Description

Proton Pump Inhibitors (PPIs): Avoid use with DACOMITINIB; use locally-acting antacids or H2-receptor antagonist; administer DACOMITINIB at least 6 hours before or 10 hours after H2-receptor antagonist CYP2D6 Substrates: Avoid concomitant use with DACOMITINIB where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities

Dacomitinib can cause fetal harm when administered to a pregnant woman. There is no information regarding the presence of dacomitinib or its metabolites in human milk or their effects on the breastfed infant or on milk production. Because of the potential for serious adverse reactions in breastfed infants from Dacomitinib, advise women not to breastfeed during treatment with Dacomitinib and for at least 17 days after the last dose.

Interstitial Lung Disease (ILD): Permanently discontinue Dacomitinib if ILD is confirmed Diarrhea: Withhold and reduce the dose of DACOMITINIB based on the severity Dermatologic Adverse Reactions: Withhold and reduce the dose of DACOMITINIB based on the severity Embryo-Fetal Toxicity: Dacomitinib can cause fetal harm. Advise females of reproductive potential to use effective contraception.

Pediatric Use: The safety and effectiveness of Dacomitinib in pediatrics have not been established. Renal Impairment: No dosage modification is recommended for patients with mild or moderate renal impairment (ClCr 30 to 89 mL/min estimated by Cockcroft-Gault). The recommended dose of Dacomitinib has not been established for patients with severe renal impairment (ClCr<30 mL/min)

Cytotoxic Chemotherapy

Do not store above 30⁰C. Keep away from light and out of the reach of children.