Pomalikin Capsule 2 mg (Pomalidomide)

Adult dosage

This medicine should be taken with water. The capsule must not be opened, crushed, or chewed. It may be taken with or without food. The dose is continued or adjusted based on 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 4mg orally once daily on Days 1–14 of repeated 21-day cycles. The recommended initial dose of bortezomib is 1.3mg/m2 once daily, administered intravenously or subcutaneously, and the recommended initial dose of dexamethasone is 20mg once daily. Combination therapy with this medicine, bortezomib, and dexamethasone is continued until disease progression or unacceptable toxicity occurs. Cycles 1–8: Administer this medicine (4mg) on Days 1–14 of each 21-day cycle, bortezomib (1.3mg/m2) on Days 1, 4, 8, and 11, and dexamethasone (20mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12. Cycle 9 and beyond: Administer this medicine (4mg) on Days 1–14 of each 21-day cycle, bortezomib (1.3mg/m2) on Days 1 and 8, and dexamethasone (20mg) on Days 1, 2, 8, and 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 weekly intervals. Recovery to ANC ≥1 x 109/L: Resume 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: Resume treatment with this medicine at a dose reduced by 1 dose level from the previous dose. Platelet count <25 x 109/L: Interrupt treatment with this medicine and continue to monitor the complete blood count at weekly intervals. Recovery to platelet count ≥50 x 109/L: Resume 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 platelet count ≥50 x 109/L: Resume treatment with this medicine at a dose reduced by 1 dose level from the previous dose. Grade 2–3 rash: Consider interrupting or discontinuing treatment with this medicine. Grade 4 or blistering (if angioedema, an anaphylactic reaction, exfoliative or bullous rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) is suspected): Permanently discontinue treatment. 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 reduced by 1 dose level. Dose reduction levels for this medicine: Starting dose 4 mg, first reduction 3 mg, second reduction 2 mg, third reduction 1 mg. If an adverse reaction occurs after 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 medication. 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 medication, and reduce the dose by 1 dose level when treatment is resumed. Edema ≥Grade 3: Use a diuretic if needed and reduce the dose by 1 dose level. Confusion or mood changes ≥Grade 2: Interrupt treatment until symptoms resolve. Reduce the dose by 1 dose level when treatment is resumed. 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 needed. Acute pancreatitis: Discontinue the patient's dexamethasone regimen. Other adverse reactions related to dexamethasone that are ≥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 reduced by 1 dose level from the previous dose. ≤75 years: Cycles 1–8, Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day treatment cycle; Cycle 9 and beyond, Days 1, 2, 8, and 9 of each 21-day treatment cycle. >75 years: Cycles 1–8, Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day treatment cycle; Cycle 9 and beyond, Days 1, 2, 8, and 9 of each 21-day treatment cycle. Dexamethasone dose reduction levels: ≤75 years, initial dose 20mg, first reduction 12mg, second reduction 8mg; >75 years, initial dose 10mg, first reduction 6mg, second reduction 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. 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 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 is continued until disease progression or unacceptable toxicity occurs. ≤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. Dexamethasone dose reduction levels: ≤75 years, initial dose 40mg, first reduction 20mg, second reduction 10mg; >75 years, initial dose 20mg, first reduction 12mg, second reduction 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 drug should not be taken during pregnancy. There is a risk of causing serious birth defects in the fetus. Women of childbearing potential must undergo two pregnancy tests before taking this medication and should continue to have regular pregnancy tests during and after therapy. Additionally, from four weeks before treatment starts until four weeks after treatment ends, they must use two or more reliable methods of contraception or refrain from heterosexual intercourse. Male patients must use condoms during and after therapy for four weeks and should not donate semen or sperm. While taking this medication, blood tests to check for neutrophil and platelet counts should be performed regularly, and the doctor should be informed immediately if fever or bleeding symptoms occur, as neutropenia or thrombocytopenia may develop. Due to the risk of thromboembolism, patients with risk factors for thrombosis should be closely monitored, and anticoagulation therapy may be needed if necessary. This drug may cause neurological side effects such as peripheral neuropathy, dizziness, and confusion; hence, it is important to avoid hazardous activities and consult a physician if these symptoms occur. Severe skin reactions or allergic reactions may occur, so if symptoms such as rash, breathing difficulties, or swelling appear, treatment should be discontinued immediately and healthcare personnel should be notified. Various side effects such as liver dysfunction, hypothyroidism, and increased infection risks have been reported, thus regular health status checks and consultations with healthcare personnel are necessary. This drug must be taken exactly as prescribed by a doctor, and patients should not adjust the dosage or discontinue use on their own. Additionally, this medication requires caution while driving or operating machinery. If dizziness or confusion occurs, it is advisable to avoid hazardous tasks. Finally, care should be taken when handling this drug to avoid the powder contacting the skin, and if it does, wash thoroughly with soap and water immediately.

Neutropenia, thrombocytopenia, anemia, peripheral neuropathy, pneumonia, fever, lower respiratory tract infection, influenza, acute kidney injury, febrile neutropenia, lymphocytopenia, hypokalemia, hyperglycemia, hypomagnesemia, hypocalcemia, hypophosphatemia, hyperkalemia, hypercalcemia, insomnia, depression, dizziness, tremor, syncope, sensory disturbances, taste disturbances, cataract, atrial fibrillation, deep vein thrombosis, hypotension, hyperuricemia, dyspnea, cough, pulmonary embolism, diarrhea, vomiting, nausea, constipation, abdominal pain, upper abdominal pain, stomatitis, dry mouth, abdominal distension, rash, muscle weakness, back pain, muscle cramps, acute kidney injury, chronic kidney disease, urinary retention, fatigue, peripheral edema, edema, increased alanine aminotransferase, weight loss, falls, confusion, vertigo, deep vein thrombosis, neutropenic sepsis, bronchopneumonia, nasopharyngitis, pancytopenia, decreased appetite, decreased level of consciousness, vertigo, deep vein thrombosis, pulmonary embolism, itching, renal failure, pelvic pain, headache, delirium, sleep disorders, liver toxicity, hyperhidrosis, seborrheic dermatitis, 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, asthenia, systemic edema, deterioration of condition, facial edema, hypercalcemia, hypocalcemia, type 2 diabetes mellitus, pneumonia, nasal bleeding, pleural effusion, pulmonary inflammation, pneumothorax, colitis, dyspepsia, hemorrhoids, abdominal discomfort, anal inflammation, dry mouth, gastritis, gastroesophageal reflux disease, oral pain, toxic kidney disease, increased blood creatinine, increased blood urea, decreased hemoglobin, decreased blood pressure, lower back pain, muscle weakness, myalgia, jaw pain, falls, delirium, sleep disorders, liver toxicity, hyperhidrosis, seborrheic dermatitis

This drug must be stored in a tightly sealed container to protect it from exposure to air or moisture. The recommended storage temperature is room temperature between 1 to 30 degrees Celsius.

Appearance

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

Package unit

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