Lenalidomide Capsule 25mg (Lenalidomide)

Adult dosage

For multiple myeloma, the recommended initial dose is 25mg once daily, taken on days 1~21 of each 28-day cycle. When administered in combination with dexamethasone, 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. Thereafter, administer 40mg once daily on days 1~4 of each 28-day cycle. Dose adjustments are made according to the platelet count and absolute neutrophil count. For patients with newly diagnosed disease who are ineligible for transplantation, the recommended initial dose is 25mg once daily, taken 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, or 20mg for patients aged 75 years or older. Dose reduction steps are provided, and dose adjustments are made according to the platelet count and absolute neutrophil count. When used in combination with melphalan and prednisolone for the treatment of patients with newly diagnosed disease, the recommended initial dose is 10mg once daily, taken on days 1~21 of each 28-day cycle. Dose reduction steps and dose adjustments according to the platelet count and absolute neutrophil count are provided in conjunction with the other medicines. For the combination regimen of this medicine with bortezomib and dexamethasone in patients with newly diagnosed disease, take 25mg of this medicine once daily on days 1~14 of each 21-day cycle; after the initial 8 cycles of treatment, take 25mg once daily on days 1~21 of each 28-day cycle. Take dexamethasone 20mg once daily on each 21-day cycle, and thereafter take 40mg on days 1, 8, 15, and 22 of each 28-day cycle (20mg for patients aged 75 years or older). Maintenance therapy after autologous hematopoietic stem cell transplantation is 10mg once daily, taken on days 1~28 of each 28-day cycle; the dose may be increased to 15mg if tolerated. Dose adjustments include dose reduction steps according to the platelet count and absolute neutrophil count. For myelodysplastic syndromes, take 10mg once daily on days 1~21 of each 28-day cycle; subsequent stepwise dose reductions and dose adjustments according to the platelet count and absolute neutrophil count are provided. For mantle cell lymphoma, take 25mg once daily on days 1~21 of each 28-day cycle, with dose reduction steps and dose adjustments according to the platelet count and absolute neutrophil count. For follicular lymphoma, take 20mg once daily on days 1~21 of each 28-day cycle, for up to 12 cycles. Dose reduction and dose adjustments according to the platelet count and absolute neutrophil count are provided. Take with water. Do not crush, chew, or open the capsule. The administered dose may be adjusted based on clinical or laboratory test results.

This drug can cause serious birth defects or miscarriage if taken during pregnancy, so women of childbearing potential must take a pregnancy test twice before taking this medication. Women of childbearing age should avoid sexual relations or use two or more contraceptive methods from 4 weeks prior to treatment, during treatment, and for 4 weeks after treatment. This medication may reduce the number of white blood cells and platelets, so regular blood tests should be performed during treatment, and any symptoms of fever or bleeding should be reported to a doctor immediately. Patients at risk for heart disease should be closely monitored for serious heart issues such as myocardial infarction when this drug is used with other medications. The risk of thrombosis may increase, so patients with a history of thrombosis or risk factors must take thorough preventive measures, and seek treatment immediately if symptoms arise. This drug may affect liver function, so patients with a history of liver disease or liver function abnormalities should have regular liver function tests and consult a doctor if any abnormal signs occur. Patients with impaired kidney function may require dosage adjustments, and kidney function should be checked regularly. In patients with a high tumor burden, there may be a temporary worsening of tumors, thus special care and monitoring are needed at the beginning of treatment or during dose increments. The risk of infection may increase, so immediate consultation with medical personnel is necessary if any symptoms of infection occur, and patients with a history of herpes zoster or hepatitis B infection should be tested prior to treatment due to the risk of viral reactivation. This drug can cause serious adverse effects, including severe skin reactions, anaphylaxis, pulmonary hypertension, and progressive multifocal leukoencephalopathy, so immediate medical attention is required if any unusual symptoms occur. Moreover, this drug cannot be administered to certain genetically lactose intolerant patients and should never be used by pregnant women or women of childbearing potential. While taking this medication, regular health check-ups, blood tests, liver and kidney function tests, and heart condition assessments should be done to consistently monitor for side effects.

Skeletal deformity, congenital malformation, abortion, neutropenia, thrombocytopenia, febrile reaction, hemorrhage, myocardial infarction, venous thromboembolism, arterial thromboembolism, secondary primary malignant tumors, acute liver failure, toxic hepatitis, cytolytic hepatitis, cholestatic hepatitis, liver function abnormality, vascular edema, anaphylactic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash syndrome with eosinophilia and systemic symptoms, pulmonary hypertension, tumor lysis syndrome, infection, reactivation of herpes zoster, reactivation of hepatitis B virus, progressive multifocal leukoencephalopathy, cataract, fatigue, constipation, diarrhea, muscle cramps, anemia, rash, pneumonia, renal failure, weakness, insomnia, loss of appetite, cough, fever, back pain, peripheral neuropathy, paresthesia, dizziness, tremor, dysgeusia, headache, stroke, syncope, neuralgia, ataxia, impaired sense of balance, intracranial hemorrhage, transient ischemic attack, cerebral ischemia, cataract, blurriness, vision decline, blindness, hearing loss, tinnitus, atrial fibrillation, bradycardia, congestive heart failure, tachycardia, heart failure, myocardial ischemia, arrhythmia, QT prolongation, atrial flutter, premature ventricular contractions, hypotension, hypertension, petechiae, vasculitis, ischemia, peripheral ischemia, intracranial venous sinus thrombosis, dyspnea, epistaxis, respiratory distress, pleuritic pain, hypoxia, dysphonia, vomiting, abdominal pain, nausea, dry mouth, stomatitis, gastrointestinal hemorrhage, small bowel obstruction, gastrointestinal hemorrhage, dysphagia, colitis, appendicitis, elevated alanine aminotransferase, elevated aspartate aminotransferase, cholestasis, hepatotoxicity, hepatocyte damage, hyperbilirubinemia, urticaria, hyperhidrosis, dry skin, skin hyperpigmentation, eczema, erythema, drug rash, skin depigmentation, photosensitivity reaction, muscle weakness, bone pain, musculoskeletal and connective tissue pain, arthralgia, joint edema, renal failure, hematuria, urinary retention, urinary incontinence, acquired Fanconi syndrome, erectile dysfunction, edema, influenza-like symptoms, chest pain, drowsiness, elevated blood alkaline phosphatase, increased C-reactive protein, falls, contusions, pneumonia, septic shock, influenza, pulmonary embolism, pleural effusion, interstitial pneumonia, aspiration pneumonia, acute respiratory distress syndrome, bronchiectasis, pneumothorax, chronic obstructive pulmonary disease, congestion, tachypnea, oropharyngeal pain, mediastinal emphysema, pulmonary arterial hypertension, pulmonary edema, pulmonary congestion, pulmonary mass, obstructive bronchiolitis, respiratory abnormalities, pleuritic pain, hiccups, peripheral motor neuropathy, dementia, hypertension-induced muscle cramps, neuromyalgia, mental disorder, speech disturbance, epilepsy, intracranial mass, chronic inflammatory demyelinating polyneuropathy, myelin sheath syndrome, discomfort in the head, hemiplegia, seizures, neuritis, uremic encephalopathy, cognitive impairment, paresthesia syndrome, third cranial nerve palsy, Parkinson's disease, postherpetic neuralgia, action tremor, hyperkalemia, hypercalcemia, hypoalbuminemia, hypoglycemia, hyperphosphatemia, diabetic ketoacidosis, metabolic acidosis, iron deficiency, delirium, agitation, bipolar disorder, changes in mental state, attention deficit disorder, rib fracture, limb injury, upper limb fracture, spinal fracture, femoral neck fracture, femoral fracture, radiation pneumonia, avascular necrosis, laceration, traumatic fracture, lumbar fracture, ligament sprain, spinal cord injury, tooth fracture, forearm fracture, thoracic vertebra fracture, acute kidney injury, dysuria, nitrogenemia, end-stage renal disease, polyuria, nocturia, abnormal urination, urethral discharge, mucosal inflammation, swelling, multiple organ failure, multiple organ dysfunction, facial swelling, overall deterioration of condition, generalized edema, thoracic pain, papulosquamous rash, hair loss, skin reaction, skin lesions, skin desquamation, subcutaneous hemorrhage, jaw pain, osteoporosis, spinal anterior displacement, joint stiffness, bone lysis, limb discomfort, rhabdomyolysis, chest wall mass, pustular rash, gingivitis, otitis media, elevated serum creatinine, weight gain, decreased renal creatinine clearance, elevated blood urea, conjunctival hemorrhage, borderline glaucoma, myopia, dry eyes, eyelid swelling, eye pain, retinal disorder, retinal disease, diplopia, blepharitis, periorbital swelling, cardiac effusion, stress-induced cardiomyopathy, subendocardial ischemia, cardiac arrest, restrictive cardiomyopathy, Cushing's syndrome, inappropriate antidiuretic hormone secretion, cervical dysplasia, vaginal discharge, vaginal bleeding, perineal rash, hyperbilirubinemia, adrenal insufficiency, flushing, shock, ear discomfort, ear purulence, hearing loss, hemolytic uremic syndrome

This medication should be stored in a tightly sealed container to prevent air or moisture ingress, and it is best kept in a cool place at a temperature between 15 degrees and 30 degrees.

Appearance

Opaque white hard capsule containing a white or almost white powder

Package unit

21 capsules/case (3 capsules/PTPX7)