Revlimid Capsule 5 Milligrams (Lenalidomide)

Adult dosage

This medicine must 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 must be prescribed only by physicians enrolled in the Pregnancy Prevention Program and dispensed only by pharmacists enrolled in the program. When prescribing to women of childbearing potential, negative pregnancy test results must be confirmed continuously according to the schedule specified in the program. 1. Multiple myeloma 1) Combination therapy with dexamethasone for the treatment of patients who have received one or more prior therapies Treatment should not be initiated if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <75,000/㎕. The recommended 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 adjustment during treatment ① Dose adjustment based on platelet count Table 1. Platelet count Recommended dose If decreased to <30,000/㎕ Withhold treatment and monitor complete blood counts weekly When recovered to ≧30,000/㎕ Resume treatment at 15mg once daily If subsequently decreased to <30,000/㎕ Withhold 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 (ANC) Table 2. Absolute neutrophil count Recommended dose If decreased to <1,000/㎕ Withhold 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/㎕ Withhold 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, use of growth factors should be considered for patient management. 2) Combination therapy with dexamethasone for the treatment of newly diagnosed patients who are ineligible for transplantation Treatment should not be initiated if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <50,000/㎕. The recommended 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 progression or unacceptable toxicity occurs. Dose adjustment during treatment <Dose reduction levels> This medicine Dexamethasone Initial dose 25 mg 40 mg First dose reduction 20 mg 20 mg Second dose reduction 15 mg 12 mg Third dose reduction 10 mg 8 mg Fourth dose reduction 5 mg 4 mg Fifth dose reduction 2.5 mg N/A ① Dose adjustment based on platelet count Table 3. Platelet count Recommended dose If decreased to <25,000/㎕ Withhold this medicine and dexamethasone and monitor complete blood counts weekly When recovered to ≧50,000/㎕ Resume at a dose reduced by one dose level from the dose being administered ② Dose adjustment based on absolute neutrophil count (ANC) Table 4. Absolute neutrophil count Recommended dose If decreased to <500/㎕ Withhold 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 a dose reduced by one dose level from the dose being administered If subsequently decreased to <500/㎕ Withhold this medicine and dexamethasone When recovered to ≧500/㎕ Resume at a dose reduced by one dose level from 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/㎕): Withhold treatment and monitor complete blood counts weekly. If the patient is not receiving a growth factor, use of a growth factor should be considered. On the first day of the next treatment cycle, resume treatment at the dose being administered, continuing use of a growth factor if needed, if neutropenia was the only dose-limiting toxicity. Otherwise, resume treatment at a dose reduced by one dose level from the dose being administered. If the patient is not receiving a growth factor, administer a growth factor. If the dose of this medicine was reduced due to hematologic dose-limiting toxicity (DLT), and bone marrow function improves while treatment continues (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/㎕), treatment may be resumed at an increased dose of this medicine at the physician’s discretion (up to the maximum starting dose). 3) Combination therapy with melphalan and prednisolone for the treatment of newly diagnosed patients who are ineligible for transplantation Treatment should not be initiated if the absolute neutrophil count is <1,500/㎕ and/or the platelet count is <75,000/㎕. The recommended 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 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 who cannot complete combination therapy because of tolerability, administer this medicine alone at 10mg once daily on days 1~21 of each 28-day cycle until disease progression. Dose adjustment during treatment <Dose reduction levels> This medicine Melphalan Prednisolone Initial dose 10 mg 0.18 mg/kg 2 mg/kg First dose reduction 7.5 mg 0.14 mg/kg 1 mg/kg Second dose reduction 5 mg 0.10 mg/kg 0.5 mg/kg Third dose reduction 2.5 mg N/A 0.25 mg/kg ① Dose adjustment based on platelet count Table 5. Platelet count Recommended dose If decreased to <25,000/㎕ Withhold this medicine, melphalan, and prednisolone and monitor complete blood counts weekly When recovered to ≧25,000/㎕ Resume with this medicine and melphalan at doses reduced by one dose level If subsequently decreased to <30,000/㎕ Withhold this medicine, melphalan, and prednisolone When recovered to ≧30,000/㎕ Resume with this medicine and melphalan at doses reduced by one dose level from the doses being administered ② Dose adjustment based on absolute neutrophil count (ANC) Table 6. Absolute neutrophil count Recommended dose If decreased to <500/㎕ Withhold 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 with this medicine and melphalan at doses reduced by one dose level If subsequently decreased to <500/㎕ Withhold this medicine, melphalan, and prednisolone When recovered to ≧500/㎕ Resume with this medicine and melphalan at doses reduced by one dose level from the doses being administered For neutropenia, use of growth factors should be considered for patient management. ③ Dose adjustment for febrile neutropenia (fever≥38.5℃ and ANC<1,000/㎕): Withhold 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 doses being administered, continuing use of a growth factor if needed, if neutropenia was the only dose-limiting toxicity. Otherwise, resume treatment at doses reduced by one dose level from the doses 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 ineligible for transplantation Treatment should not be initiated if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <80,000/㎕. The recommended initial dose of this medicine 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 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 therapy, take 25mg of this medicine once daily in combination with dexamethasone on days 1-21 of each 28-day cycle. The recommended dexamethasone dose and regimen 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 medicine 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 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 adjustment during treatment <Dose reduction levels> This medicine Initial dose 25 mg First dose reduction 20 mg Second dose reduction 15 mg Third dose reduction 10 mg Fourth dose reduction 5 mg Fifth dose reduction 2.5 mg ① Dose adjustment based on platelet count Platelet count Recommended dose If decreased to <30,000/㎕ Withhold treatment and monitor complete blood counts weekly When recovered to ≧50,000/㎕ Resume at a dose reduced by one dose level from the dose being administered If subsequently decreased to <30,000/㎕ Withhold treatment When recovered to ≧50,000/㎕ Resume at a dose reduced by one dose level from the dose being administered ② Dose adjustment based on absolute neutrophil count (ANC) Neutrophil count Recommended dose If decreased to <500/㎕ Withhold 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 a dose reduced by one dose level from the dose being administered If subsequently decreased to <500/㎕ Withhold treatment When recovered to ≧500/㎕ Resume at a dose reduced by one dose level from the dose being administered For neutropenia, use of growth factors should be considered for patient management. *For dose adjustment of concomitant medicines, refer to the prescribing information for the respective 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 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 10 mg capsules on days 1~28 of each 28-day cycle until intolerability 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 adjustment during treatment <Dose reduction levels> Starting dose (10mg) If the dose has been increased (15mg)* First dose reduction 5 mg 10 mg Second dose reduction 5mg (days 1~21 of a 28-day cycle) 5 mg Third dose reduction N/A 5mg (days 1~21 of a 28-day cycle) Do not reduce the dose below 5mg (days 1~21 of a 28-day cycle). *After 3 cycles of maintenance therapy with this medicine, the dose may be increased to 15mg once daily if tolerated. ① Dose adjustment based on platelet count Table 7. Platelet count Recommended dose If decreased to <30,000/㎕ Withhold treatment and monitor complete blood counts weekly When recovered to ≧30,000/㎕ Resume at a dose reduced by one dose level If subsequently decreased to <30,000/㎕ Withhold treatment When recovered to ≧30,000/㎕ Resume at a dose reduced by one dose level from the dose being administered ② Dose adjustment based on absolute neutrophil count (ANC) Table 8. Absolute neutrophil count Recommended dose If decreased to <500/㎕ Withhold treatment and monitor complete blood counts weekly When recovered to ≧500/㎕ Resume at a dose reduced by one dose level If subsequently decreased to <500/㎕ Withhold treatment When recovered to ≧500/㎕ Resume at a dose reduced by one dose level from the dose being administered For neutropenia, use of growth factors should be considered for patient management. 2. Myelodysplastic syndromes Treatment should not be initiated if the absolute neutrophil count is <500/㎕ and/or the platelet count is <25,000/㎕. The recommended initial dose is 10mg once daily. Take 10 mg capsules on days 1~21 of each 28-day cycle. Dose adjustment during treatment <Dose reduction levels> This medicine Initial dose 10 mg once daily on days 1~21 of each 28-day cycle First dose reduction 5 mg once daily on days 1~28 of each 28-day cycle Second dose reduction 2.5 mg once daily on days 1~28 of each 28-day cycle Third dose reduction 2.5 mg every other day on days 1~28 of each 28-day cycle ① Dose adjustment based on platelet count Table 9. Platelet count Recommended dose If decreased to <25,000/㎕ Withhold treatment and monitor complete blood counts weekly When recovered to ≧50,000/㎕ or when recovered to ≧25,000/㎕~<50,000/㎕ at least 2 times over a period of 7 days or longer Resume at a dose reduced by one dose level from the dose being administered ② Dose adjustment based on absolute neutrophil count (ANC) Table 10. Absolute neutrophil count Recommended dose If decreased to <500/㎕ Withhold treatment and monitor complete blood counts weekly When recovered to ≧500/㎕ Resume at a dose reduced by one dose level from 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 response in red blood cells of at least mild severity (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) within 4 months after starting treatment. 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 adjustment during treatment <Dose reduction levels> This medicine Initial dose 25mg once daily on days 1~21 of each 28-day cycle First dose reduction 20mg once daily on days 1~21 of each 28-day cycle Second dose reduction 15mg once daily on days 1~21 of each 28-day cycle Third dose reduction 10mg once daily on days 1~21 of each 28-day cycle Fourth dose reduction 5mg once daily on days 1~21 of each 28-day cycle Fifth dose reduction 2.5mg once daily on days 1~21 of each 28-day cycle 5mg every other day on days 1~21 of each 28-day cycle ① Dose adjustment based on platelet count Table 11. Platelet count Recommended dose If decreased to <50,000/㎕ Withhold treatment and monitor complete blood counts weekly When recovered to ≧60,000/㎕ Resume at a dose reduced by one dose level from the dose being administered If subsequently decreased to <50,000/㎕ Withhold treatment and monitor complete blood counts weekly When recovered to ≧60,000/㎕ Resume at a dose reduced by one dose level from the dose being administered Do not reduce the dose below 2.5mg once daily or 5mg every other day. ② Dose adjustment based on 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 (body temperature≧38.5℃) or if decreased to <500/㎕ Withhold treatment and monitor complete blood counts weekly When recovered to ≧1,000/㎕ Resume at a dose reduced by one dose level from the dose being administered If subsequently decreased to <1,000/㎕ for at least 7 days or if decreased to <1,000/㎕ with fever (body temperature≧38.5℃) or if decreased to <500/㎕ Withhold treatment. When recovered to ≧1,000/㎕ Resume at a dose reduced by one dose level from the dose being administered Do not reduce the dose below 2.5mg once daily or 5mg every other day. For neutropenia, use of growth factors should be considered for patient management. 4. Follicular lymphoma Treatment should not be initiated if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <50,000/㎕ (except when secondary to lymphoma infiltration of the bone marrow). The recommended initial dose is 20mg once daily. Take 20mg capsules on days 1~21 of each 28-day cycle. Administer for up to 12 treatment cycles. The recommended initial dose of rituximab is based on a 28-day cycle. In cycle 1, administer 375 mg/m2 intravenously once weekly (days 1, 8, 15, and 22). In cycles 2~5, administer 375 mg/m2 intravenously only on day 1 of each 28-day cycle. Dose adjustment during treatment <Dose reduction levels> This medicine Initial dose 20mg once daily on days 1~21 of each 28-day cycle First dose reduction 15mg once daily on days 1~21 of each 28-day cycle Second dose reduction 10mg once daily on days 1~21 of each 28-day cycle Third dose reduction 5mg once daily on days 1~21 of each 28-day cycle For dose adjustment due to rituximab toxicity, refer to the relevant prescribing information. ① Dose adjustment based on platelet count Table 13. Platelet count Recommended dose If decreased to <50,000/㎕ Withhold this medicine and monitor complete blood counts weekly When recovered to ≥50,000/㎕ Resume at a dose reduced by one dose level from the dose being administered If subsequently decreased to <50,000/㎕ Withhold this medicine and monitor complete blood counts weekly When recovered to ≥50,000/㎕ Resume at a dose reduced by one dose level from the dose being administered Do not reduce the dose below 5mg once daily. 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 (body temperature≥38.5°C) or if decreased to <500/㎕ Withhold this medicine and monitor complete blood counts weekly When recovered to ≥1,000/㎕ Resume at a dose reduced by one dose level from the dose being administered If subsequently decreased to <1,000/㎕ for at least 7 days or if decreased to <1,000/㎕ with fever (body temperature≥38.5°C) or if decreased to <500/㎕ Withhold this medicine and monitor complete blood counts weekly When recovered to ≥1,000/㎕ Resume at a dose reduced by one dose level from the dose being administered 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 equivalent prophylaxis according to institutional treatment guidelines) and should receive adequate oral hydration during the first week of the first treatment cycle, or for a longer period if clinically indicated. To monitor for tumor lysis syndrome, patients should have a chemistry panel performed weekly during the first cycle and as clinically indicated. 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 have been corrected. Rasburicase treatment may be required to reduce hyperuricemia. Hospitalization is at the physician’s discretion. For patients with grade 2-4 clinical TLS, discontinue this medicine and perform a chemistry panel weekly or as clinically indicated. Provide adequate intravenous hydration and appropriate medical management according to standard treatment until electrolyte abnormalities have been corrected. Rasburicase treatment and hospitalization are at the physician’s discretion. Once TLS improves to grade 0, resume treatment at a dose reduced by one dose level, at the physician’s discretion. Tumor flare reaction (TFR) In 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. In patients who develop grade 3/4 tumor flare reaction, discontinue 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 the guidance for treatment of grade 1/2 tumor flare reaction. 5. Dose adjustment for other grade 3/4 toxicities If other grade 3/4 toxicities associated with this medicine occur, interrupt treatment. When the toxicity improves to grade 2 or lower, resume treatment at a dose reduced by one dose level from the dose being administered, at the prescriber’s discretion. 6. This medicine 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 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 and do not resume treatment even after the reaction resolves. 7. Dose in patients with renal impairment Because this medicine is excreted through the kidneys, toxicity may be greater in patients with renal impairment. Renal impairment is more common in elderly patients; therefore, care should be taken when selecting the dose and renal function should be monitored carefully. Initial doses for patients with renal impairment are as follows. The medicine has not been studied in nondialysis patients with creatinine clearance below 11 mL/min or in patients with creatinine clearance below 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 adjustment for multiple myeloma/mantle cell lymphoma Dose adjustment for post-transplant maintenance therapy Moderate renal impairment 30 ≤ CLcr <50mL/min 10mg once daily* 5mg once daily Severe renal impairment CLcr <30mL/min (nondialysis 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 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 adjustment for myelodysplastic syndromes Initial dose First dose reduction Second 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 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 17. Dose in patients with renal impairment_follicular lymphoma Category 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 (nondialysis patients) 5 mg once daily End-stage renal disease CLcr < 30mL/min (dialysis patients) 5 mg once daily Administer after dialysis on dialysis days ¹After the second treatment cycle, the dose may be increased to 15mg once daily if the patient tolerates it. 2For patients receiving an initial dose of 10mg, if the dose is reduced due to grade 3/4 neutropenia or thrombocytopenia, or other grade 3/4 toxicity considered related to this medicine, do not reduce the dose below 5mg every other day or 2.5mg once daily. 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 capsule. The dose may be adjusted based on clinical or laboratory test results.

This drug should not be used in pregnant women as it can cause serious birth defects or miscarriages. Women of childbearing potential must undergo two pregnancy tests before taking this drug and should avoid sexual intercourse or use two or more forms of reliable contraception from four weeks before treatment starts until four weeks after treatment ends. This medication may reduce white blood cell and platelet counts, so regular blood tests are necessary to monitor the condition, and should inform healthcare providers immediately if symptoms of infection or bleeding occur. For patients with heart disease or thromboembolic risk, the likelihood of myocardial infarction or thromboembolism increases while taking this medication, necessitating lifestyle changes to reduce risk factors and regular check-ups. This drug may affect liver function, requiring careful liver function tests during administration if liver disease is present or suspected. Renal function may slow the excretion of this drug, necessitating dosage adjustments and monitoring of kidney function. Tumor lysis syndrome or rapid tumor growth may occur, so symptoms should be monitored closely, and preventive measures should be taken early in treatment. Patients may be susceptible to infections, so if symptoms of infection such as fever or cough appear, prompt medical attention is required; special management might be necessary if there is a history of viral infections due to the risk of viral reactivation. This medication can lead to serious side effects such as severe skin reactions, anaphylaxis, and pulmonary hypertension, so any abnormal symptoms should be reported to the healthcare provider immediately. Certain genetic conditions contraindicate this medication, and especially those with lactose intolerance should not take it. During treatment, various side effects such as vision changes, muscle cramps, fatigue, constipation, diarrhea, rash, decreased appetite, cough, fever, weakness, insomnia, bronchitis, cataracts, headache, dizziness, taste abnormalities, peripheral neuropathy, syncope, increased blood pressure, malaise, chills, dry skin, itching, back pain, muscle weakness, arthralgia, limb pain, urinary tract infections, difficulty urinating, vomiting, abdominal pain, stomatitis, fever, lethargy, peripheral edema, or influenza may occur, so patients should consult healthcare providers when symptoms arise. Regular health check-ups and blood tests throughout treatment are essential to detect any side effects early and ensure appropriate measures are taken.

Skeletal dysplasia, congenital anomalies, miscarriage, neutropenia, thrombocytopenia, febrile reaction, hemorrhage, myocardial infarction, venous thromboembolism, arterial thromboembolism, secondary primary malignant tumors, acute myeloid leukemia, myelodysplastic syndrome, liver failure, acute liver failure, toxic hepatitis, cytolytic hepatitis, cholestatic hepatitis, abnormal liver function tests, vascular edema, anaphylactic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms syndrome, pulmonary hypertension, pneumonia, renal failure, fatigue, constipation, diarrhea, muscle cramps, anemia, rash, decreased appetite, cough, fever, weakness, insomnia, back pain, lethargy, peripheral neuropathy, sensory disturbances, dizziness, tremors, taste disturbances, headache, stroke, syncope, neuralgia, ataxia, impaired balance, intracranial hemorrhage, transient ischemic attack, cerebral ischemia, cataracts, blurriness, visual impairment, blindness, hearing loss, tinnitus, atrial fibrillation, bradycardia, congestive heart failure, tachycardia, heart failure, myocardial ischemia, arrhythmia, QT prolongation, atrial flutter, premature ventricular contractions, hypotension, hypertension, petechiae, vasculitis, ischemia, peripheral ischemia, intracranial venous sinus thrombosis, dyspnea, epistaxis, respiratory distress, pleuritic pain, hypoxia, dysphonia, abdominal pain, nausea, vomiting, dyspepsia, dry mouth, stomatitis, gastrointestinal bleeding, small bowel obstruction, colitis, appendicitis, increased alanine aminotransferase, increased aspartate aminotransferase, hepatotoxicity, hepatocellular damage, hyperbilirubinemia, liver failure, urticaria, hyperhidrosis, dry skin, skin pigmentation, eczema, erythema, drug rash, skin depigmentation, photosensitivity, muscle weakness, bone pain, musculoskeletal and connective tissue pain and discomfort, limb pain, myalgia, arthralgia, joint swelling, renal failure, hematuria, urinary retention, urinary incontinence, acquired Fanconi syndrome, erectile dysfunction, edema, influenza-like symptoms, chest pain, somnolence, increased serum alkaline phosphatase, increased C-reactive protein, falls, contusions, pneumonia, septic shock, influenza, pulmonary embolism, pleural effusion, interstitial pneumonia, aspiration pneumonia, acute respiratory distress syndrome, bronchiectasis, pneumothorax, chronic obstructive pulmonary disease, congestion, tachypnea, oropharyngeal pain, pneumomediastinum, pulmonary hypertension, pulmonary edema, pulmonary congestion, pulmonary mass, bronchial obstruction, respiratory abnormalities, pleuritic pain, hiccups, peripheral motor neuropathy, dementia, latent dystonia, neuropathic pain, speech disorders, epilepsy, intracranial mass, chronic multifocal neuropathy, malnutrition syndrome, discomfort in the head, hemiplegia, seizures, neuritis, uremic encephalopathy, cognitive impairment, paresthesia syndrome, third cranial nerve palsy, Parkinson's disease, postherpetic neuralgia, action tremor, hyperkalemia, hypercalcemia, hypoalbuminemia, hypoglycemia, hyperphosphatemia, diabetic ketoacidosis, metabolic acidosis, iron deficiency, delirium, anxiousness, bipolar disorder, changes in mental status, attention deficit disorder, rib fractures, limb injuries, upper limb fractures, spine fractures, femoral neck fractures, femur fractures, radiation pneumonitis, spinal cord injury, spine fractures, forearm fractures, thoracic spine fractures, acute kidney injury, dysuria, azotemia, end-stage renal disease, oliguria, nocturia, urinary abnormalities, urethral discharge, mucosal inflammation, swelling, multiple organ failure, multiple organ dysfunction, feverish sensation, injection site pain, blisters, petechiae, excessive skin pigmentation, papular scaly rash, chronic pigmented purpuric eruption, exfoliative dermatitis, macules, purpura, contact dermatitis, hair loss, skin reactions, skin lesions, skin peeling, subcutaneous hemorrhage, jaw pain, osteoporosis, joint stiffness, bone resorption, discomfort in the limbs, rhabdomyolysis, chest wall mass, pustular rash, gingivitis, increased serum creatinine, weight gain, decreased renal creatinine clearance, increased serum alkaline phosphatase, increased international normalized ratio, positive influenza A virus test, increased blood urea, increased serum lactate dehydrogenase, conjunctival hemorrhage, borderline glaucoma, myopia, dry eyes, eyelid swelling, eye pain, retinal disorders, retinal diseases, diplopia, blepharitis, periorbital swelling, cardiac effusion, stress cardiomyopathy, subendocardial ischemia, cardiac arrest, restrictive cardiomyopathy, benign prostatic hyperplasia, female reproductive tract fistula, cervical dysplasia, vaginal discharge, vaginal bleeding, perineal rash, hyperbilirubinemia, hepatic steatosis, acute cholangitis, acute cholecystitis, biliary stones, jaundice, adrenal insufficiency, Cushing's syndrome, inappropriate antidiuretic hormone secretion, flushing, shock, ear discomfort, ear discharge, hearing loss, hemolytic uremic syndrome, Candida bloodstream infection

This drug may be sensitive to air and moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained between 15 to 30 degrees Celsius to preserve the drug's efficacy and safety.

Appearance

A white powder contained in a white hard capsule with upper and lower halves.

Package unit

7 capsules/pack