Semblix 40mg (Asimotinib Hydrochloride)

Adult dose

The recommended daily dose of this medication is 80mg. This medication should be administered at the same time each day and should be taken orally as either 80mg once daily or 40mg twice daily at approximately 12-hour intervals. Patients who wish to change their regimen from 40mg twice daily to 80mg once daily should start the once-daily dose approximately 12 hours after the last twice-daily dose, and thereafter continue taking 80mg once daily. Patients who wish to change their regimen from 80mg once daily to 40mg twice daily should start the twice-daily dose approximately 24 hours after the last once-daily dose, and thereafter continue taking 40mg twice daily at approximately 12-hour intervals. Changes to the dosage regimen are at the physician’s discretion based on the need for patient management. Treatment with this medication should continue as long as clinical benefit is observed or until unacceptable toxicity occurs. Method of administration This medication should be taken on an empty stomach. Avoid eating for at least 2 hours before taking this medication and until 1 hour after taking it. This medication must be swallowed whole and must not be broken, crushed, or chewed. Missed dose Once-daily regimen: If a dose of this medication is missed by more than approximately 12 hours, skip that dose and take the next dose at the scheduled time. Twice-daily regimen: If a dose of this medication is missed by more than approximately 6 hours, skip that dose and take the next dose at the scheduled time. Dose modification As shown in Table 1 and Table 2, dose modification of this medication may be necessary based on individual safety and tolerability. If an adverse drug reaction is effectively managed, this medication may be resumed as shown in Table 1 and Table 2. If the patient cannot tolerate a total daily dose of 40mg, permanently discontinue this medication. Table 1. Dose modification Starting dose Dose reduction Resumption dose 80mg once daily 40mg once daily 80mg once daily 40mg twice daily 20mg twice daily 40mg twice daily Dose modifications of this medication for managing selected adverse drug reactions are shown in Table 2. Table 2. Dose modifications of this medication due to selected adverse drug reactions Adverse drug reaction Recommended dose modification of this medication Thrombocytopenia and/or neutropenia ANC1 <1 x 109/L and/or PLT2 <50 x 109/L Withhold this medication until recovery to ANC ≥1 x 109/L and/or PLT ≥50 x 109/L. If recovery occurs: • Within 2 weeks: Resume this medication at the starting dose. • After more than 2 weeks: Resume this medication at a reduced dose. In case of recurrent severe thrombocytopenia and/or neutropenia, withhold this medication until recovery to ANC ≥1 x 109/L and PLT ≥50 x 109/L, then resume treatment at a reduced dose. Asymptomatic amylase and/or lipase elevation >2 x ULN3 elevation Withhold this medication until recovery to <1.5 x ULN. • If recovery occurs: Resume this medication at a reduced dose. If the reaction recurs at the reduced dose, permanently discontinue this medication. • If recovery does not occur: Permanently discontinue this medication. Perform diagnostic tests to rule out pancreatitis. Nonhematologic adverse drug reactions Grade 3 or higher4 adverse reactions Withhold this medication until recovery to Grade 1 or lower. • If recovery occurs: Resume this medication at a reduced dose. • If recovery does not occur: Permanently discontinue this medication. 1ANC: absolute neutrophil count; 2PLT: platelets; 3ULN: upper limit of normal. 4Based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 4.03. Patients with hepatic impairment No dose adjustment is required for patients with mild, moderate, or severe hepatic impairment receiving this medication. Patients with renal impairment No dose adjustment is required for patients with mild, moderate, or severe renal impairment receiving this medication.

This drug contains lactose, and should not be administered to patients with genetic conditions such as galactose intolerance, lactose deficiency, or glucose-galactose malabsorption. This drug has a bone marrow suppression effect and may cause abnormalities in blood such as thrombocytopenia, neutropenia, and anemia, so regular blood tests should be conducted to monitor conditions during the early stage of treatment. Pancreatitis and elevated pancreatic enzyme levels have been reported; therefore, if there are issues with pancreatic function or symptoms occur, the healthcare provider should be informed immediately, and treatment may need to be adjusted or discontinued if necessary. QT interval prolongation may be observed in electrocardiograms, so heart conditions should be monitored before and during treatment, and hypokalemia or hypomagnesemia should be treated; caution is needed when used with other drugs that pose a risk of QT prolongation. Hypertension may occur, so blood pressure should be monitored regularly and appropriate antihypertensive treatment should be administered if necessary. Cardiovascular adverse reactions have been reported, thus patients with a history of cardiovascular disease should carefully observe for symptoms and take immediate action if abnormalities occur. Hypersensitivity reactions may occur during administration of this drug; thus, if allergic symptoms or signs of hypersensitivity appear, consult with healthcare providers promptly. For carriers of Hepatitis B virus, there is a risk of viral reactivation; therefore, a Hepatitis B test should be conducted prior to treatment, and viral activity should be monitored periodically during and after treatment. This drug may harm the fetus during pregnancy; therefore, women of childbearing potential must confirm pregnancy status before treatment, and effective contraception must be used during and for a period after treatment. This drug should be stored out of reach of children for safety, and kept in the original packaging to block moisture at room temperature below 25 degrees Celsius. Additionally, this drug should be swallowed whole and should not be crushed or chewed. There may be interactions with other medications, so if you are taking other medications, you must inform the healthcare provider, particularly when using CYP3A4-related drugs.

Thrombocytopenia, neutropenia, anemia, pancreatitis, increased pancreatic enzymes, hypertension, ventricular repolarization interval prolongation (QT prolongation), hypersensitivity, pleural effusion, lower respiratory tract infection, fever, upper respiratory tract infection, influenza, hypothyroidism, dyslipidemia, decreased appetite, headache, dizziness, blurred vision, dry eyes, palpitations, cough, dyspnea, non-cardiac chest pain, vomiting, diarrhea, nausea, abdominal pain, constipation, increased liver enzymes, increased serum bilirubin, rash, pruritus, urticaria, musculoskeletal pain, arthralgia, fatigue, edema, increased serum creatine phosphokinase, QT prolongation on ECG, abnormal T wave on ECG, pancytopenia

This drug is sensitive to air and moisture; therefore, it should be stored in a sealed container. It is also important to store the drug in a cool place below 25 degrees Celsius to maintain its efficacy.

Appearance

Light purple, round film-coated tablets with convex faces and rounded edges

Package unit

60 tablets/box [10 tablets/TPX6]