Dosage of Dacomitinib

1. Patient Selection

Select patients for the first-line treatment of metastatic NSCLC with Dacomitinib based on the presence of an EGFR exon 19 deletion or exon 21 L858R substitution mutation in tumor specimens.

2. Recommended Dosage

The recommended dosage of Dacomitinib is 45 mg taken orally once daily, until disease progression or unacceptable toxicity occurs. Dacomitinib can be taken with or without food. Take Dacomitinib 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.

3. Dosage Modifications for Adverse Reactions

Reduce the dose of Dacomitinib for adverse reactions as described in Table 1. Dosage modifications for specific adverse reactions are provided in Table 2.

4. Dosage Modifications for Acid-Reducing Agents

Avoid the concomitant use of proton pump inhibitors (PPIs) while taking Dacomitinib. As an alternative to PPIs, use locally-acting antacids or if using an histamine 2 (H2)-receptor antagonist, administer Dacomitinib at least 6 hours before or 10 hours after taking an H2-receptor antagonist.

from FDA，2020.12