Fomalikin Capsule 1 mg (Thalidomide)

Adult dosage

This medicine must be taken with water. Do not open, crush, or chew the capsules. It may be taken with or without food. The dose is continued or adjusted according to clinical and laboratory findings. 1. In combination with bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received one or more prior therapies, including lenalidomide The recommended initial dose of this medicine is 4 mg orally once daily on Days 1–14 of repeated 21-day cycles. The recommended initial dose of bortezomib is 1.3 mg/m2 once daily by intravenous or subcutaneous injection, and the recommended initial dose of dexamethasone is 20 mg once daily. Treatment with this medicine in combination with bortezomib and dexamethasone should continue until disease progression or unacceptable toxicity occurs. Cycles 1–8: Administer this medicine (4 mg) on Days 1–14 of each 21-day cycle. Administer bortezomib (1.3 mg/m2) on Days 1, 4, 8, and 11 of each 21-day cycle. Administer dexamethasone (20 mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle. Cycle 9 and later: Administer this medicine (4 mg) on Days 1–14 of each 21-day cycle. Administer bortezomib (1.3 mg/m2) on Days 1 and 8 of each 21-day cycle. Administer dexamethasone (20 mg) on Days 1, 2, 8, and 9 of each 21-day cycle. To start a new cycle of treatment with this medicine, the neutrophil count must be ≥1 x 109/L and the platelet count must be ≥50 x 109/L. Neutropenia: ANC* <0.5 x 109/L or febrile neutropenia (fever ≥38.5℃ and ANC <1 x 109/L): Interrupt treatment with this medicine and continue to monitor the complete blood count at 1-week intervals. Recovery to ANC ≥1 x 109/L: Resume treatment with this medicine at a dose 1 level lower than the previous dose. Each subsequent decrease to <0.5 x 109/L: Interrupt treatment with this medicine. Recovery to ANC ≥1 x 109/L: Resume treatment with this medicine at a dose 1 level lower than the previous dose. Thrombocytopenia: Platelet count <25 x 109/L: Interrupt treatment with this medicine and continue to monitor the complete blood count at 1-week intervals. Recovery to platelet count ≥50 x 109/L: Resume treatment with this medicine at a dose 1 level lower than the previous dose. Each subsequent decrease to <25 x 109/L: Interrupt treatment with this medicine. Recovery to platelet count ≥50 x 109/L: Resume treatment with this medicine at a dose 1 level lower than the previous dose. Grade 2–3 rash: Consider withholding or discontinuing this medicine. Grade 4 or blistering (suspected angioedema, anaphylactic reaction, exfoliative or bullous rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms [DRESS syndrome]): Permanently discontinue treatment. Other adverse reactions related to this medicine of Grade 3 or higher: Withhold this medicine until the adverse reaction resolves to ≤Grade 2. Resume treatment at a dose 1 level lower. Dose levels: Starting dose 4 mg; first dose reduction 3 mg; second dose reduction 2 mg; third dose reduction 1 mg. If an adverse reaction occurs after reduction to 1 mg, discontinue this medicine. 2. In combination with dexamethasone for the treatment of patients with relapsed or refractory disease who have received at least 2 prior therapies, including lenalidomide and bortezomib The recommended initial dose of this medicine is 4 mg orally once daily on Days 1–21 of repeated 28-day cycles. The recommended dose of dexamethasone is 40 mg orally once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle. Treatment with this medicine in combination with dexamethasone should continue until disease progression or unacceptable toxicity occurs. Follow Tables 2 and 3 for guidance on dose interruption and reduction of this medicine related to adverse reactions. Dexamethasone: For patients ≤75 years, administer on Days 1, 8, 15, and 22 of each 28-day treatment cycle; for patients >75 years, administer on Days 1, 8, 15, and 22 of each 28-day treatment cycle. Initial dose: 40 mg for patients ≤75 years, 20 mg for patients >75 years. First dose reduction: 20 mg for patients ≤75 years, 12 mg for patients >75 years. Second dose reduction: 10 mg for patients ≤75 years, 8 mg for patients >75 years. If patients aged 75 years or younger cannot tolerate dexamethasone 10 mg, or patients older than 75 years cannot tolerate dexamethasone 8 mg, dexamethasone should be discontinued. Follow Table 4 for guidance on dose interruption and reduction of dexamethasone related to adverse reactions. Dyspepsia = Grade 1–2: Maintain the dose and treat with a histamine (H2) blocker or equivalent medication. If symptoms persist, reduce the dose by 1 level. Dyspepsia ≥Grade 3: Withhold treatment until symptoms are controlled. Add a histamine (H2) blocker or equivalent medication, and reduce the dose by 1 level when treatment is resumed. Edema ≥Grade 3: Use a diuretic if needed and reduce the dose by 1 level. Confusion or mood changes ≥Grade 2: Withhold treatment until symptoms resolve. If treatment is resumed, reduce the dose by 1 level. Muscle weakness ≥Grade 2: Withhold treatment until muscle weakness is ≤Grade 1. Resume treatment at a dose reduced by 1 level. Hyperglycemia ≥Grade 3: Reduce the dose by 1 level. Treat with insulin or an oral hypoglycemic agent if needed. Acute pancreatitis: Discontinue the patient's dexamethasone regimen. Other adverse reactions related to dexamethasone of ≥Grade 3: Withhold dexamethasone until the adverse reaction resolves to ≤Grade 2. Resume treatment at a dose reduced by 1 level. If recovery from toxicity takes more than 14 days, resume treatment at a dose 1 level lower than the previous dose.

This medication can cause serious birth defects if taken during pregnancy, so it should not be taken by women who are pregnant or may become pregnant. Women of childbearing potential must use effective contraception before, during, and for a period after treatment, and regular pregnancy tests should be conducted. Male patients should also use condoms during and for a period after treatment if their partner is pregnant or may become pregnant, and they should avoid sperm or semen donation. This medication can decrease blood cell counts, so regular blood tests should be done to monitor neutrophils, platelets, and red blood cells, and any symptoms of infection or bleeding should be reported to a healthcare provider immediately. Special care is needed for patients with a history of thrombosis or risk factors for thrombosis, and anticoagulant therapy may be needed. This medication may cause peripheral neuropathy, and if symptoms such as numbness in hands or feet or sensory changes occur, consult a healthcare provider immediately. Dizziness or confusion may occur, so avoid driving or operating dangerous machinery if these symptoms are present. If severe skin reactions or allergic symptoms appear, stop taking the medication and inform a healthcare provider immediately. Patients with impaired liver or kidney function or heart disease require special caution during treatment, and regular monitoring is necessary. This medication must be taken strictly according to the doctor's instructions, following the prescribed dosage and regimen, and should be swallowed whole without opening or chewing the capsules. If any unusual symptoms occur during treatment, consult a healthcare provider for appropriate action.

Neutropenia, anemia, thrombocytopenia, febrile neutropenia, pneumonia, fever, lower respiratory tract infection, influenza, acute kidney injury, peripheral sensory neuropathy, dizziness, confusion, tremor, syncope, cataract, atrial fibrillation, deep vein thrombosis, hypotension, hyperkalemia, dyspnea, cough, pulmonary embolism, diarrhea, vomiting, nausea, constipation, abdominal pain, stomatitis, xerostomia, abdominal distension, rash, muscle weakness, back pain, muscle cramps, chronic kidney injury, urinary retention, fatigue, peripheral edema, edema, elevated alanine aminotransferase, weight loss, falls, vascular edema, anaphylactic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS syndrome), pancytopenia, tumor lysis syndrome, allergic reaction, solid organ transplant rejection, elevated liver enzyme levels, liver failure, reactivation of hepatitis B virus, herpes zoster, gastrointestinal bleeding, basal cell carcinoma, squamous cell carcinoma of the skin, subarachnoid hemorrhage, myasthenia, generalized edema, COVID-19, aspiration pneumonia, Candida infection, Clostridium difficile colitis, Pneumocystis pneumonia, Klebsiella pneumonia, septic shock, urethral infection, pelvic pain, low back pain, muscle weakness, myalgia, jaw pain, headache, delirium, sleep disturbance, hepatotoxicity, hyperhidrosis, seborrheic dermatitis

This medication should be stored in a tightly closed container that can block out air and moisture, at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the efficacy of the medication for a longer time.

Appearance

A hard capsule with a dark blue upper and yellow lower part containing yellow powder.

Package unit

For domestic use - 7 capsules/box [(7 capsules/PTP)*1]