Concise Prescribing Info
Adult patients w/ anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated w/ crizotinib.
Dosage/Direction for Use
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 hepatic impairment Recommended dose: Initially 60 mg once daily for the first 7 days, then 120 mg once daily. Severe renal impairment (eGFR <30 mL/min) Recommended dose: Initially 60 mg once daily for the 1st 7 days, then 90 mg once daily.
May be taken with or without food: Swallow whole, do not crush/chew.
Special Precautions
Regularly monitor BP during treatment; frequently monitor heart rate if concomitant use of a medicinal product known to cause bradycardia cannot be avoided; for severe HTN (≥Grade 3), withheld treatment until HTN has recovered to Grade 1 or to baseline & modify dose accordingly. Bradycardia; withheld treatment if symptomatic bradycardia occurs & evaluate concomitant medications known to cause bradycardia, & modify dose accordingly upon recovery; discontinue use in case of life-threatening bradycardia w/ no contributing concomitant medication identified, or in case of recurrence. Visual disturbances; consider ophth evaluation & dose reduction for new or worsening severe visual symptoms. Monitor for elevated CPK levels; withheld treatment based on severity of CPK elevation & modify dose accordingly; patient should report any unexplained muscle pain, tenderness, or weakness. Monitor for elevated lipase & amylase; withheld treatment based on the severity of laboratory abnormalities & modify dose accordingly. Assess fasting serum glucose prior to initiation & monitor periodically thereafter; initiate or optimize antihyperglycemic medications as needed. If adequate hyperglycemic control cannot be achieved w/ optimal medical management, withheld treatment until adequate hyperglycemic control is achieved; upon recovery, dose reduction or permanent discontinuation may be considered. Assess liver function, including AST, ALT & total bilirubin levels, prior to initiation & every 2 wk during the 1st 3 mth of treatment, & perform monitoring periodically thereafter; withheld treatment & modify dose accordingly based on the severity of laboratory abnormalities. Avoid concomitant use w/ strong CYP3A inhibitors, & strong and 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 & lactation. Elderly >85 yr. Childn <18 yr.
Adverse Reactions
Nausea, diarrhea, fatigue, cough, headache, rash, vomiting, HTN, dyspnea, myalgia, decreased appetite, muscle spasms, constipation. Pneumonia, pneumonitis.
Drug Interactions
May increase plasma conc w/ strong CYP3A inhibitors, including but not limited to certain antivirals (eg, indinavir, nelfinavir, ritonavir, saquinavir), macrolide antibiotics (eg, clarithromycin, telithroycin, troleandomycin), antifungals (eg, itraconazole, ketoconazole, posaconazole, voriconazole), mibefradil, & nefazodone; grapefruit or grapefruit juice. May decrease plasma conc w/ 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 effectiveness of CYP3A substrates w/ narrow therapeutic index (eg, alfentanil, fentanyl, quinidine, cyclosporine, sirolimus, tacrolimus). May also 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 P-gp substrates (eg, digoxin, dabigatran, colchicine, pravastatin), BCRP (eg, methotrexate, rosuvastatin, sulfasalazine), OCT1, MATE1, & MATE2K.
ATC Classification
L01XE43 - brigatinib ; Belongs to the class of protein kinase inhibitors, other antineoplastic agents. 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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