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TABRECTA is a brand name for Capmatinib, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TABRECTA® (capmatinib tablets) is indicated for: • the treatment of adult patients with locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. Efficacy in patients with NSCLC harbouring MET exon 14 skipping…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • TABRECTA has not been studied in patients with severe renal impairment. No dose adjustment is necessary in patients with mild or moderate renal impairment (See 10 CLINICAL PHARMACOLOGY). • No dose adjustment is necessary in patients with mild, moderate, or severe hepatic impairment (See 10 CLINICAL PHARMACOLOGY).
2 Recommended Dose and Dosage Adjustment • Recommended Dose The recommended dose of TABRECTA is 400 mg orally twice daily with or without food (See 10 CLINICAL PHARMACOLOGY). TABRECTA® (capmatinib) Product Monograph Page 6 of 38 • Treatment duration Treatment should be continued until disease progression or unacceptable toxicity.
• Dose modifications for adverse reactions The recommended dose reduction schedule for the management of adverse reactions (ARs) based on individual safety and tolerability is listed in Table 1. Table 1 TABRECTA dose reduction schedule Dose level Dose and schedule Number and strength of tablets Starting dose 400 mg twice daily Two 200 mg tablets / twice daily First-dose reduction 300 mg twice daily Two 150 mg tablets / twice daily Second-dose reduction 200 mg twice daily One 200 mg tablet / twice daily TABRECTA should be permanently discontinued in patients unable to tolerate 200 mg orally twice daily.
Recommendations for dose modifications of TABRECTA for adverse reactions (ARs) are provided in Table 2. Table 2 TABRECTA dose modifications for the management of adverse reactions Adverse reaction Severity Dose modification Interstitial lung disease (ILD)/pneumonitis (see 7 WARNINGS AND PRECAUTIONS) Any grade treatment- related Permanently discontinue TABRECTA.
0 x ULN) Temporarily withhold TABRECTA until recovery to baseline ALT/AST grade. If recovered to baseline within 7 days, then resume TABRECTA at the same dose, otherwise resume TABRECTA at a reduced dose as per Table 1. 0 x ULN) Permanently discontinue TABRECTA.
Combined elevations in ALT and/or AST with concurrent total bilirubin increase, in the absence of cholestasis or hemolysis (see 7 WARNINGS AND PRECAUTIONS) If patient develops ALT and/or AST >3 x ULN along with total bilirubin >2 x ULN, irrespective of baseline grade Permanently discontinue TABRECTA.
0 x ULN) Temporarily withhold TABRECTA until recovery to baseline bilirubin grade. TABRECTA® (capmatinib) Product Monograph Page 7 of 38 Adverse reaction Severity Dose modification Isolated total bilirubin elevation from baseline, without concurrent ALT and/or AST increase (see 7 WARNINGS AND PRECAUTIONS) If recovered to baseline within 7 days, then resume TABRECTA at the same dose, otherwise resume TABRECTA at a reduced dose as per Table 1.
) Grade 2 Maintain dose level. If intolerable, consider temporarily withholding TABRECTA until resolved, then resume TABRECTA at a reduced dose as per Table 1. Grade 3 Temporarily withhold TABRECTA until resolved, then resume TABRECTA at a reduced dose as per Table 1.
Grade 4 Permanently discontinue TABRECTA.
Abbreviations:
ALT, alanine aminotransferase; AST, aspartate aminotransferase; ILD, interstitial lung disease; ULN, upper limit of normal. 03 (CTCAE = Common Terminology Criteria for Adverse Events). Baseline = at the time of treatment initiation.
Pediatrics (<18 years of age):
Health Canada has not authorized an indication for pediatric use.
Geriatrics (≥65 years of age):
No dose adjustment is necessary in patients 65 years of age or older.
Renal Impairment:
No dose adjustment is recommended in patients with mild or moderate renal impairment. The pharmacokinetics and safety of TABRECTA in patients with severe renal impairment have not been studied (see 10 CLINICAL PHARMACOLOGY).
Hepatic Impairment:
No dose adjustment is necessary in patients with mild, moderate, or severe hepatic impairment (See 10 CLINICAL PHARMACOLOGY). 4 Administration TABRECTA should be taken orally twice daily with or without food. The tablets should be swallowed whole and should not be broken, chewed, or crushed (See 10 CLINICAL PHARMACOLOGY).
5 Missed dose If a dose of TABRECTA is missed or vomiting occurs, the patient should not make up the dose, but take the next dose at the scheduled time. 5 OVERDOSAGE There is limited experience with overdose in clinical studies with TABRECTA.
). 1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics (≥65 years of age): In Study A2201 (GEOMETRY mono-1), 61% of the 373 patients were 65 years of age or older, and 18% were 75 years of age or older.
No clinically important differences in safety or efficacy were observed between patients aged 65 years or older and younger patients. 2 CONTRAINDICATIONS TABRECTA 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. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX • Interstitial lung disease (ILD) / Pneumonitis (see 7 WARNINGS AND PRECAUTIONS). • Hepatotoxicity (see 7 WARNINGS AND PRECAUTIONS).
• Embryo-fetal toxicity (see 7 WARNINGS AND PRECAUTIONS). 1 Dosing Considerations • TABRECTA has not been studied in patients with severe renal impairment. No dose adjustment is necessary in patients with mild or moderate renal impairment (See 10 CLINICAL PHARMACOLOGY).
• No dose adjustment is necessary in patients with mild, moderate, or severe hepatic impairment (See 10 CLINICAL PHARMACOLOGY). 2 Recommended Dose and Dosage Adjustment • Recommended Dose The recommended dose of TABRECTA is 400 mg orally twice daily with or without food (See 10 CLINICAL PHARMACOLOGY).
TABRECTA® (capmatinib) Product Monograph Page 6 of 38 • Treatment duration Treatment should be continued until disease progression or unacceptable toxicity. • Dose modifications for adverse reactions The recommended dose reduction schedule for the management of adverse reactions (ARs) based on individual safety and tolerability is listed in Table 1.
Table 1 TABRECTA dose reduction schedule Dose level Dose and schedule Number and strength of tablets Starting dose 400 mg twice daily Two 200 mg tablets / twice daily First-dose reduction 300 mg twice daily Two 150 mg tablets / twice daily Second-dose reduction 200 mg twice daily One 200 mg tablet / twice daily TABRECTA should be permanently discontinued in patients unable to tolerate 200 mg orally twice daily.
TABRECTA 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.
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0 x ULN) Temporarily withhold TABRECTA until recovery to baseline bilirubin grade. If recovered to baseline within 7 days, then resume TABRECTA at a reduced dose as per Table 1, otherwise permanently discontinue TABRECTA. 0 x ULN) Permanently discontinue TABRECTA.
Other adverse reactions (see 8 ADVERSE REACTIONS) Grade 2 Maintain dose level. If intolerable, consider temporarily withholding TABRECTA until resolved, then resume TABRECTA at a reduced dose as per Table 1. Grade 3 Temporarily withhold TABRECTA until resolved, then resume TABRECTA at a reduced dose as per Table 1.
Grade 4 Permanently discontinue TABRECTA.
Abbreviations:
ALT, alanine aminotransferase; AST, aspartate aminotransferase; ILD, interstitial lung disease; ULN, upper limit of normal. 03 (CTCAE = Common Terminology Criteria for Adverse Events). Baseline = at the time of treatment initiation.
Pediatrics (<18 years of age):
Health Canada has not authorized an indication for pediatric use.
Geriatrics (≥65 years of age):
No dose adjustment is necessary in patients 65 years of age or older.
Renal Impairment:
No dose adjustment is recommended in patients with mild or moderate renal impairment. The pharmacokinetics and safety of TABRECTA in patients with severe renal impairment have not been studied (see 10 CLINICAL PHARMACOLOGY).
Hepatic Impairment:
No dose adjustment is necessary in patients with mild, moderate, or severe hepatic impairment (See 10 CLINICAL PHARMACOLOGY). 4 Administration TABRECTA should be taken orally twice daily with or without food. The tablets should be swallowed whole and should not be broken, chewed, or crushed (See 10 CLINICAL PHARMACOLOGY).
5 Missed dose If a dose of TABRECTA is missed or vomiting occurs, the patient should not make up the dose, but take the next dose at the scheduled time.
Patients should be closely monitored for signs or symptoms of adverse reactions, and general supportive measures and symptomatic treatment should be initiated in cases of suspected overdose. In case of overdose, TABRECTA should be withheld and symptomatic treatment initiated.
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 TABRECTA (capmatinib) 150 mg film-coated tablet: pale orange brown, ovaloid, curved film-coated tablet with beveled edges, unscored, debossed with ‘DU’ on one side and ‘NVR’ on the other side.
TABRECTA (capmatinib) 200 mg film-coated tablet: yellow, ovaloid, curved film-coated tablet with beveled edges, unscored, debossed with ‘LO’ on one side and ‘NVR’ on the other side. Packaging TABRECTA 150 mg and 200 mg tablets are supplied in blister packaging: 12 blisters/card, 5 or 10 cards/carton (60 or 120 tablets).
7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Tablets 150 mg and 200 mg capmatinib (as capmatinib hydrochloride) Cellulose microcrystalline; crospovidone; hypromellose; iron oxide, black (for the 150 mg tablets); iron oxide, red (for the 150 mg tablets); iron oxide, yellow; macrogol 4000; magnesium stearate; mannitol; povidone; silica colloidal anhydrous; sodium laurilsulfate; talc and titanium dioxide.
TABRECTA® (capmatinib) Product Monograph Page 9 of 38 General Patient selection for METex14 alterations Documentation of the presence of a METex14 alteration in tumour or plasma specimens using a validated test is required prior to treatment with TABRECTA.
If a METex14 skipping mutation is not detected in a plasma specimen, tumor tissue should be tested if feasible (see 14 CLINICAL TRIALS). Driving and Operating Machinery No studies on the effects of TABRECTA on the ability to drive or use machines have been performed.
Exercise caution when driving or operating a vehicle or potentially dangerous machinery until the patient is reasonably certain that TABRECTA does not affect them adversely. Hepatic/Biliary/Pancreatic Hepatotoxicity Hepatotoxicity occurred in patients treated with TABRECTA (see 8 ADVERSE REACTIONS).
7%) treated with TABRECTA in Study A2201 (GEOMETRY mono- 1). 0%) treated with TABRECTA. 8%) discontinued TABRECTA due to ALT/AST elevations. One patient died due to hepatitis. ALT/AST elevations mostly occurred within approximately the first 3 months of treatment.
6 weeks). Liver function tests (including ALT, AST, and total bilirubin) should be performed prior to the start of treatment, every 2 weeks during the first 3 months of treatment, then once a month or as clinically indicated, with more frequent testing in patients who develop transaminase or bilirubin elevations.
2 Recommended Dose and Dosage Adjustment). 9%) treated with TABRECTA in Study GEOMETRY mono –1. 6%) treated with TABRECTA. 8%) discontinued TABRECTA due to amylase/lipase elevations. 0 weeks. 3%). Amylase and lipase should be monitored at baseline and regularly during treatment with TABRECTA.
2 Recommended Dose and Dosage Adjustment). Immune Hypersensitivity TABRECTA® (capmatinib) Product Monograph Page 10 of 38 No […]
Recommendations for dose modifications of TABRECTA for adverse reactions (ARs) are provided in Table 2. Table 2 TABRECTA dose modifications for the management of adverse reactions Adverse reaction Severity Dose modification Interstitial lung disease (ILD)/pneumonitis (see 7 WARNINGS AND PRECAUTIONS) Any grade treatment- related Permanently discontinue TABRECTA.
0 x ULN) Temporarily withhold TABRECTA until recovery to baseline ALT/AST grade. If recovered to baseline within 7 days, then resume TABRECTA at the same dose, otherwise resume TABRECTA at a reduced dose as per Table 1. 0 x ULN) Permanently discontinue TABRECTA.
Combined elevations in ALT and/or AST with concurrent total bilirubin increase, in the absence of cholestasis or hemolysis (see 7 WARNINGS AND PRECAUTIONS) If patient develops ALT and/or AST >3 x ULN along with total bilirubin >2 x ULN, irrespective of baseline grade Permanently discontinue TABRECTA.
0 x ULN) Temporarily withhold TABRECTA until recovery to baseline bilirubin grade. TABRECTA® (capmatinib) Product Monograph Page 7 of 38 Adverse reaction Severity Dose modification Isolated total bilirubin elevation from baseline, without concurrent ALT and/or AST increase (see 7 WARNINGS AND PRECAUTIONS) If recovered to baseline within 7 days, then resume TABRECTA at the same dose, otherwise resume TABRECTA at a reduced dose as per Table 1.
0 x ULN) Temporarily withhold TABRECTA until recovery to baseline bilirubin grade. If recovered to baseline within 7 days, then resume TABRECTA at a reduced dose as per Table 1, otherwise permanently discontinue TABRECTA. 0 x ULN) Permanently discontinue TABRECTA.
Other adverse reactions (see