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Dacomitinib Dosage

Medically reviewed by Drugs.com. Last updated on Jun 11, 2021.

Applies to the following strengths: 15 mg; 30 mg; 45 mg

Usual Adult Dose for Non-Small Cell Lung Cancer

45 mg orally once a day until disease progression or unacceptable toxicity

Use: For the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test

Renal Dose Adjustments

Mild (60 to less than 90 mL/min) and moderate (30 less than 60 mL/min) renal impairment: No adjustment recommended.
Severe renal impairment (CrCl less than 30 mL/min): Data not available

Liver Dose Adjustments

Mild (total bilirubin less than or equal to the upper limit of normal [ULN] with AST greater than ULN or total bilirubin greater than 1 to 1.5 x ULN with any AST) or moderate (total bilirubin greater than 1.5 to 3 x ULN and any AST) hepatic impairment: No adjustment recommended.
Severe (total bilirubin greater than 3 to 10 x ULN and any AST) hepatic impairment: Data not available

Dose Adjustments

DOSE REDUCTIONS FOR ADVERSE REACTIONS:

  • First dose reduction: 30 mg orally once a day
  • Second dose reduction: 15 mg orally once a day

DOSE MODIFICATIONS FOR ADVERSE REACTIONS:
INTERSTITIAL LUNG DISEASE (ILD):
  • Any Grade: Permanently discontinue therapy.
DIARRHEA:
  • Grade 2: Withhold therapy until recovery to Grade 1 or less; resume at same dose level. For recurrent Grade 2 diarrhea, withhold until recovery to Grade 1 or less; resume at reduced dose.
  • Grade 3 or 4: Withhold therapy until recovery to Grade 1 or less; resume at reduced dose.
DERMATOLOGIC ADVERSE REACTIONS:
  • Grade 2: Withhold therapy until recovery to Grade 1 or less; resume at same dose level. For recurrent persistent Grade 2 reactions, withhold until recovery to Grade 1 or less; resume at reduced dose.
  • Grade 3 or 4: Withhold therapy until recovery to Grade 1 or less; resume at reduced dose.
OTHER ADVERSE REACTIONS:
  • Grade 3 or 4: Withhold therapy until recovery to Grade 2 or less; resume at reduced dose.

DOSE MODIFICATIONS FOR ACID-REDUCING AGENTS:
  • Avoid concomitant use of proton pump inhibitors (PPIs) with this drug.
  • Use locally acting antacids or if using a histamine 2 (H2)-receptor antagonist, administer this drug at least 6 hours before or 10 hours after.

Precautions

CONTRAINDICATIONS:

  • None

This drug is not recommended for use in children.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

  • This drug may be taken with or without food.
  • Take this drug at the same time each day.
  • If the patient vomits or misses a dose, do not take an additional dose or make up a missed dose but continue with the next scheduled dose.

Storage requirements:
  • Store at 20C to 25C (68F to 77F); excursions permitted between 15C to 30C (59F to 86F).

General:
  • Concomitant use of proton pump inhibitors (PPIs) with this drug should be avoided.
  • Treatment with this drug should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.

Frequently asked questions

Further information

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