Concise Prescribing Info
Anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) in adults previously not treated w/ an ALK inhibitor; previously treated w/ crizotinib.
Dosage/Direction for Use
Adult Recommended initial dose: 90 mg once daily for the 1st 7 days, then 180 mg once daily. Continue treatment as long as clinical benefit is observed. Severe renal impairment (eGFR <30 mL/min) Reduce dose by approx 50%. Severe hepatic impairment (Child-Pugh class C) Reduce dose by approx 40%.
May be taken with or without food: Swallow whole, do not crush/chew.
Special Precautions
Possible severe, life-threatening & fatal pulmonary AR including those w/ consistent interstitial lung disease/pneumonitis features; monitor for new or worsening resp symptoms (eg, dyspnoea, cough) particularly in the 1st wk of treatment; promptly investigate evidence of pneumonitis in patients w/ worsening resp symptoms; w/hold treatment if pneumonitis is suspected; evaluate & modify dose for other causes of symptoms (eg, pulmonary embolism, tumor progression & infectious pneumonia). Regularly monitor BP during treatment; frequently monitor heart rate if concomitant use of bradycardia-causing medications cannot be avoided; w/hold treatment & modify dose for severe HTN (≥Grade 3), until HTN has recovered to Grade 1 or to baseline. Regularly monitor heart rate; w/hold treatment & evaluate concomitant bradycardia-causing medications if symptomatic bradycardia occurs, modify dose upon recovery; discontinue use in case of life-threatening bradycardia if no contributing concomitant medication identified, or in case of recurrence. Visual disturbances; consider ophth evaluation & dose reduction for new or worsening severe visual symptoms. Regularly monitor for elevated creatine phosphokinase (CPK) levels during treatment; report any unexplained muscle pain, tenderness, or weakness; w/hold treatment & modify dose based on severity of CPK elevation. Regularly monitor for elevated amylase & lipase; w/hold treatment & modify dose based on severity of laboratory abnormalities. Avoid prolonged sun exposure during treatment & for at least 5 days after discontinuation; w/hold treatment & modify dose for severe photosensitivity reactions. Assess fasting serum glucose prior to initiation & monitor periodically thereafter; initiate or optimize antihyperglycemic medications as needed; w/hold treatment until adequate hyperglycemic control is achieved; consider dose reduction or permanent discontinuation upon recovery. Assess liver function, including AST, ALT & total bilirubin, prior to initiation & every 2 wk during the 1st 3 mth of treatment, & perform monitoring periodically thereafter; w/hold treatment & modify dose based on the severity of laboratory abnormalities. Avoid concomitant use w/ strong CYP3A inhibitors, & strong & moderate CYP3A inducers. May affect abilty to drive & use machines. Potential fetal risk. Females of reproductive potential should use effective non-hormonal contraception during treatment & for at least 4 mth following the final dose. Males w/ female partners of reproductive potential should use effective contraception during treatment & for at least 3 mth after last dose. Pregnancy. Discontinue breast-feeding during treatment. Childn <18 yr. Elderly >85 yr.
Adverse Reactions
Pneumonia, upper resp tract infection; anemia, decreased lymphocyte, WBC & neutrophil count, increased APTT; hyperglycemia, -insulinemia & -calcemia, & hypophosphatemia, -magnesemia, -natremia & -kalemia, decreased appetite; headache, peripheral neuropathy, dizziness; visual disturbance; HTN; cough, dyspnea; increased lipase & amylase, diarrhea, nausea, vomiting, abdominal pain, constipation, stomatitis; increased AST, ALT & alkaline phosphatase; rash, pruritus; increased blood CPK, myalgia, arthralgia; increased blood creatinine; fatigue, edema, pyrexia. Decreased platelet count; insomnia; dysgeusia, memory impairment; bradycardia, prolonged ECG QT, tachycardia, palpitations; pneumonitis; dry mouth, dyspepsia, flatulence; increased blood lactate dehydrogenase, hyperbilirubinaemia; dry skin, photosensitivity reaction; musculoskeletal chest pain, pain in extremity, musculoskeletal stiffness; non-cardiac chest pain, chest discomfort, pain; increased blood cholesterol, decreased wt.
Drug Interactions
Plasma conc may be increased by strong CYP3A inhibitors, including but not limited to certain antivirals (eg, indinavir, nelfinavir, ritonavir, saquinavir), macrolide antibiotics (eg, clarithromycin, telithromycin, troleandomycin), antifungals (eg, itraconazole, ketoconazole, posaconazole, voriconazole), & nefazodone; grapefruit or grapefruit juice. Plasma conc may be decreased by strong CYP3A inducers, including but not limited to rifampin, carbamazepine, phenytoin, rifabutin, phenobarb & St. John's Wort; moderate CYP3A inducers, including but not limited to efavirenz, modafinil, bosentan, etravirine & nafcillin. May reduce plasma conc & effectiveness of CYP3A substrates w/ narrow therapeutic index (eg, alfentanil, fentanyl, quinidine, cyclosporine, sirolimus, tacrolimus). May induce other enzymes & transporters (eg, CYP2C, P-gp) via the same mechanisms responsible for CYP3A induction (eg, pregnane X receptor activation). May increase plasma conc of substrates of P-gp (eg, digoxin, dabigatran, colchicine, pravastatin), BCRP (eg, methotrexate, rosuvastatin, sulfasalazine), OCT1, MATE1, & MATE2K.
ATC Classification
L01ED04 - brigatinib ; Belongs to the class of anaplastic lymphoma kinase (ALK) inhibitors. Used in the treatment of cancer.
Alunbrig FC tab 90 mg
Alunbrig FC tab 30 mg
Alunbrig FC tab 180 mg
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