Fomalist Capsule 1 mg (Thalidomide)

Adult dosage

1. In combination with bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy including lenalidomide The recommended starting dose of this medicine is 4mg orally once daily on Days 1–14 of repeated 21-day cycles. The recommended starting dose of bortezomib is 1.3mg/m2 once daily, administered intravenously or subcutaneously, and the recommended starting dose of dexamethasone is 20mg once daily. Combination therapy with this medicine, bortezomib, and dexamethasone should be continued until disease progression or unacceptable toxicity occurs. Cycles 1–8: This medicine (4mg) on Days 1–14, bortezomib (1.3mg/m2) on Days 1, 4, 8, 11, dexamethasone (20mg) on Days 1, 2, 4, 5, 8, 9, 11, 12 Cycle 9 and beyond: This medicine (4mg) on Days 1–14, bortezomib (1.3mg/m2) on Days 1, 8, dexamethasone (20mg) on Days 1, 2, 8, 9 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. 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: Restart treatment with this medicine at a dose 1 dose 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: Restart treatment with this medicine at a dose 1 dose level lower than the previous dose. 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: Restart treatment with this medicine at a dose 1 dose 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: Restart treatment with this medicine at a dose 1 dose level lower than the previous dose. Grade 2–3 rash: Consider interruption or discontinuation of this medicine Grade 4 or blistering (if angioedema, anaphylactic reaction, exfoliative or bullous rash, Stevens-Johnson syndrome or toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) is suspected): Permanently discontinue treatment (see Precautions for Use). Other Grade 3 or higher adverse reactions related to this medicine: Interrupt treatment with this medicine until the adverse reaction resolves to ≤Grade 2. Resume treatment at a dose 1 dose level lower. Dose levels: Starting dose 4 mg, 1st dose reduction 3 mg, 2nd dose reduction 2 mg, 3rd dose reduction 1 mg If an adverse reaction occurs after dose reduction to 1 mg, this medicine should be discontinued. Dyspepsia = Grade 1–2: Maintain the dose and treat with a histamine (H2) blocker or equivalent medicine. If symptoms persist, reduce the dose by 1 dose level. Dyspepsia ≥Grade 3: Interrupt treatment until symptoms are controlled. Add a histamine (H2) blocker or equivalent medicine and, when treatment is resumed, reduce the dose by 1 dose level. Edema ≥Grade 3: Use a diuretic if necessary and reduce the dose by 1 dose level. Confusion or mood changes ≥Grade 2: Interrupt treatment until symptoms resolve. When treatment is resumed, reduce the dose by 1 dose level. Muscle weakness ≥Grade 2: Interrupt treatment until muscle weakness is ≤Grade 1. Resume treatment at a dose reduced by 1 dose level. Hyperglycemia ≥Grade 3: Reduce the dose by 1 dose level. Treat with insulin or an oral hypoglycemic agent if necessary. Acute pancreatitis: Discontinue the patient's dexamethasone regimen. Other adverse reactions related to dexamethasone, ≥Grade 3: Interrupt dexamethasone treatment until the adverse reaction resolves to ≤Grade 2. Resume treatment at a dose reduced by 1 dose level. If recovery from toxicity takes more than 14 days, resume treatment at a dose 1 dose level lower than the previous dose. ≤75 years: Cycles 1–8: Days 1, 2, 4, 5, 8, 9, 11, 12 of each 21-day treatment cycle; Cycle 9 and beyond: Days 1, 2, 8, 9 of each 21-day treatment cycle >75 years: Cycles 1–8: Days 1, 2, 4, 5, 8, 9, 11, 12 of each 21-day treatment cycle; Cycle 9 and beyond: Days 1, 2, 8, 9 of each 21-day treatment cycle Starting dose: 20mg, 10mg 1st dose reduction: 12mg, 6mg 2nd dose reduction: 8mg, 4mg If patients aged 75 years or younger cannot tolerate dexamethasone 8mg, or patients aged over 75 years cannot tolerate dexamethasone 4mg, dexamethasone should be discontinued. 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 starting dose of this medicine is 4mg orally once daily on Days 1–21 of repeated 28-day cycles. The recommended dose of dexamethasone is 40mg orally once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle. Combination therapy with this medicine and dexamethasone should be continued until disease progression or unacceptable toxicity occurs. For guidance on dose interruption and reduction of this medicine related to adverse reactions, follow Tables 2 and 3. For guidance on dose interruption and reduction of dexamethasone related to adverse reactions, follow Table 4. ≤75 years: Days 1, 8, 15, and 22 of each 28-day treatment cycle >75 years: Days 1, 8, 15, and 22 of each 28-day treatment cycle Starting dose: 40mg, 20mg 1st dose reduction: 20mg, 12mg 2nd dose reduction: 10mg, 8mg If patients aged 75 years or younger cannot tolerate dexamethasone 10mg, or patients aged over 75 years cannot tolerate dexamethasone 8mg, dexamethasone should be discontinued.

This medication should not be taken by pregnant women as it poses a very high risk of causing severe fetal malformations. This drug is structurally related to thalidomide and may cause congenital disabilities. Women of childbearing potential must undergo two pregnancy tests before use and strictly follow pregnancy prevention measures during and after treatment. Women of childbearing age should use two or more methods of contraception or refrain from sexual intercourse starting four weeks prior to and continuing for four weeks after treatment. This medication can reduce white blood cell and platelet counts in the blood, increasing the risk of infection and bleeding, so regular blood tests are necessary. In particular, if there are symptoms of infection such as fever, they should be reported immediately, especially in cases of severe neutropenia. The risk of thromboembolism may increase while using this medication, so any symptoms of thrombosis, such as swelling in arms or legs, shortness of breath, or chest pain should be reported to a healthcare professional immediately. Peripheral neuropathy may occur, so if symptoms such as numbness in hands or feet or sensory abnormalities appear, consult a physician. There may be severe skin reactions or allergic reactions, so if symptoms such as rashes, shortness of breath, or facial swelling occur, treatment should be stopped immediately and medical attention sought. This medication is not to be administered to specific patients, particularly pregnant women or women of childbearing potential, patients with severe heart disease, or patients with significantly impaired kidney or liver function, and special caution is required for these patients. While taking this medication, dizziness or confusion may occur, so driving or operating hazardous machinery should be avoided. This medication should be taken with water at the same time every day; do not open, chew, or break the capsule but swallow it whole.

Teratogenic effects, neutropenia, anemia, thrombocytopenia, fever, lower respiratory tract infections, influenza, acute kidney injury, dizziness, confusion, vascular edema, anaphylactic reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS syndrome), pneumonia, bronchitis, upper respiratory tract infections, viral upper respiratory tract infections, sepsis, septic shock, Clostridium difficile colitis, airway infections, lung infections, urethral infections, basal cell carcinoma, leukopenia, lymphopenia, hypokalemia, hyperglycemia, hypomagnesemia, hypocalcemia, hypophosphatemia, hyperkalemia, hypercalcemia, insomnia, depression, tremors, syncope, sensory disturbances, taste disturbances, cataracts, atrial fibrillation, deep vein thrombosis, hypotension, hyperlipidemia, dyspnea, cough, pulmonary embolism, diarrhea, vomiting, nausea, constipation, abdominal pain, upper abdominal pain, stomatitis, dry mouth, abdominal distention, rash, muscle weakness, back pain, bone pain, muscle cramps, acute kidney injury, chronic kidney injury, urinary retention, fatigue, peripheral edema, non-cardiac chest pain, edema, alanine aminotransferase elevation, weight loss, falls, febrile neutropenia, pancytopenia, decreased appetite, altered mental status, decreased level of consciousness, vertigo, pruritus, renal failure, pelvic pain, pelvic discomfort, asthenia, generalized edema, hyperhidrosis, seborrheic dermatitis, delirium, sleep disturbances, liver toxicity, immune system disorders, hepatitis, nephritis, pneumonia, myocarditis, pericarditis, lymphadenopathy, fever, herpes zoster, gastrointestinal bleeding, cutaneous squamous cell carcinoma, subarachnoid hemorrhage

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. It is recommended to maintain storage temperature between 1 degree and 30 degrees Celsius to ensure the medication retains its effectiveness for a longer period.

Appearance

This medication is a hard capsule with a dark blue upper part and a yellow lower part containing yellow powder.

Package unit

7 capsules/PTP [pack], 21 capsules/PTP [pack]