cker 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.
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LAB-1238-1.0
For more information, go to www.VIZIMPRO.com or call 1-800-438-1985.
http://labeling.pfizer.com/ShowLabeling.aspx?id=11019
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211288 |
