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ALUNBRIG is a brand name for Brigatinib, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ALUNBRIG (brigatinib) is indicated: as a monotherapy for the first line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC). as a monotherapy for the treatment of adult patients with…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations For patient monitoring and assessment prior to and during treatment with ALUNBRIG, see 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests.
Geriatrics:
No dose adjustment of ALUNBRIG is required in patients ≥ 65 years of age.
CYP3A Inhibitors:
The concomitant use of ALUNBRIG with strong or moderate CYP3A inhibitors should be avoided. 2 Recommended Dose and Dosage Adjustment; 7 WARNINGS AND PRECAUTIONS, General).
CYP3A Inducers:
ALUNBRIG should not be administered with strong CYP3A inducers. The concomitant use of ALUNBRIG with moderate CYP3A inducers should be avoided. 2 Recommended Dose and Dosage Adjustment; 7 WARNINGS AND PRECAUTIONS, General).
Hepatic Impairment:
No dose adjustment of ALUNBRIG is required for patients with mild hepatic impairment (Child-Pugh class A) or moderate hepatic impairment (Child-Pugh class B). The dose of ALUNBRIG should be reduced for patients with severe hepatic impairment (Child - Pugh class C).
) Renal Impairment: No dose adjustment of ALUNBRIG is required for patients with mild or moderate renal impairment (creatinine clearance (CLcr) ≥ 30 mL/min). The dose of ALUNBRIG should be reduced for patients with severe renal impairment (CLcr < 30 mL/min).
2 Recommended Dose and Dosage Adjustment Standard Dose ALUNBRIG (Brigatinib Tablets) Page 6 of 58 The recommended dosing regimen for ALUNBRIG (brigatinib) is: 90 mg orally once daily for the first 7 days; If 90 mg is tolerated during the first 7 days, increase the dose to 180 mg orally once daily.
Duration of Treatment Treatment with ALUNBRIG should be continued until disease progression or unacceptable toxicity. Dose Modification Recommendations Management of adverse events may require dosing interruption, dose reduction, or dose discontinuation of ALUNBRIG based on individual safety and tolerability.
Once reduced for adverse reactions, do not subsequently increase the dosage of ALUNBRIG. ALUNBRIG should be permanently discontinued if patient is unable to tolerate the 60 mg once daily dose. If ALUNBRIG is interrupted for 14 days or longer for reasons other than adverse reactions, treatment should be resumed at 90 mg once daily for 7 days before increasing to the previously tolerated dose.
) For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 3 – Dosage Forms, Strengths, Composition and Packaging Packaging: ALUNBRIG (brigatinib) is supplied as follows: One-month initiation pack – Aclar/foil blister strip containing 7 of the 90 mg film-coated Route of Administration Dosage Form / Strength / Composition Non-medicinal Ingredients oral tablet 30 mg, 90 mg, and 180 mg Lactose monohydrate, Magnesium stearate, Microcrystalline cellulose, Silica colloidal hydrophobic, Sodium starch glycolate (type A).
The tablet coating consists of polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. ALUNBRIG (Brigatinib Tablets) Page 12 of 58 tablets (1 card of 7 tablets) in a carton box and 21 of the 180 mg film-coated tablets (3 cards of 7 tablets) in a carton box, co-packaged in a single outer carton box 30 mg – Aclar/foil blister containing 28 film-coated tablets (2 cards of 14 tablets) 90 mg – Aclar/foil blister 28 film-coated tablets (4 cards of 7 tablets) 180 mg – Aclar/foil blister 28 film-coated tablets (4 cards of 7 tablets) 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX.
General Patients treated with ALUNBRIG (brigatinib) must have a documented ALK-positive status based on a validated ALK assay. Assessment for ALK-positive locally advanced or metastatic NSCLC should be performed by laboratories with demonstrated proficiency in the specific technology being utilized.
Drug Interactions The concomitant use of ALUNBRIG with strong or moderate CYP3A inhibitors should be avoided. , from 180 mg to 90 mg, or from 90 mg to 60 mg). If concomitant use of moderate CYP3A inhibitors cannot be avoided, the dose of ALUNBRIG should be reduced from 180 mg to 120 mg, 120 mg to 90 mg, or from 90 mg to 60 mg.
After discontinuation of a strong or moderate CYP3A inhibitor, ALUNBRIG should be resumed at the dose that was tolerated prior to the initiation of the CYP3A inhibitor. (See
2 Study Results 07/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
4 1 INDICATIONS .............................................................................................................. 1 Pediatrics ..........................................................................................................
2 Geriatrics........................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 4 4 DOSAGE AND ADMINISTRATION................................................................................. 1 Dosing Considerations .......................................................................................
2 Recommended Dose and Dosage Adjustment..................................................... 4 Administration................................................................................................. 5 Missed Dose ....................................................................................................
11 5 OVERDOSAGE ........................................................................................................... 11 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................... 11 7 WARNINGS AND PRECAUTIONS ................................................................................
ALUNBRIG (brigatinib) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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ALUNBRIG dose reduction levels for adverse reactions are summarized in Table 1. Table 1 ALUNBRIG Dose Reduction Levels Dose Dose Reduction Levels First Second Third 90 mg once daily (first 7 days) 60 mg once daily Permanently discontinue N/A* 180 mg once daily 120 mg once daily 90 mg once daily 60 mg once daily *Not applicable Recommendations for dose modifications of ALUNBRIG for the management of adverse reactions are summarized in Table 2.
ALUNBRIG (Brigatinib Tablets) Page 7 of 58 Table 2 ALUNBRIG Dose Modifications for Specific Adverse Reactions Adverse Reaction Severity* ALUNBRIG Dosing Interstitial Lung Disease (ILD) /Pneumonitis Grade 1 If ILD/pneumonitis occurs during the first 7 days of treatment, withhold ALUNBRIG until recovery to baseline, then resume at same dose and do not escalate to 180 mg if ILD/pneumonitis is suspected.
If ILD/pneumonitis occurs after the first 7 days of treatment, withhold ALUNBRIG until recovery to baseline, then resume at same dose. If ILD/pneumonitis recurs, permanently discontinue ALUNBRIG. Grade 2 If ILD/pneumonitis occurs during the first 7 days of treatment, withhold ALUNBRIG until recovery to baseline.
Resume at next lower dose (Table 1) and do not dose escalate if ILD/pneumonitis is suspected. If ILD/pneumonitis occurs after the first 7 days of treatment, withhold ALUNBRIG until recovery to baseline. If ILD/pneumonitis is suspected, resume at next lower dose (Table 1); otherwise, resume at same dose.
If ILD/pneumonitis recurs, permanently discontinue ALUNBRIG. Grade 3 or 4 Permanently discontinue ALUNBRIG. Hypertension Grade 3 hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg, medical intervention indicated, more than one anti- hypertensive drug, or more intensive therapy than previously used indicated) Withhold ALUNBRIG until hypertension has recovered to Grade ≤ 1 (SBP < 140 mmHg and DBP < 90 mmHg), or to baseline, then resume ALUNBRIG at same dose.
Recurrence: withhold ALUNBRIG until recovery to Grade ≤ 1, and resume at next lower dose (Table 1) or permanently discontinue treatment. ALUNBRIG (Brigatinib Tablets) Page 8 of 58 Adverse Reaction Severity* ALUNBRIG Dosing Grade 4 hypertension (life- threatening consequences, urgent intervention indicated) Withhold ALUNBRIG until recovery to Grade ≤1, and resume at next lower dose or permanently discontinue treatment (Table 1).
Recurrence: permanently discontinue ALUNBRIG for recurrence of Grade 4 hypertension. Bradycardia (HR < 60 bpm) Symptomatic bradycardia Withhold ALUNBRIG until recovery to asymptomatic bradycardia or to a resting heart rate of 60 bpm or above.
If a concomitant medication known to cause bradycardia is identified and discontinued or dose-adjusted, resume ALUNBRIG at same dose upon recovery to asymptomatic bradycardia or to resting heart rate of 60 bpm or above. If no concomitant medication known to cause bradycardia is identified, or if contributing concomitant medications are not discontinued or dose-adjusted, resume ALUNBRIG at next lower dose (Table 1) upon recovery to […]
1 Special Populations .......................................................................................... 1 Pregnant Women ....................................................................................... 2 Breast-feeding............................................................................................
3 Pediatrics ................................................................................................... 4 Geriatrics ................................................................................................... 5 Hepatic Impairment ...................................................................................
6 Renal Impairment....................................................................................... 20 8 ADVERSE REACTIONS ................................................................................................ 1 Adverse Reaction Overview..............................................................................
2 Clinical Trial Adverse Reactions ........................................................................ 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ......................................................................................................
31 9 DRUG INTERACTIONS................................................................................................ 2 Drug Interactions Overview.............................................................................. 3 Drug-Behavioural Interactions..........................................................................
4 Drug-Drug Interactions .................................................................................... 5 Drug-Food Interactions .................................................................................... 6 Drug-Herb Interactions ....................................................................................
7 Drug-Laboratory Test Interactions .................................................................... 38 10 CLINICAL PHARMACOLOGY ....................................................................................... 1 Mechanism of Action..................................................................................
2 Pharmacodynamics .................................................................................... 3 Pharmacokinetics....................................................................................... 39 11 STORAGE, STABILITY AND DISPOSAL .........................................................................
40 12 SPECIAL HANDLING INSTRUCTIONS........................................................................... 40 PART II: SCIENTIFIC INFORMATION ......................................................................................
41 13 PHARMACEUTICAL INFORMATION............................................................................ 41 14 CLINICAL TRIALS........................................................................................................
1 Trial Design and Study Demographics ......................................................... 2 Study Results ............................................................................................. 45 15 Microbiology ............................................................................................................
49 16 NON-CLINICAL TOXICOLOGY ..................................................................................... 49 PATIENT MEDICATION INFORMATION ................................................................................. 50 ALUNBRIG (Brigatinib Tablets) Page 4 of 58 PART […]