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Recommended Starting Dose: 40 mg orally once daily.
Dose Adjustment for Adverse Reactions: Symptomatic adverse drug reactions (e.g. severe/ persistent diarrhea or skin related adverse reactions) may be successfully managed by treatment interruption and dose reductions of GIOTRIF as outlined in Table 2.
Click on icon to see table/diagram/imageUse of P-glycoprotein (P-gp) Inhibitors: Concurrent use of strong P-gp inhibitors or inducers with GIOTRIF should be avoided. If P-gp inhibitors need to be taken, they should be administered simultaneously with or after GIOTRIF.
Patients should be closely monitored for GIOTRIF-related toxicities that may warrant GIOTRIF dose adjustment.
For patients with emesis, a replacement dose of GIOTRIF is NOT to be taken to make up any potential loss. Take the next dose as scheduled.
Interstitial Lung Disease (ILD): See Respiratory, Interstitial Lung Disease under Precautions.
Missed Dose: If a dose of 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.
Children: Treatment of children or adolescents with GIOTRIF is not recommended.
Renal Impairment: Renal impairment increases exposure to afatinib. No starting dose adjustment is recommended, although patients with moderate renal impairment may be at greater risk of drug-associated toxicities. Close monitoring is recommended in this patient population.
GIOTRIF treatment in patients with severely impaired renal function (<30 ml/min creatinine clearance) is not recommended.
Hepatic Impairment: Adjustment to the starting dose is not recommended in patients with mild or moderate hepatic impairment. GIOTRIF treatment is not recommended in patients with severe (Child-Pugh C) hepatic impairment.
Administration: Take GIOTRIF on an empty stomach at least 1 hour before or 3 hours after eating. Tablets should be swallowed whole with water.
