VIZIMPRO

The maximum dacomitinib plasma concentration (C max ) and AUC at steady state increased proportionally over the dose range of VIZIMPRO 2 mg to 60 mg orally once daily (0.04 to 1.3 times the recommended dose) across dacomitinib studies in patients with cancer. At a dose of 45 mg orally once daily, the geometric mean [coefficient of variation (CV%)] C max was 108 ng/mL (35%) and the AUC 0–24h was 2213 ng∙h/mL (35%) at steady state in a dose-finding clinical study conducted in patients with solid t...

The efficacy of VIZIMPRO was demonstrated in a randomized, multicenter, multinational, open-label study (ARCHER 1050; [NCT01774721]). Patients were required to have unresectable, metastatic NSCLC with no prior therapy for metastatic disease or recurrent disease with a minimum of 12 months disease-free after completion of systemic therapy; an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; EGFR exon 19 deletion or exon 21 L858R substitution mutations. EGFR mutation status was prospectively determined by local laboratory or commercially available tests (e.g., therascreen ...

The following adverse drug reactions are described elsewhere in the labeling:

• Interstitial Lung Disease [see Warnings and Precautions (5.1) ]
• Diarrhea [see Warnings and Precautions (5.2) ]
• Dermatologic Adverse Reactions [see Warnings and Precautions (5.3) ] Most common adverse reactions (incidence >20%) are diarrhea, rash, paronychia, stomatitis, decreased appetite, dry skin, decreased weight, alopecia, cough, and pruritus. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc....

None. None. ( 4 )

• Interstitial Lung Disease (ILD): Permanently discontinue VIZIMPRO if ILD is confirmed. ( 5.1 )
• Diarrhea: Withhold and reduce the dose of VIZIMPRO based on the severity. ( 2.3 , 5.2 )
• Dermatologic Adverse Reactions: Withhold and reduce the dose of VIZIMPRO based on the severity. ( 2.3 , 5.3 )
• Embryo-Fetal Toxicity: VIZIMPRO can cause fetal harm. Advise females of reproductive potential to use effective contraception. ( 5.4 , 8.1 , 8.3 ) 5.1 Interstitial Lung Disease (ILD) Severe and fatal...

7 DRUG INTERACTIONS

• Proton Pump Inhibitors (PPIs): Avoid use with VIZIMPRO; use locally-acting antacids or H2-receptor antagonist; administer VIZIMPRO at least 6 hours before or 10 hours after H2-receptor antagonist. ( 2.4 , 7.1 )
• CYP2D6 Substrates: Avoid concomitant use with VIZIMPRO where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxic...