Reblikin Capsule 5 mg (Lenalidomide)

Adult dosage

1. Multiple myeloma - Patients who have received at least one prior treatment: 25mg once daily, on days 1~21 of each 28-day cycle. - Newly diagnosed patients who are ineligible for transplantation: 25mg once daily, on days 1~21 of each 28-day cycle. - Newly diagnosed patients who are ineligible for transplantation, in combination with melphalan and prednisolone: 10mg once daily, on days 1~21 of each 28-day cycle. - Newly diagnosed mantle cell lymphoma: 25mg once daily, on days 1~21 of each 28-day cycle. - Newly diagnosed follicular lymphoma: 20mg once daily, on days 1~21 of each 28-day cycle, for a maximum of 12 cycles. - Myelodysplastic syndrome: 10mg once daily, on days 1~21 of each 28-day cycle. - Maintenance therapy: 10mg once daily, on days 1~28 of each 28-day cycle; may be increased to 15mg if tolerated. 2. Take the capsule with water. Do not crush, chew, or open it. 3. Dose reductions may be made stepwise according to platelet count, absolute neutrophil count, renal function, and toxic reactions. 4. When used in combination with dexamethasone, melphalan, prednisolone, etc., follow the recommended doses and dose-reduction steps for each medicine. (No separate dosage and administration instructions for children are mentioned)

This medication can cause severe birth defects if taken during pregnancy, thus women who are pregnant or could become pregnant must not take it under any circumstances. Women who could become pregnant must have two pregnancy tests before taking this medication, and avoid sexual intercourse from 4 weeks prior to treatment until 4 weeks after treatment, or use two or more contraceptive methods concurrently. This medication can only be prescribed and dispensed by doctors and pharmacists registered in a specific pregnancy prevention program, and patients must comply with the program's regulations. This medication can reduce white blood cell and platelet counts in the blood, increasing the risk of infection or bleeding, thus regular blood tests should be performed to monitor the condition. Depending on the results of blood tests, temporary discontinuation of the medication or adjustment of the dose may be necessary, and any symptoms of infection or bleeding should be reported to healthcare providers immediately. Patients with heart disease risks may experience cardiovascular issues such as myocardial infarction when taking this medication with dexamethasone, thus risk factors should be managed and monitored cautiously. This medication may increase the risk of thrombosis, so patients with a history of thrombosis or risk factors should exercise special caution and may require preventive anticoagulation treatment. During treatment, if symptoms of thromboembolism such as shortness of breath, chest pain, or leg swelling occur, immediate medical attention should be sought. This medication may increase the risk of secondary malignancies, so regular cancer screenings and monitoring before and during treatment are necessary. It can affect liver function; thus, patients with liver disease or suspected liver dysfunction must undergo regular liver function tests, and dose adjustments may be necessary as required. Patients with reduced kidney function may have delayed elimination of this medication, so dose adjustments and kidney function monitoring are essential. Elderly patients or those in poor physical condition have a higher risk of adverse effects from this medication, thus careful evaluation and monitoring prior to administration are needed. Severe skin reactions, including rash, allergic reactions, anaphylaxis, or Stevens-Johnson syndrome, may occur during treatment, so if these symptoms appear, the medication should be discontinued immediately, and healthcare providers should be notified. Symptoms of cardiopulmonary diseases such as pulmonary hypertension may manifest, thus thorough assessment and monitoring of cardiopulmonary status before and during treatment is crucial. Tumor lysis syndrome or tumor flare reactions may occur, so patients with a significant tumor burden should be especially careful, ensuring adequate fluid supply and preventive care. The risk of infections may increase, so if symptoms of infection such as fever or cough arise, prompt treatment is necessary. There is a risk of reactivation of viral infections; hence patients with a history of herpes zoster or hepatitis B infection should check their viral status prior to treatment and consult a specialist if necessary. Combining this medication with certain immunotherapy agents may increase mortality risk, thus using this medication concomitantly with immune checkpoint inhibitors is not recommended. This medication contains Yellow No. 5 dye, so patients who are allergic to this component should exercise caution. Various adverse reactions may occur during treatment; careful observation is especially required for blood-related side effects, infections, skin reactions, gastrointestinal symptoms, and neurological anomalies. It is important to regularly consult with healthcare providers during treatment and promptly report any unusual symptoms.

Skeletal dysplasia, congenital malformations, miscarriage, neutropenia, thrombocytopenia, febrile reaction, bleeding, myocardial infarction, venous thromboembolism, arterial thromboembolism, secondary primary malignant tumors, acute myeloid leukemia, myelodysplastic syndrome, liver failure, acute liver failure, toxic hepatitis, cytolytic hepatitis, cholestatic hepatitis, pneumonia, renal failure, diarrhea, fatigue, back pain, weakness, insomnia, rash, loss of appetite, cough, fever, muscle cramps, peripheral neuropathy, sensory disturbance, dizziness, tremor, taste disturbance, headache, stroke, syncope, neuralgia, ataxia, impaired balance, cataract, blurriness, diminished vision, blindness, hearing loss, tinnitus, atrial fibrillation, bradycardia, congestive heart failure, heart failure, myocardial ischemia, arrhythmia, QT prolongation, atrial flutter, premature ventricular contraction, hypotension, hypertension, petechiae, vasculitis, ischemia, peripheral ischemia, intracranial venous thrombosis, dyspnea, epistaxis, respiratory distress, pleuritic pain, hypoxia, speech disorder, vomiting, abdominal pain, nausea, dyspepsia, dry mouth, stomatitis, gastrointestinal bleeding, small bowel obstruction, colitis, appendicitis, increased alanine aminotransferase, increased aspartate aminotransferase, hepatotoxicity, hepatocellular damage, hyperbilirubinemia, abnormal liver function tests, urticaria, hyperhidrosis, skin dryness, skin pigmentation, eczema, erythema, eosinophilia, drug rash, depigmentation, photosensitivity, muscle weakness, bone pain, musculoskeletal pain, arthralgia, joint swelling, renal failure, hematuria, urinary retention, urinary incontinence, acquired Fanconi syndrome, erectile dysfunction, fatigue, edema, weakness, influenza-like symptoms, chest pain, somnolence, increased serum alkaline phosphatase, increased C-reactive protein, falls, contusions, pulmonary embolism, pneumonia, sepsis, influenza, bronchitis, rhinitis, soft tissue infection, lung infection, urinary tract infection, sinusitis, basal cell carcinoma, squamous cell carcinoma, T-cell acute leukemia, hemolysis, autoimmune hemolytic anemia, hypercoagulation, coagulopathy, hypersensitivity, hypothyroidism, hypokalemia, hyperglycemia, hypoglycemia, hypocalcemia, hyponatremia, dehydration, weight loss, diabetes, hypophosphatemia, hyperuricemia, hypercalcemia, depression, insomnia, decreased libido, cerebral infarction, mood changes, hallucinations, blindness, glaucoma, gastrointestinal bleeding, tongue pain, fatigue, hematoma, cardiac tamponade, stress cardiomyopathy, subendocardial ischemia, cardiac arrest, Prinzmetal angina, restrictive cardiomyopathy, vertebral compression fracture, rib fracture, femoral neck fracture, radiation pneumonitis, spinal cord injury, spinal fracture, forearm fracture, thoracic fracture, acute kidney injury, dysuria, azotemia, insomnia, delirium, bipolar disorder, changes in mental status, papulosquamous rash, hair loss, skin reactions, skin peeling, subcutaneous bleeding, hyperbilirubinemia, adrenal insufficiency, Cushing's syndrome, inappropriate antidiuretic hormone secretion, cervical dysplasia, vaginal discharge, vaginal bleeding, perineal rash, hypercalcemia, reduced oral intake, diabetic ketoacidosis, metabolic acidosis, iron deficiency, delirium, anxiety, attention deficit disorder, rib fracture, limb injury, upper limb fracture, femur fracture, laceration, traumatic fracture, lumbar fracture, ligament sprain, tooth fracture, forearm fracture, thoracic fracture, urethral obstruction, erectile dysfunction, hiccups, pulmonary artery hypertension, interstitial pneumonia, pulmonary edema, pulmonary congestion, lung mass, obstructive bronchiolitis, respiratory abnormalities, pleuritic pain, pneumocystis pneumonia, septic shock, positive influenza A virus test, increased blood urea, increased lactate dehydrogenase, conjunctival bleeding, borderline glaucoma, myopia, dry eyes, eyelid edema, eye pain, retinal disorders, retinopathy, diplopia, blepharitis, periorbital edema, cardiac tamponade, stress cardiomyopathy, subendocardial ischemia, cardiac arrest, restrictive cardiomyopathy, atrial fibrillation, cardiac arrest, benign prostatic hyperplasia, female genital fistula, cervical dysplasia, vaginal discharge, vaginal bleeding, perineal rash, hyperbilirubinemia, liver dysfunction, hepatic steatosis, acute cholangitis, acute cholecystitis, biliary stones, jaundice, adrenal insufficiency, Cushing's syndrome, inappropriate antidiuretic hormone secretion, hepatocellular carcinoma, acute leukemia, cholangiocarcinoma, malignant pleural effusion, gastric cancer, flushing, shock, ear discomfort, ear discharge, hearing loss, hemolytic uremic syndrome, candidemia

This medication should be stored in a sealed container to prevent air exposure and is best kept at room temperature between 15 to 30 degrees Celsius. This storage method helps maintain the drug's efficacy for a prolonged period.

Appearance

Hard capsule with a green upper part and pale yellow-brown lower part containing white powder.

Package unit

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