VIZIMPRO® (dacomitinib) 2 DOSAGE AND ADMINISTRATION

(dacomitinib)

Prescribing Information

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.
Diarrhea [see Warnings and Precautions (5.2)]	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)].

Medication Guide

MEDICATION GUIDE

This Patient Information has been approved by the U.S. Food and Drug Administration.		Issued: September 2018
PATIENT INFORMATION VIZIMPRO® (vih-ZIM-pro) (dacomitinib) tablets
What is VIZIMPRO? VIZIMPRO is a prescription medicine used to treat non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic): As your first treatment if your tumor has certain types of abnormal epidermal growth factor receptor (EGFR) gene(s). Your healthcare provider will perform a test to make sure that VIZIMPRO is right for you. It is not known if VIZIMPRO is safe and effective in children.
Before taking VIZIMPRO, tell your healthcare provider about all your medical conditions, including if you: have frequent diarrhea. have a history of lung or breathing problems other than lung cancer. are pregnant, or plan to become pregnant. VIZIMPRO can harm your unborn baby. Females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start treatment with VIZIMPRO. You should use effective birth control (contraception) during treatment and for at least 17 days after your last dose of VIZIMPRO. Talk to your healthcare provider about birth control methods that may be right for you during this time. Tell your healthcare provider right away if you become pregnant during your treatment with VIZIMPRO. are breastfeeding or plan to breastfeed. It is not known if VIZIMPRO passes into your breast milk. Do not breastfeed during treatment and for at least 17 days after your last dose of VIZIMPRO. Talk to your healthcare provider about the best way to feed your baby during this time. Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. VIZIMPRO and other medicines or supplements may affect each other causing side effects.
How should I take VIZIMPRO? Take VIZIMPRO exactly as your healthcare provider tells you. Take your dose at approximately the same time each day. Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with VIZIMPRO if you have side effects. Take VIZIMPRO 1 time each day with or without food. If you take an antacid or H2 blocker medicine during treatment with VIZIMPRO, take your dose of VIZIMPRO at least 6 hours before or 10 hours after taking the antacid or H2 blocker medicine. Do not change your dose or stop taking VIZIMPRO unless your healthcare provider tells you. If you vomit or miss a dose of VIZIMPRO, do not take another dose or make up for the missed dose. Take your next dose at your regular time.
What should I avoid during treatment with VIZIMPRO? Minimize exposure to sunlight. VIZIMPRO can cause skin reactions. See "What are the possible side effects of VIZIMPRO?"
What are the possible side effects of VIZIMPRO? VIZIMPRO may cause serious side effects, including: Lung or breathing problems. VIZIMPRO may cause severe inflammation of the lung that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away if you have any new or worsening lung symptoms, including trouble breathing or shortness of breath, cough, or fever. Diarrhea. Diarrhea is common during treatment with VIZIMPRO, and can be severe and lead to death. Diarrhea can cause you to lose too much body fluid (dehydration). Your healthcare provider may tell you to start drinking more fluids or start taking your anti-diarrheal medicines. Tell your healthcare provider right away, if you have any loose stools or have stools more often than is normal for you. Skin reactions. Skin reactions are common with VIZIMPRO and can be severe. These skin reactions may include: dry skin, redness, rash, acne, itching, and peeling or blistering of your skin. Use moisturizers every day when taking VIZIMPRO. Use sunscreen and wear protective clothing that covers your skin, while exposed to sunlight, while you are taking VIZIMPRO. Your healthcare provider may prescribe other medicines to help skin reactions. Tell your healthcare provider right away about any worsening skin reactions. The most common side effects of VIZIMPRO include:
rash diarrhea mouth pain and sores nail inflammation common cold	dry skin decreased appetite decreased weight dry, red, itchy eyes hair loss itching
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store VIZIMPRO? Store VIZIMPRO at 20 °C to 25 °C (68 °F to 77 °F). Keep VIZIMPRO and all medicines out of the reach of children.
General information about the safe and effective use of VIZIMPRO. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use VIZIMPRO for a condition for which it was not prescribed. Do not give VIZIMPRO to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for more information about VIZIMPRO that is written for health professionals.
What are the ingredients in VIZIMPRO? Active ingredient: dacomitinib Inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate. Film coating contains: Opadry II® Blue 85F30716 containing: Polyvinyl alcohol – partially hydrolyzed, Talc, Titanium dioxide, Macrogol/PEG 3350, and FD&C Blue #2/Indigo Carmine Aluminum Lake. LAB-1238-1.0 For more information, go to www.VIZIMPRO.com or call 1-800-438-1985.

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