Alunbrik Tablet 180 mg (Brigatinib)

Adult dose

Orally administer 90 mg once daily for the first 7 days; If the dose is well tolerated during the first 7 days, increase the dose to 180 mg once daily. Continue treatment with this drug until disease progression or unacceptable toxicity occurs. If treatment with this drug is interrupted for 14 days or longer for reasons other than an adverse reaction, resume treatment at 90 mg once daily for 7 days before increasing to the previous dose. This drug may be taken with or without food. Do not crush or chew the tablets; swallow them whole. If a dose of this drug is missed or vomiting occurs after taking it, do not take an additional dose; take the next dose at the scheduled time. Table 1: Recommended dose modification levels 90 mg once daily: First dose reduction: administer 60 mg once daily; second dose reduction: permanently discontinue; third dose reduction: not applicable 180 mg once daily: First dose reduction: administer 120 mg once daily; second dose reduction: administer 90 mg once daily; third dose reduction: administer 60 mg once daily Do not increase the dose of this drug after a dose reduction due to an adverse reaction. Permanently discontinue treatment if the patient cannot tolerate a dose of 60 mg once daily. Interstitial lung disease (ILD)/pneumonitis, Grade 1: If new pulmonary symptoms occur within the first 7 days after starting treatment, withhold this drug and, after recovery to baseline, resume treatment at the same dose; do not increase the dose to 180 mg if ILD/pneumonitis is suspected. If new pulmonary symptoms occur after the first 7 days of treatment, withhold this drug and, after recovery to baseline, resume treatment at the same dose. Permanently discontinue this drug if ILD/pneumonitis recurs. Interstitial lung disease (ILD)/pneumonitis, Grade 2: If new pulmonary symptoms occur within the first 7 days after starting treatment, withhold this drug until recovery to baseline. Resume treatment at the next lower dose level according to Table 1; do not increase the dose if ILD/pneumonitis is suspected. If new pulmonary symptoms occur after the first 7 days of treatment, withhold this drug until recovery to baseline. If ILD/pneumonitis is suspected, resume treatment at the next lower dose level according to Table 1; otherwise, resume treatment at the same dose. Permanently discontinue this drug if ILD/pneumonitis recurs. Interstitial lung disease (ILD)/pneumonitis, Grade 3 or 4: Permanently discontinue this drug. Hypertension, Grade 3 hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg, requiring medical intervention, treatment with 2 or more antihypertensive agents, or requiring more intensive treatment than previously): Withhold this drug and, after hypertension recovers to Grade 1 (SBP<140 mmHg and DBP<90 mmHg) or lower, resume treatment at the next lower dose level according to Table 1. If it recurs, withhold this drug and, after hypertension recovers to Grade 1 or lower, resume treatment at the next lower dose level according to Table 1 or permanently discontinue treatment. Hypertension, Grade 4 hypertension (life-threatening consequences; urgent intervention required): Withhold this drug and, after hypertension recovers to Grade 1 (SBP<140 mmHg and DBP<90 mmHg) or lower, resume treatment at the next lower dose level according to Table 1 or permanently discontinue treatment. Permanently discontinue this drug if Grade 4 hypertension recurs. Bradycardia (heart rate <60 bpm), symptomatic bradycardia: Withhold this drug until bradycardia is asymptomatic or the resting heart rate recovers to 60 bpm or higher. If a concomitant medication causing bradycardia is identified and that medication is discontinued or its dose is adjusted, resume this drug at the same dose when bradycardia is asymptomatic or the resting heart rate recovers to 60 bpm or higher. If no concomitant medication causing bradycardia is identified, or if the causative concomitant medication is not discontinued or its dose is not adjusted, resume this drug at the next lower dose level according to Table 1 when bradycardia is asymptomatic or the resting heart rate recovers to 60 bpm or higher. Bradycardia (heart rate <60 bpm), with life-threatening consequences and requiring urgent intervention: Permanently discontinue this drug if no causative concomitant medication is identified. If a causative concomitant medication is identified and that medication is discontinued or its dose is adjusted, resume treatment at the next lower dose level according to Table 1 when bradycardia is asymptomatic or the resting heart rate recovers to 60 bpm or higher, and monitor frequently as clinically indicated. Permanently discontinue this drug if bradycardia recurs. Visual impairment, Grade 2 or 3: Withhold this drug and, after recovery to Grade 1 or baseline, resume treatment at the next lower dose level according to Table 1. Visual impairment, Grade 4: Permanently discontinue this drug. Creatine phosphokinase (CPK) elevation, Grade 3 or 4 CPK elevation (>5.0 × ULN) accompanied by myalgia or muscle weakness of Grade 2 or higher: Withhold this drug and, after CPK levels recover to Grade 1 (≤2.5×ULN) or lower or to baseline, resume treatment at the same dose. If Grade 3 or 4 CPK elevation accompanied by myalgia or muscle weakness of Grade 2 or higher recurs, withhold this drug and, after CPK levels recover to Grade 1 (≤ 2.5 × ULN) or lower or to baseline, resume treatment at the next lower dose level according to Table 1. Lipase or amylase elevation, Grade 3 lipase or amylase elevation (>2.0 × ULN): Withhold this drug and, after recovery to Grade 1 (≤1.5×ULN) or lower or to baseline, resume treatment at the same dose. Lipase or amylase elevation, Grade 4 lipase or amylase elevation (>5.0 x ULN) or recurrence of Grade 3 elevation: Withhold this drug and, after recovery to Grade 1 (≤1.5×ULN) or lower or to baseline, resume treatment at the next lower dose level according to Table 1. Hyperglycemia, Grade 3 (>250 mg/dL or>13.9 mmol/L) or higher: If hyperglycemia is not adequately controlled despite optimal medical management, withhold this drug until it is adequately controlled, consider dose reduction to the next lower dose level according to Table 1, or permanently discontinue this drug. Hepatotoxicity, ALT or AST elevation to Grade 3 or higher (>5 x ULN) with concurrent total bilirubin elevation to Grade 1 or lower (≤2 x ULN): Withhold this drug and, after ALT or AST recovers to baseline or Grade 1 or lower (≤3 × ULN), resume treatment at the next lower dose level according to Table 1. Hepatotoxicity, ALT or AST elevation to Grade 2 or higher (>3 x ULN) with concurrent total bilirubin elevation to Grade 2 or higher (>2 x ULN) (without cholestasis or hemolysis): Permanently discontinue this drug. Other adverse reactions, Grade 3: Withhold this drug and, after recovery to baseline, resume treatment at the same dose. If the reaction recurs, withhold this drug and, after recovery to baseline, resume treatment at the next lower dose level according to Table 1 or discontinue treatment. Other adverse reactions, Grade 4: First occurrence: Withhold this drug and, after recovery to baseline, resume treatment at the next lower dose level according to Table 1 or permanently discontinue treatment. If the reaction recurs, permanently discontinue this drug. No dose adjustment of this drug is required in patients with mild hepatic impairment (Child‑Pugh Class A) or moderate hepatic impairment (Child‑Pugh Class B). In patients with severe hepatic impairment (Child‑Pugh Class C), it is recommended to start this drug at a reduced dose of 60 mg once daily for the first 7 days, followed by 120 mg once daily. No dose adjustment of this drug is required in patients with mild or moderate renal impairment (estimated glomerular filtration rate (eGFR) ≥ 30 mL/min). In patients with severe renal impairment (eGFR < 30 mL/min), it is recommended to start this drug at a reduced dose of 60 mg once daily for the first 7 days, followed by 90 mg once daily. Patients with severe renal impairment should be closely monitored during the first week for the occurrence or worsening of new respiratory symptoms (e.g., dyspnea, cough, etc.) that may indicate interstitial lung disease/pneumonitis. Concomitant use of strong CYP3A inhibitors should be avoided during treatment with this drug. If concomitant use of a strong CYP3A inhibitor is unavoidable, reduce the once-daily dose of this drug by approximately 50% (180 mg → 90 mg or 90 mg → 60 mg). After discontinuing the strong CYP3A inhibitor, resume this drug at the dose that was tolerated before the strong CYP3A inhibitor was administered. Concomitant use of moderate CYP3A inhibitors should be avoided during treatment with this drug. If concomitant use of a moderate CYP3A inhibitor is unavoidable, reduce the dose of this drug by approximately 40% (e.g., 180 mg → 120 mg, 120 mg → 90 mg, or 90mg → 60mg). After discontinuing the moderate CYP3A inhibitor, resume this drug at the dose that was tolerated before the moderate CYP3A inhibitor was administered.

This medication can cause severe pulmonary diseases such as interstitial lung disease or pneumonia; therefore, if new or worsening symptoms such as shortness of breath or cough occur, especially within the first week of treatment, immediate medical attention should be sought. Patients with allergies to any of the ingredients in this medication or genetic metabolic disorders such as lactose intolerance or galactose intolerance should not take this drug. During treatment, various side effects such as liver dysfunction, elevated blood sugar, hypertension, visual disturbances, muscle pain, fatigue, and gastrointestinal symptoms may occur, making it necessary to have regular check-ups and blood tests. Particularly, blood pressure may increase, so it is important to check it frequently and receive appropriate treatment if necessary, and if bradycardia occurs, immediate notification is required. As visual disturbances may occur, if blurred vision or any eye-related issues arise, an ophthalmologist should be consulted. In cases of muscle pain or weakness, blood levels of creatine phosphokinase (CPK) should be checked; if abnormalities are found, cessation or dosage adjustment should be performed. Pancreatic enzyme levels may increase, necessitating regular checks and consulting with a doctor if abnormalities are discovered. Liver function tests should be conducted regularly before and during treatment to detect liver damage early and take appropriate measures. Blood sugar levels may rise, so it is necessary to monitor blood sugar consistently before and during treatment and use blood sugar-lowering medications if needed. Photosensitivity reactions may occur due to sunlight, so direct sunlight should be avoided during and for some time after treatment, and sunscreen should be used. Both fertile men and women should use effective contraception during treatment and for a period after cessation, as it may harm the fetus during pregnancy. This medication interacts with many other drugs, particularly those metabolized in the liver and medications for blood pressure, antifungals, and antibiotics, so it is essential to inform the physician and adjust dosages accordingly. Patients with severely impaired liver or kidney function may have elevated blood levels of this medication, requiring caution. This drug should not be used in children as its safety and efficacy have not been established; however, it can be administered to the elderly without special dose adjustments. Finally, this medication should be stored out of reach of children and expired drugs should not be used.

• Interstitial lung disease
• pneumonia
• dyspnea
• cough
• fever
• increased AST
• increased CPK
• hyperglycemia
• increased lipase
• hyperinsulinemia

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

White or off-white oval film-coated tablet

Package unit

30 tablets/bottle, 28 tablets (7 tablets/PTP x 4)