Renaloma Capsule 2.5 mg (Renalidomide)

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 enrolled in the risk management program and dispensed only by pharmacists enrolled in the program. When prescribed to women of childbearing potential, negative pregnancy test results must be confirmed on an ongoing basis according to the schedule specified in this program. 1. Multiple myeloma 1) In combination 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 starting 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 40 mg once daily on Days 1~4, 9~12, and 17~20 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 according to platelet count Table 1. Platelet count Recommended dose If decreased to <30,000/㎕ Interrupt treatment and monitor complete blood counts weekly If recovered to ≧30,000/㎕ Resume treatment at 15mg once daily If subsequently decreased to <30,000/㎕ Interrupt treatment If recovered to ≧30,000㎕ Resume treatment after reducing the current dose by 5mg. Do not reduce the dose below 5mg once daily. ② Dose adjustment according to absolute neutrophil count (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 If recovered to ≧1,000/㎕ and neutropenia is the only toxicity Resume treatment at 25mg once daily If recovered to ≧1,000/㎕ and other toxicities have occurred Resume treatment at 15mg once daily If subsequently decreased to <1,000/㎕ Interrupt treatment If recovered to ≧1,000/㎕ Resume treatment after reducing the current dose by 5mg. Do not reduce the dose 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 should 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 25 mg capsules on Days 1~21 of each 28-day cycle. The recommended dose of dexamethasone, based on a 28-day cycle, is 40 mg 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 20 mg once daily on Days 1, 8, 15, and 22. Continue treatment until disease progression or unacceptable toxicity occurs. Dose adjustments during treatment <Dose reduction levels> This 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 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 If recovered to ≧50,000㎕ Resume at one dose level below the current dose ② Dose adjustment according to absolute neutrophil count (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 If recovered to ≧1,000/㎕ and neutropenia is the only toxicity Resume at the starting dose If recovered to ≧500/㎕ and dose-dependent hematologic toxicity other than neutropenia has occurred Resume at one dose level below the current dose If subsequently decreased to <500/㎕ Interrupt this medicine and dexamethasone If recovered to ≧500/㎕ Resume at one dose level below the current dose 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, its use should be considered. On the first day of the next treatment cycle, resume treatment at the current dose, continuing growth factor use if necessary, if neutropenia is the only dose-limiting toxicity. Otherwise, resume treatment at one dose level below the current dose. If the patient is not receiving a growth factor, administer one. If the dose of this medicine has been reduced due to a hematologic dose-limiting toxicity (DLT), treatment may be resumed at a higher dose, at the physician’s discretion (up to the starting dose), if bone marrow function improves during continued treatment (no DLT for at least 2 consecutive cycles, and an 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 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 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 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 due to tolerability, 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 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 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 If recovered to ≧25,000㎕ Resume treatment with this medicine and melphalan at one dose level below the current dose If subsequently decreased to <30,000/㎕ Interrupt this medicine, melphalan, and prednisolone If recovered to ≧30,000㎕ Resume treatment with this medicine and melphalan at one dose level below the current dose ② Dose adjustment according to absolute neutrophil count (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 If recovered to ≧500/㎕ and neutropenia is the only toxicity Resume at the starting dose If 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 current dose If subsequently decreased to <500/㎕ Interrupt this medicine, melphalan, and prednisolone If recovered to ≧500/㎕ Resume treatment with this medicine and melphalan at one dose level below the current dose 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 with this medicine, melphalan, and prednisolone and monitor complete blood counts weekly. If the patient is not receiving a growth factor, its use should be considered. On the first day of the next treatment cycle, resume treatment at the current dose, continuing growth factor use if necessary, if neutropenia is the only dose-limiting toxicity. Otherwise, resume treatment at one dose level below the current dose. If the patient is not receiving a growth factor, administer one. 4) In combination 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 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 dosage regimen for dexamethasone is 40mg once daily on Days 1, 8, 15, and 22 of each 28-day cycle. For patients aged 75 years or older, the starting dose of dexamethasone is 20mg once daily on Days 1, 8, 15, and 22 of each 28-day cycle. Treatment may continue until disease progression or unacceptable toxicity occurs. (2) Induction therapy in combination 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 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 according to platelet count Table 7. Platelet count Recommended dose If decreased to <30,000/㎕ Interrupt treatment and monitor complete blood counts weekly If recovered to ≧50,000㎕ Resume at one dose level below the current dose If subsequently decreased to <30,000/㎕ Interrupt treatment If recovered to ≧50,000㎕ Resume treatment at a dose one level below the current dose ② Dose adjustment according to absolute neutrophil count (Absolute Neutrophil Count: ANC) Table 8. Absolute neutrophil count Recommended dose If decreased to <500/㎕ Interrupt treatment and monitor complete blood counts weekly If recovered to ≧1,000/㎕ and neutropenia is the only toxicity Resume at the starting dose If recovered to ≧500/㎕ and dose-dependent hematologic toxicity other than neutropenia has occurred Resume at one dose level below the current dose If subsequently decreased to <500/㎕ Interrupt treatment If recovered to ≧500/㎕ Resume at one dose level below the current dose 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 newly diagnosed patients 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 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 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 the dose 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 according to platelet count Table 9. Platelet count Recommended dose If decreased to <30,000/㎕ Interrupt treatment and monitor complete blood counts weekly If recovered to ≧30,000㎕ Resume at a dose one level below the current dose If subsequently decreased to <30,000/㎕ Interrupt treatment If recovered to ≧30,000㎕ Resume at a dose one level below the current dose ② Dose adjustment according to absolute neutrophil count (Absolute Neutrophil Count: ANC) Table 10. Neutrophil count Recommended dose If decreased to <500/㎕ Interrupt treatment and monitor complete blood counts weekly If recovered to ≧500/㎕ Resume at a dose one level below the current dose If subsequently decreased to <500/㎕ Interrupt treatment If recovered to ≧500/㎕ Resume at a dose one level below the current dose 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 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 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 according to platelet count Table 11. Platelet count Recommended dose If decreased to <25,000/㎕ Interrupt treatment and monitor complete blood counts weekly If recovered to ≧50,000/㎕, or if recovered to ≧25,000/㎕~<50,000/㎕ at least 2 times over a period of 7 days or longer Resume at one dose level below the current dose ② Dose adjustment according to absolute neutrophil count (Absolute Neutrophil Count: ANC) Table 12. Absolute neutrophil count Recommended dose If decreased to <500/㎕ Interrupt treatment and monitor complete blood counts weekly If recovered to ≧500/㎕ Resume at one dose level below the current dose 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 of starting treatment (demonstrated by at least a 50% reduction in transfusion requirements or, in patients who have not received transfusions, a hemoglobin increase of 1g/dl). 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 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 according to platelet count Table 13. Platelet count Recommended dose If decreased to <50,000/㎕ Interrupt treatment and monitor complete blood counts weekly If recovered to ≧60,000/㎕ Resume at one dose level below the current dose If subsequently decreased to <50,000/㎕ Interrupt treatment and monitor complete blood counts weekly If recovered to ≧60,000/㎕ Resume at one dose level below the current dose Do not reduce the dose below 2.5mg once daily or 5mg every other day. ② Dose adjustment according to absolute neutrophil count (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℃), or if decreased to <500/㎕ Interrupt treatment and monitor complete blood counts weekly If recovered to ≧1,000/㎕ Resume at one dose level below the current dose 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/㎕ Interrupt treatment. If recovered to ≧1,000/㎕ Resume at one dose level below the current dose 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 starting dose is 20mg once daily. Take 20mg capsules on Days 1~21 of each 28-day cycle. Take for up to 12 treatment cycles. The recommended starting dose of rituximab is based on a 28-day cycle: administer 375 mg/m2 intravenously weekly during Cycle 1 (Days 1, 8, 15, and 22). During Cycles 2~5, administer 375 mg/m2 intravenously only on Day 1 of each 28-day cycle. Dose adjustments during treatment <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 adjustments due to rituximab toxicity, refer to the relevant prescribing information. ① Dose adjustment according to platelet count Table 15. Platelet count Recommended dose If decreased to <50,000/㎕ Interrupt this medicine and monitor complete blood counts weekly If recovered to ≥50,000/㎕ Resume at one dose level below the current dose If subsequently decreased to <50,000/㎕ Interrupt this medicine and monitor complete blood counts weekly If recovered to ≥50,000/㎕ Resume at one dose level below the current dose Do not reduce the dose below 5mg once daily. ② Dose adjustment according to absolute neutrophil count (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 (body temperature ≥38.5°C), or if decreased to <500/㎕ Interrupt this medicine and monitor complete blood counts weekly If recovered to ≥1,000/㎕ Resume at one dose level below the current dose 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/㎕ Interrupt this medicine and monitor complete blood counts weekly If recovered to ≥1,000/㎕ Resume at one dose level below the current dose Do not reduce the dose below 5mg once daily. Mantle cell lymphoma or follicular lymphoma Tumor lysis syndrome (TLS) All patients should receive prophylaxis for tumor lysis syndrome (allopurinol, rasburicase, or an equivalent regimen according to institutional treatment guidelines) and should be given 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 undergo a chemistry panel during the first cycle and weekly thereafter if 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 level. Provide adequate intravenous hydration and appropriate medical management according to standard treatment until electrolyte abnormalities are corrected. Treatment with rasburicase may be needed to reduce hyperuricemia. Hospitalization is at the physician’s discretion. For patients with Grade 2-4 clinical 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 are corrected. Rasburicase treatment and hospitalization are at the physician’s discretion. Once TLS improves to Grade 0, resume treatment at a dose one level lower, at the physician’s discretion. Tumor flare reaction (TFR) For patients who develop Grade 1/2 tumor flare reaction, this medicine may be continued without interruption or dose reduction, at the prescriber’s discretion. Non-steroidal anti-inflammatory drugs (NSAIDs), a limited course of corticosteroids, and/or narcotic analgesics may be administered at the prescriber’s discretion. For patients who develop Grade 3/4 tumor flare reaction, discontinue 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 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 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 should 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. 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 As this medicine is excreted through the kidneys, toxicity may be greater in patients with renal impairment. Because renal impairment is more common in elderly patients, care should be taken when selecting a dose, and renal function should be monitored carefully. The initial doses for patients with renal impairment are as follows. Patients who are not on dialysis and have creatinine clearance less than 11 mL/min, and patients with creatinine clearance less than 7 mL/min, have not been studied. Table 17. Initial doses in patients with renal impairment (Days 1 ~ 21 of each 28-day cycle)_multiple myeloma or mantle cell lymphoma Category Renal function (Cockcroft-Gault CLcr) Dose adjustment in multiple myeloma/mantle cell lymphoma Dose adjustment in 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 tolerates treatment. Table 18. Initial doses in patients with renal impairment_myelodysplastic syndromes Category Renal function (Cockcroft-Gault CLcr) Dose adjustment in 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 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 19. Dose in patients with renal impairment_follicular lymphoma Category Renal function (Cockcroft-Gault CLcr) Dose adjustment in 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, 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. 3Patients with severe and end-stage renal impairment were excluded from clinical trials. After initiation of 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 capsule. The dose may be adjusted according to clinical or laboratory test results.

This medication must not be taken during pregnancy as it can cause serious congenital malformations to the fetus. Women of childbearing potential must have two pregnancy tests before taking this medication, and strict contraception is required during and for a period after treatment. This medication may reduce white blood cell and platelet counts in the blood, so regular blood tests are necessary to monitor the condition. Patients with a history of heart disease or risk of thrombosis should be cautious as the risk of myocardial infarction or thrombosis may increase with this medication. Patients at high risk for thrombosis should take appropriate preventive measures and notify medical staff immediately if symptoms arise. This medication can affect liver function, so regular liver function tests are necessary in patients with liver disease or suspected liver dysfunction. Patients with impaired kidney function require dosage adjustments and monitoring of kidney function. Patients with a high tumor burden should be closely monitored for the risk of sudden tumor flare or tumor lysis syndrome. Because it can make patients more susceptible to infections, prompt treatment should be sought if symptoms of infection arise. Though rare, severe skin reactions or allergic reactions may occur during this medication, so any symptoms like rash or difficulty breathing should be reported to the healthcare provider immediately. Symptoms of cardiopulmonary diseases like pulmonary hypertension should also be closely observed. This medication should not be given to patients with certain genetic lactose intolerance. Caution is advised when taking this medication concurrently with other immunosuppressants or specific chemotherapeutic agents, as the risk of mortality may increase when used with some immunotherapeutics. Long-term use may increase the risk of cataracts, so regular eye exams are recommended. This medication can cause various side effects, particularly hematologic abnormalities, infections, gastrointestinal symptoms, neurological issues, and skin reactions, so immediate consultation with healthcare professionals is advised upon symptom occurrence.

Limb malformation, congenital malformation, miscarriage, neutropenia, thrombocytopenia, febrile reaction, bleeding, myocardial infarction, venous thromboembolism, arterial thromboembolism, secondary primary malignant tumors, acute myeloid leukemia, myelodysplastic syndrome, basal cell carcinoma, squamous cell carcinoma, liver failure, acute liver failure, toxic hepatitis, cytolytic hepatitis, cholestatic hepatitis, abnormal liver function tests, 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, infection, reactivation of herpes zoster, reactivation of hepatitis B virus, progressive multifocal leukoencephalopathy, cataract, fatigue, constipation, diarrhea, muscle cramps, anemia, rash, weakness, insomnia, decreased appetite, cough, fever, myalgia, thrombocytopenia, leukopenia, lymphopenia, pancytopenia, hemolytic anemia, hypercoagulability, hypersensitivity reaction, hypothyroidism, hypokalemia, hyperglycemia, hypoglycemia, hypocalcemia, hyponatremia, dehydration, weight loss, depression, insomnia, decreased libido, peripheral neuropathy, paresthesia, dizziness, tremor, dysgeusia, headache, stroke, syncope, neuralgia, ataxia, impaired balance, intracranial hemorrhage, transient ischemic attack, cerebral ischemia, cataract, blurry vision, visual impairment, 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, ischemia, peripheral ischemia, cerebral venous thrombosis, dyspnea, epistaxis, respiratory distress, pleuritic pain, hypoxemia, voice disorder, vomiting, abdominal pain, nausea, dry mouth, stomatitis, gastrointestinal bleeding, small bowel obstruction, colitis, appendicitis, alanine aminotransferase increase, aspartate aminotransferase increase, cholestasis, hepatotoxicity, hepatocyte damage, hyperbilirubinemia, urticaria, hyperhidrosis, dry skin, skin pigmentation, eczema, erythema, drug rash, skin depigmentation, photosensitivity, muscle weakness, bone pain, musculoskeletal and connective tissue pain, arthralgia, limb pain, myalgia, 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, bruising, pulmonary embolism, lung infection, bronchitis, rhinitis, soft tissue infection, sepsis, urinary tract infection, sinusitis, basal cell carcinoma, squamous cell carcinoma, T-cell acute leukemia, tumor lysis syndrome, hemolysis, autoimmune hemolytic anemia, shock, pericardial effusion, cardiac arrest, stress-induced cardiomyopathy, subendocardial ischemia, restrictive cardiomyopathy, cardiac arrest, spinal compression fracture, rib fracture, femoral neck fracture, radiation pneumonitis, spinal cord injury, vertebral fracture, forearm fracture, thoracic spine fracture, acute kidney injury, dysuria, azotemia, insomnia, delirium, bipolar disorder, changes in mental state, papulosquamous rash, hair loss, skin reactions, skin lesions, subcutaneous hemorrhage, jaw pain, osteoporosis, joint stiffness, bone resorption, rhabdomyolysis, chest wall mass, pustular rash, gingivitis, elevated serum creatinine, weight gain, decreased renal creatinine clearance, elevated blood urea nitrogen, conjunctival hemorrhage, borderline glaucoma, myopia, dry eyes, eye swelling, eye pain, retinal disorder, retinopathy, diplopia, blepharitis, periorbital edema, female genital discharge, hyperbilirubinemia, adrenal insufficiency, Cushing's syndrome, inappropriate antidiuretic hormone secretion, cervical dysplasia, vaginal discharge, vaginal bleeding, perianal rash, flushing, ear discomfort, ear pus, hearing impairment, splenomegaly, hemolytic uremic syndrome, hypogammaglobulinemia, Candida bacteremia

This medication should be stored in a tightly sealed container to prevent air ingress and is best kept at room temperature between 15 to 30 degrees Celsius. Storing it this way helps maintain the effectiveness of the drug.

Appearance

Hard capsule with a greenish-blue upper part and a white lower part containing a white or pale yellow powder

Package unit

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