Revlimid Capsule 15 mg (Lenalidomide)

Adult dosage

Administer only to patients who have agreed to comply with the requirements specified in the Pregnancy Prevention Program. Women of childbearing potential must have negative pregnancy test results confirmed continuously according to the specified schedule. 1. Multiple myeloma 1) Patients who have received at least one prior therapy: Treatment must not be initiated if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <75,000/㎕. The recommended initial dose is 25mg once daily. Take 25mg capsules on days 1–21 of each 28-day cycle. During the first 4 cycles, administer dexamethasone 40mg once daily on days 1–4, 9–12, and 17–20 of each 28-day cycle. After 4 cycles, administer 40mg once daily only on days 1–4 of each 28-day cycle. Dose adjustment according to platelet count: If the count decreases to <30,000/㎕, interrupt treatment and monitor a complete blood count weekly. When it recovers to ≧30,000/㎕, resume treatment at 15mg once daily. Thereafter, interrupt treatment whenever the count decreases to <30,000/㎕. When it recovers to ≧30,000/㎕, resume treatment at a dose reduced by 5mg from the dose being taken. Do not reduce the dose below 5mg daily. Dose adjustment according to absolute neutrophil count (ANC): If the count decreases to <1,000/㎕, interrupt treatment, add G-CSF, and monitor a complete blood count weekly. When it recovers to ≧1,000/㎕ and neutropenia is the only toxicity, resume treatment at 25mg once daily. When it recovers to ≧1,000/㎕ and other toxicities have occurred, resume treatment at 15mg once daily. Thereafter, interrupt treatment whenever the count decreases to <1,000/㎕. When it recovers to ≧1,000/㎕, resume treatment at a dose reduced by 5mg from the dose being taken. Do not reduce the dose below 5mg daily. 2) Newly diagnosed patients who are not eligible for transplantation: Treatment must not be initiated if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <50,000/㎕. The recommended initial dose is 25mg once daily. Take 25 mg capsules on days 1–21 of each 28-day cycle. Administer dexamethasone 40mg once daily on days 1, 8, 15, and 22 of each 28-day cycle. For patients aged 75 years or older, administer 20mg once daily on the same days. Continue until disease progression or unacceptable toxicity occurs. Dose reduction levels: Initial dose of this drug, 25 mg; first reduction, 20 mg; second reduction, 15 mg; third reduction, 10 mg; fourth reduction, 5 mg; fifth reduction, 2.5 mg. Initial dose of dexamethasone, 40 mg; first reduction, 20 mg; second reduction, 12 mg; third reduction, 8 mg; fourth reduction, 4 mg; fifth reduction, N/A. Dose adjustment according to platelet count: If the count decreases to <25,000/㎕, interrupt administration of this drug and dexamethasone and monitor a complete blood count weekly. When it recovers to ≧50,000/㎕, resume treatment at a dose reduced by one level from the dose being taken. Dose adjustment according to absolute neutrophil count (ANC): If the count decreases to <500/㎕, interrupt administration of this drug and dexamethasone and monitor a complete blood count weekly. When it recovers to ≧1,000/㎕ and neutropenia is the only toxicity, resume treatment at the starting dose. When it recovers to ≧500/㎕ and dose-dependent hematologic toxicity other than neutropenia has occurred, resume treatment at a dose reduced by one level from the dose being taken. Thereafter, interrupt administration of this drug and dexamethasone whenever the count decreases to <500/㎕. When it recovers to ≧500/㎕, resume treatment at a dose reduced by one level from the dose being taken. Febrile neutropenia (fever ≥38.5℃ and ANC<1,000/㎕): Interrupt treatment and monitor a complete blood count weekly. On the first day of the next treatment cycle, if neutropenia is the only dose-limiting toxicity, resume treatment at the dose being taken, continuing growth factor use if necessary. Otherwise, resume treatment at a dose reduced by one level from the dose being taken. If the dose was reduced because of a hematologic dose-limiting toxicity (DLT), when bone marrow function improves (no DLT for at least 2 consecutive cycles and, at the start of a new cycle at the current dose level, absolute neutrophil count ≥1,500/㎕ and platelet count ≥100,000/㎕), treatment may be resumed at an increased dose, up to the maximum starting dose, at the physician’s discretion. 3) Newly diagnosed patients who are not eligible for transplantation, in combination with melphalan and prednisolone: Treatment must 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 0.18mg/kg orally on days 1–4 of each 28-day cycle and prednisolone 2mg/kg orally on days 1–4 during the same period. Patients who have completed 9 cycles or cannot complete combination therapy because of tolerability may receive this drug as monotherapy at 10mg once daily on days 1–21 of each 28-day cycle until disease progression. Dose reduction levels: Initial dose of this drug/melphalan/prednisolone, 10 mg/0.18 mg/kg/2 mg/kg; first reduction, 7.5 mg/0.14 mg/kg/1 mg/kg; second reduction, 5 mg/0.10 mg/kg/0.5 mg/kg; third reduction, 2.5 mg/N/A/0.25 mg/kg. Dose adjustment according to platelet count: If the count decreases to <25,000/㎕, interrupt administration of this drug, melphalan, and prednisolone and monitor a complete blood count weekly. When it recovers to ≧25,000/㎕, resume treatment with this drug and melphalan at doses reduced by one level. Thereafter, interrupt administration of this drug, melphalan, and prednisolone whenever the count decreases to <30,000/㎕. When it recovers to ≧30,000/㎕, resume treatment with this drug and melphalan at doses reduced by one level from the doses being taken. Dose adjustment according to absolute neutrophil count (ANC): If the count decreases to <500/㎕, interrupt administration of this drug, melphalan, and prednisolone and monitor a complete blood count weekly. When it recovers to ≧500/㎕ and neutropenia is the only toxicity, resume treatment at the starting dose. When it recovers to ≧500/㎕ and dose-dependent hematologic toxicity other than neutropenia has occurred, resume treatment with this drug and melphalan at doses reduced by one level. Thereafter, interrupt administration of this drug, melphalan, and prednisolone whenever the count decreases to <500/㎕. When it recovers to ≧500/㎕, resume treatment with this drug and melphalan at doses reduced by one level from the doses being taken. Febrile neutropenia (fever ≥38.5℃ and ANC<1,000/㎕): Interrupt administration of this drug, melphalan, and prednisolone and monitor a complete blood count weekly. On the first day of the next treatment cycle, if neutropenia is the only dose-limiting toxicity, resume treatment at the dose being taken, continuing growth factor use if necessary. Otherwise, resume treatment at a dose reduced by one level from the dose being taken. 4) Newly diagnosed patients, in combination with bortezomib and dexamethasone: In patients who are not eligible for transplantation, treatment must not be initiated if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <80,000/㎕. The recommended initial dose of this drug is 25mg once daily, taken on days 1–14 of each 21-day cycle. Bortezomib is administered by subcutaneous injection at 1.3mg/m2 per body surface area on days 1, 4, 8, and 11 of each 21-day cycle. Dexamethasone is taken at 20mg once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle. Treat for 8 cycles (24 weeks total) as initial therapy. After initial therapy, take this drug 25mg once daily in combination with dexamethasone on days 1–21 of each 28-day cycle. Take dexamethasone 40mg once daily on days 1, 8, 15, and 22 of each 28-day cycle. Patients aged 75 years or older take the dexamethasone starting dose of 20mg once daily on the same days. In patients eligible for transplantation, treatment must not be initiated if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <80,000/㎕. The recommended initial dose of this drug is 25mg once daily, taken on days 1–21 of each 28-day cycle. Bortezomib is administered by subcutaneous injection at 1.3mg/m2 per body surface area on days 1, 4, 8, and 11 of each 28-day cycle. Dexamethasone is taken at 40mg once daily on days 1–4 and 9–12 of each 28-day cycle. Treat for 6 cycles (24 weeks total) as induction therapy. Dose reduction levels: Initial dose of this drug, 25 mg; first reduction, 20 mg; second reduction, 15 mg; third reduction, 10 mg; fourth reduction, 5 mg; fifth reduction, 2.5 mg. Dose adjustment according to platelet count: If the count decreases to <30,000/㎕, interrupt treatment and monitor a complete blood count weekly. When it recovers to ≧50,000/㎕, resume treatment at a dose reduced by one level from the dose being taken. Thereafter, interrupt treatment whenever the count decreases to <30,000/㎕. When it recovers to ≧50,000/㎕, resume treatment at a dose reduced by one level from the dose being taken. Dose adjustment according to absolute neutrophil count (ANC): If the count decreases to <500/㎕, interrupt treatment and monitor a complete blood count weekly. When it recovers to ≧1,000/㎕ and neutropenia is the only toxicity, resume treatment at the starting dose. When it recovers to ≧500/㎕ and dose-dependent hematologic toxicity other than neutropenia has occurred, resume treatment at a dose reduced by one level from the dose being taken. Thereafter, interrupt treatment whenever the count decreases to <500/㎕. When it recovers to ≧500/㎕, resume treatment at a dose reduced by one level from the dose being taken. 5) Maintenance therapy in patients who have undergone autologous hematopoietic stem cell transplantation: Treatment must not be initiated if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <75,000/㎕. The recommended initial dose is 10mg once daily. Take 10 mg capsules on days 1–28 of each 28-day cycle until intolerance or disease progression. After 3 cycles, the dose may be increased to 15mg once daily if tolerated. Dose reduction levels: For the starting dose (10mg), first reduction, 5 mg; second reduction, 5mg (days 1–21 of a 28-day cycle). After dose escalation (15mg), first reduction, 10 mg; second reduction, 5 mg; third reduction, 5mg (days 1–21 of a 28-day cycle). Do not reduce below 5mg (days 1–21 of a 28-day cycle). Dose adjustment according to platelet count: If the count decreases to <30,000/㎕, interrupt treatment and monitor a complete blood count weekly. When it recovers to ≧30,000/㎕, resume treatment at a dose reduced by one level. Thereafter, interrupt treatment whenever the count decreases to <30,000/㎕. When it recovers to ≧30,000/㎕, resume treatment at a dose reduced by one level from the dose being taken. Dose adjustment according to absolute neutrophil count (ANC): If the count decreases to <500/㎕, interrupt treatment and monitor a complete blood count weekly. When it recovers to ≧500/㎕, resume treatment at a dose reduced by one level. Thereafter, interrupt treatment whenever the count decreases to <500/㎕. When it recovers to ≧500/㎕, resume treatment at a dose reduced by one level from the dose being taken. 2. Myelodysplastic syndromes: Treatment must not be initiated if the absolute neutrophil count is <500/㎕ and/or the platelet count is <25,000/㎕. The recommended initial dose is 10mg once daily. Take 10 mg capsules on days 1–21 of each 28-day cycle. Dose reduction levels: Initial dose is 10 mg once daily on days 1–21 of a 28-day cycle; first reduction is 5 mg once daily on days 1–28 of a 28-day cycle; second reduction is 2.5 mg once daily on days 1–28 of a 28-day cycle; third reduction is 2.5 mg every other day on days 1–28 of a 28-day cycle. Dose adjustment according to platelet count: If the count decreases to <25,000/㎕, interrupt treatment and monitor a complete blood count weekly. When it recovers to ≧50,000/㎕, or when it has recovered to ≧25,000/㎕ to <50,000/㎕ at least twice for 7 or more days, resume treatment at a dose reduced by one level from the dose being taken. Dose adjustment according to absolute neutrophil count (ANC): If the count decreases to <500/㎕, interrupt treatment and monitor a complete blood count weekly. When it recovers to ≧500/㎕, resume treatment at a dose reduced by one level from the dose being taken. Discontinue treatment in patients who have no at least minor erythroid response within 4 months of starting treatment (demonstrated by at least a 50% reduction in transfusion requirements or, in patients who were not transfusion-dependent, a hemoglobin increase of 1g/dl). 3. Mantle cell lymphoma: The recommended initial dose is 25mg once daily. Take 25mg capsules on days 1–21 of each 28-day cycle. Dose reduction levels: Initial dose is 25mg once daily on days 1–21 of a 28-day cycle; first reduction is 20mg once daily for the same period of the same cycle; second reduction is 15mg once daily; third reduction is 10mg once daily; fourth reduction is 5mg once daily; fifth reduction is 2.5mg once daily or 5mg every other day on days 1–21 of a 28-day cycle. Dose adjustment according to platelet count: If the count decreases to <50,000/㎕, interrupt treatment and monitor a complete blood count weekly. When it recovers to ≧60,000/㎕, resume treatment at a dose reduced by one level from the dose being taken. Thereafter, interrupt treatment and monitor a complete blood count weekly whenever the count decreases to <50,000/㎕. When it recovers to ≧60,000/㎕, resume treatment at a dose reduced by one level from the dose being taken. Do not reduce below 2.5mg once daily or 5mg every other day. Dose adjustment according to absolute neutrophil count (ANC): If the count decreases to <1,000/㎕ for at least 7 days, or decreases to <1,000/㎕ with fever (temperature ≧38.5℃), or decreases to <500/㎕, interrupt treatment and monitor a complete blood count weekly. When it recovers to ≧1,000/㎕, resume treatment at a dose reduced by one level from the dose being taken. Thereafter, interrupt treatment if the count decreases according to the same criteria. When it recovers to ≧1,000/㎕, resume treatment at a dose reduced by one level from the dose being taken. Do not reduce below 2.5mg once daily or 5mg every other day. 4. Follicular lymphoma: Treatment must not be initiated if the absolute neutrophil count is <1,000/㎕ and/or the platelet count is <50,000/㎕ (except when secondary to lymphoma 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. Take for a maximum of 12 treatment cycles. Administer rituximab intravenously at 375 mg/m2 weekly during cycle 1 (days 1, 8, 15, and 22), and administer 375 mg/m2 intravenously only on day 1 of each 28-day cycle during cycles 2–5. Dose reduction levels: Initial dose is 20mg once daily on days 1–21 of a 28-day cycle; first reduction is 15mg once daily for the same period of the same cycle; second reduction is 10mg once daily; third reduction is 5mg once daily. Dose adjustment according to platelet count: If the count decreases to <50,000/㎕, interrupt treatment with this drug and monitor a complete blood count weekly. When it recovers to ≥50,000/㎕, resume treatment at a dose reduced by one level from the dose being taken. Thereafter, interrupt treatment with this drug and monitor a complete blood count weekly whenever the count decreases to <50,000/㎕. When it recovers to ≥50,000/㎕, resume treatment at a dose reduced by one level from the dose being taken. Do not reduce below 5mg daily. Dose adjustment according to absolute neutrophil count (ANC): If the count decreases to <1,000/㎕ for at least 7 days, or decreases to <1,000/㎕ with fever (temperature ≥38.5°C), or decreases to <500/㎕, interrupt treatment with this drug and monitor a complete blood count weekly. When it recovers to ≥1,000/㎕, resume treatment at a dose reduced by one level from the dose being taken. Thereafter, interrupt treatment with this drug and monitor a complete blood count weekly if the count decreases according to the same criteria. When it recovers to ≥1,000/㎕, resume treatment at a dose reduced by one level from the dose being taken. Do not reduce below 5mg daily. Tumor lysis syndrome in mantle cell lymphoma or follicular lymphoma: All patients must receive prophylaxis for tumor lysis syndrome and adequate oral hydration during the first week of the first treatment cycle or for longer if clinically necessary. Patients with laboratory tumor lysis syndrome or grade 1 clinical tumor lysis syndrome may continue at the same dose or, at the physician’s discretion, continue at a dose reduced by one level. Patients with grade 2–4 clinical tumor lysis syndrome must discontinue treatment. When tumor lysis syndrome improves to grade 0, treatment may be resumed at a dose one level lower, at the physician’s discretion. Tumor flare reaction: For grade 1/2, treatment may be continued without interruption or dose reduction at the prescriber’s discretion. For grade 3/4, discontinue treatment. When the condition recovers to grade 1 or lower, resume treatment at the same dose for the remainder of the cycle. If other grade 3/4 toxicities occur, interrupt treatment; when they improve to grade 2 or lower, resume treatment at a dose one level below the dose being taken, at the prescriber’s discretion. Do not administer to patients with a history of grade 4 rash caused by thalidomide. Consider interruption or discontinuation in case of grade 2–3 skin rash. If angioedema, anaphylactic reaction, grade 4 rash, exfoliative or bullous rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, or DRESS syndrome is suspected, discontinue treatment and do not resume it. 7. Patients with renal impairment: This drug has not been studied in non-dialysis patients with creatinine clearance below 11 mL/min or in patients with creatinine clearance below 7 mL/min. Multiple myeloma/mantle cell lymphoma: Moderate renal impairment (30 ≤ CLcr <50mL/min): 10mg once daily; post-transplant maintenance therapy, 5mg daily. If there is no response after the second treatment cycle and the drug is tolerated, the dose may be increased to 15mg daily. Severe renal impairment (CLcr <30mL/min, non-dialysis patients): 7.5mg daily or 15mg every other day; post-transplant maintenance therapy, 2.5mg daily. End-stage renal disease (CLcr <30mL/min, dialysis patients): 5mg daily, administered after dialysis on dialysis days; post-transplant maintenance therapy, 2.5mg daily, administered after dialysis on dialysis days. Myelodysplastic syndromes: Moderate renal impairment (30 ≤ CLcr <50mL/min): initial dose, 5mg once daily (days 1–21 of each 28-day cycle); first reduction, 2.5mg daily (days 1–28 of each 28-day cycle); second reduction, 2.5mg every other day (days 1–28 of each 28-day cycle). Severe renal impairment (CLcr <30mL/min, non-dialysis patients): initial dose, 2.5mg daily (days 1–21 of each 28-day cycle); first reduction, 2.5mg every other day (days 1–28 of each 28-day cycle); second reduction, 2.5mg twice weekly (days 1–28 of each 28-day cycle). End-stage renal disease (CLcr <30mL/min, dialysis patients): initial dose, 2.5mg daily (days 1–21 of each 28-day cycle); first reduction, 2.5mg every other day (days 1–28 of each 28-day cycle); second reduction, 2.5mg twice weekly (days 1–28 of each 28-day cycle). Administer each dose after dialysis on dialysis days. Follicular lymphoma (days 1–21 of each 28-day cycle): Moderate renal impairment (30 ≤ CLcr < 60mL/min): 10mg once daily. If tolerated after the second treatment cycle, the dose may be increased to 15mg once daily. In patients receiving an initial dose of 10mg who require a dose reduction because of grade 3/4 neutropenia or thrombocytopenia, or another grade 3/4 toxicity considered related to this drug, do not reduce below 5mg every other day or 2.5mg once daily. Severe renal impairment (CLcr < 30mL/min, non-dialysis patients): 5 mg once daily. End-stage renal disease (CLcr < 30mL/min, dialysis patients): 5 mg once daily, administered after dialysis on dialysis days. 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 can cause severe fetal malformations or abortion if taken during pregnancy, so women who are pregnant or may become pregnant should not take it. Women of childbearing potential must have two pregnancy tests before taking this drug and use appropriate contraceptive methods for a certain period both before and after treatment. This medication can reduce the number of white blood cells and platelets in the blood; therefore, regular blood tests should be done to check blood cell counts, and symptoms of infection or bleeding should be reported to a healthcare provider immediately. Caution is required for heart and vascular health due to the risk of myocardial infarction or thrombosis, so patients with cardiovascular risk factors need careful observation and management. This drug can affect liver function; therefore, patients with liver disease or abnormal liver function test results should have their liver function monitored regularly. Patients with reduced kidney function need dosage adjustments, and it is important to regularly check their kidney function. Tumor lysis syndrome and tumor flare reaction can occur, so high-risk patients should be monitored closely and take appropriate precautions at the start of treatment and when dose increases occur. There may be an increased risk of infection, so if any symptoms of infection occur, promptly visit a medical institution for appropriate treatment. While taking this medication, serious adverse reactions such as severe skin reactions, anaphylaxis, pulmonary hypertension may occur, and if any unusual symptoms develop, consult a doctor immediately. This drug should not be administered to patients with certain genetic disorders (such as galactose intolerance) and should be avoided by patients who have experienced hypersensitivity reactions. While on treatment, various adverse reactions should be regularly monitored, and immediate actions should be taken if any unusual symptoms appear. This medication requires professional clinical management and monitoring, so it should be taken exactly as prescribed by a physician, along with regular check-ups.

Limb malformation, 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, 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, infection, pneumonia, renal failure, diarrhea, fatigue, back pain, weakness, insomnia, rash, decreased appetite, cough, fever, muscle cramps, anemia, cataract, blurred vision, vision loss, 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, petechial hemorrhage, vasculitis, ischemia, peripheral ischemia, intracranial venous sinus thrombosis, dyspnea, epistaxis, breathing difficulties, pleuritic pain, hypoxia, vocal disturbances, abdominal pain, nausea, vomiting, dyspepsia, dry mouth, stomatitis, gastrointestinal bleeding, small bowel obstruction, colitis, appendicitis, increased alanine aminotransferase, increased aspartate aminotransferase, hepatotoxicity, hepatocellular injury, hyperbilirubinemia, urticaria, hyperhidrosis, dry skin, skin hyperpigmentation, eczema, erythema, drug rash, skin depigmentation, photosensitivity, muscle weakness, bone pain, musculoskeletal and connective tissue pain, arthralgia, joint swelling, renal failure, hematuria, urinary retention, urinary incontinence, acquired Fanconi syndrome, erectile dysfunction, fatigue, edema, weakness, influenza-like symptoms, increased serum alkaline phosphatase, increased C-reactive protein, falls, contusions, pneumonia, upper respiratory tract infection, bacterial infection, viral infection, fungal infection, rhinosinusitis, pharyngitis, bronchitis, rhinitis, sepsis, lung infection, urinary tract infection, sinusitis, basal cell carcinoma, squamous cell carcinoma, T-cell acute leukemia, hemolysis, autoimmune hemolytic anemia, hypercoagulability, coagulopathy, hypersensitivity reaction, hypothyroidism, hypokalemia, hyperglycemia, hypoglycemia, hypocalcemia, hyponatremia, dehydration, weight loss, diabetes, hypophosphatemia, hyperuricemia, depression, insomnia, decreased libido, paresthesia, dizziness, tremors, dysgeusia, headache, stroke, syncope, neuralgia, ataxia, impaired balance, intracranial hemorrhage, transient ischemic attack, cerebral ischemia, cataract, hearing loss, tinnitus, atrial fibrillation, myocardial infarction, heart failure, hypotension, hypertension, pulmonary embolism, dyspnea, diarrhea, constipation, vomiting, dry mouth, rash, pruritus, diaphoresis, dry skin, muscle cramps, back pain, muscle weakness, arthralgia, limb pain, renal failure, lethargy, chills, malaise, hiccups, anxiety, sleep disorders, spinal compression fracture, dysuria, chest discomfort, flank pain, pustular rash, gingivitis, tympanitis, hemorrhoids, muscle weakness, sensory loss, depression, erectile dysfunction, hiccups

Store this medication in a tightly closed container to protect from air and moisture, preferably at room temperature between 15 to 30 degrees Celsius.

Appearance

A hard capsule with a blue upper part and a white lower part filled with white powder.

Package unit

7 capsules/pack