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TAGRISSO is a brand name for Osimertinib, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 04/2025 1 INDICATIONS, 1.2 Geriatrics 06/2024 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 06/2024 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 04/2025 7 WARNINGS AND PRECAUTIONS 04/2025 7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics 06/2024 TABLE OF CONTENTS Sections or subsections…
Verbatim from this product's HC label. Tap a section to expand.
4 Geriatrics 06/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 5 Missed Dose....................................................................................................
10 5 OVERDOSAGE .......................................................................................................... 10
). 4 Drug-Drug Interactions). • Left Ventricular Dysfunction and Cardiomyopathy (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular, Monitoring and Laboratory Tests; 8 ADVERSE REACTIONS, Left Ventricular Performance). TAGRISSO® (osimertinib) Product Monograph.
2 Geriatrics).
Hepatic Impairment:
Based on clinical studies, no dose adjustments are necessary in patients with mild hepatic impairment (Child Pugh A) or moderate hepatic impairment (Child Pugh B). 5 to 3 times ULN and any AST). 3 Pharmacokinetics).
Renal Impairment:
Based on clinical studies and population PK analysis, no dose adjustments are necessary in patients with mild, moderate or severe renal impairment. The safety and efficacy of TAGRISSO has not been established in patients with end -stage renal disease [Creatinine clearance (CLcr) less than 15 mL/min, calculated by the Cockcroft and Gault equation], or on dialysis.
3 Pharmacokinetics). 2 Recommended Dose and Dosage Adjustment The recommended dose of TAGRISSO (osimertinib) is 80 mg tablet taken orally once a day. TAGRISSO can be used as a monotherapy or in combination with pemetrexed and platinum- based (cisplatin or carboplatin) chemotherapy in patients with locally advanced or metastatic NSCLC.
Refer to the Product Monographs for pemetrexed and cisplatin/carboplatin for dosing information when TAGRISSO is used in combination with chemotherapy. Patients in the adjuvant setting should receive treatment for up to 3 years or until disease recurrence or unacceptable toxicity.
Patients with locally advanced or metastatic lung cancer should receive TAGRISSO treatment until disease progression or unacceptable toxicity regardless of if prescribed as monotherapy or in combination with pemetrexed and platinum-based chemotherapy.
4 Geriatrics 06/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 5 Missed Dose....................................................................................................
10 5 OVERDOSAGE .......................................................................................................... 10 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ....................... 10 7 WARNINGS AND PRECAUTIONS .............................................................................
1 Special Populations ......................................................................................... 1 Pregnant Women ........................................................................................ 2 Breast-feeding.............................................................................................
3 Pediatrics.................................................................................................... 4 Geriatrics .................................................................................................... 18 8 ADVERSE REACTIONS .............................................................................................
1 Adverse Reaction Overview ............................................................................. 18 TAGRISSO® (osimertinib) Product Monograph. 2 Clinical Trial Adverse Reactions .......................................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ........................................................................................................ 5 Post-Market Adverse Reactions .......................................................................
34 9 DRUG INTERACTIONS .............................................................................................. 2 Drug Interactions Overview .............................................................................. 4 Drug-Drug Interactions.....................................................................................
Do not use TAGRISSO (osimertinib) 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 of ingredients, 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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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Dose adjustments are not necessary for generally manageable adverse reactions. If dose reduction or modification is necessary based on individual safety and tolerability, then the dose of TAGRISSO should be reduced to 40 mg taken once daily.
Dose reduction guidelines for adverse reactions toxicities are provided in Table 1. TAGRISSO® (osimertinib) Product Monograph. Page 8 of 83 Protected B / Protégé B Table 1 Recommended dose modifications for TAGRISSO Target Organ Adverse Reactiona Dose Modification Pulmonaryb ILD/Pneumonitis if no recent definitive chemoradiation therapy was received Permanently discontinue TAGRISSO if ILD is confirmed.
See 7 WARNINGS AND PRECAUTIONS, Interstitial Lung Disease (ILD) for further guidance and management.
ILD/Pneumonitis following definitive platinum-based chemoradiation therapy:
Asymptomatic (Grade 1) Continue TAGRISSO or interrupt and restart, as appropriate.
ILD/Pneumonitis following definitive platinum-based chemoradiation therapy:
Grade ≥2 Permanently discontinue TAGRISSO Radiation Pneumonitis: Symptomatic (Grade 2) Withhold TAGRISSO until symptoms resolve and restart, as appropriate.
Radiation Pneumonitis if:
Permanently discontinue TAGRISSO Symptoms do not resolve after 4 weeks of interrupting TAGRISSO Symptoms (Grade 2) recur after restarting TAGRISSO Severe or life-threatening (Grade 3 or 4) Cardiacb QTc interval greater than 500 msec on at least 2 separate ECGs Withhold TAGRISSO until QTc interval is less than 481 msec or recovery to baseline if baseline QTc is greater than or equal to 481 msec, then restart at a reduced dose (40 mg).
QTc interval prolongation with signs/symptoms of serious arrhythmia Permanently discontinue TAGRISSO. Asymptomatic, absolute decrease in LVEF of 10% from baseline and below 50% Withhold TAGRISSO for up to 4 weeks. If improved to baseline LVEF, resume.
If not improved to baseline, permanently discontinue. Symptomatic congestive heart failure Permanently discontinue TAGRISSO. TAGRISSO® (osimertinib) Product Monograph. Page 9 of 83 Protected B / Protégé B Target Organ Adverse Reactiona Dose Modification Cutaneousb Stevens-Johnson Syndrome and Toxic epidermal necrolysis Permanently discontinue TAGRISSO.
Blood and Lymphatic systemb Aplastic Anemia Permanently discontinue TAGRISSO. Other Grade 3 or higher adverse reaction Withhold TAGRISSO for up to 3 weeks. If Grade 3 or higher adverse reaction improves to Grade 0-2 after withholding of TAGRISSO for up to 3 weeks TAGRISSO may be restarted at the same dose (80 mg) or a lower dose (40 mg).
Grade 3 or higher adverse reaction that does not improve to Grade 0-2 after withholding for up to 3 weeks Permanently discontinue TAGRISSO. 0. b See 7 WARNINGS AND PRECAUTIONS When TAGRISSO is administered in combination with pemetrexed and platinum-based chemotherapy, modify the dose of any one of the treatments for the management of adverse reactions, as appropriate.
For TAGRISSO dose modification instructions, see Table 1. Withhold, reduce the dose or […]
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 ............................................................................................ 38 11 STORAGE, STABILITY AND DISPOSAL ................................................................... 42 PART II: SCIENTIFIC INFORMATION ...................................................................................
43 13 PHARMACEUTICAL INFORMATION ......................................................................... 43 14 CLINICAL TRIALS ..................................................................................................... 1 Clinical Trials by Indication ...............................................................................
44 Adjuvant Treatment of EGFR Mutation-Positive Non-Small Cell Lung Cancer (NSCLC), With or Without Prior Adjuvant Chemotherapy ............................................................ 44 Locally Advanced Unresectable (Stage III) EGFR Mutation-Positive NSCLC, Following Prior Chemoradiation .................................................................................................
50 EGFR Mutation-Positive NSCLC ................................................................................ 54 EGFR T790M Mutation-Positive Advanced NSCLC..................................................... 66 15 MICROBIOLOGY........................................................................................................
72 16 NON-CLINICAL TOXICOLOGY .................................................................................. 72 PATIENT MEDICATION INFORMATION ............................................................................... 74 PART I: HEALTH PROFESSIONAL […]