clothing and use of sunscreen at the time of initiation of VIZIMPRO. Advise patients to contact their healthcare provider immediately to report new or worsening rash, erythematous and exfoliative reactions [see Warning and Precautions (5.3)].
Drug Interactions
Advise patients to avoid use of PPIs while taking VIZIMPRO. Short-acting antacids or H2 receptor antagonists may be used if needed. Advise patients to take VIZIMPRO at least 6 hours before or 10 hours after taking an H2-receptor antagonist [see Drug Interactions (7.1)].
Embryo-Fetal Toxicity
Advise females of reproductive potential that VIZIMPRO can result in fetal harm and to use effective contraception during treatment with VIZIMPRO and for 17 days after the last dose of VIZIMPRO. Advise females of reproductive potential to contact their healthcare provider with a known or suspected pregnancy [see Use in Specific Populations (8.1 and 8.3)].
Lactation
Advise women not to breastfeed during treatment with VIZIMPRO and for 17 days after the last dose of VIZIMPRO [see Use in Specific Populations (8.2)].
This product's label may have been updated. For full prescribing information, please visit www.VIZIMPRO.com.
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LAB-1237-1.0
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 blo |
