(PDF/38.73 KB) If a diagnosis of ulcerative keratitis is confirmed, treatment should be interrupted or discontinued. It is mainly used to treat cases of NSCLC that harbour mutations in the epidermal growth factor receptor gene. These elevations were mainly transient and did not lead to discontinuation.

GIOTRIF 30 mg film-coated tablets One film-coated tablet contains 30 mg afatinib (as dimaleate). Patients with a history of ILD have not been studied.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. (PDF/599.73 KB)

The dispersion can also be administered through a gastric tube.Hypersensitivity to afatinib or to any of the excipients listed in section 6.1.When assessing the EGFR mutation status of a patient, it is important that a well-validated and robust methodology is chosen to avoid false negative or false positive determinations.Diarrhoea, including severe diarrhoea, has been reported during treatment with GIOTRIF (see section 4.8). (PDF/38.08 KB) (PDF/35.87 KB) (PDF/52.79 KB) (PDF/81.46 KB)

(PDF/664.49 KB) (PDF/101.41 KB) Diarrhoea may result in dehydration with or without renal impairment, which in rare cases has resulted in fatal outcomes. Bullous, blistering and exfoliative skin conditions have been reported including rare cases suggestive of Stevens-Johnson syndrome and toxic epidermal necrolysis. Treatment should continue for as long as possible, until the disease worsens or the side effects become too severe.The tablets should be taken without food and no food should be eaten for at least 3 hours before and 1 hour after taking the tablets.EGFR proteins are part of the ErbB family. (PDF/79.5 KB) Periodic liver function testing is recommended in patients with pre-existing liver disease. It belongs to the tyrosine kinase inhibitor family of medications.

No other liquids should be used. Curr oncol 2015;22(2):123-132. (PDF/79.34 KB) White to yellowish, round, biconvex and bevel-edged film-coated tablet debossed with the code “T20” on one side and the Boehringer Ingelheim company logo on the other.Dark blue, round, biconvex and bevel-edged film-coated tablet debossed with the code “T30” on one side and the Boehringer Ingelheim company logo on the other.Light blue, round, biconvex and bevel-edged film-coated tablet debossed with the code “T40” on one side and the Boehringer Ingelheim company logo on the other.Dark blue, oval, biconvex film-coated tablet debossed with the code “T50” on one side and the Boehringer Ingelheim company logo on the other.GIOTRIF as monotherapy is indicated for the treatment of

It belongs to the tyrosine kinase inhibitor family of medications. In most countries it is restricted to EGFR tyrosine kinase inhibitor (TKI)-naïve patients. (PDF/467.58 KB) Exposure to afatinib in subjects with renal impairment was compared to healthy volunteers following a single dose of 40 mg GIOTRIF. (PDF/49.52 KB) The individual effect sizes of these covariates were considered not clinically relevant. Patients who received at least 4 cycles of platinum-based therapy in the first line setting were subsequently randomized 1:1 to daily GIOTRIF 40 mg or erlotinib 150 mg until progression. (PDF/18.68 KB) Antidiarrhoeal medicinal products (e.g.

(PDF/591.17 KB) Keep the bottle tightly closed when not in use.Throw away any afatinib tablets not used before the Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 12 hours. (PDF/19.38 KB) It is taken by mouth.

This is consistent with population pharmacokinetic data derived from clinical trials in various tumour types (see “Population pharmacokinetic analysis in special populations” below). 4 Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. (PDF/30.76 KB) Afatinib works by stopping the growth of certain proteins found in certain types of lung cancer called “tyrosine kinases" and “epidermal growth factor receptor proteins" which cause cancer cells to grow.

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Afatinib blocks the proteins from sending signals to the cancer to grow. In patients with tumours harbouring de-novo T790M mutations (N=14) the confirmed ORR was 14.3% and the median duration of response was 8.3 months.GIOTRIF in patients with NSCLC of squamous histologyThe efficacy and safety of GIOTRIF as second-line treatment for patients with advanced NSCLC of squamous histology was investigated in a randomized open-label global Phase III trial LUX-Lung 8.

Excipient with known effect One film-coated tablet contains 118 mg lactose (as monohydrate). (PDF/17.89 KB)

Afatinib is a type of drug called a tyrosine kinase inhibitor (TKI), also known as a cancer growth inhibitor.

The median PFS was 12.0 months by independent review. Dose interruption may become necessary in patients who experience worsening of liver function (see section 4.2). (PDF/624.34 KB) (PDF/52.79 KB)

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If a dose is missed, it should be taken within the same day as soon as the patient remembers. 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.

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