Lenalidomide Capsule 5mg (Lenalidomide)

Adult dosage

This medicine should be administered only to patients who agree to comply with the requirements specified in the Pregnancy Prevention Programme (see “5. General Precautions” under Precautions for Use). In addition, this medicine must be prescribed only by physicians registered with the Pregnancy Prevention Programme and dispensed only by pharmacists registered with the programme. When prescribing to women of childbearing potential, negative pregnancy test results must be confirmed continuously according to the schedule specified in this programme. 1. Multiple myeloma 1) In combination with dexamethasone for the treatment of patients who have received one or more prior therapies Treatment must not be started if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <75,000/㎕. The recommended starting dose is 25mg once daily. Take 25mg capsules on days 1~21 of each 28-day cycle. The recommended dose of dexamethasone is 40mg 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 40mg once daily only on days 1~4 of each 28-day cycle. Dose adjustments during treatment ① Dose adjustment 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 administered. Do not reduce the dose to less than 5mg once daily. ② Dose adjustment 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 administered. Do not reduce the dose to less than 5mg once daily. For neutropenia, use of growth factors should be considered for patient management. 2) In combination with dexamethasone for the treatment of patients with newly diagnosed, transplant-ineligible disease Treatment must not be started if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <50,000/㎕. The recommended starting dose is 25mg once daily. Take 25 mg capsules 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 recommended dose of dexamethasone is 20mg 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 steps> This medicine Dexamethasone Starting dose 25 mg 40 mg First dose reduction 20 mg 20 mg Second dose reduction 15 mg 12 mg Third dose reduction 10 mg 8 mg Fourth dose reduction 5 mg 4 mg Fifth dose reduction 2.5 mg N/A ① Dose adjustment according to platelet count 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 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 administered For each subsequent decrease 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, resume treatment at the dose being administered, continuing use of a growth factor if needed, if neutropenia is the only dose-limiting toxicity. Otherwise, resume treatment at one dose level below the dose being administered. If the patient is not receiving a growth factor, administer a growth factor. If the dose of this medicine was reduced due to hematologic dose-limiting toxicity (DLT), treatment may be resumed at an increased dose, at the physician’s discretion, up to the maximum starting dose, 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) In combination with melphalan and prednisolone for the treatment of patients with newly diagnosed, transplant-ineligible disease Treatment must not be started if the absolute neutrophil count is <1,500/㎕ and/or the platelet count is <75,000/㎕. The recommended starting dose is 10mg once daily. Take 10 mg 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 cannot complete combination therapy due to intolerance, administer 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 steps> This medicine Melphalan Prednisolone Starting dose 10 mg 0.18 mg/kg 2 mg/kg First dose reduction 7.5 mg 0.14 mg/kg 1 mg/kg Second dose reduction 5 mg 0.10 mg/kg 0.5 mg/kg Third dose reduction 2.5 mg N/A 0.25 mg/kg ① Dose adjustment according to platelet count 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 below the doses being administered 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 doses being administered ② Dose adjustment 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 below the doses being administered 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 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, resume treatment at the dose being administered, continuing use of a growth factor if needed, if neutropenia is the only dose-limiting toxicity. 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 patients with newly diagnosed disease (1) In combination with bortezomib and dexamethasone for the treatment of patients with newly diagnosed, transplant-ineligible disease Treatment must not be started 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 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 treatment, take this medicine 25mg once daily in combination with dexamethasone on days 1-21 of each 28-day cycle. The recommended dose and schedule 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 with dexamethasone and bortezomib for the treatment of patients with newly diagnosed, transplant-eligible disease Treatment must not be started 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 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 adjustments during treatment <Dose reduction steps> This medicine Starting dose 25 mg First dose reduction 20 mg Second dose reduction 15 mg Third dose reduction 10 mg Fourth dose reduction 5 mg Fifth dose reduction 2.5 mg ① Dose adjustment according to platelet count 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 For each subsequent decrease to <30,000/㎕ Interrupt treatment When recovered to ≧50,000/㎕ Resume at one dose level below the dose being administered ② Dose adjustment 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 administered For each subsequent decrease to <500/㎕ Interrupt treatment When recovered to ≧500/㎕ Resume at one dose level below the dose being administered For neutropenia, use of growth factors should be considered for patient management. *For dose adjustments of concomitant medicines, refer to the prescribing information for the respective products. 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 started 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 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 adjustments during treatment <Dose reduction steps> 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 to less than 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 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 administered For each subsequent decrease to <30,000/㎕ Interrupt treatment When recovered to ≧30,000/㎕ Resume treatment at one dose level below the dose being administered ② Dose adjustment 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 administered For each subsequent decrease 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 started if the absolute neutrophil count is <500/㎕ and/or the platelet count is <25,000/㎕. The recommended starting dose is 10mg once daily. Take 10 mg capsules on days 1~21 of each 28-day cycle. Dose adjustments during treatment <Dose reduction steps> This medicine Starting dose 10 mg once daily on days 1~21 of each 28-day cycle First dose reduction 5 mg once daily on days 1~28 of each 28-day cycle Second dose reduction 2.5 mg once daily on days 1~28 of each 28-day cycle Third dose reduction 2.5 mg every other day on days 1~28 of each 28-day cycle ① Dose adjustment according to platelet count 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 or more days Resume at one dose level below the dose being administered ② Dose adjustment 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 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 not achieved at least a minor erythroid response 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 25mg capsules on days 1~21 of each 28-day cycle. Dose adjustments during treatment <Dose reduction steps> This medicine Starting dose 25mg once daily on days 1~21 of each 28-day cycle First dose reduction 20mg once daily on days 1~21 of each 28-day cycle Second dose reduction 15mg once daily on days 1~21 of each 28-day cycle Third dose reduction 10mg once daily on days 1~21 of each 28-day cycle Fourth dose reduction 5mg once daily on days 1~21 of each 28-day cycle Fifth dose reduction 2.5mg once daily on days 1~21 of each 28-day cycle 5mg every other day on days 1~21 of each 28-day cycle ① Dose adjustment according to platelet count 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 administered For each subsequent decrease to <50,000/㎕ Interrupt treatment and monitor complete blood counts weekly When recovered to ≧60,000/㎕ Resume at one dose level below the dose being administered Do not reduce the dose to less than 2.5mg once daily or less than 5mg every other day. ② Dose adjustment 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 (body 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 For each subsequent decrease 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/㎕ Interrupt treatment. When recovered to ≧1,000/㎕ Resume at one dose level below the dose being administered Do not reduce the dose to less than 2.5mg once daily or less than 5mg every other day. For neutropenia, use of growth factors should be considered for patient management. 4. Follicular lymphoma Treatment must not be started if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <50,000/㎕ (except when secondary to lymphoma infiltration of the bone marrow). The recommended starting dose is 20mg once daily. Take 20mg capsules on days 1~21 of each 28-day cycle. Administer for a maximum of 12 treatment cycles. The recommended starting dose of rituximab is based on a 28-day cycle, and 375 mg/m2 is administered intravenously weekly during cycle 1 (days 1, 8, 15, and 22). During cycles 2~5, administer 375 mg/m2 intravenously only on day 1 of each 28-day cycle. Dose adjustments during treatment <Dose reduction steps> This medicine Starting dose 20mg once daily on days 1~21 of each 28-day cycle First dose reduction 15mg once daily on days 1~21 of each 28-day cycle Second dose reduction 10mg once daily on days 1~21 of each 28-day cycle Third dose reduction 5mg once daily on days 1~21 of each 28-day cycle For dose adjustment due to rituximab toxicity, refer to the relevant prescribing information. ① Dose adjustment according to platelet count Table 13. Platelet count Recommended dose If decreased to <50,000/㎕ Interrupt treatment with this medicine and monitor complete blood counts weekly When recovered to ≥50,000/㎕ Resume at one dose level below the dose being administered For each subsequent decrease to <50,000/㎕ Interrupt treatment with this 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 the dose to less than 5mg once daily. ② Dose adjustment 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 (body temperature ≥38.5°C), or if decreased to <500/㎕ Interrupt treatment with this medicine and monitor complete blood counts weekly When recovered to ≥1,000/㎕ Resume at one dose level below the dose being administered For each subsequent decrease to <1,000/㎕ for at least 7 days, or if decreased to <1,000/㎕ with fever (body temperature ≥38.5°C), or if decreased to <500/㎕ Interrupt treatment with 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 the dose to less than 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. In 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 in accordance with standard treatment until electrolyte abnormalities are corrected. Rasburicase treatment may be required to reduce hyperuricemia. The decision to hospitalize the patient is at the physician’s discretion. In 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 in accordance with 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 dose level, at the physician’s discretion. Tumor flare reaction (TFR) In patients who develop a grade 1/2 tumor flare reaction, treatment with this medicine may continue 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 narcotic analgesics may be administered. In 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 treatment of grade 1/2 tumor flare reactions. 5. Dose adjustment for other grade 3/4 toxicities If other grade 3/4 toxicities associated with this medicine occur, interrupt treatment. Once the toxicity improves 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 due to thalidomide. For grade 2-3 skin rash, interruption or discontinuation of this medicine should be considered. Treatment must be discontinued if angioedema, an anaphylactic reaction, grade 4 rash, exfoliative or bullous rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) is suspected; treatment must not be resumed even after these reactions resolve. 7. Dose in patients with renal impairment This medicine is excreted through the kidneys; therefore, toxicity may be greater in patients with renal impairment. As renal impairment is more common in elderly patients, care should be taken when selecting the dose, and renal function should be monitored carefully. The initial dose for patients with renal impairment is as follows. Patients who are not on dialysis and have creatinine clearance below 11 mL/min, and patients with creatinine clearance below 7 mL/min, have not been studied. 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 (non-dialysis 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 is tolerating it. Table 16. Initial dose in patients with renal impairment_ myelodysplastic syndromes Category Renal function (Cockcroft-Gault CLcr) Dose adjustment for myelodysplastic syndromes Starting 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 (non-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) 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 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 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 treatment. 2For patients receiving an initial dose of 10mg who require dose reduction due to grade 3/4 neutropenia or thrombocytopenia, or other grade 3/4 toxicities considered related to this medicine, do not reduce the dose to less than 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 adjustments in patients with renal impairment should be made according to the individual patient’s tolerability, as described above. 8. Take with water. Do not crush, chew, or open the capsules. The dose may be adjusted based on clinical or laboratory test results.

This drug must not be used during pregnancy as it can cause severe congenital malformations or miscarriage. Women who may become pregnant must take two pregnancy tests before starting this medication and must use effective contraception before, during, and after treatment. This drug can reduce white blood cell and platelet counts in the blood, so regular blood tests are required while on treatment, and any signs of infection or bleeding should be reported to a physician immediately. Patients at risk for heart disease should be closely monitored due to the possible risk of myocardial infarction. There may be an increased risk of thrombosis, so patients with a history of thrombosis or risk factors should be particularly cautious, and preventive anticoagulation therapy may be recommended as needed. It may affect liver function, so patients with liver disease or abnormal liver function tests need regular liver function monitoring. In patients with reduced kidney function, drug elimination may be slowed, so dose adjustments and kidney function monitoring are important. Patients with high tumor burden are at risk for tumor lysis syndrome and rapid tumor progression, so special attention is needed at the beginning of treatment and with dose escalation. There is an increased risk of infection, so any symptoms of infection should be consulted with a healthcare provider immediately, and caution is advised for those with a history of viral infections due to possible reactivation. Severe allergic reactions such as severe skin rash, anaphylaxis, Stevens-Johnson syndrome may occur, so treatment should be stopped, and healthcare providers notified immediately if unusual symptoms arise. Regular vision and neurological checks should be performed during treatment to monitor for potential side effects such as peripheral neuropathy and cataracts. This medication may cause various side effects including hematological abnormalities, infections, gastrointestinal issues, and neurological problems, so it is crucial to consult with healthcare providers if any unusual symptoms occur while taking it.

Acrocyanosis, congenital malformation, miscarriage, neutropenia, thrombocytopenia, febrile reaction, hemorrhage, myocardial infarction, venous thromboembolism, arterial thromboembolism, secondary primary malignant tumor, acute myeloid leukemia, myelodysplastic syndrome, liver failure, toxic hepatitis, cytolytic hepatitis, cholestatic hepatitis, vascular edema, 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, decreased appetite, cough, fever, muscle cramps, anemia, cataract, blurred vision, diminished vision, 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 thrombosis, dyspnea, epistaxis, respiratory distress, pleuritic pain, hypoxia, speech disorder, abdominal pain, nausea, vomiting, dyspepsia, dry mouth, stomatitis, gastrointestinal bleeding, small bowel obstruction, colitis, appendicitis, elevated alanine aminotransferase, elevated aspartate aminotransferase, hepatotoxicity, hepatocyte damage, hyperbilirubinemia, abnormal liver function tests, urticaria, hyperhidrosis, dry skin, skin hyperpigmentation, eczema, erythema, drug rash, skin depigmentation, photosensitivity reaction, muscle weakness, bone pain, musculoskeletal and connective tissue pain and discomfort, arthralgia, joint swelling, renal failure, hematuria, urinary retention, urinary incontinence, acquired Fanconi syndrome, erectile dysfunction, fatigue, edema, influenza-like symptoms, chest pain, drowsiness, increased serum alkaline phosphatase, increased C-reactive protein, falls, contusions, pneumonia, upper respiratory infection, bacterial infection, viral infection, fungal infection, rhinosinusitis, pharyngitis, bronchitis, rhinitis, soft tissue infection, sepsis, lung infection, neutropenic infection, bronchopneumonia, folate pneumonia, Pneumocystis pneumonia, Klebsiella pneumonia, Legionella pneumonia, Mycoplasma pneumonia, pneumococcal pneumonia, streptococcal pneumonia, viral pneumonia, pulmonary anomalies, interstitial pneumonia, acute respiratory distress syndrome, bronchiectasis, pneumothorax, chronic obstructive pulmonary disease, congestion, tachypnea, oropharyngeal pain, mediastinal emphysema, pulmonary arterial hypertension, pulmonary edema, pulmonary congestion, pulmonary mass, bronchial obstruction, respiratory abnormalities, pleuritic pain, hiccups, pleural effusion, peripheral motor neuropathy, dementia, hypertonic muscle spasms, neuralgia, loss of consciousness, mental disorder, speech disturbance, epilepsy, intracranial mass, chronic polyneuropathy, Charcot-Marie-Tooth syndrome, head discomfort, hemiplegia, seizures, neuritis, neuralgia, uremic encephalopathy, cognitive impairment, numb chin syndrome, third cranial nerve palsy, Parkinson's disease, postherpetic neuralgia, action tremor, hyperkalemia, hypercalcemia, hypoalbuminemia, hypoglycemia, hyperphosphatemia, diabetic ketoacidosis, metabolic acidosis, iron deficiency, delirium, anxiety, bipolar disorder, change in mental state, attention deficit disorder, shock, pericardial effusion, stress-induced cardiomyopathy, subendocardial ischemia, cardiac arrest, Prinzmetal angina, restrictive cardiomyopathy, spinal compression fractures, rib fractures, femoral neck fractures, radiation pneumonia, spinal cord injury, vertebral fractures, forearm fractures, thoracic vertebral fractures, acute kidney injury, dysuria, azotemia, end-stage renal disease, frequency of urination, nocturia, urinary abnormalities, urethral discharge, mucosal inflammation, swelling, multiple organ failure, multiple organ dysfunction, heat sensation, injection site pain, blisters, petechiae, skin hyperpigmentation, dry eczema, papular scaly rash, chronic hyperpigmented macules, exfoliative dermatitis, macules, purpura, contact dermatitis, hair loss, skin reaction, skin lesions, skin peeling, subcutaneous hemorrhage, jaw pain, osteoporosis, joint stiffness, bone resorption, limb discomfort, rhabdomyolysis, chest wall mass, pustular rash, gingivitis, otitis media, increased serum creatinine, weight gain, decreased renal creatinine clearance, increased alkaline phosphatase in the blood, increased international normalized ratio, positive influenza A virus test, increased blood urea, increased serum lactate dehydrogenase, conjunctival hemorrhage, borderline glaucoma, myopia, dry eyes, eyelid edema, ocular pain, retinal disorders, retinopathy, diplopia, blepharitis, orbital edema, pericardial effusion, stress-induced cardiomyopathy, subendocardial ischemia, cardiac arrest, restrictive cardiomyopathy, benign prostatic hyperplasia, female genital tract fistula, cervical dysplasia, vaginal discharge, vaginal bleeding, perineal rash, hyperbilirubinemia, liver dysfunction, hepatic steatosis, acute cholangitis, acute cholecystitis, biliary stone, jaundice, adrenal insufficiency, Cushing's syndrome, inappropriate antidiuretic hormone secretion, hepatocellular carcinoma, acute leukemia, bile duct carcinoma, malignant pleural effusion, gastric cancer, flushing, shock, ear discomfort, ear discharge, hearing loss, splenomegaly, hemolytic uremic syndrome

This medication should be stored in a tightly sealed container to protect it from air and moisture, in a cool place at temperatures between 15 degrees and 30 degrees Celsius. Proper storage helps maintain the drug's effectiveness and prevent degradation.

Appearance

An opaque white hard capsule containing a white or almost white powder

Package unit

21 capsules/box [(3 capsules/PTPX7)]