemia, hypersensitivity reaction, hypothyroidism, hypokalemia, hyperglycemia, hypoglycemia, hypocalcemia, hyponatremia, dehydration, weight loss, depression, insomnia, decreased libido, peripheral neuropathy, paresthesia, dizziness, tremor, taste distortion, headache, stroke, syncope, neuralgia, ataxia, impaired balance, intracranial hemorrhage, transient ischemic attack, cerebral ischemia, cataract, blurriness, vision loss, blindness, hearing loss, tinnitus, atrial fibrillation, bradycardia, congestive heart failure, tachycardia, heart failure, myocardial ischemia, arrhythmia, QT prolongation, atrial flutter, ventricular ectopic beats, hypotension, hypertension, petechiae, vasculitis, dyspnea, epistaxis, respiratory distress, pleuritic pain, hypoxia, vocal cord dysfunction, abdominal pain, nausea, vomiting, dyspepsia, dry mouth, stomatitis, gastrointestinal bleeding, small bowel obstruction, gastrointestinal bleeding, dysphagia, colitis, appendicitis, alanine aminotransferase increase, aspartate aminotransferase increase, hepatocellular damage, hyperbilirubinemia, urticaria, diaphoresis, skin dryness, skin hyperpigmentation, eczema, erythema, drug rash, skin depigmentation, photosensitivity reaction, muscle weakness, bone pain, limb pain, joint swelling, renal failure, hematuria, urinary retention, urinary incontinence, acquired Fanconi syndrome, erectile dysfunction, edema, influenza-like symptoms, increased serum alkaline phosphatase, increased C-reactive protein, falls, contusions, pulmonary embolism, pneumonia, sepsis, bronchitis, rhinitis, pharyngolaryngitis, otitis media, tumor lysis reaction, squamous cell carcinoma, basal cell carcinoma, febrile neutropenia, pancytopenia, autoimmune hemolytic anemia, hirsutism, blindness, glaucoma, gastrointestinal bleeding, tongue pain, fatigue, interstitial pneumonia, pulmonary arterial hypertension, Stevens-Johnson syndrome, toxic epidermal necrolysis, acquired hemophilia, candidemia

This medication should be stored in a tightly sealed container to prevent air from entering, ideally at room temperature between 15 degrees and 30 degrees. Proper storage will help maintain the effectiveness of the medication for a longer period.

Appearance

A hard capsule with a green upper part and a light yellow lower part containing a white or off-white powder

Package unit

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