Generic drug: dacomitinib
Brand name: Vizimpro
What is Vizimpro (dacomitinib), and how does it work?
Vizimpro (dacomitinib) 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.
What are the 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.
- 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:
- mouth pain and sores
- nail inflammation
- common cold
- dry skin
- decreased appetite
- decreased weight
- dry, red, itchy eyes
- hair loss
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Vizimpro?
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.
- 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 the Dosage Modifications For Acid-Reducing Agents section below].
- 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.
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||Severitya||Dosage Modification|
|Interstitial lung disease (ILD)||Any Grade||
|Grade 3 or 4||
|Dermatologic Adverse Reactions||Grade 2||
|Grade 3 or 4||
|Other||Grade 3 or 4||
|a National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03.|
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.
What drugs interact with Vizimpro?
Effect Of Other Drugs On Vizimpro
- Concomitant use with a PPI decreases dacomitinib concentrations, which may reduce Vizimpro efficacy.
- Avoid the concomitant use of PPIs with Vizimpro. As an alternative to PPIs, use locally-acting antacids or an H2-receptor antagonist.
- Administer Vizimpro at least 6 hours before or 10 hours after taking an H2-receptor antagonist.
Effect Of Vizimpro On CYP2D6 Substrates
- Concomitant use of Vizimpro increases the concentration of drugs that are CYP2D6 substrates which may increase the risk of toxicities of these drugs.
- Avoid concomitant use of Vizimpro with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.
Is Vizimpro safe to use while pregnant or breastfeeding?
- Based on findings from animal studies and its mechanism of action, Vizimpro can cause fetal harm when administered to a pregnant woman.
- There are no available data on Vizimpro use in pregnant women. There is no information regarding the presence of dacomitinib or its metabolites in human milk or their effects on the breastfed infant or on milk production.
- Because of the potential for serious adverse reactions in breastfed infants from Vizimpro, advise women not to breastfeed during treatment with Vizimpro and for at least 17 days after the last dose.
Latest Cancer News
Daily Health News
Multimedia: Slideshows, Images & Quizzes
Lung Cancer: Early Signs, Symptoms, Stages
Learn about lung cancer early warning signs, symptoms and treatments. What causes stage IV lung cancer? Get more information on...
Lung Cancer Risks: Myths and Facts
Learn about lung cancer myths and facts. Explore how cigar smoke, menthol, and pollution can increase your risk of lung cancer...
Lung Cancer Quiz: Signs and Symptoms
Lung cancer is the number one cause of cancer deaths in both men and women in the U.S. and worldwide. Get the facts about lung...
Picture of Lung Cancer
Cancer of the lung, like all cancers, results from an abnormality in the body's basic unit of life, the cell. See a picture of...
Related Disease Conditions
Lung cancer kills more men and women than any other form of cancer. Eight out of 10 lung cancers are due to tobacco smoke. Lung cancers are classified as either small-cell or non-small-cell lung cancers.
Small Cell Lung Cancer vs. Non-Small Cell Lung Cancer
Non-small cell lung cancers (NSCLC) consist of large cell carcinomas, adenocarcinomas, and squamous cell carcinomas. Small cell lung cancer (SCLC) usually starts in the bronchi and typically appears in those who smoke. SCLC and NSCLC are staged in different manners, and SCLC tends to metastasize more quickly than NSCLC. Signs and symptoms of NSCLC and SCLC include shortness of breath, coughing up blood, recurring lung infections, and chest pain. Treatment may involve radiation therapy, chemotherapy, and surgery.
What Are the Four Types of Lung Cancer?
The four types of lung cancer are classified by what kind of cells the cancer affects and what the tumor cells look like under a microscope. Lung cancers can be small-cell or non-small cell, further classified as squamous cell carcinoma or adenocarcinoma.
Can Pancoast Lung Cancer Be Cured?
Pancoast tumors are a rare type of lung cancer that forms at the extreme top of either of the lungs. Due to their location at the top of the lung, there’s a high chance that cancer might attack the adjacent tissue and produce typical symptoms.
What Should I Do After an Unwanted Pregnancy?
There are a variety of options that may help you handle your situation. It might help you to visualize each option and decide how you feel about it. Consider reaching out to trained professionals or close friends if you get overwhelmed.
What Is the Survival Rate of Non-Small Cell Lung Cancer?
There are two main types of lung cancers, namely, small cell lung cancer and non-small cell lung cancer (NSCLC). NSCLC accounts for 85% of all lung cancer cases in the United States. It must be noted that medical science is progressing with leaps and bounds, and treatment for lung cancer must be initiated and maintained despite the stage of diagnosis.
Six Early Signs of Lung Cancer
Lung cancer is the third most common cancer in the United States. It may not show its signs and symptoms in its early stages. Signs and symptoms typically appear in the advanced stage of the disease.
Treatment & Diagnosis
- Lung Cancer FAQs
- Sensitive to Smoke, Lung Cancer Gene
- Lung Cancer and Chemotherapy
- Lung Cancer Signs and Symptoms
- 5 Causes of Lung Cancer in Non-Smokers
- Dana Reeve Dies of Lung Cancer by Dr. Stoppler
- What Is the Survival Rate for Lung Cancer Nodules?
- Why Does Lung Cancer Spread So Fast?
- Can You Get Lung Cancer After Quitting Smoking?
- Stage IV Lung Cancer With ALK (Anaplastic Lymphoma Kinase) Rearrangement
- Lung Cancer - Health Beat Audio Segment
Medications & Supplements
Prevention & Wellness
Health Solutions From Our Sponsors
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.