RIBING INFORMATION
1 INDICATIONS AND USAGE
VIZIMPRO is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test [see Dosage and Administration (2.1)].
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.
Table 1. VIZIMPRO Recommended Dose Reductions for Adverse Reactions
Dose Level Dose (Once Daily)
First dose reduction 30 mg
Second dose reduction 15 mg
Table 2. VIZIMPRO Dosage Modifications for Adverse Reactions
Adverse Reaction Severity* Dosage Modification
*
National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03.
Interstitial lung disease (ILD) [see Warnings and Precautions (5.1)] Any Grade
Permanently discontinue VIZIMPRO.
Diarrhea [see Warnings and Precautions (5.2)] Grade 2
Withhold VIZIMPRO until recovery to less than or equal to Grade 1; then resume VIZIMPRO at the same dose level.
For recurrent Grade 2 diarrhea, withhold until recovery to less than or equal to Grade 1; then resume VIZIMPRO at a reduced dose.
Grade 3 or 4
Withhold VIZIMPRO until recovery to less than or equal to Grade 1; then resume VIZIMPRO at a reduced dose.
Dermatologic Adverse Reactions [see Warnings and Precautions (5.3)] Grade 2
Withhold VIZIMPRO for persistent dermatologic adverse reactions; upon recovery to less than or equal to Grade 1, resume VIZIMPRO at the same dose level.
For recurrent persistent Grade 2 dermatologic adverse reactions, withhold until recovery to less than or equal to Grade 1; then resume VIZIMPRO at a reduced dose.
Grade 3 or 4
Withhold VIZIMPRO until recovery to less than or equal to Grade 1; then resume VIZIMPRO at a reduced dose.
Other Grade 3 or 4
Withhold VIZIMPRO until recovery to less than or equal to Grade 2; then resume VIZIMPRO at a reduced dose.
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)].
3 DOSAGE FORMS AND STRENGTHS
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