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Tagrisso is a brand name for Osimertinib. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TAGRISSO as monotherapy is indicated for: • the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non- small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (see section 5.1). • the…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment with TAGRISSO should be initiated by a physician experienced in the use of anticancer therapies. 4). Posology Monotherapy The recommended dose is 80 mg osimertinib once a day. Combination therapy The recommended dose of TAGRISSO is 80 mg osimertinib once a day when taken with pemetrexed and platinum-based chemotherapy.
Refer to the Summary of Product Characteristics for pemetrexed and cisplatin or carboplatin for the respective dosing information. Patients in the adjuvant setting should receive treatment until disease recurrence or unacceptable toxicity.
Treatment duration for more than 3 years was not studied. Patients with locally advanced or metastatic lung cancer should receive TAGRISSO treatment until disease progression or unacceptable toxicity. If a dose of TAGRISSO is missed, the dose should be made up unless the next dose is due within 12 hours.
TAGRISSO can be taken with or without food at the same time each day. Dose adjustments Dosing interruption and/or dose reduction may be required based on individual safety and tolerability. If dose reduction is necessary, then the dose should be reduced to 40 mg taken once daily.
Dose reduction guidelines for adverse reactions toxicities are provided in Table 1. 4 Table 1. Recommended dose modifications for TAGRISSO Target organ Adverse reactiona Dose modification Pulmonaryb ILD/Pneumonitisc Permanently discontinue TAGRISSO Grade 1 Radiation Pneumonitis Consider withholding or continue TAGRISSO, as clinically indicated Grade 2 Radiation Pneumonitis Withhold TAGRISSO until symptoms resolve.
TAGRISSO may be restarted. 0. 4. c ILD/Pneumonitis including ILD/Pneumonitis following definitive platinum-based chemoradiation therapy.
ECGs:
Electrocardiograms; QTc: QT interval corrected for heart rate Combination therapy When TAGRISSO is used in combination, any of the treatment components should be dose modified, as appropriate. For TAGRISSO dose modification instructions, see Table 1.
The pemetrexed, cisplatin or carboplatin dose should be modified in accordance with the instructions in their respective Summary of Product Characteristics. Cisplatin and/or carboplatin should be used for up to 4 cycles. 2). 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).
Summary of the safety profile Studies in EGFR mutation-positive NSCLC patients The safety of TAGRISSO as a monotherapy is based on pooled data from 1956 patients with EGFR mutation-positive non-small cell lung cancer. 1). Most adverse reactions were Grade 1 or 2 in severity.
The most commonly reported adverse drug reactions (ADRs) were diarrhoea (46%), rash (45%), paronychia (33%), dry skin (31%), and stomatitis (23%). 2%, respectively. 4% of the patients. 5%. The safety of TAGRISSO given in combination with pemetrexed and platinum-based chemotherapy is based on data in 276 patients with EGFR mutation-positive NSCLC and was consistent with TAGRISSO monotherapy and known safety profiles of pemetrexed and platinum-based chemotherapy.
The most commonly reported ADRs when TAGRISSO was given in combination with pemetrexed and platinum-based chemotherapy were rash (49%), diarrhoea (43%), decreased appetite (31%), stomatitis (31%), paronychia (27%) and dry skin (24%).
When TAGRISSO is administered as combination therapy, refer to the Summary of Product Characteristics for the respective combination therapy components prior to initiation of treatment. Patients with a medical history of ILD, drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD were excluded from clinical studies.
g. QTc interval greater than 470 msec) were excluded from these studies. Patients were evaluated for LVEF at screening and every 12 weeks thereafter. Tabulated list of adverse reactions Adverse reactions have been assigned to the frequency categories in Table 2 where possible based on the incidence of comparable adverse event reports in a pooled dataset from the 1956 EGFR mutation-positive NSCLC patients who received TAGRISSO monotherapy at a dose of 80 mg daily in the ADAURA, FLAURA, FLAURA2, LAURA, AURA3, AURAex, AURA 2 and AURA1 studies and in 276 patients treated with TAGRISSO in combination with pemetrexed and platinum-based chemotherapy in the FLAURA2 study.
Assessment of EGFR mutation status When considering the use of TAGRISSO as adjuvant treatment after complete tumour resection in patients with NSCLC, EGFR mutation positive status (exon 19 deletions [Ex19del] or exon 21 L858R substitution mutations [L858R]) indicates treatment eligibility.
A validated test should be performed in a clinical laboratory using tumour tissue DNA from biopsy or surgical specimen. When considering the use of TAGRISSO in patients with locally advanced, unresectable NSCLC and whose disease has not progressed during or following platinum-based chemoradiation therapy, EGFR mutation positive status (exon 19 deletions or exon 21 [L858R] substitution mutations) indicates treatment eligibility.
A validated test should be performed in a clinical laboratory using tumour tissue DNA from a biopsy specimen. 6 When considering the use of TAGRISSO as a treatment for locally advanced or metastatic NSCLC, it is important that the EGFR mutation positive status is determined.
A validated test should be performed using either tumour DNA derived from a tissue sample or circulating tumour DNA (ctDNA) obtained from a plasma sample. Positive determination of EGFR mutation status (activating EGFR mutations for first-line treatment, exon 19 deletion or exon 21 (L858R) substitution mutations when TAGRISSO is given in combination with pemetrexed and platinum-based chemotherapy for first-line treatment, or T790M mutations following progression on or after EGFR TKI therapy) using either a tissue-based or plasma-based test, indicates eligibility for treatment with TAGRISSO.
However, if a plasma-based ctDNA test is used and the result is negative, it is advisable to follow-up with a tissue test wherever possible due to the potential for false negative results using a plasma-based test. Only robust, reliable and sensitive tests with demonstrated utility for the determination of EGFR mutation status should be used.
1. St. 5).
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5 to 3 times ULN and any AST). The safety and efficacy of this medicinal product has not been established in patients with severe hepatic impairment. 2). 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 this medicinal product 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. 2).
Paediatric population The safety and efficacy of TAGRISSO in children or adolescents aged less than 18 years have not been established. No data are available. Method of administration This medicinal product is for oral use. The tablet should be swallowed whole with water and it should not be crushed, split or chewed.
If the patient is unable to swallow the tablet, the tablet may first be dispersed in 50 mL of non-carbonated water. It should be dropped in the water, without crushing, stirred until dispersed and immediately swallowed. An additional half a glass of water should be added to ensure that no residue remains and then immediately swallowed.
No other liquids should be added. If administration via nasogastric tube is required, the same process as above should be […]
Adverse reactions are listed according to system organ class (SOC) in MedDRA. Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.
In addition, the corresponding frequency category for each adverse reaction is based on the CIOMS III convention and is defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from available data).
Table 2. 02%) 0% 0% Toxic Epidermal Necrolysisd Not known 0% 0% 12 MedDRA SOC and MedDRA term TAGRISSOa TAGRISSO with pemetrexed and platinum-based chemotherapyb CIOMS descriptor/ overall frequency (all CTCAE grades)c Frequency of CTCAE grade 3 or higherc CIOMS descriptor/ overall frequency (all CTCAE grades)c Frequency of CTCAE grade 3 or higherc Investigations Left ventricular ejection fraction […]
g. pneumonitis) have been observed in patients treated with TAGRISSO in clinical studies, including TAGRISSO following definitive platinum-based chemoradiation therapy. Most cases improved or resolved with interruption of treatment. 8).
Careful assessment of all patients with an acute onset and/or unexplained worsening of pulmonary symptoms (dyspnoea, cough, fever) should be performed to exclude ILD. Treatment with this medicinal product should be interrupted pending investigation of these symptoms.
If ILD is diagnosed, TAGRISSO should be discontinued and appropriate treatment initiated as necessary. Reintroduction of TAGRISSO should be considered only after careful consideration of the individual patient’s benefits and risk. Radiation pneumonitis Radiation pneumonitis is usually observed for up to a year after patients receive radiation therapy to the lungs.
2. Severe Cutaneous Adverse Reactions (SCARs) Case reports of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with frequency categories of rare and not known, respectively, in association with TAGRISSO treatment.
Before initiating treatment, patients should be advised of signs and symptoms of SJS and TEN. If signs and symptoms suggestive of SJS or TEN appear, TAGRISSO should be interrupted. TAGRISSO should be discontinued immediately if SJS or TEN are diagnosed.
QTc interval prolongation QTc interval prolongation occurs in patients treated with TAGRISSO. g. torsade de pointes) or sudden death. 8). g. 8). When possible, the use of TAGRISSO in patients with congenital long QT syndrome should be avoided.
Periodic monitoring with electrocardiograms (ECGs) and electrolytes should be considered in 7 patients with congestive heart failure, electrolyte abnormalities, or those who are taking medicinal products that are known to prolong the QTc interval.
Treatment should be withheld in patients who develop a QTc interval greater than 500 msec on at least 2 separate ECGs until the QTc interval is less than 481 msec or recovery to baseline if the QTc interval is greater than or equal to 481 msec, then resume TAGRISSO at a reduced dose as described in Table 1.
TAGRISSO should be permanently discontinued in patients who develop QTc interval prolongation in combination with any of the following: Torsade de pointes, polymorphic ventricular tachycardia, signs/symptoms of serious arrhythmia. 2% (65/1557) of patients treated with TAGRISSO monotherapy who had baseline and at least one follow-up LVEF assessment.
In patients with cardiac risk factors and those with conditions that can affect LVEF, cardiac monitoring, including an assessment of LVEF at baseline and during treatment, should be considered. In patients who develop relevant cardiac signs/symptoms during treatment, cardiac monitoring including LVEF assessment should be considered.
5% (5/331) of patients […]