Alunbrig奧朗格

Alunbrig

brigatinib

Manufacturer:

Takeda

Distributor:

Zuellig
/
Firma Chun Cheong
Concise Prescribing Info
Contents
Brigatinib
Indications/Uses
Treatment of patients w/ anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. This indication is approved based on tumor response rate & duration of response. Continued approval for this indication may be contingent upon verification & description of clinical benefit in a confirmatory trial.
Dosage/Direction for Use
Initially 90 mg once daily for the 1st 7 days, increased to 180 mg once daily if initial dose is tolerated.
Administration
May be taken with or without food: Swallow whole, do not crush/chew.
Special Precautions
Risk of interstitial lung disease (ILD)/pneumonitis; HTN; bradycardia; visual disturbances (eg, blurred vision, diplopia, & reduced visual acuity); creatine phosphokinase (CPK) & pancreatic enzyme elevation; hyperglycemia. Withhold treatment in patients w/ Grade 3 or 4 CPK elevation; Grade 3 or 4 pancreatic enzyme elevation; inadequate hyperglycemic control. Discontinue in case of Grade 3 or 4 ILD/pneumonitis or recurrence of Grade 1 or 2 ILD/pneumonitis; Grade 4 HTN or recurrence of Grade 3 HTN; life-threatening bradycardia; Grade 4 visual disturbances. Use w/ caution in combination w/ antihypertensive agents causing bradycardia. 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. Childn.
Adverse Reactions
Pneumonia, ILD/pneumonitis; increased CPK. Nausea, diarrhea, vomiting, constipation, abdominal pain; fatigue, pyrexia; cough, dyspnea, hypoxia; headache, peripheral neuropathy; rash; HTN; muscle spasms, back pain, myalgia, arthralgia, pain in extremity; decreased appetite; visual disturbance; insomnia; increased AST, lipase, ALT, amylase, alkaline phosphatase; hyperglycemia, decreased phosphorus, prolonged activated partial thromboplastin time; anemia, lymphopenia.
Drug Interactions
Increased plasma conc & adverse reactions w/ strong CYP3A inhibitors [eg, certain antivirals (boceprevir, cobicistat, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir), macrolide antibiotics (clarithromycin), antifungals (itraconazole, ketoconazole, posaconazole, voriconazole), conivaptan]; grapefruit or grapefruit juice. Decreased plasma conc & efficacy w/ strong CYP3A inducers (eg, rifampin, carbamazepine, phenytoin, St. John's Wort). Decreased conc & loss of efficacy of CYP3A substrates (eg, hormonal contraceptives).
ATC Classification
L01ED04 - brigatinib ; Belongs to the class of anaplastic lymphoma kinase (ALK) inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Alunbrig FC tab 30 mg
Packing/Price
28's
Form
Alunbrig FC tab 180 mg
Packing/Price
28's
Form
Alunbrig FC tab 90 mg
Packing/Price
28's;7's
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