2 DOSAGE AND ADMINISTRATION
2.1 Patient Selection
Select patients for the first-line treatment of metastatic NSCLC with VIZIMPRO based on the presence of an EGFR exon 19 deletion or exon 21 L858R substitution mutation in tumor specimens. Information on FDA-approved tests for the detection of EGFR mutations in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics.
2.2 Recommended Dosage
The recommended dosage of VIZIMPRO is 45 mg taken orally once daily, until disease progression or unacceptable toxicity occurs. VIZIMPRO can be taken with or without food [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3)].
Take VIZIMPRO 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.
2.3 Dosage Modifications for Adverse Reactions
Reduce the dose of VIZIMPRO for adverse reactions as described in Table 1. Dosage modifications for specific adverse reactions are provided in Table 2.
|Dose Level||Dose (Once Daily)|
|First dose reduction||30 mg|
|Second dose reduction||15 mg|
|Adverse Reaction||Severity*||Dosage Modification|
|Interstitial lung disease (ILD) [see Warnings and Precautions (5.1)]||Any Grade||
|Diarrhea [see Warnings and Precautions (5.2)]||Grade 2||
|Grade 3 or 4||
|Dermatologic Adverse Reactions [see Warnings and Precautions (5.3)]||Grade 2||
|Grade 3 or 4||
|Other||Grade 3 or 4||
2.4 Dosage Modifications for Acid-Reducing Agents
Avoid the concomitant use of proton pump inhibitors (PPIs) while taking VIZIMPRO. As an alternative to PPIs, use locally-acting antacids or if using an histamine 2 (H2)-receptor antagonist, administer VIZIMPRO at least 6 hours before or 10 hours after taking an H2-receptor antagonist [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].