The recommended dose is 40 mg once daily but this may be increased to up to 50 mg per day in patients who tolerate the 40 mg dose, or interrupted and reduced in patients experiencing side effects. Based on the available clinical trial data, there is no suggestion that this medicinal product causes an adverse reaction on cardiac contractility. Patients had a tumour sample with an EGFR mutation categorised as either exon 19 deletion (58%) or exon 21 L858R substitutions (42%).The co-primary endpoints include PFS by independent review and OS. (PDF/591.17 KB)
During treatment, ocular adverse reactions (conjunctivitis, dry eye, keratitis) have been reported in some patients (see section 4.8) which may affect patients ability to drive or use machines.The types of adverse reactions (ADRs) were generally associated with the EGFR inhibitory mode of action of afatinib.
(PDF/79.62 KB) (PDF/18.75 KB) For practical information about using Giotrif, patients should read the Giotrif is a medicine used to treat a type of lung cancer known as non-small cell lung cancer. (PDF/100.33 KB) (PDF/16.81 KB) (PDF/107.62 KB) (PDF/596.87 KB) (PDF/45.17 KB) This means preferably 6 hours (for P-gp inhibitors dosed twice daily) or 12 hours (for P-gp inhibitors dosed once daily) apart from GIOTRIF (see section 4.5).Exposure to afatinib was found to be increased in patients with moderate or severe renal impairment (see section 5.2). Diarrhoea may result in dehydration with or without renal impairment, which in rare cases has resulted in fatal outcomes.
Blocking the signals causes the cells to die. (PDF/617.96 KB) In the pivotal trials Grade 3 alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevations were observed in 2.4% (LUX-Lung-3) and 1.6% (LUX-Lung 8) of patients with normal baseline liver tests treated with 40 mg/day. Oral administration of single doses to mice and rats indicated a low acute toxic potential of afatinib. Therefore, treatment of children or adolescents with this medicinal product is not recommended.This medicinal product is for oral use. Afatinib is a second-generation tyrosine kinase inhibitor.
If swallowing of whole tablets is not possible, these can be dispersed in approximately 100 ml of non-carbonated drinking water. The following terms are used to rank the ADRs by frequency: 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).
In humans it was found that enzyme-catalyzed metabolic reactions play a negligible role for the metabolism of afatinib. (PDF/105.03 KB) Available non-clinical toxicology data have shown effects on reproductive organs at higher doses.
(PDF/599.73 KB) Secondary endpoints include ORR and DCR. It belongs to the tyrosine kinase inhibitor family of medications. (PDF/623.77 KB) Subjects with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment had similar exposure in comparison to healthy volunteers following a single dose of 50 mg GIOTRIF. (PDF/100.33 KB) The tablets should be swallowed whole with water.
Excipient with known effect One film-coated tablet contains 176 mg lactose (as monohydrate).
Afatinib is also approved in some countries including the US and … Following administration of an oral solution of 15 mg afatinib, 85.4% of the dose was recovered in the faeces and 4.3% in urine. 2 Lacouture ME, et al. Thus, steady state plasma concentrations of afatinib were achieved within 8 days of multiple dosing of afatinib resulting in an accumulation of 2.77-fold (AUC 0-∞) and 2.11-fold (C max).
For patients who are exposed to sun, protective clothing, and use of sun screen is advisable. Grade 2 ALT elevations occurred in 1% and Grade 3 elevations occurred in 0.8% of patients treated with GIOTRIF (see section 4.4).Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.euEllesfield Avenue, Bracknell, Berkshire, RG12 8YS To bookmark a medicine you must sign up and log in.To view the changes to a medicine you must sign up and log in.
In patients treated with once daily GIOTRIF 40 mg, dose reductions due to ADRs occurred in 57% of the patients in the LUX-Lung 3 trial and in 25% of the patients in the LUX-Lung 8 trial. Table 7 shows outcomes in the subgroups of patients with two common EGFR mutations – Del 19 and L858R.Figure 1: Kaplan-Meier curve for PFS by independent review by treatment group in trial LUX-Lung 3 (Overall Population)Table 6: Efficacy results of GIOTRIF vs. pemetrexed/cisplatin (LUX-Lung 3) gemcitabine/cisplatin (LUX-Lung 6) (Independent review)Table 7: PFS and OS efficacy results of GIOTRIF vs pemetrexed/cisplatin (LUX-Lung 3) gemcitabine/cisplatin (LUX-Lung 6) in the pre-defined EGFR mutation subgroups Del 19 and L858R (Independent review) In the pre-defined subgroup of common mutations (combined Del 19 and L858R) for GIOTRIF and chemotherapy, the median PFS was 13.6 months vs. 6.9 months (HR 0.48; 95% CI 0.35-0.66; p<0.0001; N=307) in LUX-Lung 3, and 11.0 months vs. 5.6 months (HR 0.24; 95% CI 0.17-0.35; p<0.0001; N=324) in LUX-Lung 6, respectively.PFS benefit was accompanied by improvement in disease-related symptoms and delayed time to deterioration (see Table 8).
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