Alunbrig

Alunbrig

brigatinib

Manufacturer:

Takeda

Distributor:

DKSH
Concise Prescribing Info
Contents
Brigatinib
Indications/Uses
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.
Administration
May be taken with or without food: Swallow whole, do not crush/chew.
Contraindications
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.
Presentation/Packing
Form
Alunbrig FC tab 90 mg
Packing/Price
28's;7's
Form
Alunbrig FC tab 30 mg
Packing/Price
28's
Form
Alunbrig FC tab 180 mg
Packing/Price
28's
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