BMS Thalidomide Capsule 50 Milligrams

Adult dose

Thalidomide should be administered only to patients who agree to comply with the requirements specified in the pregnancy prevention program (see “5. General Precautions” under Precautions for Use). This medicine should be prescribed only by physicians registered in the pregnancy prevention program and dispensed only by registered pharmacists. When prescribing it to women of childbearing potential, negative pregnancy test results must be confirmed on an ongoing basis according to the schedule specified in the program. 1. Erythema nodosum leprosum (adult dosage) Initially, administer 100 mg orally once daily. Increase the dose by 100 mg at 1-week intervals, according to tolerability and toxicity, only if symptoms do not improve. The maximum recommended dose is 400 mg per day. A maintenance dose lower than the dose used to control the ongoing reaction may be used, taking tolerability and toxicity into account. In patients with moderate to severe neuritis (due to leprosy) or other serious complications (e.g., uveitis), corticosteroids and other appropriate treatments may be started concurrently, and gradually tapered or discontinued once neuritis and other symptoms improve. There is no information on the recommended maintenance dose for preventing ENL recurrence. However, if there is a risk associated with thalidomide treatment, gradual dose reduction (for the purpose of discontinuing treatment) is suggested, reducing the dose by 50 mg every 2-4 weeks over a period of 3-6 months. To reduce central nervous system adverse effects during the day (somnolence, lethargy, sedation), this medicine is usually administered once in the evening. Take this medicine at least 1 hour after a meal. 2. Newly diagnosed multiple myeloma Administer in combination with dexamethasone in 28-day cycles. Take 200 mg of this medicine with water once daily at bedtime or at least 1 hour after the evening meal. Take 40 mg of dexamethasone orally once daily on days 1-4, 9-12, and 17-20 of each 28-day cycle. 3. Dose adjustment for adverse drug reactions For patients experiencing adverse drug reactions such as constipation, somnolence, or peripheral neuritis, consider temporarily discontinuing treatment and restarting at a lower dose. For patients experiencing grade 3-4 adverse drug reactions according to the National Cancer Institute Common Toxicity Criteria, consider dose reduction, delayed administration, or discontinuation based on clinical judgment. Allergic reactions and severe skin reactions For grade 2-3 skin rash, consider temporarily withholding or discontinuing this medicine. If angioedema, an anaphylactic reaction, grade 4 rash, exfoliative or bullous rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug rash with eosinophilia and systemic symptoms is suspected, permanently discontinue this medicine.

This drug can cause serious congenital malformations or miscarriages if taken during pregnancy; therefore, women who are pregnant or may become pregnant must not take it. Women taking this drug must use two or more effective methods of contraception for at least 4 weeks before, during treatment, and after stopping treatment, and must have regular pregnancy tests. Male patients must also use condoms for at least 4 weeks during and after treatment and avoid donating semen or sperm. This drug may affect the cardiovascular system, increasing the risk of myocardial infarction or thrombosis; therefore, patients with risk factors for cardiovascular disease should be monitored carefully. Symptoms such as drowsiness, sedation, and lethargy can frequently occur, so driving or operating dangerous machinery should be avoided, and alcohol or other sedatives should not be taken concurrently. Peripheral neuropathy may occur, and if numbness, pain, or abnormal sensations in the hands or feet arise, medical personnel should be informed immediately, and treatment may be stopped if necessary. Dizziness and orthostatic hypotension may occur, so movement should be gradual when standing up. Blood abnormalities such as neutropenia may occur, requiring regular blood tests. HIV-positive patients should have their viral load monitored regularly as it may increase. This drug can cause hypersensitivity reactions such as skin rash, anaphylaxis, and serious skin adverse reactions, and if symptoms appear, it should be discontinued immediately. Only physicians and pharmacists registered in the pregnancy prevention program can prescribe and dispense this drug, and patients must follow the program's guidelines. If the powder of this drug comes into contact with the skin, it should be washed immediately with soap and water, and women who are pregnant or may become pregnant should not handle this drug. This drug may interact with other drugs to enhance sedative effects; caution is needed when taken with sedative medications. Breastfeeding women should not take this drug, and safety and efficacy have not been established in children under 12 years of age. In cases of overdose, the patient's vital signs should be monitored and appropriate supportive treatment initiated. This drug may increase the risk of infection due to immune suppression, so if symptoms of infection present, medical personnel should be informed immediately.

Congenital malformations, miscarriage, limb deficiency, single organ anomaly, bone hypoplasia, external ear anomalies, facial paralysis, ocular anomalies, congenital heart defects, gastrointestinal malformations, urinary tract malformations, genital malformations, increased mortality, myocardial infarction, venous thromboembolism, arterial thromboembolism, drowsiness, sedation, somnolence, consciousness disturbances, peripheral neuropathy, numbness, dysesthesia, dizziness, orthostatic hypotension, neutropenia, increased plasma HIV RNA levels, constipation, asthenia, sensory peripheral neuropathy, Stevens-Johnson syndrome, toxic epidermal necrolysis, headache, rash, eosinophilia, peripheral edema, dyspnea, hypotension, bradycardia, symptomatic hypothyroidism, increased platelet count, decreased platelet count, anemia, fatigue, hypocalcemia, edema, leukopenia, fever, weight loss, weight gain, confusion, anxiety, tremors, loss of appetite, nausea, dry mouth, thrombosis, pain, myalgia, arthralgia, pneumonia, rash/desquamation, dry skin, elevated bilirubin, muscle weakness, tremor, reduced level of consciousness, syncope, pulmonary embolism, insomnia, vertigo, delirium, ear and labyrinthine disorders, pharyngitis, rhinitis, sinusitis, acne, fungal dermatitis, nail disorders, pruritus, sweating, albuminuria, hematuria, erectile dysfunction, abdominal distension, photosensitivity, upper limb pain, hypertension, peripheral vascular disorders, tachycardia, vasodilation, increased appetite, hepatomegaly, belching, abdominal bloating, increased liver function test results, intestinal obstruction, vomiting, aplastic anemia, macrocytic anemia, megaloblastic anemia, microcytic anemia, antidiuretic hormone abnormalities, amyloidosis, increased BUN, increased creatinine, cyanosis, diabetes, electrolyte abnormalities, hyperkalemia, hyperuricemia, hypoproteinemia, increased LDH, decreased phosphorus levels, increased SGPT, arthritis, bone pain, hypertonia, joint disorders, leg cramps, myalgia, muscle weakness, periosteal disorders, abnormal thinking, restlessness, forgetfulness, burning sensation, perioral sensory abnormalities, depression, euphoria, hypersensitivity, neuralgia, neuritis, neuropathy, psychosis, cough, emphysema, epistaxis, pulmonary embolism, rales, upper respiratory infection, degeneration, eczematous rash, exfoliative dermatitis, ichthyosis, per follicular thickening of skin, skin necrosis, seborrhea, urticaria, vesicular rash, amblyopia, hearing loss, dry eyes, eye pain, tinnitus, decreased creatinine clearance, orchitis, proteinuria, pyuria, frequency of urination, ascites, AIDS, allergic reactions, cellulitis, chest pain, cyst, decreased CD4 count, facial edema, influenza-like syndrome, hernia, changes in thyroid hormone levels, moniliasis, photosensitivity, sarcoma, sepsis, viral infections, angina pectoris, arrhythmia, cerebral ischemia, cerebrovascular disorders, congestive heart failure, deep venous thrombosis, heart attack, heart failure, auscultatory murmurs, palpitations, pericarditis, postural hypotension, venous thrombosis, thrombosis, cholangitis, cholestatic jaundice, colitis, dysphagia, esophagitis, gastroenteritis, gastrointestinal disorders, gastrointestinal bleeding, gingival disorders, hepatitis, pancreatitis, parotid gland enlargement, periodontitis, stomatitis, tongue discoloration, dental anomalies, aplastic anemia, macrocytic anemia, megaloblastic anemia, microcytic anemia, vitamin deficiency syndromes, dehydration, hypercholesterolemia, hypoglycemia, increased alkaline phosphatase, increased lipase, increased serum creatinine, abnormal gait, ataxia, decreased libido, reduced reflexes, dementia, dysesthesia, movement disorders, emotional instability, hostility, hypoalgesia, hyperactivity, cerebellar ataxia, meningitis, neurological disorders, apnea, bronchitis, lung disorders, pulmonary edema, herpes simplex, incomplete Stevens-Johnson syndrome, angioedema, benign skin neoplasms, psoriasis, skin discoloration, skin abnormalities, conjunctivitis, eye disorders, urinary incontinence, retinitis, taste disorder, acute renal failure, amenorrhea, aphthous stomatitis, biliary obstruction, carpal tunnel syndrome, chronic myelogenous leukemia, diplopia, nocturia, nodular erythema, erythroblastosis, foot drop, incontinence, gynecomastia, hangover effects, hypomagnesemia, hypothyroidism, lymphedema, lymphocytopenia, uterine bleeding, migraine, mucinous edema, nodular sclerosing Hodgkin's disease, nystagmus, oliguria, pancytopenia, petechiae, purpura, Raynaud's phenomenon, gastric ulcer, suicide attempt, interstitial lung disease, severe infections, toxic epidermal necrolysis, intestinal obstruction, hypothyroidism, sexual dysfunction, tumor lysis syndrome, gastric perforation, febrile neutropenia, pancytopenia, myocardial infarction, amenorrhea, allergic reactions, convulsions, severe infections, gastrointestinal bleeding, liver dysfunction, hearing impairment, renal failure, exacerbation of Parkinson's disease, pulmonary arterial hypertension, viral infections, leukocytoclastic vasculitis, anaphylactic reactions, progressive multifocal leukoencephalopathy

This drug must be stored in a tightly sealed container to avoid contact with air or moisture. Additionally, it should be kept at room temperature, specifically between 1 and 30 degrees Celsius.

Appearance

An opaque, hard capsule containing white or pale yellow powder.

Package unit

Wallet, accompanying documents - 28 capsules/box [(14 capsules/PTP x 2)]