Thalidomide Capsule 100 mg (Thalidomide)

Adult dose

Thalidomide should be administered only to patients who agree to comply with the requirements specified in the Risk Management Program (see “5. General Precautions” under Precautions for Use). In addition, this medicine should be prescribed only by physicians enrolled in the Risk Management Program and dispensed only by registered pharmacists. If prescribed to a woman of childbearing potential, negative pregnancy test results must be confirmed continuously according to the schedule specified in this program. 1. Erythema nodosum leprosum (adult dosage) At the start of treatment, administer 100mg orally once daily. Increase the dose by 100mg at weekly intervals only if symptoms do not improve, according to tolerability and toxicity. The maximum recommended dose is 400mg per day. A lower maintenance dose than the dose used to control the ongoing reaction may be used, based on monitoring of tolerability and toxicity. In patients with moderate to severe neuritis (due to leprosy) or other serious complications (e.g., uveitis), corticosteroids and other appropriate treatments may be initiated concomitantly and gradually tapered or discontinued once neuritis and other symptoms improve. There is no information on a recommended maintenance dose for preventing recurrence of ENL. However, if there are risks associated with thalidomide treatment, gradual dose reduction (to discontinue treatment) is suggested every 3-6 months, decreasing the dose by 50mg every 2-4 weeks. Usually administer once in the evening to reduce central nervous system adverse effects during the day (somnolence, drowsiness, sedation). This medicine should be taken at least 1 hour after a meal. 2. Newly diagnosed multiple myeloma Administer in combination with dexamethasone in 28-day cycles. Take 200mg of this medicine once daily with water at bedtime or at least 1 hour after the evening meal. Take dexamethasone orally at 40mg 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 interrupting treatment and restarting at a lower dose. For patients who experience 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 interrupting or discontinuing this medicine. Permanently discontinue 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.

This medication can cause serious congenital malformations or miscarriage if taken during pregnancy, so women who are pregnant or may become pregnant must not take it. Effective contraception using two or more methods must be used before, during, and for 4 weeks after treatment, and regular pregnancy tests must be taken. This medication may increase the risk of cardiovascular issues such as myocardial infarction and thrombosis, requiring careful observation of patients with risk factors such as smoking, hypertension, or hyperlipidemia. Drowsiness, sedation, and somnolence may commonly occur when taking this medication, so driving or operating hazardous machinery should be avoided, and it should not be taken with alcohol or other sedatives. Peripheral neuropathy may occur, and symptoms such as numbness or pain in the hands and feet should be reported immediately. Dizziness and orthostatic hypotension may occur, so one should rise slowly. There may be neutropenia, so regular blood tests to monitor white blood cell counts are necessary. This medication can cause skin or allergic reactions, so any symptoms such as rash, fever, or difficulty breathing should be reported to healthcare professionals immediately. Males with potential for fathering a child must use condoms for 4 weeks during and after treatment, and sperm donation is prohibited. This medication may lower immune function, increasing the risk of infections; therefore, rapid treatment is necessary if any signs of infection occur. Furthermore, this medication may affect liver and thyroid function, necessitating regular testing. If the drug comes into contact with skin or mucous membranes, it should be washed immediately with soap and water. Women who are pregnant or may become pregnant should not handle this medication. This medication can interact with other sedatives or specific drugs, so any ongoing medications should be reported to healthcare professionals. Safety and efficacy have not been established in children under 12 years old, and in case of an overdose, vital signs should be monitored, and appropriate treatment should be provided. Finally, strict adherence to the risk management program is mandatory during the use of this medication to ensure safety.

Congenital anomalies, miscarriage, limb deficiency, monodactyly, osteodysplasia, external ear abnormalities, facial paralysis, ocular abnormalities, congenital heart defects, digestive tract malformations, urinary tract malformations, reproductive organ malformations, increased mortality, myocardial infarction, venous thromboembolism, arterial thromboembolism, drowsiness, somnolence, sedation, consciousness impairment, peripheral neuropathy, dizziness, orthostatic hypotension, neutropenia, increased HIV virus count, rash, fever, tachycardia, hypotension, seizures, vascular edema, anaphylactic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis, headache, eosinophilia, peripheral edema, dyspnea, hypotension, bradycardia, hypothyroidism, increased platelet count, decreased platelet count, anemia, fatigue, hypocalcemia, edema, leukopenia, confusion, loss of appetite, nausea, anxiety, agitation, tremor, fever, weight loss, weight gain, thrombosis, pain, myalgia, arthralgia, pneumonia, rash/desquamation, dry skin, increased bilirubin, muscle weakness, pulmonary embolism, insomnia, confusional state, ear and labyrinth abnormalities, dizziness, abdominal pain, injury due to accident, asthenia, chills, facial edema, increased appetite, dyspepsia, abnormal liver function tests, oral candidiasis, toothache, anemia, leukopenia, lymphadenopathy, hyperlipidemia, elevated SGOT, agitation, dizziness, hyperesthesia, paresthesia, pharyngitis, rhinitis, sinusitis, acne, fungal dermatitis, nail disorder, pruritus, sweating, albuminuria, hematuria, erectile dysfunction, abdominal distension, photosensitivity, upper limb pain, hypertension, peripheral vascular disorder, tachycardia, vasodilation, belching, abdominal bloating, elevated liver function tests, bowel obstruction, vomiting, cholangitis, cholestatic jaundice, colitis, dysphagia, esophagitis, gastroenteritis, gastrointestinal disorder, gastrointestinal bleeding, gingival disorder, hepatitis, pancreatitis, parotid gland enlargement, periodontitis, stomatitis, tongue discoloration, dental anomalies, aplastic anemia, macrocytic anemia, megaloblastic anemia, microcytic anemia, dysregulation of antidiuretic hormone, amyloidosis, hyperbilirubinemia, increased BUN, increased creatinine, cyanosis, diabetes mellitus, electrolyte abnormalities, hyperkalemia, hyperuricemia, hypoalbuminemia, elevated LDH, decreased phosphorus levels, increased SGPT, arthritis, bone pain, hypertonia, joint disorders, leg cramps, myalgia, muscular weakness, periosteum disorders, abnormal thoughts, forgetfulness, euphoria, neuralgia, neuritis, neuropathy, peripheral neuritis, psychosis, cough, emphysema, epistaxis, pulmonary embolism, vesicular sounds, upper respiratory infection, degeneration, vascular edema, benign skin neoplasms, eczema, herpes simplex, incomplete Stevens-Johnson syndrome, pruritus, psoriasis, skin discoloration, skin abnormalities, conjunctivitis, ocular disorders, urinary incontinence, retinitis, gustatory dysfunction, reduced creatinine clearance, orchitis, proteinuria, pyuria, frequent urination, diplopia, hypersensitivity, polyuria, nodular erythema, erythrocytic leukemia, foot drop, incontinence, gynecomastia, hangover effect, hypomagnesemia, lymphedema, lymphocytopenia, uterine bleeding, migraine, mucous edema, nodular sclerosing Hodgkin's disease, nystagmus, oliguria, pancytopenia, petechiae, purpura, Raynaud's phenomenon, gastric ulcer, suicidal ideation, interstitial lung disease, severe infections, septic shock, toxic epidermal necrolysis, intestinal obstruction, sexual dysfunction, tumor lysis syndrome, gastrointestinal perforation, febrile neutropenia, myocardial infarction, amenorrhea, allergic reaction, convulsions, gastrointestinal bleeding, liver damage, hearing loss, renal failure, worsening of Parkinson's disease, pulmonary arterial hypertension, leukopenic vasculitis, anaphylactic reaction, progressive multifocal leukoencephalopathy, reactivation of herpes zoster, reactivation of hepatitis B virus

This medication is sensitive to light, so it should be stored in a container that blocks light. It is also advisable to store it at a cool room temperature below 25 degrees Celsius.

Appearance

Hard capsule with a dark blue upper part and a light blue lower part containing white or almost white powder

Package unit

14 capsules x 2 / Box