Vizimpro
Generic name: dacomitinib
Drug classes: EGFR inhibitors, HER2 inhibitors
Medically reviewed by A Ras MD.
What is Vizimpro used for?
Vizimpro is a prescription medicine that is used to treat lung cancer.
Description
Dacomitinib is an oral kinase inhibitor with a molecular formula of C24H25ClFN5O2 ∙ H2O and a molecular weight of 487.95 Daltons. The chemical name is: (2E)-N-{4-[(3-Chloro-4-fluorophenyl)amino]-7-methoxyquinazolin-6-yl}-4-(piperidin-1-yl)but-2-enamide monohydrate and its structural formula is:
Dacomitinib is a white to pale yellow powder.
VIZIMPRO tablets contain 45, 30, or 15 mg of dacomitinib with the following inactive ingredients in the tablet core; lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate. The film coating consists of Opadry II® Blue 85F30716 containing: Polyvinyl alcohol – partially hydrolyzed, Talc, Titanium dioxide, Macrogol/PEG 3350, and FD&C Blue #2/Indigo Carmine Aluminum Lake.
Mechanism of Action
Dacomitinib is an irreversible inhibitor of the kinase activity of the human EGFR family (EGFR/HER1, HER2, and HER4) and certain EGFR activating mutations (exon 19 deletion or the exon 21 L858R substitution mutation). In vitro dacomitinib also inhibited the activity of DDR1, EPHA6, LCK, DDR2, and MNK1 at clinically relevant concentrations.
Dacomitinib demonstrated dose-dependent inhibition of EGFR and HER2 autophosphorylation and tumor growth in mice bearing subcutaneously implanted human tumor xenografts driven by HER family targets including mutated EGFR. Dacomitinib also exhibited antitumor activity in orally-dosed mice bearing intracranial human tumor xenografts driven by EGFR amplifications.
Before taking Vizimpro, tell your doctor:
- If you are allergic to Vizimpro; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
- If you are taking any of these drugs: Dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, or rabeprazole.
- If you are breast-feeding. Do not breast-feed while you take Vizimpro and for at least 17 days after your last dose.
This is not a list of all drugs or health problems that interact with this medicine.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Vizimpro with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take Vizimpro?
- Tell all of your health care providers that you take Vizimpro. This includes your doctors, nurses, pharmacists, and dentists.
- Diarrhea is common with Vizimpro. Diarrhea can lead to dehydration. Rarely, diarrhea has been deadly. If you have diarrhea, talk with your doctor right away about what to do. Do not try to treat diarrhea without first checking with your doctor.
- Skin reactions may happen with Vizimpro. The sun may increase how often these skin reactions happen or how bad they are. While you take Vizimpro, use sunscreen and wear clothing that protects you from the sun.
- To help with skin reactions, moisturize your skin as your doctor has told you.
- If you are 65 or older, use Vizimpro with care. You could have more side effects.
- This medicine may cause harm to an unborn baby. A pregnancy test will be done before you start Vizimpro to show that you are NOT pregnant.
- Women must use birth control while taking Vizimpro and for some time after the last dose. Ask your doctor how long to use birth control. If you get pregnant, call your doctor right away.
How is Vizimpro best taken?
Use Vizimpro as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- Take with or without food.
- Take Vizimpro at the same time of day.
- Keep taking Vizimpro as you have been told by your doctor or other health care provider, even if you feel well.
- If you throw up after taking a dose, do not repeat the dose. Take your next dose at your normal time.
- Do not take antacids at the same time as Vizimpro. Ask your doctor if you have a question about how to take antacids with Vizimpro.
- Do not take cimetidine, famotidine, nizatidine, or ranitidine at the same time as Vizimpro. Talk with your doctor.
What do I do if I miss a dose?
- Skip the missed dose and go back to your normal time.
- Do not take 2 doses at the same time or extra doses.
What are the side effects of Vizimpro that I need to call my doctor about immediately?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
- Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
- Any skin reaction.
- Redness or irritation of the palms of hands or soles of feet.
- Chest pain.
- Fever.
- Very bad and sometimes deadly lung problems have happened with Vizimpro. Call your doctor right away if you have lung or breathing problems that are new or worse like cough or shortness of breath.
What are some other side effects of Vizimpro?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Hair loss.
- Change in nails.
- Mouth irritation or mouth sores.
- Weight loss.
- Dry skin.
- Constipation.
- Signs of a common cold.
- Eye irritation.
- Pain in arms or legs.
- Muscle pain.
- Feeling tired or weak.
- Trouble sleeping.
- Change in taste.
- Diarrhea, throwing up, upset stomach, and feeling less hungry are common with Vizimpro. If these happen, talk with your doctor about ways to lower these side effects. Call your doctor right away if any of these effects bother you, do not get better, or get very bad.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
If overdose is suspected:
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How do I store and/or throw out Vizimpro?
- Store at room temperature in a dry place. Do not store in a bathroom.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
Label
PRINCIPAL DISPLAY PANEL – 15 MG TABLET BOTTLE LABEL
