Pomalikin Capsule 3 mg (Pomalidomide)

Adult dosage

1. Treatment of patients with multiple myeloma who have received one or more prior therapies, including lenalidomide, in combination with bortezomib and dexamethasone 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 by intravenous or subcutaneous injection, and the recommended starting dose of dexamethasone is 20mg once daily. Combination treatment with this medicine, bortezomib, and dexamethasone should continue until disease progression or unacceptable toxicity occurs. Table 1. Recommended dosing schedule for this medicine in combination with bortezomib and dexamethasone Cycles 1~8: On Days 1~14 of each 21-day cycle, this medicine (4mg); on Days 1, 4, 8, 11, bortezomib (1.3mg/m2); on Days 1, 2, 4, 5, 8, 9, 11, 12, dexamethasone (20mg) Cycle 9 and beyond: On Days 1~14 of each 21-day cycle, this medicine (4mg); on Days 1, 8, bortezomib (1.3mg/m2); on Days 1, 2, 8, 9, dexamethasone (20mg) Dose modification or interruption of this medicine To start treatment with this medicine in a new cycle, the neutrophil count must be ≥1 x 109/L and the platelet count must be ≥50 x 109/L. Table 2. Guidelines for dose modification of this medicine 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: Restart treatment with this medicine at a dose reduced by 1 dose level from 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 reduced by 1 dose level from 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 a platelet count ≥50 x 109/L: Restart treatment with this medicine at a dose reduced by 1 dose level from the previous dose. Each subsequent decrease to <25 x 109/L: Interrupt treatment with this medicine. Recovery to a platelet count ≥50 x 109/L: Restart treatment with this medicine at a dose reduced by 1 dose level from the previous dose. Rash: Grade 2-3 rash: Consider withholding or discontinuing this medicine. Grade 4 or blistering (if angioedema, an 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. Other: 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 reduced by 1 dose level. * ANC - Absolute Neutrophil Count The use of growth factors should be considered in cases of neutropenia. Table 3. Dose reduction levels for this medicine 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 reducing the dose to 1 mg, this medicine should be discontinued. Dose modification or interruption of bortezomib For dose modification of bortezomib related to adverse reactions, healthcare professionals should follow the domestic prescribing information for bortezomib. Dose modification or interruption of dexamethasone Table 4. Guidelines for dose modification of dexamethasone 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 necessary and reduce the dose by 1 level. Confusion or mood changes ≥Grade 2: Withhold treatment until symptoms resolve. Reduce the dose by 1 level when treatment is resumed. 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 oral hypoglycemic agents if necessary. Acute pancreatitis: Discontinue the patient's dexamethasone treatment 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 reduced by 1 dose level from the previous dose. Table 5. Dexamethasone dose reduction levels ≤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: ≤75 years 20mg, >75 years 10mg 1st dose reduction: ≤75 years 12mg, >75 years 6mg 2nd dose reduction: ≤75 years 8mg, >75 years 4mg If dexamethasone 8mg in patients aged 75 years or younger, or dexamethasone 4mg in patients older than 75 years is not tolerated, dexamethasone should be discontinued. 2. Treatment of patients with relapsed or refractory disease who have received at least 2 prior therapies, including lenalidomide and bortezomib, in combination with dexamethasone 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 treatment with this medicine and dexamethasone should continue until disease progression or unacceptable toxicity occurs. Dose modification or interruption of this medicine For guidelines on dose interruption and reduction of this medicine related to adverse reactions, follow Tables 2 and 3. Dose modification or interruption of dexamethasone For guidelines on dose interruption and reduction of dexamethasone related to adverse reactions, follow Table 4. Table 6. Guidelines for dose modification of dexamethasone ≤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: ≤75 years 40mg, >75 years 20mg 1st dose reduction: ≤75 years 20mg, >75 years 12mg 2nd dose reduction: ≤75 years 10mg, >75 years 8mg If dexamethasone 10mg in patients aged 75 years or younger, or dexamethasone 8mg in patients older than 75 years is not tolerated, dexamethasone should be discontinued.

This medication should not be taken during pregnancy as it can cause serious fetal malformations. It can reduce the levels of white blood cells and platelets in the blood, thus increasing the risk of infections or bleeding. Therefore, regular blood tests are necessary, and if fever or bleeding symptoms appear, the doctor should be informed immediately. There may be an increased risk of thrombosis during the use of this medication, so signs or symptoms of thrombosis should be carefully monitored. Anticoagulant therapy may be required if necessary. Peripheral neuropathy can cause sensory disturbances or neuropathy; consult a doctor if such symptoms occur. Severe skin reactions or allergic reactions may occur, so it is important to inform medical personnel immediately if symptoms like skin rash, swelling, or difficulty breathing arise. This medication should be used with caution in specific patients, such as women of childbearing potential, individuals with severe heart conditions, or with significantly impaired kidney or liver function. During treatment, dizziness or confusion may occur, so caution is advised while driving or operating machinery. This medication is strictly managed under a pregnancy prevention program, and all patients who are capable of reproduction, both male and female, must use appropriate contraceptive methods during the treatment period. Capsules containing this medication must be taken whole with water and should not be opened, broken, or chewed. During treatment, regular pregnancy tests and blood tests should be performed, and if any unusual symptoms occur, immediate consultation with medical personnel is necessary.

Neutropenia, anemia, thrombocytopenia, fever, pneumonia, lower respiratory tract infection, influenza, acute kidney injury, peripheral neuropathy, dizziness, confusion, vascular edema, anaphylactic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS syndrome), febrile neutropenia, sepsis, septic shock, Clostridium difficile colitis, airway infection, lung infection, urinary tract infection, cataract, atrial fibrillation, deep vein thrombosis, hypotension, hypercalcemia, dyspnea, cough, pulmonary embolism, diarrhea, vomiting, nausea, constipation, abdominal pain, upper abdominal pain, stomatitis, dry mouth, abdominal distension, rash, muscle weakness, back pain, bone pain, muscle cramps, chronic kidney disease, urinary retention, fatigue, peripheral edema, non-cardiac chest pain, swelling, increased alanine aminotransferase, weight loss, falls, insomnia, depression, tremor, syncope, altered mental status, decreased level of consciousness, vertigo, pelvic pain, renal failure, headache, delirium, sleep disorders, liver toxicity, sweating, seborrheic dermatitis, pancytopenia, tumor lysis syndrome, 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, worsening condition, facial edema, hypercalcemia, hypocalcemia, type 2 diabetes, nosebleed, pleural effusion, pulmonary inflammation, pneumothorax, colitis, dyspepsia, hemorrhoids, abdominal discomfort, anal inflammation, dry mouth, gastritis, gastroesophageal reflux disease, oral pain, toxic nephropathy, decreased platelet count, increased serum creatinine, increased blood urea nitrogen, decreased hemoglobin, decreased blood pressure, muscle weakness, myalgia, jaw pain, delirium, sleep disorders

This medication should be stored in a tightly sealed container to prevent air and moisture from entering, ideally at a temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication for a longer period.

Appearance

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

Package unit

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