Dacomitinib/Dacomitinib detailed instructions

1. Indications and Usage

Dacomitinib is a kinase inhibitor indicated for epidermal growth factor receptor (EGFR) with a U.S. Food and Drug Administration (FDA)-approved test.19exon deletion or 21exonL858R substitution mutation.

2. Dosage and usage

Recommended dosage: One dose per time45mg, taken with or without food.

Three. Dosage form and strength

Tablets: 15mg, 30mg and 45mg.

Four. Contraindications

No.

Five. Warnings and Precautions

▪Interstitial lung disease (ILD):If ILD is diagnosed, permanently discontinue dacomitinib.

▪Diarrhea:Withhold or reduce dacomitinib dose based on severity.

▪Skin Adverse Reactions:Withhold or reduce the dosage of dacomitinib based on severity.

▪Embryo-Fetal Toxicity:Dacomitinib may cause fetal harm. Women of childbearing potential are advised to use effective contraception.

6. Adverse reactions

The most common adverse reactions (incidence>20%) are diarrhea, rash, paronychia, stomatitis, decreased appetite, dry skin, weight loss, hair loss, cough and itching.

7. Drug interactions

▪Proton pump inhibitors (PPIs):Avoid use with dacomitinib; use local-acting antacids or H2receptor antagonist;H2take dacomitinib at least6 hours before taking it or at least 10 hours after taking it.

▪CYP2D6Substrates:Avoid concurrent use withdacomitinib as minimal increases in CYP2D6substrate concentrations may result in serious or life-threatening toxicity.

8. Use among specific groups of people

▪Lactation:It is not recommended to breastfeed.

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