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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 MHRA 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. Table 1. Recommended dose modifications for TAGRISSO Target organ Adverse reactiona Dose modification Pulmonaryb,c ILD/Pneumonitis Discontinue TAGRISSO ILD/Pneumonitis following definitive platinum-based chemoradiation therapy: Asymptomatic (Grade 1) Continue TAGRISSO or interrupt and restart, as appropriate.
0. 4. 4 for modification instructions in patients with radiation 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 1813 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 (47%), rash (46%), paronychia (34%), dry skin (32%), and stomatitis (24%). 2%, respectively. 9% of the patients. 2%. The safety of TAGRISSO (80 mg once daily) following platinumbased chemoradiation therapy is based on data from 143 patients with EGFR mutationpositive NSCLC.
It was manageable and was consistent with TAGRISSO monotherapy and the known safety profile of treatment following platinum-based chemoradiation therapy. The most commonly reported adverse drug reactions (ADRs) were diarrhoea (36%), rash (36%), paronychia (23%) and dry skin (17%).
1% and 0%, respectively. 6% of 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.
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 (stage III) NSCLC, 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. 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. Only robust, reliable and sensitive tests with demonstrated utility for the determination of EGFR mutation status should be used.
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. g. pneumonitis) have been observed in patients treated with TAGRISSO in clinical studies.
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 followed but using volumes of 15 mL for the initial dispersion and 15 mL […]
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 1813 EGFR mutation positive NSCLC patients who received TAGRISSO monotherapy at a dose of 80 mg daily in the ADAURA, FLAURA, FLAURA2, AURA3, AURAex, AURA2 and AURA1 studies, in 143 patients treated with TAGRISSO following platinum-based chemoradiation therapy in the LAURA study and in 276 patients treated with TAGRISSO in combination with pemetrexed and platinum-based chemotherapy in the FLAURA2 study.
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. 7% Very common (24%) 0% […]
Most cases improved or resolved with interruption of treatment. 8). g. 0% of the 1813 patients who received TAGRISSO monotherapy in the ADAURA, FLAURA, FLAURA2 and AURA studies. Seven fatal cases were reported in the locally advanced or metastatic setting.
No fatal cases were reported in the adjuvant setting. 8). 4% (n=1) of the 276 patients who received TAGRISSO in combination with pemetrexed and platinum-based chemotherapy in FLAURA2. 7% in non-Asian patients; no patients of non- Japanese Asian ethnicity had an event of ILD in the FLAURA2 combination arm.
The median time from first dose to onset of ILD or ILD-like adverse reactions was 161 days. 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.
g. 4% of the 73 patients who received placebo. 8). For patients treated with TAGRISSO following definitive platinumbased chemoradiation therapy, use the following dose modification instructions: • If patients develop asymptomatic (Grade 1) ILD or ILD-like adverse reactions, continue TAGRISSO, or alternatively interrupt and restart TAGRISSO, as clinically indicated • Permanently discontinue the use of TAGRISSO if the patient develops a Grade ≥2 ILD or ILD-like adverse reaction.
Radiation pneumonitis Radiation pneumonitis is usually observed for up to a year after patients receive radiation therapy to the lungs. In the LAURA study, following definitive platinum- based chemoradiation therapy, radiation pneumonitis was reported in 48% of the 143 patients who received TAGRISSO and 38% of the 73 patients who received placebo.
8 months in the placebo arm. 6 months in the placebo arm. 1%) patients had Grade 3 events, all in the TAGRISSO arm, and no Grade 4 or Grade 5 events were reported in either arm. For patients treated with TAGRISSO following definitive platinumbased chemoradiation therapy, use the following dose modification instructions: • If patients develop symptomatic (Grade 2) radiation pneumonitis, interrupt TAGRISSO until symptoms resolve; TAGRISSO may be restarted.
• Permanently discontinue the use of TAGRISSO if: - symptoms do not resolve after 4 weeks of interrupting TAGRISSO; - symptomatic (Grade 2) radiation pneumonitis recurs after restarting TAGRISSO; - patients develop severe or life threatening (Grade 3 or 4) radiation […]