Giotrif Dosage/Direction for Use

The recommended dose of Afatinib dimaleate (Giotrif): for patients with EGFR mutation positive NSCLC not previously treated with EGFR Tyrosine Kinase Inhibitor (EGFR TKI-naïve patients) is 40 mg orally once daily; for patients with EGFR mutation positive NSCLC previously treated with EGFR TKI is 50 mg orally once daily; for patients with squamous NSCLC who have previously received first-line platinum-containing regimen is 40 mg orally once daily.
Afatinib dimaleate (Giotrif) should be taken without food. Food should not be consumed for at least 3 hours before and at least 1 hour after taking Afatinib dimaleate (Giotrif) (see Interactions and Pharmacology: Pharmacokinetics under Actions). Tablets should be swallowed whole with water.
Afatinib dimaleate (Giotrif) treatment should be continued until disease progression or until no longer tolerated by the patient (see Table 8 as follows).
Alternative method of administration: If dosing of whole tablets is not possible, Afatinib dimaleate (Giotrif) tablets can be dispersed in approximately 100 mL of noncarbonated drinking water. No other liquids should be used. The tablet should be dropped into the water without crushing it, and stirred occasionally for up to 15 min until the tablet is broken up into very small particles. The dispersion should be consumed immediately. The glass should be rinsed with approximately 100 mL of water which should also be consumed. The dispersion can also be administered through a gastric tube.
Dosage: Dose escalation: A dose escalation to a maximum of 50 mg/day may be considered in patients who tolerate a 40 mg/day dose (i.e. absence of diarrhoea, skin rash, stomatitis, and other drug related events of CTCAE Grade >1) in the first cycle of treatment (for the definition of treatment cycle see Pharmacology under Actions).
The dose should not be escalated in patients with a prior dose reduction. Dose escalation in EGFR TKI pre-treated patients is not recommended.
The maximum daily dose in any setting is 50 mg.
Dose adjustment for adverse reactions: Symptomatic adverse drug reactions (e.g. severe/persistent diarrhoea or skin related adverse reactions) may be successfully managed by treatment interruption and dose reductions of Afatinib dimaleate (Giotrif) as outlined in Table 8 (see Adverse Reactions and for further details on management of specific drug related Adverse Events (AEs) see Precautions). (See Table 8.)

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Interstitial Lung Disease (ILD) should be considered if a patient develops acute or worsening of respiratory symptoms in which case Afatinib dimaleate (Giotrif) should be interrupted pending evaluation. If ILD is diagnosed, Afatinib dimaleate (Giotrif) should be discontinued and appropriate treatment instituted as necessary (see Precautions).
Missed dose: If a dose of Afatinib dimaleate (Giotrif) is missed, it should be taken during the same day as soon as the patient remembers. However, if the next scheduled dose is due within 8 hours then the missed dose must be skipped.
Special Populations: Patients with renal impairment: Exposure to afatinib was found to be increased in patients with moderate or severe renal impairment (see Pharmacology: Pharmacokinetics under Actions). Adjustments to the starting dose are not necessary in patients with mild, moderate or severe (eGFR 15-29 mL/min/1.73 m²) renal impairment. Monitor patients with severe renal impairment and adjust Afatinib dimaleate (Giotrif) dose if not tolerated. Afatinib dimaleate (Giotrif) treatment in patients with eGFR <15 mL/min/1.73 m² or on dialysis is not recommended.
Patients with hepatic impairment: Exposure to afatinib is not significantly changed in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment (see Pharmacology: Pharmacokinetics under Actions). Adjustments to the starting dose are not necessary in patients with mild or moderate hepatic impairment. Afatinib dimaleate (Giotrif) has not been studied in patients with severe (Child Pugh C) hepatic impairment. Afatinib dimaleate (Giotrif) treatment in this population is not recommended.
Age, Race, Gender: No dose adjustment is necessary based on patient age, race, or gender (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of Afatinib dimaleate (Giotrif) have not been established in paediatric patients. Treatment of children or adolescents with Afatinib dimaleate (Giotrif) was not supported by a clinical trial conducted in paediatric patients and is therefore not recommended (see Pharmacology: Pharmacodynamics: Clinical Trials under Actions).
Use of P-glycoprotein (P-gp) inhibitors: If P-gp inhibitors need to be taken, they should be administered simultaneously with or after Afatinib dimaleate (Giotrif) (see Precautions, Interactions and Pharmacology: Pharmacokinetics under Actions).