Pomalikine Capsule 4mg (Pomalidomide)

Adult dosage

The initial recommended dose of this drug is 4mg orally once daily on Days 1–14 of each repeated 21-day cycle. The recommended dosing schedule for this drug in combination with bortezomib and dexamethasone is shown in Table 1. The initial recommended dose of bortezomib is 1.3mg/m2 once daily by intravenous or subcutaneous injection, and the initial recommended dose of dexamethasone is 20mg once daily. Combination therapy with this drug, bortezomib, and dexamethasone should continue until disease progression or unacceptable toxicity occurs. Table 1. Recommended dosing schedule for this drug in combination with bortezomib and dexamethasone Cycles 1–8: During each 21-day cycle, administer this drug (4mg) on Days 1–14, 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 subsequent cycles: During each 21-day cycle, administer this drug (4mg) on Days 1–14, bortezomib (1.3mg/m2) on Days 1 and 8, and dexamethasone (20mg) on Days 1, 2, 8, and 9. To start treatment with this drug in a new cycle, 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 drug and continue to monitor the complete blood count at 1-week intervals. Recovery to ANC ≥1 x 109/L: Resume treatment with this drug 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 drug. Recovery to ANC ≥1 x 109/L: Resume treatment with this drug at a dose reduced by 1 dose level from the previous dose. Thrombocytopenia Platelet count <25 x 109/L: Interrupt treatment with this drug and continue to monitor the complete blood count at 1-week intervals. Recovery to a platelet count ≥50 x 109/L: Resume treatment with this drug at a dose reduced by 1 dose level from the previous dose. Each subsequent decrease to <25 x 109/L: Interrupt treatment with this drug. Recovery to a platelet count ≥50 x 109/L: Resume treatment with this drug at a dose reduced by 1 dose level from the previous dose. Rash Grade 2–3 rash: Consider interrupting or discontinuing this drug. Grade 4 rash 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 (see Precautions for Use). Other drug-related adverse reactions of Grade 3 or higher: Interrupt this drug until the adverse reaction resolves to ≤Grade 2. Resume treatment at a dose reduced by 1 dose level. * ANC - Absolute Neutrophil Count Consider the use of growth factors in cases of neutropenia. Table 3. Dose reduction levels for this drug 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 reduction to 1 mg, this medicinal product should be discontinued. For dose adjustments of bortezomib related to adverse reactions, healthcare professionals should follow the locally approved prescribing information for bortezomib. 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, if 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. If 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 of ≥Grade 3: Interrupt dexamethasone 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. Table 5. Dexamethasone dose reduction levels ≤75 years: Cycles 1–8: Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day treatment cycle; Cycle 9 and subsequent cycles: 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 subsequent cycles: Days 1, 2, 8, and 9 of each 21-day treatment cycle Initial 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 ≤75 years or dexamethasone 4mg in patients >75 years is not tolerated, dexamethasone should be discontinued. The initial recommended dose of this drug is 4mg orally once daily on Days 1–21 of each repeated 28-day cycle. 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 drug and dexamethasone should continue until disease progression or unacceptable toxicity occurs. Follow Tables 2 and 3 for guidance on interruption and dose reduction of this drug related to adverse reactions. Follow Table 4 for guidance on interruption and dose reduction of dexamethasone related to adverse reactions. Table 6. Guidance on dexamethasone dose adjustment ≤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 Initial 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 ≤75 years or dexamethasone 8mg in patients >75 years is not tolerated, dexamethasone should be discontinued.

This medication can cause severe fetal deformities if taken during pregnancy, so it must not be taken during pregnancy. Women of childbearing potential must undergo pregnancy testing before, during, and after treatment, and must use two effective forms of contraception. Male patients should also use condoms during treatment and for some time after treatment if their partner may become pregnant, as this medication is present in semen, and sperm donation is prohibited. Blood cell counts can decrease, so regular blood tests are necessary, and if symptoms such as fever or bleeding occur, medical personnel should be notified immediately. The risk of thrombosis may increase, so risk factors such as smoking or high blood pressure should be managed, and treatment should be sought immediately if thrombosis symptoms occur. Peripheral neuropathy may develop, so medical consultation should be sought if there are symptoms like numbness or sensory changes in the hands and feet. Severe allergic reactions, skin rashes, anaphylaxis, etc., may occur, so if such symptoms occur, medication should be stopped immediately and medical personnel should be notified. Abnormal liver function, hypothyroidism, interstitial lung disease, etc., can also occur, so regular check-ups and symptom monitoring are necessary. When handling this medication, care must be taken to avoid contact with skin; if contact occurs, it should be washed off immediately with soap and water. Dizziness or confusion may occur when driving or operating machinery, so caution is required if such symptoms are present. There is no experience using this medication in children, and elderly patients may require special dosage adjustments, so consult medical personnel. In case of overdose, immediately visit a medical institution for appropriate treatment.

Teratogenic effects, neutropenia, anemia, thrombocytopenia, fever, lower respiratory tract infection, influenza, acute kidney injury, pneumonia, sepsis, septic shock, Clostridium difficile colitis, bronchitis, upper respiratory tract infection, airway infection, lung infection, urinary tract infection, fever-induced neutropenia, lymphocytopenia, hypokalemia, hyperglycemia, hypomagnesemia, hypocalcemia, hypophosphatemia, hyperkalemia, hypercalcemia, insomnia, depression, peripheral sensory neuropathy, dizziness, tremors, syncope, peripheral sensorimotor neuropathy, paresthesia, dysgeusia, cataract, atrial fibrillation, deep vein thrombosis, hypotension, respiratory distress, 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 damage, urinary retention, fatigue, peripheral edema, non-cardiac chest pain, edema, elevated 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, renal failure, pelvic pain, non-cardiac chest pain, diaphoresis, seborrheic dermatitis, vascular edema, anaphylactic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS syndrome), tumor lysis syndrome, elevated liver enzyme levels, liver failure, reactivation of hepatitis B virus, herpes zoster, gastrointestinal bleeding, basal cell carcinoma, squamous cell carcinoma, subarachnoid hemorrhage, myasthenia, generalized edema, death, deterioration of condition, decreased food intake, type 2 diabetes, epistaxis, pleural effusion, lung inflammation, pulmonary embolism, 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, headache, delirium, sleep disorder, hepatotoxicity, immune system disorder

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is recommended to keep the storage temperature between 1 degree and 30 degrees Celsius at room temperature. Storing it this way helps maintain the medication's effectiveness safely.

Appearance

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

Package unit

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