Zuellig Pharma
Concise Prescribing Info
Monotherapy for adults w/ anaplastic lymphoma kinase (ALK) +ve advanced NSCLC previously not treated w/ ALK inhibitor. Monotherapy for adults w/ ALK +ve advanced NSCLC previously treated w/ crizotinib.
Dosage/Direction for Use
Initially 90 mg once daily for 1st 7 days, then 180 mg once daily. Severe hepatic impairment (Child-Pugh class C) Initially 60 mg once daily for 1st 7 days, then 120 mg once daily. Severe renal impairment (eGFR <30 mL/min) Initially 60 mg once daily for 1st 7 days, then 90 mg once daily.
May be taken with or without food: Swallow whole, do not crush/chew. Avoid grapefruit or grapefruit juice.
Special Precautions
Withhold use if pneumonitis, severe HTN (≥Grade 3), symptomatic bradycardia occur. History of ILD or drug induced-pneumonitis. Monitor for new or worsening resp symptoms eg, dyspnoea, cough particularly during 1st wk of treatment. Regularly monitor heart rate & BP, creatine phosphokinase (CPK) levels, lipase & amylase during treatment. Hepatotoxicity. Assess LFTs including AST, ALT & total bilirubin prior to then every 2 wk during 1st 3 mth of treatment & periodically thereafter. Perform ophth evaluation for new or worsening severe visual symptoms. Assess fasting serum glucose prior to & periodically thereafter. Not to be taken by patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Avoid concomitant use w/ strong CYP3A inhibitors, strong & moderate CYP3A inducers; grapefruit or grapefruit juice. Combination w/ other agents causing bradycardia. May affect ability to drive & use machines. Men should use effective contraception during & for at least 3 mth after last dose. Women of childbearing potential should use effective contraception during & for at least 4 mth after last dose. Not to be used during pregnancy & lactation. Paed patients <18 yr. Elderly >85 yr.
Adverse Reactions
Pneumonia, URTI; anemia, decreased lymphocyte, WBC & neutrophil count, increased aPTT; hyperglycaemia, hyperinsulinaemia, hypophosphataemia, hypomagnesaemia, hypercalcaemia, hyponatraemia, hypokalaemia, decreased appetite; headache, peripheral neuropathy, dizziness; visual disturbance; HTN; cough, dyspnoea; increased lipase & amylase, diarrhoea, nausea, vomiting, abdominal pain, constipation, stomatitis; increased AST, ALT & alkaline phosphatase; rash, pruritus; increased blood CPK, myalgia, arthralgia; increased blood creatinine; fatigue, oedema, pyrexia. Decreased platelet count; insomnia; memory impairment, dysgeusia; bradycardia, ECG prolonged QT interval, tachycardia, palpitations; pneumonitis; dry mouth, dyspepsia, flatulence; increased blood LDH, hyperbilirubinaemia; dry skin, photosensitivity reaction; musculoskeletal chest pain & stiffness, pain in extremity; non-cardiac chest pain, chest discomfort, pain; increased blood cholesterol, decreased wt.
Drug Interactions
Increased plasma conc w/ strong CYP3A inhibitors eg, certain antivirals (indinavir, nelfinavir, ritonavir, saquinavir), macrolides (clarithromycin, telithromycin, troleandomycin), antifungals (ketoconazole, voriconazole), nefazodone; moderate CYP3A inhibitors eg, diltiazem, verapamil; grapefruit or grapefruit juice. Decreased plasma conc w/ strong CYP3A inducers eg, rifampicin, carbamazepine, phenytoin, rifabutin, phenobarb, St. John's wort; moderate CYP3A inducers eg, efavirenz, modafinil, bosentan, etravirine, nafcillin. Reduced effectiveness of CYP3A substrates w/ narrow therapeutic index eg, alfentanil, fentanyl, quinidine, cyclosporine, sirolimus, tacrolimus. Increased plasma conc of P-gp (eg, digoxin, dabigatran, colchicine, pravastatin), BCRP (eg, MTX, rosuvastatin, sulfasalazine), OCT1, MATE1 & MATE2K substrates.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01ED04 - brigatinib ; Belongs to the class of anaplastic lymphoma kinase (ALK) inhibitors. Used in the treatment of cancer.
Alunbrig FC tab 180 mg
4 × 7's
Alunbrig FC tab 30 mg
2 × 14's
Alunbrig FC tab 90 mg
1 × 7's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in