Revlimid Capsule 20 mg (Lenalidomide)

Adult dosage

1. Multiple myeloma 1) Treatment of patients who have received at least one prior therapy: The recommended initial dose is 25mg once daily, taken on days 1~21 of each 28-day cycle. 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 on days 1~4 of each 28-day cycle. 2) Treatment of newly diagnosed patients who are ineligible for transplantation: The recommended initial dose is 25mg once daily, taken 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; patients aged 75 years and older should receive 20mg. 3) Treatment of newly diagnosed patients who are ineligible for transplantation in combination with melphalan and prednisolone: The recommended initial dose is 10mg once daily, taken on days 1~21 of each 28-day cycle. 4) Treatment of newly diagnosed patients who are eligible for transplantation in combination with bortezomib and dexamethasone: The recommended initial dose is 25mg once daily, taken on days 1~14 of each 21-day cycle. Administer bortezomib 1.3mg/m2 per body surface area by subcutaneous injection on days 1, 4, 8, and 11 of each 21-day cycle. Take dexamethasone 20mg once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle. After initial treatment, maintenance therapy consists of 25mg once daily on days 1~21 of each 28-day cycle; take 40mg dexamethasone, or 20mg for patients aged 75 years and older. 5) Maintenance therapy in patients with newly diagnosed disease who have undergone autologous hematopoietic stem cell transplantation: The recommended initial dose is 10mg once daily on days 1~28 of each 28-day cycle. After 3 cycles, the dose may be increased to 15mg once daily if tolerated. 6) Myelodysplastic syndrome: The recommended initial dose is 10mg once daily, taken on days 1~21 of each 28-day cycle. 7) Mantle cell lymphoma: The recommended initial dose is 25mg once daily, taken on days 1~21 of each 28-day cycle. 8) Follicular lymphoma: The recommended initial dose is 20mg once daily, taken on days 1~21 of each 28-day cycle. Take for a maximum of 12 treatment cycles. Depending on platelet count and absolute neutrophil count, the dose is reduced in steps or treatment is interrupted and then resumed. Refer to the tables and guidelines in the package insert for details. Take with water. Do not crush, chew, or open the capsule.

This drug can cause serious birth defects or miscarriage if used during pregnancy, so it must not be taken by women who are pregnant or may become pregnant. Women of childbearing potential must undergo two pregnancy tests before taking this medication, and proper contraceptive measures should be taken during and after treatment for a certain period. This drug can reduce white blood cell and platelet counts, so regular blood tests are necessary during treatment to monitor blood cell levels, and adjustments in dosage or discontinuation of treatment may be required as needed. Patients with a risk of heart disease may have an increased risk of myocardial infarction and should be monitored closely, as there is also an increased risk of thrombosis; any signs of thrombosis should be reported to healthcare providers immediately. This drug can affect liver function, and patients with liver disease or suspected liver dysfunction should have routine liver function tests. Patients with impaired kidney function may have a higher blood concentration of this drug, necessitating dosage adjustments and monitoring of kidney function. Patients with a high tumor burden may experience tumor flare reactions or tumor lysis syndrome, requiring careful monitoring and preventive measures at the initiation of treatment and during dose escalation. Patients who are susceptible to infections should seek prompt treatment if symptoms of infection appear, and there is a risk of viral reactivation (e.g., herpes zoster, hepatitis B); pre-treatment virus status should be checked, and caution should be exercised during treatment. This drug can cause severe skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS syndrome), and any rash or allergic symptoms should be reported to healthcare providers immediately. During treatment, serious complications such as pulmonary hypertension or progressive multifocal leukoencephalopathy may occur, so any new symptoms such as difficulty breathing or neurological symptoms should be evaluated immediately. This drug should not be administered to patients with certain genetic disorders (e.g., lactose intolerance), and those with hypersensitivity should avoid it. During treatment, various adverse reactions may occur, and any symptoms such as fatigue, fever, bleeding, difficulty breathing, neurological symptoms, or gastrointestinal symptoms should be discussed with healthcare providers. This drug must only be prescribed and dispensed by healthcare providers registered in the Pregnancy Prevention Program for this drug, and patients must comply with all the program's regulations.

Skeletal dysplasia, congenital malformation, miscarriage, neutropenia, thrombocytopenia, febrile reaction, bleeding, myocardial infarction, venous thromboembolism, arterial thromboembolism, secondary primary malignancy, basal cell skin cancer, squamous cell skin cancer, acute myeloid leukemia, myelodysplastic syndrome, liver failure, toxic hepatitis, cytolytic hepatitis, cholestatic hepatitis, abnormal liver function tests, vascular edema, anaphylactic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug eruption syndrome with eosinophilia and systemic symptoms, pulmonary hypertension, tumor lysis syndrome, pneumonia, renal failure, fatigue, constipation, diarrhea, muscle cramps, anemia, rash, decreased appetite, cough, fever, asthenia, insomnia, back pain, weakness, bronchitis, rhinitis, cataract, blurriness, vision impairment, blindness, hearing loss, tinnitus, atrial fibrillation, bradycardia, congestive heart failure, tachycardia, heart failure, myocardial ischemia, arrhythmia, QT prolongation, atrial flutter, ventricular premature contraction, hypotension, hypertension, petechiae, vasculitis, ischemia, peripheral ischemia, intracranial venous sinus thrombosis, dyspnea, epistaxis, respiratory distress, pleuritic pain, hypoxia, dysphonia, abdominal pain, nausea, vomiting, dyspepsia, dry mouth, stomatitis, gastrointestinal bleeding, intestinal obstruction, colitis, appendicitis, elevated alanine aminotransferase, elevated aspartate aminotransferase, hepatotoxicity, hepatocellular injury, hyperbilirubinemia, urticaria, hyperhidrosis, dry skin, skin hyperpigmentation, eczema, erythema, drug rash, skin depigmentation, photosensitivity reaction, muscle weakness, myalgia, arthralgia, joint swelling, renal failure, hematuria, urinary retention, urinary incontinence, acquired Fanconi syndrome, erectile dysfunction, edema, influenza-like symptoms, chest pain, somnolence, increased serum alkaline phosphatase, increased C-reactive protein, falls, contusion, pulmonary embolism, pneumonia, sepsis, urinary tract infection, shingles, viral infection, progressive multifocal leukoencephalopathy, shock, papulosquamous rash, hair loss, petechial hemorrhage, skin pigmentation excess, oral pain, dental pain, oral ulceration, chronic gastritis, gastritis, dental caries, hemorrhoids, ascites, ischemic colitis, colonic ulcer, colonic perforation, colonic polyp, epigastric discomfort, erosive esophagitis, esophagitis, gastric ulcer, gum swelling, hemorrhagic diverticulitis, intestinal obstruction, intestinal obstruction syndrome, rectal pain, periodontal disease, anal erosion, melena, pleural effusion, asthma, rhorrhea, hemoptysis, acute respiratory distress syndrome, bronchiectasis, pneumothorax, chronic obstructive pulmonary disease, nasal congestion, hyperventilation, oropharyngeal pain, mediastinal emphysema, pulmonary arterial hypertension, pulmonary edema, pulmonary congestion, lung mass, bronchial obstruction, respiratory abnormalities, pleuritic pain, peripheral neuropathy, dementia, hypertrophic muscle spasms, neuropathic pain, speech disorders, epilepsy, intracranial mass, chronic polyneuropathy, cauda equina syndrome, discomfort in the head, hemiplegia, seizures, neuritis, neuralgia, uremic encephalopathy, cognitive impairment, paresthesia syndrome, third cranial nerve palsy, Parkinson's disease, postherpetic neuralgia, action tremor, hyperkalemia, hypercalcemia, hypoalbuminemia, hypoglycemia, hyperphosphatemia, diabetic ketoacidosis, metabolic acidosis, iron deficiency, delirium, agitation, bipolar disorder, changes in mental status, attention deficit disorder, rib fracture, limb injury, upper limb fracture, femoral neck fracture, femoral fracture, radiation pneumonitis, bone fragment formation, laceration, traumatic fracture, vertebral fracture, ligament sprain, spinal cord injury, tooth fracture, forearm fracture, thoracic vertebra fracture, acute kidney injury, urinary discomfort, azotemia, end-stage renal disease, frequent urination, nocturia, abnormal urination, urethral discharge, mucosal inflammation, swelling, multiple organ failure, multiple organ dysfunction, warmth sensation, injection site pain, blister, papulosquamous rash, chronic pigmentary maculopathy, exfoliative dermatitis, spots, purpura, contact dermatitis, skin reactions, skin peeling, subcutaneous hemorrhage, jaw pain, osteoporosis, anterior spinal displacement, joint stiffness, bone resorption, limb discomfort, rhabdomyolysis, chest wall mass, increased serum creatinine, weight gain, decreased renal creatinine clearance, increased serum alkaline phosphatase, increased international normalized ratio, positive influenza A virus test, increased serum urea, increased serum lactate dehydrogenase, conjunctival hemorrhage, borderline glaucoma, myopia, dry eyes, eyelid swelling, eye pain, retinal disorder, retinopathy, diplopia, blepharitis, periorbital edema, pericardial effusion, stress cardiomyopathy, subendocardial ischemia, cardiac arrest, restrictive cardiomyopathy, adrenal insufficiency, Cushing's syndrome, inappropriate antidiuretic hormone secretion, cervical dysplasia, vaginal discharge, vaginal bleeding, perineal rash, hyperbilirubinemia, flushing, ear discomfort, ear discharge, hearing impairment, splenomegaly, hemolytic uremic syndrome, candidemia

This medication should be stored in a tightly closed container to prevent contact with air or moisture. It is best to maintain storage temperatures between 15 and 30 degrees Celsius.

Appearance

A hard capsule with a dark red upper part and light gray lower part containing white powder.

Package unit

21 capsules/box [(7 capsules/blister X 3)], 7 capsules/box [(7 capsules/blister X 1)]