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Afatinib Dosage

Medically reviewed by Drugs.com. Last updated on Apr 25, 2023.

Applies to the following strengths: 30 mg; 40 mg; 20 mg

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Non-Small Cell Lung Cancer

40 mg orally once a day until disease progression or intolerance by the patient

Comments:

  • Take on an empty stomach at least 1 hour before or 2 hours after a meal.
  • Epidermal growth factor receptor (EGFR) mutation status should be established prior to therapy initiation.
  • Do not take a missed dose within 12 hours of the next dose.

Uses:
  • EGFR Mutation-Positive, Metastatic Non-Small Cell Lung Cancer: For the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an approved test.
  • Previously Treated, Metastatic Squamous NSCLC: For the treatment of patients with metastatic squamous NSCLC progressing after platinum-based chemotherapy.

Renal Dose Adjustments

  • Mild to moderate renal impairment (CrCl 30 mL/min or greater): No adjustment recommended.
  • Severe renal impairment (CrCl 15 to 29 mL/min): 30 mg orally once a day
  • End stage renal disease (CrCl less than 15 mL/min) or dialysis: Data not available

Liver Dose Adjustments

  • Mild (Child-Pugh A) to moderate (Child-Pugh B) hepatic impairment: No adjustment recommended.
  • Severe (Child-Pugh C) hepatic impairment: Closely monitor patient and adjust dose if not tolerated.

Dose Adjustments

Dose Modifications for Adverse Reactions:
WITHHOLD THERAPY FOR:

  • National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 3 or higher.
  • Diarrhea Grade 2 or higher persisting for 2 or more consecutive days while taking antidiarrheal medication.
  • Cutaneous reactions of Grade 2 that are prolonged (lasting more than 7 days) or intolerable.
  • Renal impairment Grade 2 or higher.
Resume therapy when the adverse reaction fully resolves, returns to baseline, or improves to Grade 1. Reinstitute therapy at a reduced dose (e.g., 10 mg per day less than the dose at which the adverse reaction occurred).
PERMANENTLY DISCONTINUE THERAPY FOR:
  • Life-threatening bullous, blistering, or exfoliative skin lesions
  • Confirmed interstitial lung disease (ILD)
  • Severe drug-induced hepatic impairment
  • Persistent ulcerative keratitis
  • Symptomatic left ventricular dysfunction
  • Severe or intolerable adverse reaction occurring at a dose of 20 mg per day

Dose Modifications for Drug Interactions:
  • P-gp Inhibitors: Reduce the daily dose by 10 mg if not tolerated for patients who require therapy with a P-glycoprotein (P-gp) inhibitor. Resume the previous dose after discontinuation of the P-gp inhibitor as tolerated.
  • P-gp Inducers: Increase the daily dose by 10 mg as tolerated for patients who require chronic therapy with a P-gp inducer. Resume the previous dose 2 to 3 days after discontinuation of the P-gp inducer.

Precautions

CONTRAINDICATIONS:

  • None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

  • Swallow tablets whole with water.
  • In case of swallowing difficulties, the tablets may be dispersed (not crushed) in approximately 100 mL of noncarbonated water. The dispersion may also be given via a gastric tube.
  • Take on an empty stomach.
  • Do not take a missed dose within 12 hours of the next dose.

Storage requirements:
  • Store in original container to protect from exposure to moisture and light.

General:
  • If P-glycoprotein (P-gp) inhibitors are required, they should be administered simultaneously with or after this drug.
  • A well-validated test is recommended when determining EGFR mutation status.
  • Limitation of use: The safety and efficacy of this drug have not been established in patients whose tumors have resistant EGFR mutations.

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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