Alunbrik Tablets 30 mg (Brigatinib)

Adult dose

Administer orally once daily at 90 mg for the first 7 days; if well tolerated during the first 7 days, increase the dose to 180 mg once daily. If this medicine is discontinued for 14 days or longer for reasons other than adverse reactions, resume treatment at 90 mg once daily for 7 days before increasing to the previous dose. This medicine may be taken with food or on an empty stomach. Do not crush or chew the tablets; swallow them whole. If a dose is missed or vomiting occurs after taking this medicine, do not take an additional dose; take the dose at the next scheduled administration time. 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 after a dose reduction due to adverse reactions. Permanently discontinue treatment if the patient cannot tolerate a dose of 60 mg once daily. No dose adjustment 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 medicine at a reduced dose of 60 mg once daily for the first 7 days, followed by 120 mg once daily. No dose adjustment 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 medicine 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 onset or worsening of new respiratory symptoms (e.g., dyspnea, cough, etc.) that may suggest interstitial lung disease/pneumonitis. Avoid concomitant administration of strong CYP3A inhibitors during treatment with this medicine. If concomitant administration of a strong CYP3A inhibitor is unavoidable, reduce the once-daily dose of this medicine by approximately 50% (180 mg → 90 mg or 90 mg → 60 mg). After discontinuation of the strong CYP3A inhibitor, resume this medicine at the dose that was tolerated before the strong CYP3A inhibitor was administered. Avoid concomitant administration of moderate CYP3A inhibitors during treatment with this medicine. If concomitant administration of a moderate CYP3A inhibitor is unavoidable, reduce the dose of this medicine by approximately 40% (e.g., 180 mg → 120 mg, 120 mg → 90 mg, or 90mg → 60mg). After discontinuation of the moderate CYP3A inhibitor, resume this medicine at the dose that was tolerated before the moderate CYP3A inhibitor was administered.

This drug can cause serious side effects in the lungs, so if symptoms like difficulty breathing or coughing occur, especially during the first week of administration, notify a hospital immediately. This medication should not be taken by individuals allergic to the active ingredient or excipients, or those with certain genetic lactose-related disorders. Various side effects such as liver dysfunction, increased blood glucose, blood abnormalities, digestive issues, skin rashes, muscle pain, visual disturbances, and difficulty breathing may occur, so caution is advised. Blood pressure may increase, so blood pressure should be measured regularly, and appropriate treatment should be received if necessary. Heart rate may decrease, so when taking heart-related medications, heart rate and blood pressure should be frequently monitored. If any visual problems occur, seek ophthalmological treatment immediately, and adjust the dosage if symptoms are severe. If muscle pain or weakness occurs, inform a physician and regularly check muscle enzyme levels. Pancreatic enzyme levels may increase, so relevant tests should be conducted periodically, and if abnormalities are found, medication adjustments may be necessary. Liver function abnormalities may occur, so liver function tests should be performed frequently before and during treatment. Blood glucose levels may rise, so blood glucose should be checked before and during treatment, and hypoglycemic agents should be used if necessary. During and for a period after taking this medication, care should be taken to avoid exposure to sunlight, and using sunscreen is advisable. There can be many drug interactions; therefore, especially when taking certain antibiotics, antifungals, antivirals, and other medications affecting liver enzymes, consult a doctor beforehand. Both fertile women and men should use effective contraception while taking this medication and for a period after, and it should not be used during pregnancy. If breastfeeding, avoid breastfeeding during the period of taking this medication and for a period afterward. Safety in children under 18 years has not been established, so it is advisable not to use it. Elderly patients aged 65 and over can use it without special dosage adjustments, but their condition should be closely monitored. Patients with severe liver or kidney dysfunction may have increased concentrations of this drug in their bodies, thus requiring caution. This medication should be kept out of reach of children, and expired medications should not be taken.

• Interstitial lung disease
• pneumonia
• increased AST
• increased CPK
• hyperglycemia
• increased lipase
• hyperinsulinemia
• diarrhea
• increased ALT
• increased amylase

This medication should be stored in a tightly closed container to avoid contact with air or moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius. Proper storage will maintain the medication's effectiveness and safety.

Appearance

White or off-white round film-coated tablets

Package unit

30 tablets/bottle, 28 tablets (14 tablets/PTP x 2), 56 tablets (14 tablets/PTP x 4)