Pomalidomide Capsule 2 mg (Pomalidomide)

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 drug 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. Treatment with this drug in combination with bortezomib and dexamethasone should continue until disease progression or unacceptable toxicity occurs. Cycles 1–8 (21-day cycles): Administer this drug (4mg) on Days 1–14. Administer bortezomib (1.3mg/m2) on Days 1, 4, 8, and 11. Administer dexamethasone (20mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12. Cycle 9 and beyond (21-day cycles): Administer this drug (4mg) on Days 1–14. Administer bortezomib (1.3mg/m2) on Days 1 and 8. Administer dexamethasone (20mg) on Days 1, 2, 8, and 9. To start a new cycle of treatment with this drug, 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: Restart treatment with this drug at a dose 1 level below the previous dose. Each subsequent decrease to <0.5 x 109/L: Interrupt treatment with this drug. Recovery to ANC ≥1 x 109/L: Restart treatment with this drug at a dose 1 level below 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: Restart treatment with this drug at a dose 1 level below 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: Restart treatment with this drug at a dose 1 level below the previous dose. Rash: Grade 2–3 rash: Consider withholding or discontinuing this drug. Grade 4 or blistering (if angioedema, 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 adverse reactions related to this drug of Grade 3 or higher: Withhold this drug until the adverse reaction resolves to ≤Grade 2. Resume treatment at a dose 1 level lower. Dose reduction levels for this drug: 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 the drug. Dexamethasone dyspepsia = Grade 1–2: Maintain the dose and treat with a histamine (H2) blocker or an equivalent medication. If symptoms persist, reduce the dose by 1 level. Dexamethasone dyspepsia ≥Grade 3: Withhold treatment until symptoms are controlled. Add a histamine (H2) blocker or an equivalent medication, and reduce the dose by 1 level when treatment is resumed. Dexamethasone edema ≥Grade 3: Use a diuretic if necessary and reduce the dose by 1 level. Dexamethasone confusion or mood changes ≥Grade 2: Withhold treatment until symptoms resolve. Reduce the dose by 1 level when treatment is resumed. Dexamethasone muscle weakness ≥Grade 2: Withhold treatment until muscle weakness is ≤Grade 1. Resume treatment at a dose reduced by 1 level. Dexamethasone hyperglycemia ≥Grade 3: Reduce the dose by 1 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: 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 below the previous dose. Dexamethasone dose reduction levels (≤75 years): Starting dose 20mg, first dose reduction 12mg, second dose reduction 8mg. 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): Starting dose 10mg, first dose reduction 6mg, second dose reduction 4mg. 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. If dexamethasone 8mg in patients ≤75 years or dexamethasone 4mg in patients >75 years is not tolerated, dexamethasone should be discontinued. 2. In combination with dexamethasone for the treatment of patients who have received at least 2 prior therapies including lenalidomide and bortezomib and whose disease has relapsed or is refractory The recommended starting dose of this drug 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. Treatment with this drug in combination with dexamethasone should continue until disease progression or unacceptable toxicity occurs. Dexamethasone dose reduction levels (≤75 years): Starting dose 40mg, first dose reduction 20mg, second dose reduction 10mg. Days 1, 8, 15, and 22 of each 28-day treatment cycle. Dexamethasone dose reduction levels (>75 years): Starting dose 20mg, first dose reduction 12mg, second dose reduction 8mg. Days 1, 8, 15, and 22 of each 28-day treatment cycle. 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 birth defects if taken during pregnancy, and should never be used while pregnant. It is structurally similar to thalidomide and carries a very high risk of teratogenicity. Women of childbearing potential should undergo regular pregnancy testing before, during, and after treatment with this medication, and should use two reliable methods of contraception. Male patients whose partners are pregnant or may become pregnant must use condoms during the treatment period and for a period after treatment. Severe leukopenia may occur, increasing the risk of infection, so medical attention should be sought immediately if symptoms such as fever or elevated body temperature occur. There is a risk of thrombosis, so immediate medical attention is needed if symptoms like leg swelling, breathing difficulties, or chest pain appear. Sensory abnormalities or pain due to peripheral nerve damage may occur; consult medical staff should these symptoms arise. If severe allergic reactions or symptoms like skin rashes or difficulty breathing occur, medication should be discontinued immediately and medical personnel informed. Liver dysfunction or hypothyroidism may occur, and regular blood tests are necessary to monitor liver and thyroid functionality. This medication can cause dizziness or confusion, so driving or operating hazardous machinery should be avoided during treatment. If the powder comes into contact with the skin, it should be washed off immediately with soap and water, and gloves should be worn when handling the medication. Capsules should be taken whole with water at scheduled times; they should not be broken or chewed. This drug is mainly excreted through the kidneys and liver, so patients with kidney or liver impairment require careful dose adjustment. There is no specific antidote in case of overdose, thus symptomatic treatment is required, and some may be removed through dialysis. Safety and efficacy in pediatric patients have not been established, hence it should not be administered to children. While no special dose adjustments are needed for elderly patients, those over 75 years of age should have their dexamethasone dose adjusted. This medication has a low potential for drug interactions but dose adjustments may be required when used with specific enzyme-inhibiting drugs. Regular blood tests and clinical checks should be performed to closely monitor for adverse reactions during treatment.

Teratogenicity, neutropenia, anemia, thrombocytopenia, fever, hemorrhage, venous thromboembolic disease, arterial thromboembolic disease, pneumonia, lower respiratory tract infection, influenza, acute kidney injury, dizziness, confusion, vascular edema, anaphylactic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS syndrome), febrile neutropenia, leukopenia, lymphocytopenia, hypokalemia, hyperglycemia, hypomagnesemia, hypocalcemia, hypophosphatemia, hyperkalemia, hypercalcemia, insomnia, depression, tremors, syncope, cataract, atrial fibrillation, hypotension, deep vein thrombosis, dyspnea, cough, pulmonary embolism, diarrhea, vomiting, nausea, constipation, abdominal pain, stomatitis, dry mouth, abdominal distension, rash, muscle weakness, back pain, muscle cramps, chronic kidney injury, urinary retention, fatigue, peripheral edema, non-cardiac chest pain, increased alanine aminotransferase, weight loss, falls, neutropenic sepsis, bronchopneumonia, nasopharyngitis, hyperbilirubinemia, pruritus, pelvic pain, renal failure, pelvic pain, delirium, sleep disorder, hepatotoxicity, diaphoresis, seborrheic dermatitis, 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, cutaneous squamous cell carcinoma, subarachnoid hemorrhage

This medication may be sensitive to air or moisture and should be stored in a tightly sealed container. Additionally, it should be kept away from extreme temperatures, ideally between 1 and 30 degrees Celsius.

Appearance

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

Package unit

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